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VOLTAREN 50MG DISPERSIBLE TABLETS

Active substance(s): DICLOFENAC / DICLOFENAC FREE ACID

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Ref: 0173/250815/1/F

®

Voltarol 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet
What you need to know about Voltarol Dispersible Tablets
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to take your medicine.
It contains important information.
* Keep the leaflet in a safe place because you may want to read it again.
* If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Never give it to someone else.
It may not be the right medicine for them even if their symptoms seem to
be the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Voltarol 50mg Dispersible Tablets but will be referred
to as Voltarol Dispersible Tablets throughout this leaflet.
In this leaflet:
1 What Voltarol Dispersible Tablets are, and what they are used for
2 Things to consider before you start to take Voltarol Dispersible Tablets
3 How to take Voltarol Dispersible Tablets
4 Possible side effects
5 How to store Voltarol Dispersible Tablets
6 Further information

1

What Voltarol Dispersible Tablets are, and what they
are used for

Diclofenac sodium, the active ingredient in Voltarol Dispersible Tablets, is
one of a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs reduce pain and inflammation.
Voltarol Dispersible Tablets act quickly and so are used to treat short term
painful conditions affecting the joints and muscles. They are especially useful for the treatment of sprains, strains and back pain. They should not be
taken for more than three months.

Are you taking other medicines?
Some medicines can interfere with your treatment.
Tell your doctor or pharmacist if you are taking any of the following:
* Medicines to treat diabetes
* Anticoagulants (blood thinning tablets like warfarin)
* Diuretics (water tablets)
* Lithium (used to treat some mental problems)
* Methotrexate (for some inflammatory diseases and some cancers)
* Ciclosporin and tacrolimus (used to treat some inflammatory diseases and
after transplants)
* Trimethoprim (a medicine used to prevent or treat urinary tract infections)
* Quinolone antibiotics (for infections)
* Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example
aspirin or ibuprofen
* Mifepristone (a medicine used to terminate pregnancy)
* Cardiac glycosides (for example digoxin), used to treat heart problems
* Medicines known as SSRIs used to treat depression
* Oral steroids (an anti-inflammatory drug)
* Medicines used to treat heart conditions or high blood pressure, for
example beta- blockers or ACE inhibitors.
* Voriconazole (a medicine used to treat fungal infections).
* Phenytoin (a medicine used to treat seizures)
* Colestipol/cholestyramine (used to lower cholesterol)
Always tell your doctor or pharmacist about all the medicines you are taking.
This means medicines you have bought yourself as well as medicines on
prescription from your doctor.
Pregnancy
* Are you pregnant or planning to become pregnant? Although not common,
abnormalities have been reported in babies whose mothers have taken
NSAIDs during pregnancy. You should not take Voltarol Dispersible Tablets
during the last 3 months of pregnancy as it may affect the baby’s
circulation.
* Are you trying for a baby? Taking Voltarol Dispersible Tablets may make it
more difficult to conceive. You should talk to your doctor if you are
planning to become pregnant, or if you have problems getting pregnant.
Will there be any problems with driving or using machinery?
Very occasionally people have reported that Voltarol Dispersible Tablets
have made them feel dizzy, tired or sleepy. Problems with eyesight have
also been reported. If you are affected in this way, you should not drive or
operate machinery.
Other special warnings

* You should take the lowest dose of Voltarol Dispersible Tablets for the
2

Things to consider before you start to take Voltarol
Dispersible Tablets

Some people MUST NOT take Voltarol Dispersible Tablets. Talk to your
doctor if:
* you think you may be allergic to diclofenac sodium, aspirin, ibuprofen or
any other NSAID, or to any of the other ingredients of Voltarol Dispersible
Tablets. (These are listed at the end of the leaflet.) Signs of a
hypersensitivity reaction include swelling of the face and mouth
angioedema), breathing problems, runny nose, skin rash or any other
allergic type reaction
* you have now, or have ever had, a stomach (gastric) or duodenal (peptic)
ulcer, or bleeding in the digestive tract (this can include blood in vomit,
bleeding when emptying bowels, fresh blood in faeces or black, tarry
faeces)
* you have had stomach or bowel problems after you have taken other
NSAIDs
* you have severe heart, kidney or liver failure
* if you have established heart disease and/or cerebrovascular disease e.g.
if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to
blood vessels to the heart or brain or an operation to clear or bypass
blockages
* if you have or have had problems with your blood circulation (peripheral
arterial disease)
* you are more than six months pregnant.
You should also ask yourself these questions before taking Voltarol
Dispersible Tablets:
* Do you suffer from any stomach or bowel disorders including ulcerative
colitis or Crohn’s disease?
* Do you have kidney or liver problems, or are you elderly?
* Do you have a condition called porphyria?
* Do you suffer from any blood or bleeding disorder? If you do, your doctor
may ask you to go for regular check-ups while you are taking these
tablets.
* Have you ever had asthma?
* Are you breast-feeding?
* Do you have angina, blood clots, high blood pressure, raised cholesterol
or
raised triglycerides
Do
you have heart problems, or have you had a stroke, or do you think
*
you might be at risk of these conditions (for example, if you have high
blood pressure, diabetes, or high cholesterol or are you a smoker)?
* Do you have diabetes
* Do you smoke
* Do you have Lupus (SLE) or any similar condition?
If the answer to any of these questions is YES, discuss your treatment
with your doctor or pharmacist because Voltarol Dispersible Tablets

shortest possible time, particularly if you are underweight or elderly.

* There is a small increased risk of heart attack or stroke when you are

*
*
*

*

taking any medicine like Voltarol. The risk is higher if you are taking high
doses for a long time. Always follow the doctor’s instructions on how much
to take and how long to take it for.
Whilst you are taking these medicines your doctor may want to give you a
check-up from time to time.
If you have a history of stomach problems when you are taking NSAIDs,
particularly if you are elderly, you must tell your doctor straight away if you
notice any unusual symptoms.
Because it is an anti-inflammatory medicine, Voltarol Dispersible Tablets
may reduce the symptoms of infection, for example headache, and high
temperature. If you feel unwell and need to see a doctor, remember to tell
him or her that you are taking Voltarol Dispersible Tablets.
Voltarol Dispersible Tablets are not suitable for children.

The tablets contain erythrosine and may be unsuitable for some people.

3

How to take Voltarol Dispersible Tablets

The doctor will tell you how many Voltarol Dispersible Tablets to take and
when to take them. Always follow his/her instructions carefully. The dose will
be on the pharmacist’s label. Check the label carefully. If you are not sure,
ask your doctor or pharmacist. Keep taking your tablets for as long as you
have been told, unless you have any problems. In that case, check with
your doctor.
Take the tablets before or with food.
Drop the tablets into a glass of water, and stir. Drink the liquid at once. To
make sure you get all of the medicine, rinse the glass round with a small
amount of water and drink this as well.
The usual doses are:
Adults
One tablet two or three times a day.
Elderly
Your doctor may advise you to take a dose that is lower than the usual adult
dose if you are elderly. Your doctor may also want to check closely that the
Voltarol Dispersible Tablets are not affecting your stomach.
These tablets are not suitable for children.

Ref: 0173/250815/1/B

®

Voltarol 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet (continued)
The doctor may also prescribe another drug to protect the stomach to be
taken at the same time, particularly if you have had stomach problems
before, or if you are elderly, or taking certain other drugs as well.
What if you forget to take a dose?
If you forget to take a dose, take one as soon as you remember. If it is
nearly time for your next dose, though, just take the next dose and forget
about the one you missed. Do not double up on the next dose to make up
for the one missed. Do not take more than 150 mg (three tablets) in 24
hours.
What if you take too many tablets?
If you, or anyone else, accidentally takes too much, tell your doctor or your
nearest hospital casualty department. Take your medicine pack with you so
that people can see what you have taken.

4

Possible side effects

Voltarol Dispersible Tablets are suitable for most people, but, like all
medicines, they can sometimes cause side effects. Side effects may be
minimised by using the lowest effective dose for the shortest duration
necessary.
Some side effects can be serious
Stop taking Voltarol Dispersible Tablets and tell your doctor straight
away if you notice:
* Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or
vomiting (being sick)
* Any sign of bleeding in the stomach or intestine, for example, when
emptying your bowels, blood in vomit or black, tarry faeces
* Allergic reactions which can include skin rash, itching, bruising, painful red
areas, peeling or blistering
* Wheezing or shortness of breath (bronchospasm)
* Swollen face, lips, hands or fingers
* Yellowing of your skin or the whites of your eyes
* Persistent sore throat or high temperature
* An unexpected change in the amount of urine produced and/or its
appearance.

Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure, presence of blood or
protein in the urine.
Effects on skin or hair:
Serious skin rashes including Stevens-Johnson syndrome and Lyell’s
syndrome and other skin rashes which may be made worse by exposure to
sunlight.
Hair loss.
Other side effects that have also been reported include:
Inflammation of the pancreas, impotence. Facial swelling, inflammation of
the lining of the brain (meningitis), stroke, throat disorders, confusion,
hallucinations, malaise (general feeling of discomfort), inflammation of the
nerves in the eye.
Do not be alarmed by this list - most people take Voltarol Dispersible
Tablets without any problems.
If any of the symptoms become troublesome, or if you notice anything
else not mentioned here, please go and see your doctor. He/she may
want to give you a different medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* This product contains no flavour.
* Do not store above 25°C.
* Protect from heat and moisture
* Do not use this medicine after the expiry date shown on the carton or

If you notice that you are bruising more easily than usual or have frequent
sore throats or infections, tell your doctor.
The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 10 in every 100
patients):
* Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind,
loss of appetite
* Headache, dizziness, vertigo
* Skin rash or spots
* Raised levels of liver enzymes in the blood
Rare side effects (These may affect between 1 in every 1000 to 1 in every
10,000 patients):
* Stomach ulcers or bleeding (there have been very rare reported cases
resulting in death, particularly in the elderly)
* Gastritis (inflammation, irritation or swelling of the stomach lining)
* Vomiting blood
* Diarrhoea with blood in it or bleeding from the back passage
* Black, tarry faeces or stools
* Drowsiness, tiredness
* Hypotension (low blood pressure, symptoms of which may include
faintness, giddiness or light headedness)
* Skin rash and itching
* Fluid retention, symptoms of which include swollen ankles
* Liver function disorders, including hepatitis and jaundice
Very Rare side effects (These may affect less than 1 in every 10,000
patients):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual disturbances such as
blurred or double vision, hearing loss or impairment, tinnitus (ringing in the
ears), sleeplessness, nightmares, mood changes, depression, anxiety,
mental disorders, disorientation, and loss of memory, fits, headaches
together with a dislike of bright lights, fever and a stiff neck, disturbances in
sensation.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation of the
inside of the mouth or lips, taste changes, lower gut disorders (including
inflammation of the colon, or worsening of ulcerative colitis or Crohn’s
disease).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain, hypertension (high
blood pressure), inflammation of blood vessels (vasculitis), inflammation of
the lung (pneumonitis), heart disorders, including congestive heart failure or
heart attack, blood disorders (including anaemia), stroke.

How to store Voltarol Dispersible Tablets

*

blister strip. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult your pharmacist who will
tell you what to do.
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about any
thing, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Further information

What this medicine contains:
Each tablet contains 46.5mg of diclofenac free acid, which is equivalent to
50mg of diclofenac sodium as the active ingredient.
Voltarol 50mg Dispersible Tablets also has the following inactive ingredients:
cellulose microcrystalline, sodium starch glycollate, croscarmellose sodium,
silica aerogel, hydrogenated castor oil and talc.
What this medicine looks like and contents of the pack
Voltarol 50mg Dispersible Tablets are white triangular shaped, uncoated,
impressed CG on one side and embossed “V” on the other side.
Voltarol 50mg Dispersible Tablets come in packs of 20 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Novartis Pharma AG, Stein, Switzerland
and are procured from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0173

Voltarol 50mg Dispersible Tablets

Voltarol is a registered trademark of Novartis AG
Revision date: 25/08/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0173/250815/2/F

®

Voltarol 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet
What you need to know about Voltarol Dispersible Tablets
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to take your medicine.
It contains important information.
* Keep the leaflet in a safe place because you may want to read it again.
* If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Never give it to someone else.
It may not be the right medicine for them even if their symptoms seem to
be the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Voltarol 50mg Dispersible Tablets but will be referred
to as Voltarol Dispersible Tablets throughout this leaflet.
In this leaflet:
1 What Voltarol Dispersible Tablets are, and what they are used for
2 Things to consider before you start to take Voltarol Dispersible Tablets
3 How to take Voltarol Dispersible Tablets
4 Possible side effects
5 How to store Voltarol Dispersible Tablets
6 Further information

1

What Voltarol Dispersible Tablets are, and what they
are used for

Diclofenac sodium, the active ingredient in Voltarol Dispersible Tablets, is
one of a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs reduce pain and inflammation.
Voltarol Dispersible Tablets act quickly and so are used to treat short term
painful conditions affecting the joints and muscles. They are especially useful for the treatment of sprains, strains and back pain. They should not be
taken for more than three months.

Are you taking other medicines?
Some medicines can interfere with your treatment. Tell your doctor or
pharmacist if you are taking any of the following:
* Medicines to treat diabetes
* Anticoagulants (blood thinning tablets like warfarin)
* Diuretics (water tablets)
* Lithium (used to treat some mental problems)
* Methotrexate (for some inflammatory diseases and some cancers)
* Ciclosporin and tacrolimus (used to treat some inflammatory diseases and
after transplants)
* Trimethoprim (a medicine used to prevent or treat urinary tract infections)
* Quinolone antibiotics (for infections)
* Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example
aspirin or ibuprofen
* Mifepristone (a medicine used to terminate pregnancy)
* Cardiac glycosides (for example digoxin), used to treat heart problems
* Medicines known as SSRIs used to treat depression
* Oral steroids (an anti-inflammatory drug)
* Medicines used to treat heart conditions or high blood pressure, for
example beta- blockers or ACE inhibitors.
* Voriconazole (a medicine used to treat fungal infections).
* Phenytoin (a medicine used to treat seizures)
* Colestipol/cholestyramine (used to lower cholesterol)
Always tell your doctor or pharmacist about all the medicines you are taking.
This means medicines you have bought yourself as well as medicines on
prescription from your doctor.
Pregnancy
* Are you pregnant or planning to become pregnant? Although not common,
abnormalities have been reported in babies whose mothers have taken
NSAIDs during pregnancy. You should not take Voltarol Dispersible Tablets
during the last 3 months of pregnancy as it may affect the baby’s
circulation.
* Are you trying for a baby? Taking Voltarol Dispersible Tablets may make it
more difficult to conceive. You should talk to your doctor if you are
planning to become pregnant, or if you have problems getting pregnant.
Will there be any problems with driving or using machinery?
Very occasionally people have reported that Voltarol Dispersible Tablets
have made them feel dizzy, tired or sleepy. Problems with eyesight have
also been reported. If you are affected in this way, you should not drive or
operate machinery.
Other special warnings

2

Things to consider before you start to take Voltarol
Dispersible Tablets

Some people MUST NOT take Voltarol Dispersible Tablets. Talk to your
doctor if:
* you think you may be allergic to diclofenac sodium, aspirin, ibuprofen or
any other NSAID, or to any of the other ingredients of Voltarol Dispersible
Tablets. (These are listed at the end of the leaflet.) Signs of a
hypersensitivity reaction include swelling of the face and mouth
(angioedema), breathing problems, runny nose, skin rash or any other
allergic type reaction
* you have now, or have ever had, a stomach (gastric) or duodenal (peptic)
ulcer, or bleeding in the digestive tract (this can include blood in vomit,
bleeding when emptying bowels, fresh blood in faeces or black, tarry
faeces)
* you have had stomach or bowel problems after you have taken other
NSAIDs
* you have severe heart, kidney or liver failure
* if you have established heart disease and/or cerebrovascular disease e.g.
if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to
blood vessels to the heart or brain or an operation to clear or bypass
blockages
* if you have or have had problems with your blood circulation (peripheral
arterial disease)
* you are more than six months pregnant.
You should also ask yourself these questions before taking Voltarol
Dispersible Tablets:
* Do you suffer from any stomach or bowel disorders including ulcerative
colitis or Crohn’s disease?
* Do you have kidney or liver problems, or are you elderly?
* Do you have a condition called porphyria?
* Do you suffer from any blood or bleeding disorder? If you do, your doctor
may ask you to go for regular check-ups while you are taking these
tablets.
* Have you ever had asthma?
* Are you breast-feeding?
* Do you have angina, blood clots, high blood pressure, raised cholesterol
or raised triglycerides
* Do you have heart problems, or have you had a stroke, or do you think
you might be at risk of these conditions (for example, if you have high
blood pressure, diabetes, or high cholesterol or are you a smoker)?
* Do you have diabetes
* Do you smoke
* Do you have Lupus (SLE) or any similar condition?
If the answer to any of these questions is YES, discuss your treatment
with your doctor or pharmacist because Voltarol Dispersible Tablets
might not be the right medicine for you.

* You should take the lowest dose of Voltarol Dispersible Tablets for the
shortest possible time, particularly if you are underweight or elderly.

* There is a small increased risk of heart attack or stroke when you are

*
*
*

*

taking any medicine like Voltarol. The risk is higher if you are taking high
doses for a long time. Always follow the doctor’s instructions on how much
to take and how long to take it for.
Whilst you are taking these medicines your doctor may want to give you a
check-up from time to time.
If you have a history of stomach problems when you are taking NSAIDs,
particularly if you are elderly, you must tell your doctor straight away if you
notice any unusual symptoms.
Because it is an anti-inflammatory medicine, Voltarol Dispersible Tablets
may reduce the symptoms of infection, for example headache, and high
temperature. If you feel unwell and need to see a doctor, remember to tell
him or her that you are taking Voltarol Dispersible Tablets.
Voltarol Dispersible Tablets are not suitable for children.

The tablets contain erythrosine and may be unsuitable for some people.

3

How to take Voltarol Dispersible Tablets

The doctor will tell you how many Voltarol Dispersible Tablets to take and
when to take them. Always follow his/her instructions carefully. The dose will
be on the pharmacist’s label. Check the label carefully. If you are not sure,
ask your doctor or pharmacist. Keep taking your tablets for as long as you
have been told, unless you have any problems. In that case, check with
your doctor.
Take the tablets before or with food.
Drop the tablets into a glass of water, and stir. Drink the liquid at once. To
make sure you get all of the medicine, rinse the glass round with a small
amount of water and drink this as well.
The usual doses are:
Adults
One tablet two or three times a day.
Elderly
Your doctor may advise you to take a dose that is lower than the usual adult
dose if you are elderly. Your doctor may also want to check closely that the
Voltarol Dispersible Tablets are not affecting your stomach.
These tablets are not suitable for children.

Ref: 0173/250815/2/B

®

Voltarol 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet (continued)
The doctor may also prescribe another drug to protect the stomach to be
taken at the same time, particularly if you have had stomach problems
before, or if you are elderly, or taking certain other drugs as well.

Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure, presence of blood or
protein in the urine.

What if you forget to take a dose?
If you forget to take a dose, take one as soon as you remember. If it is
nearly time for your next dose, though, just take the next dose and forget
about the one you missed. Do not double up on the next dose to make up
for the one missed. Do not take more than 150 mg (three tablets) in 24
hours.

Effects on skin or hair:
Serious skin rashes including Stevens-Johnson syndrome and Lyell’s
syndrome and other skin rashes which may be made worse by exposure to
sunlight.
Hair loss.

What if you take too many tablets?
If you, or anyone else, accidentally takes too much, tell your doctor or your
nearest hospital casualty department. Take your medicine pack with you so
that people can see what you have taken.

4

Possible side effects

Voltarol Dispersible Tablets are suitable for most people, but, like all
medicines, they can sometimes cause side effects. Side effects may be
minimised by using the lowest effective dose for the shortest duration
necessary.
Some side effects can be serious
Stop taking Voltarol Dispersible Tablets and tell your doctor straight
away if you notice:
* Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or
vomiting (being sick)
* Any sign of bleeding in the stomach or intestine, for example, when
emptying your bowels, blood in vomit or black, tarry faeces
* Allergic reactions which can include skin rash, itching, bruising, painful red
areas, peeling or blistering
* Wheezing or shortness of breath (bronchospasm)
* Swollen face, lips, hands or fingers
* Yellowing of your skin or the whites of your eyes
* Persistent sore throat or high temperature
* An unexpected change in the amount of urine produced and/or its
appearance.
If you notice that you are bruising more easily than usual or have frequent
sore throats or infections, tell your doctor.

Other side effects that have also been reported include:
Inflammation of the pancreas, impotence. Facial swelling, inflammation of
the lining of the brain (meningitis), stroke, throat disorders, confusion,
hallucinations, malaise (general feeling of discomfort), inflammation of the
nerves in the eye.
Do not be alarmed by this list - most people take Voltarol Dispersible
Tablets without any problems.
If any of the symptoms become troublesome, or if you notice anything
else not mentioned here, please go and see your doctor. He/she may
want to give you a different medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* This product contains no flavour.
* Do not store above 25°C.
* Protect from heat and moisture
* Do not use this medicine after the expiry date shown on the carton or

The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 10 in every 100
patients):
* Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind,
loss of appetite
* Headache, dizziness, vertigo
* Skin rash or spots
* Raised levels of liver enzymes in the blood
Rare side effects (These may affect between 1 in every 1000 to 1 in every
10,000 patients):
* Stomach ulcers or bleeding (there have been very rare reported cases
resulting in death, particularly in the elderly)
* Gastritis (inflammation, irritation or swelling of the stomach lining)
* Vomiting blood
* Diarrhoea with blood in it or bleeding from the back passage
* Black, tarry faeces or stools
* Drowsiness, tiredness
* Hypotension (low blood pressure, symptoms of which may include
faintness, giddiness or light headedness)
* Skin rash and itching
* Fluid retention, symptoms of which include swollen ankles
* Liver function disorders, including hepatitis and jaundice
Very Rare side effects (These may affect less than 1 in every 10,000
patients):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual disturbances such as
blurred or double vision, hearing loss or impairment, tinnitus (ringing in the
ears), sleeplessness, nightmares, mood changes, depression, anxiety,
mental disorders, disorientation, and loss of memory, fits, headaches
together with a dislike of bright lights, fever and a stiff neck, disturbances in
sensation.

How to store Voltarol Dispersible Tablets

*

blister strip. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult your pharmacist who will
tell you what to do.
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about any
thing, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Further information

What this medicine contains:
Each tablet contains 46.5mg of diclofenac free acid, which is equivalent to
50mg of diclofenac sodium as the active ingredient.
Voltarol 50mg Dispersible Tablets also has the following inactive ingredients:
cellulose microcrystaline, sodium starch glycollate, croscarmellose sodium,
silica aerogel, hydrogenated castor oil and talc.
What this medicine looks like and contents of the pack
Voltarol 50mg Dispersible Tablets are white triangular shaped, uncoated,
impressed CG on one side and embossed “V” on the other side.
Voltarol 50mg Dispersible Tablets come in packs of 20 tablets
Manufacturer and Licence Holder
The tablets are manufactured by Novartis Pharma Productions GmbH, Wehr,
Germany and are procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0173

Voltarol 50mg Dispersible Tablets

Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation of the
inside of the mouth or lips, taste changes, lower gut disorders (including
inflammation of the colon, or worsening of ulcerative colitis or Crohn’s
disease).

Voltarol is a registered trademark of Novartis AG

Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain, hypertension (high
blood pressure),inflammation of blood vessels (vasculitis), inflammation of
the lung (pneumonitis), heart disorders, including congestive heart failure or
heart attack, blood disorders (including anaemia), stroke.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Revision date: 25/08/15

Ref: 0173/250815/3/F

®

Voltarol 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet
What you need to know about Voltarol Dispersible Tablets
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to take your medicine.
It contains important information.
* Keep the leaflet in a safe place because you may want to read it again.
* If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Never give it to someone else.
It may not be the right medicine for them even if their symptoms seem to
be the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Voltarol 50mg Dispersible Tablets but will be referred
to as Voltarol Dispersible Tablets throughout this leaflet.
In this leaflet:
1 What Voltarol Dispersible Tablets are, and what they are used for
2 Things to consider before you start to take Voltarol Dispersible Tablets
3 How to take Voltarol Dispersible Tablets
4 Possible side effects
5 How to store Voltarol Dispersible Tablets
6 Further information

1

What Voltarol Dispersible Tablets are, and what they
are used for

Diclofenac sodium, the active ingredient in Voltarol Dispersible Tablets, is
one of a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs reduce pain and inflammation.
Voltarol Dispersible Tablets act quickly and so are used to treat short term
painful conditions affecting the joints and muscles. They are especially useful for the treatment of sprains, strains and back pain. They should not be
taken for more than three months.

2

Things to consider before you start to take Voltarol
Dispersible Tablets

Some people MUST NOT take Voltarol Dispersible Tablets. Talk to your
doctor if:
* you think you may be allergic to diclofenac sodium, aspirin, ibuprofen or
any other NSAID, or to any of the other ingredients of Voltarol Dispersible
Tablets. (These are listed at the end of the leaflet.) Signs of a
hypersensitivity reaction include swelling of the face and mouth
(angioedema), breathing problems, runny nose, skin rash or any other
allergic type reaction
* you have now, or have ever had, a stomach (gastric) or duodenal (peptic)
ulcer, or bleeding in the digestive tract (this can include blood in vomit,
bleeding when emptying bowels, fresh blood in faeces or black, tarry
faeces)
* you have had stomach or bowel problems after you have taken other
NSAIDs
you
have severe heart, kidney or liver failure
*
* if you have established heart disease and/or cerebrovascular disease e.g.
if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to
blood vessels to the heart or brain or an operation to clear or bypass
blockages
* if you have or have had problems with your blood circulation (peripheral
arterial disease)
* you are more than six months pregnant.
You should also ask yourself these questions before taking Voltarol
Dispersible Tablets:
* Do you suffer from any stomach or bowel disorders including ulcerative
colitis or Crohn’s disease?
* Do you have kidney or liver problems, or are you elderly?
* Do you have a condition called porphyria?
* Do you suffer from any blood or bleeding disorder? If you do, your doctor
may ask you to go for regular check-ups while you are taking these
tablets.
* Have you ever had asthma?
* Are you breast-feeding?
* Do you have angina, blood clots, high blood pressure, raised cholesterol or
raised triglycerides
* Do you have heart problems, or have you had a stroke, or do you think
you might be at risk of these conditions (for example, if you have high
blood pressure, diabetes, or high cholesterol or are you a smoker)?
* Do you have diabetes
* Do you smoke
* Do you have Lupus (SLE) or any similar condition?

If the answer to any of these questions is YES, discuss your treatment
with your doctor or pharmacist because Voltarol Dispersible Tablets
might not be the right medicine for you.
Are you taking other medicines?
Some medicines can interfere with your treatment.
Tell your doctor or pharmacist if you are taking any of the following:
* Medicines to treat diabetes
* Anticoagulants (blood thinning tablets like warfarin)
* Diuretics (water tablets)
* Lithium (used to treat some mental problems)
* Methotrexate (for some inflammatory diseases and some cancers)
* Ciclosporin and tacrolimus (used to treat some inflammatory diseases and
after transplants)
* Trimethoprim (a medicine used to prevent or treat urinary tract infections)
* Quinolone antibiotics (for infections)
* Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example
aspirin or ibuprofen
* Mifepristone (a medicine used to terminate pregnancy)
* Cardiac glycosides (for example digoxin), used to treat heart problems
* Medicines known as SSRIs used to treat depression
* Oral steroids (an anti-inflammatory drug)
* Medicines used to treat heart conditions or high blood pressure, for
example beta- blockers or ACE inhibitors.
* Voriconazole (a medicine used to treat fungal infections).
* Phenytoin (a medicine used to treat seizures)
* Colestipol/cholestyramine (used to lower cholesterol)
Always tell your doctor or pharmacist about all the medicines you are taking.
This means medicines you have bought yourself as well as medicines on
prescription from your doctor.
Pregnancy
* Are you pregnant or planning to become pregnant? Although not common,
abnormalities have been reported in babies whose mothers have taken
NSAIDs during pregnancy. You should not take Voltarol Dispersible Tablets
during the last 3 months of pregnancy as it may affect the baby’s
circulation.
* Are you trying for a baby? Taking Voltarol Dispersible Tablets may make it
more difficult to conceive. You should talk to your doctor if you are
planning to become pregnant, or if you have problems getting pregnant.
Will there be any problems with driving or using machinery?
Very occasionally people have reported that Voltarol Dispersible Tablets
have made them feel dizzy, tired or sleepy. Problems with eyesight have
also been reported. If you are affected in this way, you should not drive or
operate machinery.
Other special warnings

* You should take the lowest dose of Voltarol Dispersible Tablets for the
shortest possible time, particularly if you are underweight or elderly.

* There is a small increased risk of heart attack or stroke when you are

*
*
*

*

taking any medicine like Voltarol. The risk is higher if you are taking high
doses for a long time. Always follow the doctor’s instructions on how much
to take and how long to take it for.
Whilst you are taking these medicines your doctor may want to give you a
check-up from time to time.
If you have a history of stomach problems when you are taking NSAIDs,
particularly if you are elderly, you must tell your doctor straight away if you
notice any unusual symptoms.
Because it is an anti-inflammatory medicine, Voltarol Dispersible Tablets
may reduce the symptoms of infection, for example headache, and high
temperature. If you feel unwell and need to see a doctor, remember to tell
him or her that you are taking Voltarol Dispersible Tablets.
Voltarol Dispersible Tablets are not suitable for children.

The tablets contain erythrosine and may be unsuitable for some people.

3

How to take Voltarol Dispersible Tablets

The doctor will tell you how many Voltarol Dispersible Tablets to take and
when to take them. Always follow his/her instructions carefully. The dose will
be on the pharmacist’s label. Check the label carefully. If you are not sure,
ask your doctor or pharmacist. Keep taking your tablets for as long as you
have been told, unless you have any problems. In that case, check with
your doctor.
Take the tablets before or with food.
Drop the tablets into a glass of water, and stir. Drink the liquid at once. To
make sure you get all of the medicine, rinse the glass round with a small
amount of water and drink this as well.
The usual doses are:
Adults
One tablet two or three times a day.
Elderly
Your doctor may advise you to take a dose that is lower than the usual adult
dose if you are elderly. Your doctor may also want to check closely that the
Voltarol Dispersible Tablets are not affecting your stomach.
These tablets are not suitable for children.

Ref: 0173/250815/3/B

®

Voltarol 50mg Dispersible Tablets
(diclofenac sodium)
The doctor may also prescribe another drug to protect the stomach to be
taken at the same time, particularly if you have had stomach problems
before, or if you are elderly, or taking certain other drugs as well.
What if you forget to take a dose?
If you forget to take a dose, take one as soon as you remember. If it is
nearly time for your next dose, though, just take the next dose and forget
about the one you missed. Do not double up on the next dose to make up
for the one missed. Do not take more than 150 mg (three tablets) in 24
hours.
What if you take too many tablets?
If you, or anyone else, accidentally takes too much, tell your doctor or your
nearest hospital casualty department. Take your medicine pack with you so
that people can see what you have taken.

4

Possible side effects

Voltarol Dispersible Tablets are suitable for most people, but, like all
medicines, they can sometimes cause side effects. Side effects may be
minimised by using the lowest effective dose for the shortest duration
necessary.
Some side effects can be serious
Stop taking Voltarol Dispersible Tablets and tell your doctor straight
away if you notice:
* Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or
vomiting (being sick)
* Any sign of bleeding in the stomach or intestine, for example, when
emptying your bowels, blood in vomit or black, tarry faeces
* Allergic reactions which can include skin rash, itching, bruising, painful red
areas, peeling or blistering
* Wheezing or shortness of breath (bronchospasm)
* Swollen face, lips, hands or fingers
* Yellowing of your skin or the whites of your eyes
* Persistent sore throat or high temperature
* An unexpected change in the amount of urine produced and/or its
appearance.
If you notice that you are bruising more easily than usual or have frequent
sore throats or infections, tell your doctor.

Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure, presence of blood or
protein in the urine.
Effects on skin or hair:
Serious skin rashes including Stevens-Johnson syndrome and Lyell’s
syndrome and other skin rashes which may be made worse by exposure to
sunlight.
Hair loss.
Other side effects that have also been reported include:
Inflammation of the pancreas, impotence. Facial swelling, inflammation of
the lining of the brain (meningitis), stroke, throat disorders, confusion,
hallucinations, malaise (general feeling of discomfort), inflammation of the
nerves in the eye.
Do not be alarmed by this list - most people take Voltarol Dispersible
Tablets without any problems.
If any of the symptoms become troublesome, or if you notice anything
else not mentioned here, please go and see your doctor. He/she may
want to give you a different medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* This product contains no flavour.
* Do not store above 25°C.
* Protect from heat and moisture
* Do not use this medicine after the expiry date shown on the carton or

The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 10 in every 100
patients):
* Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind,
loss of appetite
* Headache, dizziness, vertigo
* Skin rash or spots
* Raised levels of liver enzymes in the blood
Rare side effects (These may affect between 1 in every 1000 to 1 in every
10,000 patients):
* Stomach ulcers or bleeding (there have been very rare reported cases
resulting in death, particularly in the elderly)
* Gastritis (inflammation, irritation or swelling of the stomach lining)
* Vomiting blood
* Diarrhoea with blood in it or bleeding from the back passage
* Black, tarry faeces or stools
* Drowsiness, tiredness
* Hypotension (low blood pressure, symptoms of which may include
faintness, giddiness or light headedness)
* Skin rash and itching
* Fluid retention, symptoms of which include swollen ankles
* Liver function disorders, including hepatitis and jaundice
Very Rare side effects (These may affect less than 1 in every 10,000
patients):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual disturbances such as
blurred or double vision, hearing loss or impairment, tinnitus (ringing in the
ears), sleeplessness, nightmares, mood changes, depression, anxiety,
mental disorders, disorientation, and loss of memory, fits, headaches
together with a dislike of bright lights, fever and a stiff neck, disturbances in
sensation.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation of the
inside of the mouth or lips, taste changes, lower gut disorders (including
inflammation of the colon, or worsening of ulcerative colitis or Crohn’s
disease).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain, hypertension (high
blood pressure),inflammation of blood vessels (vasculitis), inflammation of
the lung (pneumonitis), heart disorders, including congestive heart failure or
heart attack, blood disorders (including anaemia), stroke.

How to store Voltarol Dispersible Tablets

*

blister strip. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult your pharmacist who will
tell you what to do.
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about any
thing, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Further information

What this medicine contains:
Each tablet contains 46.5mg of diclofenac free acid, which is equivalent to
50mg of diclofenac sodium as the active ingredient.
Voltarol 50mg Dispersible Tablets also has the following inactive ingredients:
cellulose microcrystaline, sodium starch glycollate, croscarmellose sodium,
silica aerogel, hydrogenated castor oil and talc.
What this medicine looks like and contents of the pack
Voltarol 50mg Dispersible Tablets are white triangular shaped, uncoated,
impressed CG on one side and embossed “V” on the other side.
Voltarol 50mg Dispersible Tablets come in packs of 20 tablets
Manufacturer and Licence Holder
The tablets are manufactured by Novartis Istanbul Turkey and are procured
from within the EU and repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0173

Voltarol 50mg Dispersible Tablets

Voltarol is a registered trademark of Novartis AG
Revision date: 25/08/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0173/250815/1/F

®

Voltaren 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet
What you need to know about Voltaren Dispersible Tablets
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to take your medicine.
It contains important information.
* Keep the leaflet in a safe place because you may want to read it again.
* If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Never give it to someone else.
It may not be the right medicine for them even if their symptoms seem to
be the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Voltaren 50mg Dispersible Tablets but will be
referred to as Voltaren Dispersible Tablets throughout this leaflet.
In this leaflet:
1 What Voltaren Dispersible Tablets are, and what they are used for
2 Things to consider before you start to take Voltaren Dispersible Tablets
3 How to take Voltaren Dispersible Tablets
4 Possible side effects
5 How to store Voltaren Dispersible Tablets
6 Further information

1

What Voltaren Dispersible Tablets are, and what they
are used for

Diclofenac sodium, the active ingredient in Voltaren Dispersible Tablets, is
one of a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs reduce pain and inflammation.
Voltaren Dispersible Tablets act quickly and so are used to treat short term
painful conditions affecting the joints and muscles. They are especially useful for the treatment of sprains, strains and back pain. They should not be
taken for more than three months.

2

Things to consider before you start to take Voltaren
Dispersible Tablets

Some people MUST NOT take Voltaren Dispersible Tablets. Talk to your
doctor if:
* you think you may be allergic to diclofenac sodium, aspirin, ibuprofen or
any other NSAID, or to any of the other ingredients of Voltarol Dispersible
Tablets. (These are listed at the end of the leaflet.) Signs of a
hypersensitivity reaction include swelling of the face and mouth
(angioedema), breathing problems, runny nose, skin rash or any other
allergic type reaction
* you have now, or have ever had, a stomach (gastric) or duodenal (peptic)
ulcer, or bleeding in the digestive tract (this can include blood in vomit,
bleeding when emptying bowels, fresh blood in faeces or black, tarry
faeces)
* you have had stomach or bowel problems after you have taken other
NSAIDs
* you have severe heart, kidney or liver failure
* if you have established heart disease and/or cerebrovascular disease e.g.
if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to
blood vessels to the heart or brain or an operation to clear or bypass
blockages
* if you have or have had problems with your blood circulation (peripheral
arterial disease)
* you are more than six months pregnant.
You should also ask yourself these questions before taking Voltaren
Dispersible Tablets:

* Do you suffer from any stomach or bowel disorders including ulcerative
colitis or Crohn’s disease?

* Do you have kidney or liver problems, or are you elderly?
* Do you have a condition called porphyria?
* Do you suffer from any blood or bleeding disorder? If you do, your doctor
may ask you to go for regular check-ups while you are taking these
tablets.
* Have you ever had asthma?
* Are you breast-feeding?
* Do you have angina, blood clots, high blood pressure, raised cholesterol or
raised triglycerides
* Do you have heart problems, or have you had a stroke, or do you think
you might be at risk of these conditions (for example, if you have high
blood pressure, diabetes, or high cholesterol or are you a smoker)?
* Do you have diabetes
* Do you smoke
* Do you have Lupus (SLE) or any similar condition?
If the answer to any of these questions is YES, discuss your treatment
with your doctor or pharmacist because Voltaren Dispersible Tablets
might not be the right medicine for you.

Are you taking other medicines?
Some medicines can interfere with your treatment.
Tell your doctor or pharmacist if you are taking any of
the following:
* Medicines to treat diabetes
* Anticoagulants (blood thinning tablets like warfarin)
* Diuretics (water tablets)
* Lithium (used to treat some mental problems)
* Methotrexate (for some inflammatory diseases and some cancers)
* Ciclosporin and tacrolimus (used to treat some inflammatory diseases and
after transplants)
* Trimethoprim (a medicine used to prevent or treat urinary tract infections)
* Quinolone antibiotics (for infections)
* Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example
aspirin or ibuprofen
* Mifepristone (a medicine used to terminate pregnancy)
* Cardiac glycosides (for example digoxin), used to treat heart problems
* Medicines known as SSRIs used to treat depression
* Oral steroids (an anti-inflammatory drug)
* Medicines used to treat heart conditions or high blood pressure, for
example beta- blockers or ACE inhibitors.
* Voriconazole (a medicine used to treat fungal infections).
* Phenytoin (a medicine used to treat seizures)
* Colestipol/cholestyramine (used to lower cholesterol)
Always tell your doctor or pharmacist about all the medicines you are taking.
This means medicines you have bought yourself as well as medicines on
prescription from your doctor.
Pregnancy
* Are you pregnant or planning to become pregnant? Although not common,
abnormalities have been reported in babies whose mothers have taken
NSAIDs during pregnancy. You should not take Voltaren Dispersible
Tablets during the last 3 months of pregnancy as it may affect the baby’s
circulation.
* Are you trying for a baby? Taking Voltaren Dispersible Tablets may make it
more difficult to conceive. You should talk to your doctor if you are
planning to become pregnant, or if you have problems getting pregnant.
Will there be any problems with driving or using machinery?
Very occasionally people have reported that Voltaren Dispersible Tablets
have made them feel dizzy, tired or sleepy. Problems with eyesight have
also been reported. If you are affected in this way, you should not drive or
operate machinery.
Other special warnings
* You should take the lowest dose of Voltaren Dispersible Tablets for the
shortest possible time, particularly if you are underweight or elderly.
* There is a small increased risk of heart attack or stroke when you are
taking any medicine like Voltaren. The risk is higher if you are taking high
doses for a long time. Always follow the doctor’s instructions on how much
to take and how long to take it for.
* Whilst you are taking these medicines your doctor may want to give you a
check-up from time to time.
* If you have a history of stomach problems when you are taking NSAIDs,
particularly if you are elderly, you must tell your doctor straight away if you
notice any unusual symptoms.
* Because it is an anti-inflammatory medicine, Voltaren Dispersible Tablets
may reduce the symptoms of infection, for example headache, and high
temperature. If you feel unwell and need to see a doctor, remember to tell
him or her that you are taking Voltaren Dispersible Tablets.
* Voltaren Dispersible Tablets are not suitable for children.
The tablets contain erythrosine and may be unsuitable for some people.

3

How to take Voltaren Dispersible Tablets

The doctor will tell you how many Voltaren Dispersible Tablets to take and
when to take them. Always follow his/her instructions carefully. The dose will
be on the pharmacist’s label. Check the label carefully. If you are not sure,
ask your doctor or pharmacist. Keep taking your tablets for as long as you
have been told, unless you have any problems. In that case, check with
your doctor.
Take the tablets before or with food.
Drop the tablets into a glass of water, and stir. Drink the liquid at once. To
make sure you get all of the medicine, rinse the glass round with a small
amount of water and drink this as well.
The usual doses are:
Adults
One tablet two or three times a day.
Elderly
Your doctor may advise you to take a dose that is lower than the usual adult
dose if you are elderly. Your doctor may also want to check closely that the
Voltaren Dispersible Tablets are not affecting your stomach.
These tablets are not suitable for children.

Ref: 0173/250815/1/B

®

Voltaren 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet (continued)
The doctor may also prescribe another drug to protect the stomach to be
taken at the same time, particularly if you have had stomach problems
before, or if you are elderly, or taking certain other drugs as well.

Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure, presence of blood or
protein in the urine.

What if you forget to take a dose?
If you forget to take a dose, take one as soon as you remember. If it is
nearly time for your next dose, though, just take the next dose and forget
about the one you missed. Do not double up on the next dose to make up
for the one missed. Do not take more than 150 mg (three tablets) in 24
hours.

Effects on skin or hair:
Serious skin rashes including Stevens-Johnson syndrome and Lyell’s
syndrome and other skin rashes which may be made worse by exposure to
sunlight.
Hair loss.

What if you take too many tablets?
If you, or anyone else, accidentally takes too much, tell your doctor or your
nearest hospital casualty department. Take your medicine pack with you so
that people can see what you have taken.

Other side effects that have also been reported include:
Inflammation of the pancreas, impotence. Facial swelling, inflammation of
the lining of the brain (meningitis), stroke, throat disorders, confusion,
hallucinations, malaise (general feeling of discomfort), inflammation of the
nerves in the eye.
Do not be alarmed by this list – most people take Voltaren Dispersible
Tablets without any problems.

4

Possible side effects

Voltarol Dispersible Tablets are suitable for most people, but, like all
medicines, they can sometimes cause side effects. Side effects may be
minimised by using the lowest effective dose for the shortest duration
necessary.
Some side effects can be serious
Stop taking Voltaren Dispersible Tablets and tell your doctor straight
away if you notice:
* Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or
vomiting (being sick)
* Any sign of bleeding in the stomach or intestine, for example, when
emptying your bowels, blood in vomit or black, tarry faeces
* Allergic reactions which can include skin rash, itching, bruising, painful red
areas, peeling or blistering
* Wheezing or shortness of breath (bronchospasm)
* Swollen face, lips, hands or fingers
* Yellowing of your skin or the whites of your eyes
* Persistent sore throat or high temperature
* An unexpected change in the amount of urine produced and/or its
appearance.
If you notice that you are bruising more easily than usual or have frequent
sore throats or infections, tell your doctor.

If any of the symptoms become troublesome, or if you notice anything
else not mentioned here, please go and see your doctor. He/she may
want to give you a different medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* This product contains no flavour.
* Do not store above 25°C.
* Protect from heat and moisture
* Do not use this medicine after the expiry date shown on the carton or

The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 10 in every 100
patients):
* Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind,
loss of appetite
* Headache, dizziness, vertigo
* Skin rash or spots
* Raised levels of liver enzymes in the blood
Rare side effects (These may affect between 1 in every 1000 to 1 in every
10,000 patients):
* Stomach ulcers or bleeding (there have been very rare reported cases
resulting in death, particularly in the elderly)
* Gastritis (inflammation, irritation or swelling of the stomach lining)
* Vomiting blood
* Diarrhoea with blood in it or bleeding from the back passage
* Black, tarry faeces or stools
* Drowsiness, tiredness
* Hypotension (low blood pressure, symptoms of which may include
faintness, giddiness or light headedness)
* Skin rash and itching
* Fluid retention, symptoms of which include swollen ankles
* Liver function disorders, including hepatitis and jaundice
Very Rare side effects (These may affect less than 1 in every 10,000
patients):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual disturbances such as
blurred or double vision, hearing loss or impairment, tinnitus (ringing in the
ears), sleeplessness, nightmares, mood changes, depression, anxiety,
mental disorders, confusion, and loss of memory, fits, headaches together
with a dislike of bright lights, fever and a stiff neck, disturbances in
sensation.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation of the
inside of the mouth or lips, taste changes, lower gut disorders (including
inflammation of the colon, or worsening of ulcerative colitis or Crohn’s
disease).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain, hypertension (high
blood pressure), inflammation of blood vessels (vasculitis), inflammation of
the lung (pneumonitis), heart disorders, including congestive heart failure or
heart attack, blood disorders (including anaemia), stroke.

How to store Voltaren Dispersible Tablets

*

blister strip. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult your pharmacist who will
tell you what to do.
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about any
thing, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Further information

What this medicine contains:
Each tablet contains 46.5mg of diclofenac free acid, which is equivalent to
50mg of diclofenac sodium as the active ingredient.
Voltaren 50mg Dispersible Tablets also has the following inactive ingredients: cellulose microcrystaline, sodium starch glycollate, croscarmellose
sodium, silica aerogel, hydrogenated castor oil and talc.
What this medicine looks like and contents of the pack
Voltaren 50mg Dispersible Tablets are white triangular shaped, uncoated,
impressed CG on one side and embossed “V” on the other side.
Voltaren 50mg Dispersible Tablets come in packs of 20 tablets
Manufacturer and Licence Holder
The tablets are manufactured by Novartis Pharma AG, Stein, Switzerland
and are procured from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0173

Voltaren 50mg Dispersible Tablets

Voltaren is a registered trademark of Novartis AG
Revision date: 25/08/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0173/250815/2/F

®

Voltaren 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet
What you need to know about Voltaren Dispersible Tablets
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to take your medicine.
It contains important information.
* Keep the leaflet in a safe place because you may want to read it again.
* If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Never give it to someone else.
It may not be the right medicine for them even if their symptoms seem to
be the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Voltaren 50mg Dispersible Tablets but will be
referred to as Voltaren Dispersible Tablets throughout this leaflet.
In this leaflet:
1 What Voltaren Dispersible Tablets are, and what they are used for
2 Things to consider before you start to take Voltaren Dispersible Tablets
3 How to take Voltaren Dispersible Tablets
4 Possible side effects
5 How to store Voltaren Dispersible Tablets
6 Further information

1

What Voltaren Dispersible Tablets are, and what they
are used for

Diclofenac sodium, the active ingredient in Voltaren Dispersible Tablets, is
one of a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs reduce pain and inflammation.
Voltaren Dispersible Tablets act quickly and so are used to treat short term
painful conditions affecting the joints and muscles. They are especially useful for the treatment of sprains, strains and back pain. They should not be
taken for more than three months.

Are you taking other medicines?
Some medicines can interfere with your treatment. Tell your doctor or
pharmacist if you are taking any of the following:
* Medicines to treat diabetes
* Anticoagulants (blood thinning tablets like warfarin)
* Diuretics (water tablets)
* Lithium (used to treat some mental problems)
* Methotrexate (for some inflammatory diseases and some cancers)
* Ciclosporin or tacrolimus (used to treat some inflammatory diseases and
after transplants)
* Quinolone antibiotics (for infections)
* Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example
aspirin or ibuprofen
* Mifepristone (a medicine used to terminate pregnancy)
* Cardiac glycosides (for example digoxin), used to treat heart problems
* Medicines known as SSRIs used to treat depression
* Oral steroids (an anti-inflammatory drug)
* Medicines used to treat heart conditions or high blood pressure, for
example beta- blockers or ACE inhibitors.
* Sulfinpyrazone (a medicine used to treat gout) or voriconazole (a medicine
used to treat fungal infections).
* Phenytoin ( a medicine used to treat seizures)
* Colestipol/cholestyramine (used to lower cholesterol)
Always tell your doctor or pharmacist about all the medicines you are taking.
This means medicines you have bought yourself as well as medicines on
prescription from your doctor.
Pregnancy
* Are you pregnant or planning to become pregnant? Although not common,
abnormalities have been reported in babies whose mothers have taken
NSAIDs during pregnancy. You should not take Voltaren Dispersible
Tablets during the last 3 months of pregnancy as it may affect the baby’s
circulation.
* Are you trying for a baby? Taking Voltaren Dispersible Tablets may make it
more difficult to conceive. You should talk to your doctor if you are
planning to become pregnant, or if you have problems getting pregnant.
Will there be any problems with driving or using machinery?
Very occasionally people have reported that Voltaren Dispersible Tablets
have made them feel dizzy, tired or sleepy. Problems with eyesight have
also been reported. If you are affected in this way, you should not drive or
operate machinery.
Other special warnings

2

Things to consider before you start to take Voltaren
Dispersible Tablets

Some people MUST NOT take Voltaren Dispersible Tablets. Talk to your
doctor if:
* you think you may be allergic to diclofenac sodium, aspirin, ibuprofen or
any other NSAID, or to any of the other ingredients of Voltarol Dispersible
Tablets. (These are listed at the end of the leaflet.) Signs of a
hypersensitivity reaction include swelling of the face and mouth
(angioedema), breathing problems, runny nose, skin rash or any other
allergic type reaction
* you have now, or have ever had, a stomach (gastric) or duodenal (peptic)
ulcer, or bleeding in the digestive tract (this can include blood in vomit,
bleeding when emptying bowels, fresh blood in faeces or black, tarry
faeces)
* you have had stomach or bowel problems after you have taken other
NSAIDs
you
have severe heart, kidney or liver failure
*
* if you have established heart disease and/or cerebrovascular disease e.g.
if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to
blood vessels to the heart or brain or an operation to clear or bypass
blockages
* if you have or have had problems with your blood circulation (peripheral
arterial disease)
* you are more than six months pregnant.
You should also ask yourself these questions before taking Voltaren
Dispersible Tablets:
* Do you suffer from any stomach or bowel disorders including ulcerative
colitis or Crohn’s disease?
* Do you have kidney or liver problems, or are you elderly?
* Do you have a condition called porphyria?
* Do you suffer from any blood or bleeding disorder? If you do, your doctor
may ask you to go for regular check-ups while you are taking these
tablets.
* Have you ever had asthma?
* Are you breast-feeding?
* Do you have angina, blood clots, high blood pressure, raised cholesterol or
raised triglycerides
* Do you have heart problems, or have you had a stroke, or do you think
you might be at risk of these conditions (for example, if you have high
blood pressure, diabetes, or high cholesterol or are you a smoker)?
* Do you have diabetes
* Do you smoke
* Do you have Lupus (SLE) or any similar condition?
If the answer to any of these questions is YES, discuss your treatment
with your doctor or pharmacist because Voltaren Dispersible Tablets
might not be the right medicine for you.

* You should take the lowest dose of Voltaren Dispersible Tablets for the
shortest possible time, particularly if you are underweight or elderly.

* There is a small increased risk of heart attack or stroke when you are

*
*
*

*

taking any medicine like Voltaren. The risk is higher if you are taking high
doses for a long time. Always follow the doctor’s instructions on how much
to take and how long to take it for.
Whilst you are taking these medicines your doctor may want to give you a
check-up from time to time.
If you have a history of stomach problems when you are taking NSAIDs,
particularly if you are elderly, you must tell your doctor straight away if you
notice any unusual symptoms.
Because it is an anti-inflammatory medicine, Voltaren Dispersible Tablets
may reduce the symptoms of infection, for example headache, and high
temperature. If you feel unwell and need to see a doctor, remember to tell
him or her that you are taking Voltaren Dispersible Tablets.
Voltaren Dispersible Tablets are not suitable for children.

The tablets contain erythrosine and may be unsuitable for some people.

3

How to take Voltaren Dispersible Tablets

The doctor will tell you how many Voltaren Dispersible Tablets to take and
when to take them. Always follow his/her instructions carefully. The dose will
be on the pharmacist’s label. Check the label carefully. If you are not sure,
ask your doctor or pharmacist. Keep taking your tablets for as long as you
have been told, unless you have any problems. In that case, check with
your doctor.
Take the tablets before or with food.
Drop the tablets into a glass of water, and stir. Drink the liquid at once. To
make sure you get all of the medicine, rinse the glass round with a small
amount of water and drink this as well.
The usual doses are:
Adults
One tablet two or three times a day.
Elderly
Your doctor may advise you to take a dose that is lower than the usual adult
dose if you are elderly. Your doctor may also want to check closely that the
Voltaren Dispersible Tablets are not affecting your stomach.
These tablets are not suitable for children.

Ref: 0173/2500815/2/B

®

Voltaren 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet (continued)
The doctor may also prescribe another drug to protect the stomach to be
taken at the same time, particularly if you have had stomach problems
before, or if you are elderly, or taking certain other drugs as well.

Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure, presence of blood or
protein in the urine.

What if you forget to take a dose?
If you forget to take a dose, take one as soon as you remember. If it is
nearly time for your next dose, though, just take the next dose and forget
about the one you missed. Do not double up on the next dose to make up
for the one missed. Do not take more than 150 mg (three tablets) in 24
hours.

Effects on skin or hair:
Serious skin rashes including Stevens-Johnson syndrome and Lyell’s
syndrome and other skin rashes which may be made worse by exposure to
sunlight.
Hair loss.

What if you take too many tablets?
If you, or anyone else, accidentally takes too much, tell your doctor or your
nearest hospital casualty department. Take your medicine pack with you so
that people can see what you have taken.

Other side effects that have also been reported include:
Inflammation of the pancreas, impotence. Facial swelling, inflammation of
the lining of the brain (meningitis), stroke, throat disorders, confusion,
hallucinations, malaise (general feeling of discomfort), inflammation of the
nerves in the eye.
Do not be alarmed by this list – most people take Voltaren Dispersible
Tablets without any problems.

4

Possible side effects

Voltarol Dispersible Tablets are suitable for most people, but, like all
medicines, they can sometimes cause side effects. Side effects may be
minimised by using the lowest effective dose for the shortest duration
necessary.
Some side effects can be serious
Stop taking Voltaren Dispersible Tablets and tell your doctor straight
away if you notice:
* Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or
vomiting (being sick)
* Any sign of bleeding in the stomach or intestine, for example, when
emptying your bowels, blood in vomit or black, tarry faeces
* Allergic reactions which can include skin rash, itching, bruising, painful red
areas, peeling or blistering
* Wheezing or shortness of breath (bronchospasm)
* Swollen face, lips, hands or fingers
* Yellowing of your skin or the whites of your eyes
* Persistent sore throat or high temperature
* An unexpected change in the amount of urine produced and/or its
appearance.
If you notice that you are bruising more easily than usual or have frequent
sore throats or infections, tell your doctor.

If any of the symptoms become troublesome, or if you notice anything
else not mentioned here, please go and see your doctor. He/she may
want to give you a different medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

* KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
* This product contains no flavour.
* Do not store above 25°C.
* Protect from heat and moisture
* Do not use this medicine after the expiry date shown on the carton or

The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 10 in every 100
patients):
* Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind,
loss of appetite
* Headache, dizziness, vertigo
* Skin rash or spots
* Raised levels of liver enzymes in the blood
Rare side effects (These may affect between 1 in every 1000 to 1 in every
10,000 patients):
* Stomach ulcers or bleeding (there have been very rare reported cases
resulting in death, particularly in the elderly)
* Gastritis (inflammation, irritation or swelling of the stomach lining)
* Vomiting blood
* Diarrhoea with blood in it or bleeding from the back passage
* Black, tarry faeces or stools
* Drowsiness, tiredness
* Hypotension (low blood pressure, symptoms of which may include
faintness, giddiness or light headedness)
* Skin rash and itching
* Fluid retention, symptoms of which include swollen ankles
* Liver function disorders, including hepatitis and jaundice
Very Rare side effects (These may affect less than 1 in every 10,000
patients):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual disturbances such as
blurred or double vision, hearing loss or impairment, tinnitus (ringing in the
ears), sleeplessness, nightmares, mood changes, depression, anxiety,
mental disorders, disorientation, and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck, disturbances in
sensation.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation of the
inside of the mouth or lips, taste changes, lower gut disorders (including
inflammation of the colon, or worsening of ulcerative colitis or Crohn’s
disease).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain, hypertension (high
blood pressure), inflammation of blood vessels (vasculitis), inflammation of
the lung (pneumonitis), heart disorders, including congestive heart failure or
heart attack, blood disorders (including anaemia), stroke.

How to store Voltaren Dispersible Tablets

*

blister strip. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult your pharmacist who will
tell you what to do.
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about any
thing, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Further information

What this medicine contains:
Each tablet contains 46.5mg of diclofenac free acid, which is equivalent to
50mg of diclofenac sodium as the active ingredient.
Voltaren 50mg Dispersible Tablets also has the following inactive ingredients: cellulose microcrystaline, sodium starch glycollate, croscarmellose
sodium, silica aerogel, hydrogenated castor oil and talc.
What this medicine looks like and contents of the pack
Voltaren 50mg Dispersible Tablets are white triangular shaped, uncoated,
impressed CG on one side and embossed “V” on the other side.
Voltaren 50mg Dispersible Tablets come in packs of 20 tablets
Manufacturer and Licence Holder
The tablets are manufactured by Novartis Pharma Productions GmbH, Wehr,
Germany and are procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0173

Voltaren 50mg Dispersible Tablets

Voltaren is a registered trademark of Novartis AG
Revision date: 25/08/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0173/250815/3/F

®

Voltaren 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet
What you need to know about Voltaren Dispersible Tablets
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to take your medicine.
It contains important information.
* Keep the leaflet in a safe place because you may want to read it again.
* If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Never give it to someone else.
It may not be the right medicine for them even if their symptoms seem to
be the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Voltaren 50mg Dispersible Tablets but will be
referred to as Voltaren Dispersible Tablets throughout this leaflet.
In this leaflet:
1 What Voltaren Dispersible Tablets are, and what they are used for
2 Things to consider before you start to take Voltaren Dispersible Tablets
3 How to take Voltaren Dispersible Tablets
4 Possible side effects
5 How to store Voltaren Dispersible Tablets
6 Further information

1

What Voltaren Dispersible Tablets are, and what they
are used for

Diclofenac sodium, the active ingredient in Voltaren Dispersible Tablets, is
one of a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs reduce pain and inflammation.
Voltaren Dispersible Tablets act quickly and so are used to treat short term
painful conditions affecting the joints and muscles. They are especially useful for the treatment of sprains, strains and back pain. They should not be
taken for more than three months.

2

Things to consider before you start to take Voltaren
Dispersible Tablets

Some people MUST NOT take Voltaren Dispersible Tablets. Talk to your
doctor if:
* you think you may be allergic to diclofenac sodium, aspirin, ibuprofen or
any other NSAID, or to any of the other ingredients of Voltarol Dispersible
Tablets. (These are listed at the end of the leaflet.) Signs of a
hypersensitivity reaction include swelling of the face and mouth
(angioedema), breathing problems, runny nose, skin rash or any other
allergic type reaction
* you have now, or have ever had, a stomach (gastric) or duodenal (peptic)
ulcer, or bleeding in the digestive tract (this can include blood in vomit,
bleeding when emptying bowels, fresh blood in faeces or black, tarry
faeces)
* you have had stomach or bowel problems after you have taken other
NSAIDs
you
have severe heart, kidney or liver failure
*
* if you have established heart disease and/or cerebrovascular disease e.g.
if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to
blood vessels to the heart or brain or an operation to clear or bypass
blockages
* if you have or have had problems with your blood circulation (peripheral
arterial disease)
* you are more than six months pregnant.
You should also ask yourself these questions before taking Voltaren
Dispersible Tablets:
* Do you suffer from any stomach or bowel disorders including ulcerative
colitis or Crohn’s disease?
* Do you have kidney or liver problems, or are you elderly?
* Do you have a condition called porphyria?
* Do you suffer from any blood or bleeding disorder? If you do, your doctor
may ask you to go for regular check-ups while you are taking these
tablets.
* Have you ever had asthma?
* Are you breast-feeding?
* Do you have angina, blood clots, high blood pressure, raised cholesterol or
raised triglycerides
* Do you have heart problems, or have you had a stroke, or do you think
you might be at risk of these conditions (for example, if you have high
blood pressure, diabetes, or high cholesterol or are you a smoker)?
* Do you have diabetes
* Do you smoke
* Do you have Lupus (SLE) or any similar condition?

If the answer to any of these questions is YES, discuss your treatment
with your doctor or pharmacist because Voltaren Dispersible Tablets
might not be the right medicine for you.
Are you taking other medicines?
Some medicines can interfere with your treatment. Tell your doctor or
pharmacist if you are taking any of the following:
* Medicines to treat diabetes
* Anticoagulants (blood thinning tablets like warfarin)
* Diuretics (water tablets)
* Lithium (used to treat some mental problems)
* Methotrexate (for some inflammatory diseases and some cancers)
* Ciclosporin or tacrolimus (used to treat some inflammatory diseases and
after transplants)
* Quinolone antibiotics (for infections)
* Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example
aspirin or ibuprofen
* Mifepristone (a medicine used to terminate pregnancy)
* Cardiac glycosides (for example digoxin), used to treat heart problems
* Medicines known as SSRIs used to treat depression
* Oral steroids (an anti-inflammatory drug)
* Medicines used to treat heart conditions or high blood pressure, for
example beta- blockers or ACE inhibitors.
* Sulfinpyrazone (a medicine used to treat gout) or voriconazole (a medicine
used to treat fungal infections).
* Phenytoin ( a medicine used to treat seizures)
* Colestipol/cholestyramine (used to lower cholesterol)
Always tell your doctor or pharmacist about all the medicines you are taking.
This means medicines you have bought yourself as well as medicines on
prescription from your doctor.
Pregnancy
* Are you pregnant or planning to become pregnant? Although not common,
abnormalities have been reported in babies whose mothers have taken
NSAIDs during pregnancy. You should not take Voltaren Dispersible
Tablets during the last 3 months of pregnancy as it may affect the baby’s
circulation.
* Are you trying for a baby? Taking Voltaren Dispersible Tablets may make it
more difficult to conceive. You should talk to your doctor if you are
planning to become pregnant, or if you have problems getting pregnant.
Will there be any problems with driving or using machinery?
Very occasionally people have reported that Voltaren Dispersible Tablets
have made them feel dizzy, tired or sleepy. Problems with eyesight have
also been reported. If you are affected in this way, you should not drive or
operate machinery.
Other special warnings

* You should take the lowest dose of Voltaren Dispersible Tablets for the
shortest possible time, particularly if you are underweight or elderly.

* There is a small increased risk of heart attack or stroke when you are

*
*
*

*

taking any medicine like Voltaren. The risk is higher if you are taking high
doses for a long time. Always follow the doctor’s instructions on how much
to take and how long to take it for.
Whilst you are taking these medicines your doctor may want to give you a
check-up from time to time.
If you have a history of stomach problems when you are taking NSAIDs,
particularly if you are elderly, you must tell your doctor straight away if you
notice any unusual symptoms.
Because it is an anti-inflammatory medicine, Voltaren Dispersible Tablets
may reduce the symptoms of infection, for example headache, and high
temperature. If you feel unwell and need to see a doctor, remember to tell
him or her that you are taking Voltaren Dispersible Tablets.
Voltaren Dispersible Tablets are not suitable for children.

The tabletsb contain erythrosine and may be unsuitable for some people.

3

How to take Voltaren Dispersible Tablets

The doctor will tell you how many Voltaren Dispersible Tablets to take and
when to take them. Always follow his/her instructions carefully. The dose will
be on the pharmacist’s label. Check the label carefully. If you are not sure,
ask your doctor or pharmacist. Keep taking your tablets for as long as you
have been told, unless you have any problems. In that case, check with
your doctor.
Take the tablets before or with food.
Drop the tablets into a glass of water, and stir. Drink the liquid at once. To
make sure you get all of the medicine, rinse the glass round with a small
amount of water and drink this as well.
The usual doses are:
Adults
One tablet two or three times a day.
Elderly
Your doctor may advise you to take a dose that is lower than the usual adult
dose if you are elderly. Your doctor may also want to check closely that the
Voltaren Dispersible Tablets are not affecting your stomach.
These tablets are not suitable for children.

Ref: 0173/250815/3/B

®

Voltaren 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet (continued)
The doctor may also prescribe another drug to protect the stomach to be
taken at the same time, particularly if you have had stomach problems
before, or if you are elderly, or taking certain other drugs as well.

Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure, presence of blood or
protein in the urine.

What if you forget to take a dose?
If you forget to take a dose, take one as soon as you remember. If it is
nearly time for your next dose, though, just take the next dose and forget
about the one you missed. Do not double up on the next dose to make up
for the one missed. Do not take more than 150 mg (three tablets) in 24
hours.

Effects on skin or hair:
Serious skin rashes including Stevens-Johnson syndrome and Lyell’s
syndrome and other skin rashes which may be made worse by exposure to
sunlight.
Hair loss.

What if you take too many tablets?
If you, or anyone else, accidentally takes too much, tell your doctor or your
nearest hospital casualty department. Take your medicine pack with you so
that people can see what you have taken.

4

Possible side effects

Voltarol Dispersible Tablets are suitable for most people, but, like all
medicines, they can sometimes cause side effects. Side effects may be
minimised by using the lowest effective dose for the shortest duration
necessary.
Some side effects can be serious
Stop taking Voltaren Dispersible Tablets and tell your doctor straight
away if you notice:
* Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or
vomiting (being sick)
* Any sign of bleeding in the stomach or intestine, for example, when
emptying your bowels, blood in vomit or black, tarry faeces
* Allergic reactions which can include skin rash, itching, bruising, painful red
areas, peeling or blistering
* Wheezing or shortness of breath (bronchospasm)
* Swollen face, lips, hands or fingers
* Yellowing of your skin or the whites of your eyes
* Persistent sore throat or high temperature
* An unexpected change in the amount of urine produced and/or its
appearance.
If you notice that you are bruising more easily than usual or have frequent
sore throats or infections, tell your doctor.

Other side effects that have also been reported include:
Inflammation of the pancreas, impotence. Facial swelling, inflammation of
the lining of the brain (meningitis), stroke, throat disorders, confusion,
hallucinations, malaise (general feeling of discomfort), inflammation of the
nerves in the eye.
Do not be alarmed by this list – most people take Voltaren Dispersible
Tablets without any problems.
If any of the symptoms become troublesome, or if you notice anything
else not mentioned here, please go and see your doctor. He/she may
want to give you a different medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* This product contains no flavour.
* Do not store above 25°C.
* Protect from heat and moisture
* Do not use this medicine after the expiry date shown on the carton or

The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 10 in every 100
patients):
* Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind,
loss of appetite
* Headache, dizziness, vertigo
* Skin rash or spots
* Raised levels of liver enzymes in the blood
Rare side effects (These may affect between 1 in every 1000 to 1 in every
10,000 patients):
* Stomach ulcers or bleeding (there have been very rare reported cases
resulting in death, particularly in the elderly)
* Gastritis (inflammation, irritation or swelling of the stomach lining)
* Vomiting blood
* Diarrhoea with blood in it or bleeding from the back passage
* Black, tarry faeces or stools
* Drowsiness, tiredness
* Hypotension (low blood pressure, symptoms of which may include
faintness, giddiness or light headedness)
* Skin rash and itching
* Fluid retention, symptoms of which include swollen ankles
* Liver function disorders, including hepatitis and jaundice
Very Rare side effects (These may affect less than 1 in every 10,000
patients):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual disturbances such as
blurred or double vision, hearing loss or impairment, tinnitus (ringing in the
ears), sleeplessness, nightmares, mood changes, depression, anxiety,
mental disorders, disorientation, and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck, disturbances in
sensation.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation of the
inside of the mouth or lips, taste changes, lower gut disorders (including
inflammation of the colon, or worsening of ulcerative colitis or Crohn’s
disease).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain, hypertension (high
blood pressure), inflammation of blood vessels (vasculitis), inflammation of
the lung (pneumonitis), heart disorders, including congestive heart failure or
heart attack, blood disorders (including anaemia), stroke.

How to store Voltaren Dispersible Tablets

*

blister strip. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult your pharmacist who will
tell you what to do.
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about any
thing, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Further information

What this medicine contains:
Each tablet contains 46.5mg of diclofenac free acid, which is equivalent to
50mg of diclofenac sodium as the active ingredient.
Voltaren 50mg Dispersible Tablets also has the following inactive ingredients: cellulose microcrystaline, sodium starch glycollate, croscarmellose
sodium, silica aerogel, hydrogenated castor oil and talc.
What this medicine looks like and contents of the pack
Voltaren 50mg Dispersible Tablets are white triangular shaped, uncoated,
impressed CG on one side and embossed “V” on the other side.
Voltaren 50mg Dispersible Tablets come in packs of 20 tablets
Manufacturer and Licence Holder
The tablets are manufactured by Novartis Istanbul Turkey and are procured
from within the EU and repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0173

Voltaren 50mg Dispersible Tablets

Voltaren is a registered trademark of Novartis AG
Revision date: 25/08/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0173/250815/1/F

Diclofenac Sodium 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet
What you need to know about Diclofenac Sodium Dispersible Tablets
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to take your medicine.
It contains important information.
* Keep the leaflet in a safe place because you may want to read it again.
* If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Never give it to someone else.
It may not be the right medicine for them even if their symptoms seem to
be the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Diclofenac Sodium 50mg Dispersible Tablets but will
be referred to as Diclofenac Sodium Dispersible Tablets throughout this
leaflet.
In this leaflet:
1
2

What Diclofenac Sodium Dispersible Tablets are, and what they are
used for
Things to consider before you start to take Diclofenac Sodium
Dispersible Tablets

3 How to take Diclofenac Sodium Dispersible Tablets
4 Possible side effects

5 How to store Diclofenac Sodium Dispersible Tablets
6 Further information

1

What Diclofenac Sodium Dispersible Tablets are, and
what they are used for

Diclofenac sodium, the active ingredient in Diclofenac Sodium Dispersible
Tablets, is one of a group of medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). NSAIDs reduce pain and inflammation.
Diclofenac Sodium Dispersible Tablets act quickly and so are used to treat
short term painful conditions affecting the joints and muscles. They are
especially useful for the treatment of sprains, strains and back pain. They
should not be taken for more than three months.

2

Things to consider before you start to take
Diclofenac Sodium Dispersible Tablets

Some people MUST NOT take Diclofenac Sodium Dispersible Tablets.
Talk to your doctor if:
* you think you may be allergic to diclofenac sodium, aspirin, ibuprofen or
any other NSAID, or to any of the other ingredients of Diclofenac Sodium
Dispersible Tablets. (These are listed at the end of the leaflet.) Signs of a
hypersensitivity reaction include swelling of the face and mouth
(angioedema), breathing problems, runny nose, skin rash or any other
allergic type reaction
* you have now, or have ever had, a stomach (gastric) or duodenal (peptic)
ulcer, or bleeding in the digestive tract (this can include blood in vomit,
bleeding when emptying bowels, fresh blood in faeces or black, tarry
faeces)
* you have had stomach or bowel problems after you have taken other
NSAIDs
* you have severe heart, kidney or liver failure
* if you have established heart disease and/or cerebrovascular disease e.g.
if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to
blood vessels to the heart or brain or an operation to clear or bypass
blockages
if
* you have or have had problems with your blood circulation (peripheral
arterial disease)
* you are more than six months pregnant.
You should also ask yourself these questions before taking Diclofenac
Sodium Dispersible Tablets:
* Do you suffer from any stomach or bowel disorders including ulcerative
colitis or Crohn’s disease?
* Do you have kidney or liver problems, or are you elderly?
* Do you have a condition called porphyria?
* Do you suffer from any blood or bleeding disorder? If you do, your doctor
may ask you to go for regular check-ups while you are taking these tablets.
* Have you ever had asthma?
* Are you breast-feeding?
* Do you have angina, blood clots, high blood pressure, raised cholesterol or
raised triglycerides
* Do you have heart problems, or have you had a stroke, or do you think
you might be at risk of these conditions (for example, if you have high
blood pressure, diabetes, or high cholesterol or are you a smoker)?
* Do you have diabetes
* Do you smoke
* Do you have Lupus (SLE) or any similar condition?

If the answer to any of these questions is YES, discuss your treatment
with your doctor or pharmacist because Diclofenac Sodium Dispersible
Tablets might not be the right medicine for you.
Are you taking other medicines?
Some medicines can interfere with your treatment. Tell your doctor or
pharmacist if you are taking any of the following:
* Medicines to treat diabetes
* Anticoagulants (blood thinning tablets like warfarin)
* Diuretics (water tablets)
* Lithium (used to treat some mental problems)
* Methotrexate (for some inflammatory diseases and some cancers)
* Ciclosporin and tacrolimus (used to treat some inflammatory diseases and
after transplants)
* Trimethoprim (a medicine used to prevent or treat urinary tract infections)
* Quinolone antibiotics (for infections)
* Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example
aspirin or ibuprofen
* Mifepristone (a medicine used to terminate pregnancy)
* Cardiac glycosides (for example digoxin), used to treat heart problems
* Medicines known as SSRIs used to treat depression
* Oral steroids (an anti-inflammatory drug)
* Medicines used to treat heart conditions or high blood pressure, for
example beta- blockers or ACE inhibitors.
* Voriconazole (a medicine used to treat fungal infections).
* Phenytoin (a medicine used to treat seizures)
* Colestipol/cholestyramine (used to lower cholesterol)
Always tell your doctor or pharmacist about all the medicines you are taking.
This means medicines you have bought yourself as well as medicines on
prescription from your doctor.
Pregnancy
* Are you pregnant or planning to become pregnant? Although not common,
abnormalities have been reported in babies whose mothers have taken
NSAIDs during pregnancy. You should not take Diclofenac Sodium
Dispersible Tablets during the last 3 months of pregnancy as it may affect
the baby’s circulation.
* Are you trying for a baby? Taking Diclofenac Sodium Dispersible Tablets
may make it more difficult to conceive. You should talk to your doctor if
you
are planning to become pregnant, or if you have problems getting
pregnant.
Will there be any problems with driving or using machinery?
Very occasionally people have reported that Diclofenac Sodium Dispersible
Tablets have made them feel dizzy, tired or sleepy. Problems with eyesight
have also been reported. If you are affected in this way, you should not drive
or operate machinery.
Other special warnings

* You should take the lowest dose of Diclofenac Sodium Dispersible Tablets

for the shortest possible time, particularly if you are underweight or elderly.

* There is a small increased risk of heart attack or stroke when you are

*
*
*

*

taking any medicine like Diclofenac Sodium. The risk is higher if you are
taking high doses for a long time. Always follow the doctor’s instructions
on how much to take and how long to take it for.
Whilst you are taking these medicines your doctor may want to give you a
check-up from time to time.
If you have a history of stomach problems when you are taking NSAIDs,
particularly if you are elderly, you must tell your doctor straight away if you
notice any unusual symptoms.
Because it is an anti-inflammatory medicine, Diclofenac Sodium
Dispersible Tablets may reduce the symptoms of infection, for example
headache, and high temperature. If you feel unwell and need to see a
doctor, remember to tell him or her that you are taking Diclofenac Sodium
Dispersible Tablets
Diclofenac Sodium Dispersible Tablets are not suitable for children.

The tablets contain erythrosine and may be unsuitable for some people.

3

How to take Diclofenac Sodium Dispersible Tablets

The doctor will tell you how many Diclofenac Sodium Dispersible Tablets to
take and when to take them. Always follow his/her instructions carefully. The
dose will be on the pharmacist’s label. Check the label carefully. If you are
not sure, ask your doctor or pharmacist. Keep taking your tablets for as long
as you have been told, unless you have any problems. In that case, check
with your doctor.
Take the tablets before or with food.
Drop the tablets into a glass of water, and stir. Drink the liquid at once. To
make sure you get all of the medicine, rinse the glass round with a small
amount of water and drink this as well.
The usual doses are:
Adults
One tablet two or three times a day.
Elderly
Your doctor may advise you to take a dose that is lower than the usual adult
dose if you are elderly. Your doctor may also want to check closely that the
Diclofenac Sodium Dispersible Tablets are not affecting your stomach.
These tablets are not suitable for children.

Ref: 0173/250815/1/B

Diclofenac Sodium 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet (continued)
The doctor may also prescribe another drug to protect the stomach to be
taken at the same time, particularly if you have had stomach problems
before, or if you are elderly, or taking certain other drugs as well.

Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure, presence of blood or
protein in the urine.

What if you forget to take a dose?
If you forget to take a dose, take one as soon as you remember. If it is
nearly time for your next dose, though, just take the next dose and forget
about the one you missed. Do not double up on the next dose to make up
for the one missed. Do not take more than 150 mg (three tablets) in 24
hours.

Effects on skin or hair:
Serious skin rashes including Stevens-Johnson syndrome and Lyell’s
syndrome and other skin rashes which may be made worse by exposure to
sunlight.
Hair loss.

What if you take too many tablets?
If you, or anyone else, accidentally takes too much, tell your doctor or your
nearest hospital casualty department. Take your medicine pack with you so
that people can see what you have taken.

4

Possible side effects

Voltarol Dispersible Tablets are suitable for most people, but, like all
medicines, they can sometimes cause side effects. Side effects may be
minimised by using the lowest effective dose for the shortest duration
necessary.
Some side effects can be serious
Stop taking Diclofenac Sodium Dispersible Tablets and tell your doctor
straight away if you notice:
* Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or
vomiting (being sick)
* Any sign of bleeding in the stomach or intestine, for example, when
emptying your bowels, blood in vomit or black, tarry faeces
* Allergic reactions which can include skin rash, itching, bruising, painful red
areas, peeling or blistering
* Wheezing or shortness of breath (bronchospasm)
* Swollen face, lips, hands or fingers
* Yellowing of your skin or the whites of your eyes
* Persistent sore throat or high temperature
* An unexpected change in the amount of urine produced and/or its
appearance.
If you notice that you are bruising more easily than usual or have frequent
sore throats or infections, tell your doctor.

Other side effects that have also been reported include:
Inflammation of the pancreas, impotence. Facial swelling, inflammation of
the lining of the brain (meningitis), stroke, throat disorders, confusion,
hallucinations, malaise (general feeling of discomfort), inflammation of the
nerves in the eye.
Do not be alarmed by this list – most people take Diclofenac Sodium
Dispersible Tablets without any problems.
If any of the symptoms become troublesome, or if you notice anything
else not mentioned here, please go and see your doctor. He/she may
want to give you a different medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* This product contains no flavour.
* Do not store above 25°C.
* Protect from heat and moisture
* Do not use this medicine after the expiry date shown on the carton or

The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 10 in every 100
patients):
* Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind,
loss of appetite
* Headache, dizziness, vertigo
* Skin rash or spots
* Raised levels of liver enzymes in the blood
Rare side effects (These may affect between 1 in every 1000 to 1 in every
10,000 patients):
* Stomach ulcers or bleeding (there have been very rare reported cases
resulting in death, particularly in the elderly)
* Gastritis (inflammation, irritation or swelling of the stomach lining)
* Vomiting blood
* Diarrhoea with blood in it or bleeding from the back passage
* Black, tarry faeces or stools
* Drowsiness, tiredness
* Hypotension (low blood pressure, symptoms of which may include
faintness, giddiness or light headedness)
* Skin rash and itching
* Fluid retention, symptoms of which include swollen ankles
* Liver function disorders, including hepatitis and jaundice
Very Rare side effects (These may affect less than 1 in every 10,000
patients):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual disturbances such as
blurred or double vision, hearing loss or impairment, tinnitus (ringing in the
ears), sleeplessness, nightmares, mood changes, depression, anxiety,
mental disorders, disorientation, and loss of memory, fits, headaches
together with a dislike of bright lights, fever and a stiff neck, disturbances in
sensation.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation of the
inside of the mouth or lips, taste changes, lower gut disorders (including
inflammation of the colon, or worsening of ulcerative colitis or Crohn’s
disease).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain, hypertension (high
blood pressure), inflammation of blood vessels (vasculitis), inflammation of
the lung (pneumonitis), heart disorders, including congestive heart failure or
heart attack, blood disorders (including anaemia), stroke.

How to store Diclofenac Sodium Dispersible Tablets

*

blister strip. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult your pharmacist who will
tell you what to do.
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about any
thing, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Further information

What this medicine contains:
Each tablet contains 46.5mg of diclofenac free acid, which is equivalent to
50mg of diclofenac sodium as the active ingredient.
Diclofenac Sodium 50mg Dispersible Tablets also has the following inactive
ingredients: cellulose microcrystaline, sodium starch glycollate,
croscarmellose sodium, silica aerogel, hydrogenated castor oil and talc.
What this medicine looks like and contents of the pack
Diclofenac Sodium 50mg Dispersible Tablets are white triangular shaped,
uncoated, impressed CG on one side and embossed “V” on the other side.
Diclofenac Sodium 50mg Dispersible Tablets come in packs of 20 tablets
Manufacturer and Licence Holder
The tablets are manufactured by Novartis Pharma AG, Stein, Switzerland
and are procured from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0173

Diclofenac Sodium 50mg Dispersible Tablets

Revision date: 25/08/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0173/250815/2/F

Diclofenac Sodium 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet
What you need to know about Diclofenac Sodium Dispersible Tablets
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to take your medicine.
It contains important information.
* Keep the leaflet in a safe place because you may want to read it again.
* If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Never give it to someone else.
It may not be the right medicine for them even if their symptoms seem to
be the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Diclofenac Sodium 50mg Dispersible Tablets but will
be referred to as Diclofenac Sodium Dispersible Tablets throughout this
leaflet.
In this leaflet:
1 What Diclofenac Sodium Dispersible Tablets are, and what they are
used for
2 Things to consider before you start to take Diclofenac Sodium
Dispersible Tablets
3 How to take Diclofenac Sodium Dispersible Tablets
4 Possible side effects
5 How to store Diclofenac Sodium Dispersible Tablets
6 Further information
1

What Diclofenac Sodium Dispersible Tablets are,
and what they are used for

Diclofenac sodium, the active ingredient in Diclofenac Sodium Dispersible
Tablets, is one of a group of medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). NSAIDs reduce pain and inflammation.
Diclofenac Sodium Dispersible Tablets act quickly and so are used to treat
short term painful conditions affecting the joints and muscles. They are
especially useful for the treatment of sprains, strains and back pain. They
should not be taken for more than three months.

2

Things to consider before you start to take
Diclofenac Sodium Dispersible Tablets

Some people MUST NOT take Diclofenac Sodium Dispersible Tablets.
Talk to your doctor if:
* you think you may be allergic to diclofenac sodium, aspirin, ibuprofen or
any other NSAID, or to any of the other ingredients of Diclofenac Sodium
Tablets. (These are listed at the end of the leaflet.) Signs of a
hypersensitivity reaction include swelling of the face and mouth
(angioedema), breathing problems, runny nose, skin rash or any other
allergic type reaction
* you have now, or have ever had, a stomach (gastric) or duodenal (peptic)
ulcer, or bleeding in the digestive tract (this can include blood in vomit,
bleeding when emptying bowels, fresh blood in faeces or black, tarry
faeces)
* you have had stomach or bowel problems after you have taken other
NSAIDs
* you have severe heart, kidney or liver failure
* if you have established heart disease and/or cerebrovascular disease e.g.
if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to
blood vessels to the heart or brain or an operation to clear or bypass
blockages
if
* you have or have had problems with your blood circulation (peripheral
arterial disease)
* you are more than six months pregnant.
You should also ask yourself these questions before taking Diclofenac
Sodium Dispersible Tablets:
* Do you suffer from any stomach or bowel disorders including ulcerative
colitis or Crohn’s disease?
Do
you have kidney or liver problems, or are you elderly?
*
* Do you have a condition called porphyria?
* Do you suffer from any blood or bleeding disorder? If you do, your doctor
may ask you to go for regular check-ups while you are taking these
tablets.
* Have you ever had asthma?
* Are you breast-feeding?
* Do you have angina, blood clots, high blood pressure, raised cholesterol
or raised triglycerides
* Do you have heart problems, or have you had a stroke, or do you think
you might be at risk of these conditions (for example, if you have high
blood pressure, diabetes, or high cholesterol or are you a smoker)?
* Do you have diabetes
* Do you smoke
* Do you have Lupus (SLE) or any similar condition?

If the answer to any of these questions is YES, discuss your treatment
with your doctor or pharmacist because Diclofenac Sodium Dispersible
Tablets might not be the right medicine for you.
Are you taking other medicines?
Some medicines can interfere with your treatment. Tell your doctor or
pharmacist if you are taking any of the following:
* Medicines to treat diabetes
* Anticoagulants (blood thinning tablets like warfarin)
* Diuretics (water tablets)
* Lithium (used to treat some mental problems)
* Methotrexate (for some inflammatory diseases and some cancers)
* Ciclosporin and tacrolimus (used to treat some inflammatory diseases and
after transplants)
* Trimethoprim (a medicine used to prevent or treat urinary tract infections)
* Quinolone antibiotics (for infections)
* Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example
aspirin or ibuprofen
* Mifepristone (a medicine used to terminate pregnancy)
* Cardiac glycosides (for example digoxin), used to treat heart problems
* Medicines known as SSRIs used to treat depression
* Oral steroids (an anti-inflammatory drug)
* Medicines used to treat heart conditions or high blood pressure, for
example beta- blockers or ACE inhibitors.
* Voriconazole (a medicine used to treat fungal infections).
* Phenytoin (a medicine used to treat seizures)
* Colestipol/cholestyramine (used to lower cholesterol)
Always tell your doctor or pharmacist about all the medicines you are taking.
This means medicines you have bought yourself as well as medicines on
prescription from your doctor.
Pregnancy
* Are you pregnant or planning to become pregnant? Although not common,
abnormalities have been reported in babies whose mothers have taken
NSAIDs during pregnancy. You should not take Diclofenac Sodium
Dispersible Tablets during the last 3 months of pregnancy as it may affect
the baby’s circulation.
* Are you trying for a baby? Taking Diclofenac Sodium Dispersible Tablets
may make it more difficult to conceive. You should talk to your doctor if
you
are planning to become pregnant, or if you have problems getting
pregnant.
Will there be any problems with driving or using machinery?
Very occasionally people have reported that Diclofenac Sodium Dispersible
Tablets have made them feel dizzy, tired or sleepy. Problems with eyesight
have also been reported. If you are affected in this way, you should not drive
or operate machinery.
Other special warnings

* You should take the lowest dose of Diclofenac Sodium Dispersible Tablets

for the shortest possible time, particularly if you are underweight or elderly.

* There is a small increased risk of heart attack or stroke when you are

*
*
*

*

taking any medicine like Diclofenac Sodium. The risk is higher if you are
taking high doses for a long time. Always follow the doctor’s instructions
on how much to take and how long to take it for.
Whilst you are taking these medicines your doctor may want to give you a
check-up from time to time.
If you have a history of stomach problems when you are taking NSAIDs,
particularly if you are elderly, you must tell your doctor straight away if you
notice any unusual symptoms.
Because it is an anti-inflammatory medicine, Diclofenac Sodium
Dispersible Tablets may reduce the symptoms of infection, for example
headache, and high temperature. If you feel unwell and need to see a
doctor, remember to tell him or her that you are taking Voltarol Dispersible
Tablets.
Diclofenac Sodium Dispersible Tablets are not suitable for children.

The tablets contain erythrosine and may be unsuitable for some people.

3

How to take Diclofenac Sodium Dispersible Tablets

The doctor will tell you how many Diclofenac Sodium Dispersible Tablets to
take and when to take them. Always follow his/her instructions carefully. The
dose will be on the pharmacist’s label. Check the label carefully. If you are
not sure, ask your doctor or pharmacist. Keep taking your tablets for as long
as you have been told, unless you have any problems. In that case, check
with your doctor.
Take the tablets before or with food.
Drop the tablets into a glass of water, and stir. Drink the liquid at once. To
make sure you get all of the medicine, rinse the glass round with a small
amount of water and drink this as well.
The usual doses are:
Adults
One tablet two or three times a day.
Elderly
Your doctor may advise you to take a dose that is lower than the usual adult
dose if you are elderly. Your doctor may also want to check closely that the
Diclofenac Sodium Dispersible Tablets are not affecting your stomach.
These tablets are not suitable for children.

Ref: 0173/250815/2/B

Diclofenac Sodium 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet (continued)
The doctor may also prescribe another drug to protect the stomach to be
taken at the same time, particularly if you have had stomach problems
before, or if you are elderly, or taking certain other drugs as well.

Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure, presence of blood or
protein in the urine.

What if you forget to take a dose?
If you forget to take a dose, take one as soon as you remember. If it is
nearly time for your next dose, though, just take the next dose and forget
about the one you missed. Do not double up on the next dose to make up
for the one missed. Do not take more than 150 mg (three tablets) in 24
hours.

Effects on skin or hair:
Serious skin rashes including Stevens-Johnson syndrome and Lyell’s
syndrome and other skin rashes which may be made worse by exposure to
sunlight.
Hair loss.

What if you take too many tablets?
If you, or anyone else, accidentally takes too much, tell your doctor or your
nearest hospital casualty department. Take your medicine pack with you so
that people can see what you have taken.

4

Possible side effects

Voltarol Dispersible Tablets are suitable for most people, but, like all
medicines, they can sometimes cause side effects. Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
Some side effects can be serious
Stop taking Diclofenac Sodium Dispersible Tablets and tell your doctor
straight away if you notice:
* Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or
vomiting (being sick)
* Any sign of bleeding in the stomach or intestine, for example, when
emptying your bowels, blood in vomit or black, tarry faeces
* Allergic reactions which can include skin rash, itching, bruising, painful red
areas, peeling or blistering
* Wheezing or shortness of breath (bronchospasm)
* Swollen face, lips, hands or fingers
* Yellowing of your skin or the whites of your eyes
* Persistent sore throat or high temperature
* An unexpected change in the amount of urine produced and/or its
appearance.
If you notice that you are bruising more easily than usual or have frequent
sore throats or infections, tell your doctor.

Other side effects that have also been reported include:
Inflammation of the pancreas, impotence. Facial swelling, inflammation of
the lining of the brain (meningitis), stroke, throat disorders, confusion,
hallucinations, malaise (general feeling of discomfort), inflammation of the
nerves in the eye.
Do not be alarmed by this list – most people take Diclofenac Sodium
Dispersible Tablets without any problems.
If any of the symptoms become troublesome, or if you notice anything
else not mentioned here, please go and see your doctor. He/she may
want to give you a different medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* This product contains no flavour.
* Do not store above 25°C.
* Protect from heat and moisture
* Do not use this medicine after the expiry date shown on the carton or

The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 10 in every 100
patients):
* Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind,
loss of appetite
* Headache, dizziness, vertigo
* Skin rash or spots
* Raised levels of liver enzymes in the blood
Rare side effects (These may affect between 1 in every 1000 to 1 in every
10,000 patients):
* Stomach ulcers or bleeding (there have been very rare reported cases
resulting in death, particularly in the elderly)
* Gastritis (inflammation, irritation or swelling of the stomach lining)
* Vomiting blood
* Diarrhoea with blood in it or bleeding from the back passage
* Black, tarry faeces or stools
* Drowsiness, tiredness
* Hypotension (low blood pressure, symptoms of which may include
faintness, giddiness or light headedness)
* Skin rash and itching
* Fluid retention, symptoms of which include swollen ankles
* Liver function disorders, including hepatitis and jaundice
Very Rare side effects (These may affect less than 1 in every 10,000
patients):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual disturbances such as
blurred or double vision, hearing loss or impairment, tinnitus (ringing in the
ears), sleeplessness, nightmares, mood changes, depression, anxiety,
mental disorders, disorientation, and loss of memory, fits, headaches
together with a dislike of bright lights, fever and a stiff neck, disturbances in
sensation.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation of the
inside of the mouth or lips, taste changes, lower gut disorders (including
inflammation of the colon, or worsening of ulcerative colitis or Crohn’s
disease).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain, hypertension (high
blood pressure), inflammation of blood vessels (vasculitis), inflammation of
the lung (pneumonitis), heart disorders, including congestive heart failure or
heart attack, blood disorders (including anaemia), stroke.

How to store Diclofenac Sodium Dispersible Tablets

*

blister strip. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult your pharmacist who will
tell you what to do.
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about any
thing, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Further information

What this medicine contains:
Each tablet contains 46.5mg of diclofenac free acid, which is equivalent to
50mg of diclofenac sodium as the active ingredient.
Diclofenac Sodium 50mg Dispersible Tablets also has the following inactive
ingredients: cellulose microcrystaline, sodium starch glycollate,
croscarmellose sodium, silica aerogel, hydrogenated castor oil and talc.
What this medicine looks like and contents of the pack
Diclofenac Sodium 50mg Dispersible Tablets are white triangular shaped,
uncoated, impressed CG on one side and embossed “V” on the other side.
Diclofenac Sodium 50mg Dispersible Tablets come in packs of 20 tablets
Manufacturer and Licence Holder
The tablets are manufactured by Novartis Pharma Productions GmbH, Wehr,
Germany and are procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0173

Diclofenac Sodium 50mg Dispersible Tablets

Revision date: 25/08/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0173/250815/3/F

Diclofenac Sodium 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet
What you need to know about Diclofenac Sodium Dispersible Tablets
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to take your medicine.
It contains important information.
* Keep the leaflet in a safe place because you may want to read it again.
* If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
* This medicine has been prescribed for you. Never give it to someone else.
It may not be the right medicine for them even if their symptoms seem to
be the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Diclofenac Sodium 50mg Dispersible Tablets but will
be referred to as Diclofenac Sodium Dispersible Tablets throughout this
leaflet.
In this leaflet:
1 What Diclofenac Sodium Dispersible Tablets are, and what they are
used for
2 Things to consider before you start to take Diclofenac Sodium
Dispersible Tablets
3 How to take Diclofenac Sodium Dispersible Tablets
4 Possible side effects
5 How to store Diclofenac Sodium Dispersible Tablets
6 Further information

1

What Diclofenac Sodium Dispersible Tablets are, and
what they are used for

Diclofenac sodium, the active ingredient in Diclofenac Sodium Dispersible
Tablets, is one of a group of medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). NSAIDs reduce pain and inflammation.
Diclofenac Sodium Dispersible Tablets act quickly and so are used to treat
short term painful conditions affecting the joints and muscles. They are
especially useful for the treatment of sprains, strains and back pain. They
should not be taken for more than three months.

2
m

Things to consider before you start to take
Diclofenac Sodium Dispersible Tablets

Some people MUST NOT take Diclofenac Sodium Dispersible Tablets.
Talk to your doctor if:
* you think you may be allergic to diclofenac sodium, aspirin, ibuprofen or
any other NSAID, or to any of the other ingredients of Diclofenac
Dispersible Tablets. (These are listed at the end of the leaflet.) Signs of a
hypersensitivity reaction include swelling of the face and mouth
(angioedema), breathing problems, runny nose, skin rash or any other
allergic type reaction
* you have now, or have ever had, a stomach (gastric) or duodenal (peptic)
ulcer, or bleeding in the digestive tract (this can include blood in vomit,
bleeding when emptying bowels, fresh blood in faeces or black, tarry
faeces)
* you have had stomach or bowel problems after you have taken other
NSAIDs
* you have severe heart, kidney or liver failure
* if you have established heart disease and/or cerebrovascular disease e.g.
if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to
blood vessels to the heart or brain or an operation to clear or bypass
blockages
* if you have or have had problems with your blood circulation
(peripheral arterial disease)
* you are more than six months pregnant.
You should also ask yourself these questions before taking Diclofenac
Sodium Dispersible Tablets:
* Do you suffer from any stomach or bowel disorders including ulcerative
colitis or Crohn’s disease?
Do
you have kidney or liver problems, or are you elderly?
*
* Do you have a condition called porphyria?
* Do you suffer from any blood or bleeding disorder? If you do, your doctor
may ask you to go for regular check-ups while you are taking these
tablets.
* Have you ever had asthma?
* Are you breast-feeding?
* Do you have angina, blood clots, high blood pressure, raised cholesterol or
raised triglycerides
* Do you have heart problems, or have you had a stroke, or do you think
you might be at risk of these conditions (for example, if you have high
blood pressure, diabetes, or high cholesterol or are you a smoker)?
Do
you have diabetes
*
* Do you smoke
* Do you have Lupus (SLE) or any similar condition?

If the answer to any of these questions is YES, discuss your treatment
with your doctor or pharmacist because Diclofenac Sodium Dispersible
Tablets might not be the right medicine for you.
Are you taking other medicines?
Some medicines can interfere with your treatment. Tell your doctor or
pharmacist if you are taking any of the following:
* Medicines to treat diabetes
* Anticoagulants (blood thinning tablets like warfarin)
* Diuretics (water tablets)
* Lithium (used to treat some mental problems)
* Methotrexate (for some inflammatory diseases and some cancers)
* Ciclosporin and tacrolimus (used to treat some inflammatory diseases and
after transplants)
* Trimethoprim (a medicine used to prevent or treat urinary tract infections)
* Quinolone antibiotics (for infections)
* Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example
aspirin or ibuprofen
* Mifepristone (a medicine used to terminate pregnancy)
* Cardiac glycosides (for example digoxin), used to treat heart problems
* Medicines known as SSRIs used to treat depression
* Oral steroids (an anti-inflammatory drug)
* Medicines used to treat heart conditions or high blood pressure, for
example beta- blockers or ACE inhibitors.
* Voriconazole (a medicine used to treat fungal infections).
* Phenytoin (a medicine used to treat seizures)
* Colestipol/cholestyramine (used to lower cholesterol)
Always tell your doctor or pharmacist about all the medicines you are taking.
This means medicines you have bought yourself as well as medicines on
prescription from your doctor.
Pregnancy
* Are you pregnant or planning to become pregnant? Although not common,
abnormalities have been reported in babies whose mothers have taken
NSAIDs during pregnancy. You should not take Diclofenac Sodium
Dispersible Tablets during the last 3 months of pregnancy as it may affect
the baby’s circulation.
* Are you trying for a baby? Taking Diclofenac Sodium Dispersible Tablets
may make it more difficult to conceive. You should talk to your doctor if
you
are planning to become pregnant, or if you have problems getting
pregnant.
Will there be any problems with driving or using machinery?
Very occasionally people have reported that Diclofenac Sodium Dispersible
Tablets have made them feel dizzy, tired or sleepy. Problems with eyesight
have also been reported. If you are affected in this way, you should not drive
or operate machinery.
Other special warnings

* You should take the lowest dose of Diclofenac Sodium Dispersible Tablets

for the shortest possible time, particularly if you are underweight or elderly.

* There is a small increased risk of heart attack or stroke when you are

*
*
*

*

taking any medicine like Diclofenac Sodium. The risk is higher if you are
taking high doses for a long time. Always follow the doctor’s instructions
on how much to take and how long to take it for.
Whilst you are taking these medicines your doctor may want to give you a
check-up from time to time.
If you have a history of stomach problems when you are taking NSAIDs,
particularly if you are elderly, you must tell your doctor straight away if you
notice any unusual symptoms.
Because it is an anti-inflammatory medicine, Diclofenac Sodium
Dispersible Tablets may reduce the symptoms of infection, for example
headache, and high temperature. If you feel unwell and need to see a
doctor, remember to tell him or her that you are taking Diclofenac Sodium
Dispersible Tablets.
Diclofenac Sodium Dispersible Tablets are not suitable for children.

The tablets contain erythrosine and may be unsuitable for some people.

3

How to take Diclofenac Sodium Dispersible Tablets

The doctor will tell you how many Diclofenac Sodium Dispersible Tablets to
take and when to take them. Always follow his/her instructions carefully. The
dose will be on the pharmacist’s label. Check the label carefully. If you are
not sure, ask your doctor or pharmacist. Keep taking your tablets for as long
as you have been told, unless you have any problems. In that case, check
with your doctor.
Take the tablets before or with food.
Drop the tablets into a glass of water, and stir. Drink the liquid at once. To
make sure you get all of the medicine, rinse the glass round with a small
amount of water and drink this as well.
The usual doses are:
Adults
One tablet two or three times a day.
Elderly
Your doctor may advise you to take a dose that is lower than the usual adult
dose if you are elderly. Your doctor may also want to check closely that the
Diclofenac Sodium Dispersible Tablets are not affecting your stomach.
These tablets are not suitable for children.

Ref: 0173/250815/3/B

Diclofenac Sodium 50mg Dispersible Tablets
(diclofenac sodium)
Patient Information Leaflet (continued)
The doctor may also prescribe another drug to protect the stomach to be
taken at the same time, particularly if you have had stomach problems
before, or if you are elderly, or taking certain other drugs as well.
What if you forget to take a dose?
If you forget to take a dose, take one as soon as you remember. If it is
nearly time for your next dose, though, just take the next dose and forget
about the one you missed. Do not double up on the next dose to make up
for the one missed. Do not take more than 150 mg (three tablets) in 24
hours.
What if you take too many tablets?
If you, or anyone else, accidentally takes too much, tell your doctor or your
nearest hospital casualty department. Take your medicine pack with you so
that people can see what you have taken.

Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure, presence of blood or
protein in the urine.
Effects on skin or hair:
Serious skin rashes including Stevens-Johnson syndrome and Lyell’s
syndrome and other skin rashes which may be made worse by exposure to
sunlight.
Hair loss.
Other side effects that have also been reported include:
Inflammation of the pancreas, impotence. Facial swelling, inflammation of
the lining of the brain (meningitis), stroke, throat disorders, confusion,
hallucinations, malaise (general feeling of discomfort), inflammation of the
nerves in the eye.
Do not be alarmed by this list – most people take Diclofenac Sodium
Dispersible Tablets without any problems.

4

Possible side effects

Voltarol Dispersible Tablets are suitable for most people, but, like all
medicines, they can sometimes cause side effects. Side effects may be
minimised by using the lowest effective dose for the shortest duration
necessary.
Some side effects can be serious
Stop taking Diclofenac Sodium Dispersible Tablets and tell your doctor
straight away if you notice:
* Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or
vomiting (being sick)
* Any sign of bleeding in the stomach or intestine, for example, when
emptying your bowels, blood in vomit or black, tarry faeces
* Allergic reactions which can include skin rash, itching, bruising, painful red
areas, peeling or blistering
* Wheezing or shortness of breath (bronchospasm)
* Swollen face, lips, hands or fingers
* Yellowing of your skin or the whites of your eyes
* Persistent sore throat or high temperature
* An unexpected change in the amount of urine produced and/or its
appearance.

If any of the symptoms become troublesome, or if you notice anything
else not mentioned here, please go and see your doctor. He/she may
want to give you a different medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

* KEEP OUT OF SIGHT AND REACH OF CHILDREN
* This product contains no flavour.
* Do not store above 25°C.
* Protect from heat and moisture
* Do not use this medicine after the expiry date shown on the carton or

If you notice that you are bruising more easily than usual or have frequent
sore throats or infections, tell your doctor.
The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 10 in every 100
patients):
* Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind,
loss of appetite
* Headache, dizziness, vertigo
* Skin rash or spots
* Raised levels of liver enzymes in the blood
Rare side effects (These may affect between 1 in every 1000 to 1 in every
10,000 patients):
* Stomach ulcers or bleeding (there have been very rare reported cases
resulting in death, particularly in the elderly)
* Gastritis (inflammation, irritation or swelling of the stomach lining)
* Vomiting blood
* Diarrhoea with blood in it or bleeding from the back passage
* Black, tarry faeces or stools
* Drowsiness, tiredness
* Hypotension (low blood pressure, symptoms of which may include
faintness, giddiness or light headedness)
* Skin rash and itching
* Fluid retention, symptoms of which include swollen ankles
* Liver function disorders, including hepatitis and jaundice
Very Rare side effects (These may affect less than 1 in every 10,000
patients):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual disturbances such as
blurred or double vision, hearing loss or impairment, tinnitus (ringing in the
ears), sleeplessness, nightmares, mood changes, depression, anxiety,
mental disorders, disorientation, and loss of memory, fits, headaches
together with a dislike of bright lights, fever and a stiff neck, disturbances in
sensation.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation of the
inside of the mouth or lips, taste changes, lower gut disorders (including
inflammation of the colon, or worsening of ulcerative colitis or Crohn’s
disease).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain, hypertension (high
blood pressure), inflammation of blood vessels (vasculitis), inflammation of
the lung (pneumonitis), heart disorders, including congestive heart failure or
heart attack, blood disorders (including anaemia), stroke.

How to store Diclofenac Sodium Dispersible Tablets

*

blister strip. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult your pharmacist who will
tell you what to do.
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about any
thing, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Further information

What this medicine contains:
Each tablet contains 46.5mg of diclofenac free acid, which is equivalent to
50mg of diclofenac sodium as the active ingredient.
Diclofenac Sodium 50mg Dispersible Tablets also has the following inactive
ingredients: cellulose microcrystaline, sodium starch glycollate,
croscarmellose sodium, silica aerogel, hydrogenated castor oil and talc.
What this medicine looks like and contents of the pack
Diclofenac Sodium 50mg Dispersible Tablets are white triangular shaped,
uncoated, impressed CG on one side and embossed “V” on the other side.
Diclofenac Sodium 50mg Dispersible Tablets come in packs of 20 tablets
Manufacturer and Licence Holder
The tablets are manufactured by Novartis Istanbul Turkey and are procured
from within the EU and repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0173

Diclofenac Sodium 50mg Dispersible Tablets

Revision date: 25/08/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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