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DICLOFENAC POTASSIUM 50MG RAPID TABLETS

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500611/PL1g

®

Voltarol Rapid 50 mg Tablets
(diclofenac potassium)

Patient Information Leaflet
®
The name of your medicine is Voltarol Rapid 50 mg Tablets,
®
throughout this leaflet it will be referred to as Voltarol Rapid.
Other strength ’25 mg’ is also available.
®

What you need to know about Voltarol Rapid
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.
In this leaflet:
®
1) What Voltarol Rapid is and what it is used for
®
2) Things to consider before you start to take Voltarol
Rapid
®
3) How to take Voltarol Rapid
4) Possible side effects
®
5) How to store Voltarol Rapid
6) Further information

If the answer to any of these questions is YES, discuss
your treatment with your doctor or pharmacist because
®
Voltarol Rapid 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.

®

1) WHAT VOLTAROL RAPID IS AND WHAT IT IS USED
FOR
®
Diclofenac potassium, the active ingredient in Voltarol Rapid,
is one of a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs). NSAIDs reduce pain and
inflammation.
®

Voltarol Rapid relieves pain, reduces swelling and eases
inflammation in:
• Rheumatoid arthritis, osteoarthrosis, acute gout, low
back pain, ankylosing spondolytis
• Migraine
• Conditions affecting the joints and muscles such as
sprains and strains, soft tissue sports injuries, frozen
shoulder, dislocations, and fractures
• Conditions affecting the tendons for example,
tendonitis, tenosynovitis, bursitis.
It is also used to treat pain and inflammation associated with
orthopaedic, dental and other minor surgery.
2) THINGS TO CONSIDER BEFORE YOU START TO TAKE
®
VOLTAROL RAPID
®
Some people MUST NOT take Voltarol Rapid. Talk to
your doctor if:
• you think you may be allergic to diclofenac potassium,
aspirin, ibuprofen or any other NSAID, or to any of the
®
other ingredients of Voltarol Rapid. (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 Rapid:
• 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 a
smoker)?
• Do you have diabetes?
• Do you smoke?
• Do you have Lupus (SLE) or any similar condition?
• Do you have an intolerance to some sugars such as
®
sucrose? (Voltarol Rapid contains sucrose.)

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 Rapid
during the last 3 months of pregnancy as it may affect
the baby’s circulation.
®
• Are you trying for a baby? Taking Voltarol Rapid 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 Rapid
has 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 Rapid 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 Rapid.
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
Rapid 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 Rapid.
®

3) HOW TO TAKE VOLTAROL RAPID
®
The doctor will tell you how much Voltarol Rapid to take and
when to take it. 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 with or after food.
®

Voltarol Rapid is specially formulated to act quickly. Swallow
the tablets whole with a drink of water. Do not crush or chew
them.
The usual doses are:
Adults
75 mg to 150 mg daily divided into two or three doses. The
number of tablets you take will depend on the strength the
doctor has given you.
For the relief of migraine in adults:
Take 50 mg at the first signs of an attack. If the migraine has
not gone after 2 hours, take another 50 mg. You can take
further doses at intervals of 4 to 6 hours if necessary, but you
must not take more than 200 mg in 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 Rapid Tablets are not
affecting your stomach.
Continued overleaf

Children over 14
75 mg to 100 mg daily divided into two or three doses.
®

Voltarol Rapid is not recommended for children under
14. It is not recommended for the treatment of migraine in
children of any age.
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 50 mg tablets
or six 25 mg 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 Rapid is suitable for most people, but, like all
medicines, it 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 Rapid 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.
The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 1
in 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.

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.
Medicines such as diclofenac may be associated with a small
increased risk of heart attack or stroke.
Do not be alarmed by this list - most people take Voltarol
Rapid without any problems.

®

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) HOW TO STORE VOLTAROL RAPID

Protect from moisture.

Do not store above 30°C.

Store in the original package.

Keep out of the sight and reach of children.
®

Do not take Voltarol Rapid after the expiry date which
is printed on the outside of the pack.

If your doctor tells you to stop taking the tablets,
please take any unused tablets back to your
pharmacist to be destroyed. Do not throw them away
with your normal household water or waste. This will
help to protect the environment.

If the tablets become discoloured or show signs of any
deterioration, consult your doctor or pharmacist who
will tell you what to do.
6) FURTHER INFORMATION
Each tablet contains 50 mg of the active ingredient diclofenac
potassium.
®

Voltarol Rapid also contains the inactive ingredients colloidal
anhydrous silica, calcium phosphate, magnesium stearate,
maize starch, sodium starch glycollate, povidone,
microcrystalline cellulose, red iron oxide (E172), macrogol,
sucrose, talc and titanium dioxide (E171).
®

Voltarol Rapid comes in blister packs containing 30 tablets.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturers:
Novartis Farmaceutica S.A., Barbera Del Valles, Barcelona,
Spain.
Novartis Farma S.p.A., Torre Annunziata, NA, Italy.
Novartis Urunleri, Kurtkoy, Turkey.
®

Voltarol Rapid 50 mg Tablets
PL No: 18067/0254
POM
®

is a registered
Voltarol
Pharmaceuticals UK Limited.

trademark

of

Novartis

th

This leaflet was revised on 28 August 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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).
Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure,
presence of blood or protein in the urine.
500611/PL1g

500613/PL1g

Diclofenac Potassium 50 mg Tablets
Patient Information Leaflet
The name of your medicine is Diclofenac Potassium 50 mg
Tablets, throughout this leaflet it will be referred to as
Diclofenac Potassium Tablets. Other strength ’25 mg’ is
available.
What you need to know about Diclofenac Potassium
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.
In this leaflet:
1) What Diclofenac Potassium Tablets are and what they
are used for
2) Things to consider before you start to take Diclofenac
Potassium Tablets
3) How to take Diclofenac Potassium Tablets
4) Possible side effects
5) How to store Diclofenac Potassium Tablets
6) Further information
1) WHAT DICLOFENAC POTASSIUM TABLETS ARE AND
WHAT THEY ARE USED FOR
Diclofenac potassium, the active ingredient in Diclofenac
Potassium Tablets, is one of a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce
pain and inflammation.
Diclofenac Potassium Tablets relieve pain, reduce swelling
and ease inflammation in:
• Rheumatoid arthritis, osteoarthrosis, acute gout, low
back pain, ankylosing spondolytis
• Migraine
• Conditions affecting the joints and muscles such as
sprains and strains, soft tissue sports injuries, frozen
shoulder, dislocations, and fractures
• Conditions affecting the tendons for example,
tendonitis, tenosynovitis, bursitis.
It is also used to treat pain and inflammation associated with
orthopaedic, dental and other minor surgery.
2) THINGS TO CONSIDER BEFORE YOU START TO TAKE
DICLOFENAC POTASSIUM TABLETS
Some people MUST NOT take Diclofenac Potassium
Tablets. Talk to your doctor if:
• you think you may be allergic to diclofenac potassium,
aspirin, ibuprofen or any other NSAID, or to any of the
other ingredients of Diclofenac Potassium 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 Potassium 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 a
smoker)?
• Do you have diabetes?
• Do you smoke?
• Do you have Lupus (SLE) or any similar condition?
• Do you have an intolerance to some sugars such as
sucrose? (Diclofenac Potassium Tablets contain
sucrose.)

If the answer to any of these questions is YES, discuss
your treatment with your doctor or pharmacist because
Diclofenac Potassium 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
Potassium Tablets during the last 3 months of
pregnancy as it may affect the baby’s circulation.
• Are you trying for a baby? Taking Diclofenac
Potassium 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
Potassium 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
Potassium 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
Potassium Tablets. 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 Potassium 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 Potassium Tablets.
3) HOW TO TAKE DICLOFENAC POTASSIUM TABLETS
The doctor will tell you how many Diclofenac Potassium
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 with or after food.
Diclofenac Potassium Tablets are specially formulated to act
quickly. Swallow the tablets whole with a drink of water. Do
not crush or chew them.
The usual doses are:
Adults
75 mg to 150 mg daily divided into two or three doses. The
number of tablets you take will depend on the strength the
doctor has given you.
For the relief of migraine in adults:
Take 50 mg at the first signs of an attack. If the migraine has
not gone after 2 hours, take another 50 mg. You can take
further doses at intervals of 4 to 6 hours if necessary, but you
must not take more than 200 mg in a day.
Continued overleaf

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 Potassium Tablets
Tablets are not affecting your stomach.
Children over 14
75 mg to 100 mg daily divided into two or three doses.
Diclofenac Potassium Tablets are not recommended for
children under 14. They are not recommended for the
treatment of migraine in children of any age.
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 50 mg tablets
or six 25 mg 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
Diclofenac Potassium Tablets are suitable for most people,
but, like all medicines, it 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 Potassium 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.
The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 1
in 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.

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.
Medicines such as diclofenac may be associated with a small
increased risk of heart attack or stroke.
Do not be alarmed by this list - most people take
Diclofenac Potassium Tablets without any problems.
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) HOW TO STORE DICLOFENAC POTASSIUM TABLETS

Protect from moisture.

Do not store above 30°C.

Store in the original package.

Keep out of the sight and reach of children.

Do not take Diclofenac Potassium Tablets after the
expiry date which is printed on the outside of the pack.

If your doctor tells you to stop taking the tablets,
please take any unused tablets back to your
pharmacist to be destroyed. Do not throw them away
with your normal household water or waste. This will
help to protect the environment.

If the tablets become discoloured or show signs of any
deterioration, consult your doctor or pharmacist who
will tell you what to do.
6) FURTHER INFORMATION
Each tablet contains 50 mg of the active ingredient diclofenac
potassium.
Diclofenac Potassium Tablets also contain the inactive
ingredients colloidal anhydrous silica, calcium phosphate,
magnesium stearate, maize starch, sodium starch glycollate,
povidone, microcrystalline cellulose, red iron oxide (E172),
macrogol, sucrose, talc and titanium dioxide (E171).
Diclofenac Potassium Tablets comes in blister packs
containing 30 tablets.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturers:
Novartis Farmaceutica S.A., Barbera Del Valles, Barcelona,
Spain.
Novartis Farma S.p.A., Torre Annunziata, NA, Italy.
Novartis Urunleri, Kurtkoy, Turkey.
Diclofenac Potassium Tablets 50 mg Tablets
PL No: 18067/0254
POM
th

This leaflet was revised on 28 August 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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).

500613/PL1g

Expand Transcript

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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