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VOLTAROL RAPID 50 MG TABLETS

Active substance(s): DICLOFENAC POTASSIUM / DICLOFENAC POTASSIUM

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Voltarol® Rapid 50 mg Tablets
(diclofenac potassium)
Patient Information Leaflet
The name of your medicine is Voltarol® Rapid 50 mg Tablets, but it will
be referred to as Voltarol Rapid in this leaflet. This product is also
available as the 25 mg strength.
What you need to know about Voltarol Rapid 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 Voltarol Rapid Tablets are, and what they are used for
2. Things to consider before you start to take Voltarol Rapid Tablets
3. How to take Voltarol Rapid Tablets
4. Possible side effects
5. How to store Voltarol Rapid Tablets
6. Further information

1. What Voltarol Rapid Tablets are and what they are
used for
Diclofenac potassium, the active ingredient in Voltarol Rapid Tablets,
is one of a group of medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). NSAIDs reduce pain and inflammation.
Voltarol Rapid 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.
They are 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 Tablets
Some people MUST NOT take Voltarol Rapid 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
Voltarol Rapid 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 Rapid 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?
(Voltarol Rapid Tablets contain sucrose.)
If the answer to any of these questions is YES, discuss your
treatment with your doctor or pharmacist because Voltarol Rapid
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 Rapid Tablets during the last 3 months of pregnancy
as it may affect the baby’s circulation.
• Are you trying for a baby? Taking Voltarol Rapid 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 Rapid 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 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 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.

3. How to take Voltarol Rapid Tablets
The doctor will tell you how many Voltarol Rapid 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.
Voltarol Rapid 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.
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.
Children over 14
75 mg to 100 mg daily divided into two or three doses.
Voltarol Rapid 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
Voltarol Rapid 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 Rapid 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.
• Mild cramping and tenderness of the abdomen, starting shortly
after the start of the treatment with Voltarol Rapid Tablets and
followed by rectal bleeding or bloody diarrhoea usually within 24
hours of the onset of abdominal pain.

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.
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.
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
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. How to store Voltarol Rapid Tablets
Protect from moisture. Do not store above 30°C. Keep the tablets in
their original pack.
Keep out of the reach and sight of children.
Do not take Voltarol Rapid 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.

6. Further information
The sugar-coated tablets contain 50 mg of the active ingredient,
diclofenac potassium.
The tablets also contain the inactive ingredients silica, calcium
phosphate, magnesium stearate, maize starch, sodium starch
glycolate (type A), povidone, microcrystalline cellulose, red iron oxide
(E172), macrogol, sucrose, talc and titanium dioxide (E171).
The tablets come in blister packs containing 30 tablets.
Manufactured by: Novartis Farma S.p.A., Origgio (VA), Italy.
Procured from within the EU & repackaged by Product Licence holder:
Kosei Pharma UK Ltd, 956 Buckingham Avenue, Slough Trading
Estate, Slough, SL1 4NL, UK

Voltarol® Rapid 50 mg Tablets,
PL: 39352/0086

POM

Voltarol® is a registered trademark of Novartis Pharmaceuticals UK
Limited.
Leaflet date: 21/08/2017

To listen to or request a copy of
this leaflet in Braille, large print
or audio please call:
01753515054 (UK only)

Diclofenac potassium 50 mg Tablets
Patient Information Leaflet
The name of your medicine is Diclofenac potassium 50 mg Tablets,
but it will be referred to as Diclofenac potassium in this leaflet. This
product is also available as the 25 mg strength.
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 non-steroidal antiinflammatory 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.
They are 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.
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 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, 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 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.

• Mild cramping and tenderness of the abdomen, starting shortly after
the start of the treatment with Diclofenac potassium Tablets
• and followed by rectal bleeding or bloody diarrhoea usually within 24
hours of the onset of abdominal pain.
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.
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.
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.
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. How to store Diclofenac potassium Tablets
Protect from moisture. Do not store above 30°C. Keep the tablets in
their original pack.
Keep out of the reach and sight 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.

6. Further information
The sugar-coated tablets contain 50 mg of the active ingredient,
diclofenac potassium.
The tablets also contain the inactive ingredients silica, calcium
phosphate, magnesium stearate, maize starch, sodium starch
glycolate (type A), povidone, microcrystalline cellulose, red iron oxide
(E172), macrogol, sucrose, talc and titanium dioxide (E171).
The tablets come in blister packs containing 30 tablets.
Manufactured by: Novartis Farma S.p.A., Origgio (VA), Italy.
Procured from within the EU & repackaged by Product Licence holder:
Kosei Pharma UK Ltd, 956 Buckingham Avenue, Slough Trading
Estate, Slough, SL1 4NL, UK.

Diclofenac potassium 50 mg Tablets,
PL: 39352/0086
Leaflet date: 21/08/2017

POM

To listen to or request a copy of
this leaflet in Braille, large print
or audio please call:
01753515054 (UK only)

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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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