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VOLTAROL TABLETS 25MG

Active substance(s): DICLOFENAC SODIUM

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VOLTAROL® Tablets
25 and 50 mg
(diclofenac sodium)
Patient Information Leaflet

What you need to know about Voltarol 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 Tablets are, and what they are used for
2. Things to consider before you start to take Voltarol
Tablets
3. How to take Voltarol Tablets
4. Possible side effects
5. How to store Voltarol Tablets
6. Further information

1. What Voltarol Tablets are, and what they are
used for

Diclofenac sodium, the active ingredient in Voltarol
Tablets, is one of a group of medicines called
non-steroidal anti‑inflammatory drugs (NSAIDs).
NSAIDs reduce pain and inflammation.
• Voltarol Tablets relieve pain, reduce swelling and
ease inflammation in conditions affecting the joints,
muscles and tendons including:
–– Rheumatoid arthritis, osteoarthritis, acute gout,
ankylosing spondylitis
–– Backache, sprains and strains, soft tissue sports
injuries, frozen shoulder, dislocations and fractures

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––Tendonitis, tenosynovitis, bursitis.
• They are also used to treat pain and inflammation
associated with dental and minor surgery.
• In children Voltarol Tablets are used to treat juvenile
chronic arthritis.

2. Things to consider before you start to take
Voltarol Tablets
Some people MUST NOT take Voltarol 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 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 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 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 inherited intolerance to some
sugars such as lactose? (Voltarol Tablets contain a
small amount of lactose.)
If the answer to any of these questions is YES,
discuss your treatment with your doctor or
pharmacist because Voltarol 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 Tablets during the last 3 months of
pregnancy as it may affect the baby’s circulation.
• Are you trying for a baby? Taking Voltarol 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
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.
• The 50 mg tablets are not suitable for children
aged under 12.

3. How to take Voltarol Tablets

The doctor will tell you how many Voltarol 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.

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Take the tablets before or with food.
Swallow the tablets whole with a drink of water. Do
not crush or chew the tablets.
The usual doses are:
Adults and children over 12
75 mg to 150 mg daily divided into two or three
doses. The number of tablets which you take will
depend on the strength the doctor has given you.
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
Tablets are not affecting your stomach.
Children aged 1-12 years
Doses vary with the age and weight of the child. The
usual dose is 1 mg to 3 mg per kilogram of body
weight a day. This is usually divided into two or three
separate doses.
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 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 Tablets and tell your doctor
straight away if you notice:

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• 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 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.

5. How to store Voltarol Tablets

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 vision, 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 of the eye.
Do not be alarmed by this list - most people take
Voltarol 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.

Store in a dry place, below 30°C. Keep the tablets in
their original pack.
Keep out of the reach and sight of children.
Do not take Voltarol 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 tablets come in two strengths containing either
25 mg or 50 mg of the active ingredient, diclofenac
sodium. The tablets are enteric-coated. This special
coating prevents absorption of diclofenac sodium in
the stomach, reducing the risk of stomach irritation. It
is absorbed when it reaches the intestine.
The tablets also contain the inactive ingredients silicon
dioxide, lactose, maize starch, sodium starch
glycollate, povidone, microcrystalline cellulose,
magnesium stearate, hydroxypropylmethylcellulose,
polyethoxylated castor oil, talc, titanium dioxide,
methacrylic acid copolymer, polyethylene glycol,
silicone, yellow iron oxide, red iron oxide (50 mg
tablets only).
The 25 mg tablets come in blister packs containing
84 tablets. The 50 mg tablets come in blister packs
containing 14 or 84 tablets.
The Product licence holder is Novartis Pharmaceuticals
UK Limited trading as Geigy Pharmaceuticals, Frimley
Business Park, Frimley, Camberley, Surrey GU16 7SR,
England.
Voltarol Tablets are released on to the market by
Novartis Pharmaceuticals UK Limited,
Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, United Kingdom.
This leaflet was revised in January 2014.
If you would like any more information, or would like
the leaflet in a different format, please contact Medical
Information at Novartis Pharmaceuticals UK Ltd,
telephone number 01276 698370.
VOLTAROL is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited

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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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