Active substance: DICLOFENAC SODIUM

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Voltarol SR FCT 75/100mg GB
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VOLTAROL 75 mg SR and
VOLTAROL® Retard Tablets
100 mg

(diclofenac sodium)

Patient Information Leaflet
These tablets will usually be called Voltarol Tablets
in this 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.  hat Voltarol Tablets are, and what they are
used for
2.  hings 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

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 nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs
reduce pain and inflammation. Voltarol SR tablets
and Voltarol Retard Tablets are specially formulated



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18 May 2007
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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
• you are more than six months pregnant.
You should also ask yourself these questions before
taking Voltarol Tablets:
•  you suffer from any stomach or bowel
disorders including ulcerative colitis or
Crohn’s disease?
•  you have kidney or liver problems, or are
you elderly?
• Do you have a condition called porphyria?
•  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?

•  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)?
•  you have Lupus (SLE) or any similar condition?
•  you have an intolerance to some sugars such
as sucrose? (These tablets contain sucrose.)
If the answer to any of these questions is YES, tell
your doctor or pharmacist because Voltarol Tablets
might not be the right medicine for you.


Are you taking other medicines?

to release the diclofenac sodium slowly.
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
– Tendonitis, tenosynovitis, bursitis.
They are also used to treat pain and inflammation
associated with dental and minor surgery.

Will there be any problems with driving or
using machinery?

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
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
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.

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.
•  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.

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.
•  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 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 Tablets.

3. ow 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.

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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.
Swallow the tablets whole with a glass of water. Do
not crush or chew them as this will affect the special
‘slow release’ system.
The usual doses are:
100–150 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.
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.
These tablets are not suitable for children.
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 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. ossible side effects
Voltarol Tablets are suitable for most people, but, like
all medicines, they can sometimes cause side effects.

Some side effects can be serious
Stop taking Voltarol 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
•  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.
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, 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, 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 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.

5. ow to store Voltarol Tablets
Store Voltarol SR Tablets in a dry place, below 30°C.
There are no special storage instructions for Voltarol
Retard Tablets.
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
Voltarol SR Tablets are pale pink triangular tablets
marked GEIGY on one side and V75 on the other
containing 75 mg of the active ingredient, diclofenac
sodium. Voltarol Retard Tablets are round red
tablets marked GEIGY on one side and VOLTAROL R
on the other containing 100 mg of the active
ingredient, diclofenac sodium.
The tablets also contain the inactive ingredients silica,
cetyl alcohol, sucrose, povidone, magnesium stearate,
hydroxypropyl methylcellulose, polysorbate 80, talc,
titanium dioxide (E171) and red iron oxide (E172).
Voltarol Retard Tablets come in blister packs
containing 2, 28 or 70 tablets. Voltarol SR Tablets
come in blister packs containing 2, 7, 28, 56
or 70 tablets. Some of these pack sizes may not
be marketed.
The Product licence holder is
Novartis Pharmaceuticals UK Limited trading as
Geigy Pharmaceuticals, Frimley Business Park,
Frimley, Camberley, Surrey GU16 7SR, England.
Manufactured by
Novartis Pharmaceuticals UK Ltd, Frimley Business
Park, Frimley, Camberley, Surrey, GU16 7SR,
United Kingdom.
This leaflet was revised in June 2013
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.