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VOLTAROL RETARD 100 MG TABLETS

Active substance(s): DICLOFENAC SODIUM

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PATIENT INFORMATION LEAFLET
®

Voltarol Retard 100 mg Tablets

 Do you suffer from any blood or bleeding disorder? If you do, your

(diclofenac sodium)





These tablets will usually be called Voltarol Tablets in this leaflet.
This medicine is available in other strengths.



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.






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?
(These tablets contain sucrose.)

If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.

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.

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.

Are you taking other medicines?

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.
2.
3.
4.
5.
6.

What Voltarol Tablets are, and what they are used for
Things to consider before you start to take Voltarol Tablets
How to take Voltarol Tablets
Possible side effects
How to store Voltarol Tablets
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 are specially formulated 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.

2. THINGS TO CONSIDER BEFORE YOU START TO TAKE
VOLTAROL TABLETS

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


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 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 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?



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 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.
S0134-RM-PIL-13.02.2014

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.
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:
Adults
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.
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.
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. 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:
 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.

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.

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 TABLETS
Do not store above 25°C. Store in the original package.
Keep out of the sight and reach 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.
If the tablets become discoloured or show any signs of deterioration,
you should seek the advice of your pharmacist.

6. FURTHER INFORMATION
Each sustained release tablet contains 100 mg of the active ingredient,
diclofenac sodium.
The tablets also contain the inactive ingredients sucrose, cetyl alcohol,
povidone, magnesium stearate, colloidal anhydrous silica,
hypromellose, talc, polysorbate 80, titanium dioxide (E171), red iron
oxide (E172), macrogol 8000, black printing ink 8015.
Voltarol Tablets are round, pale red, film-coated tablets marked ‘CGC’
on one side and ‘CG’ on the other side and available in blister packs of
either 10 or 30 tablets.
Manufactured by: Novartis Pharma GmbH, Roonstrasse 25, D90429, Nüremberg, Germany.
Procured from within the EU and repackaged by: Amimed Direct
Ltd, Hendon, London, NW9 6AQ.
Product Licence Holder: Sam Pharma Ltd, Unit 20 Garrick Industrial
Estate, Irving Way, Hendon, London, NW9 6AQ.
POM

PL No: 33902/0134

Leaflet revision date: 13/02/2014
Voltarol® is a registered trademark of Novartis AG
S0134-RM-PIL-13.02.2014

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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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