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DICLOFENAC SODIUM 50 MG TABLETS

Active substance: DICLOFENAC SODIUM

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Voltarol® 50mg Tablets
Diclofenac Sodium 50mg Tablets

1898
08.03.13[8]

(diclofenac sodium)
PATIENT INFORMATION LEAFLET
This medicine is available using any of the above names but will be
referred to as Voltarol throughout this leaflet.
Another strength (25 mg) is also available.
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
- 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
- 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 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 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.
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.
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, 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.
5. HOW TO STORE VOLTAROL TABLETS
Do not store above 30°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.
6. FURTHER INFORMATION
Voltarol Tablets contain diclofenac sodium.
Each enteric-coated tablet contains 50 mg diclofenac sodium.
The tablets also contain the following inactive ingredients: colloidal
anhydrous silica, lactose, maize starch, sodium starch glycollate, povidone,
microcrystalline cellulose, magnesium stearate, hypromellose,
polyethoxylated castor oil, talc, titanium dioxide (E171), methacrylic acid
copolymer, macrogol, silicone, yellow iron oxide (E 172) and red iron oxide
(E172).
Voltarol Tablets are available as light brown round tablets marked ‘CG’ on
one side and ‘GT’ on the other side, and come in blister strip pack of 20, 30
and 100 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by: Novartis Pharma AG, Basel, Switzerland.
Procured from within the EU by Product Licence holder Tenolol Ltd.,
Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by
Servipharm Ltd.
POM

PL No: 30900/1898

Leaflet revision and issue date (Ref) 08.03.13[8]
Voltarol is a registered trademark of Novartis AG.

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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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