NOVARTIS

VOLTAROL® Dispersible Tablets 50 mg

(diclofenac sodium)

Patient Information Leaflet

What you need to know about Voltarol Dispersible 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.

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In this leaflet:

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

2.    Things to consider before you start to take Voltarol Dispersible Tablets

3.    How to take Voltarol Dispersible Tablets

4.    Possible side effects

5.    How to store Voltarol Dispersible Tablets

6.    Further information

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

Diclofenac sodium, the active ingredient in Voltarol Dispersible Tablets, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.

Voltarol Dispersible Tablets act quickly and so are used to treat short term painful conditions affecting the joints and muscles. They are especially useful for the treatment of sprains, strains and back pain. They should not be taken for more than three months.

2.    Things to consider before you start to take Voltarol Dispersible Tablets

Some people MUST NOT take Voltarol Dispersible 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 Dispersible 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 Dispersible 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 you a smoker)?

•    Do you have diabetes

•    Do you smoke

•    Do you have Lupus (SLE) or any similar condition?

If the answer to any of these questions is YES, discuss your treatment with your doctor or pharmacist because Voltarol Dispersible 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 Dispersible Tablets during the last 3 months of pregnancy as it may affect the baby’s circulation.

•    Are you trying for a baby? Taking Voltarol Dispersible 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 Dispersible 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 Dispersible 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 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 Dispersible 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 Dispersible Tablets.

•    Voltarol Dispersible Tablets are not suitable for children.

The tablets contain erythrosine and may be unsuitable for some people.

3. How to take Voltarol Dispersible Tablets

The doctor will tell you how many Voltarol Dispersible 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.

Drop the tablets into a glass of water, and stir. Drink the pink, blackcurrant-flavoured liquid at once. To make sure you get all of the medicine, rinse the glass round with a small amount of water and drink this as well.

The usual doses are:

Adults

One tablet two or three times a day.

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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 Dispersible 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 (three 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 Dispersible 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 Dispersible 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 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), stroke.