PATIENT INFORMATION LEAFLET

VOLTAROL® DISPERSIBLE 50 mg TABLETS / VOLTAREN® DISPERSIBLE 50 mg TABLETS / DICLOFENAC SODIUM DISPERSIBLE 50 mg TABLETS (diclofenac sodium)

This product is available as any of the above names but will be referred to as Voltarol Dispersible Tablets throughout the following 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.

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 FOI

Diclofenac sodium, the active ingredient in Voltarol Dispersible Tablets, is one of a group of medicines called nonsteroidal 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 TABLETSl

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 checkups 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 TABLETSl

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.

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.

. POSSIBLE SIDE EFFECTSl

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.

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 in the eye.

Do not be alarmed by this list - most people take Voltarol Dispersible 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.

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 DISPERSIBLE TABLETSl

•    Keep your tablets in a dry place, below 30°C. Protect from heat and moisture.

•    Keep out of the sight and reach of children.

•    Do not take Voltarol Dispersible 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 signs of any deterioration, you should seek the advice of your pharmacist.

|6. FURTHER INFORMATION!

Voltarol Dispersible Tablets are white, triangular tablets with a ‘V' embossed on one side and ‘CG' printed on the reverse. Each tablet contains 50 mg diclofenac sodium, as the active ingredient.

The tablets also contain the following inactive ingredients: Microcrystalline cellulose, aerosil 200, croscarmellose sodium, sodium starch glycollate, hydrogenated castor oil, talc.

Voltarol Dispersible Tablets come in blister packs of 20 tablets.

PL No: 17805/0034    Voltarol® Dispersible 50 mg Tablets / Voltaren® Dispersible 50 mg Tablets /

Diclofenac Sodium Dispersible 50 mg Tablets    |POM|

This medicine is manufactured by Novartis Pharma AG, Stein, Switzerland and is procured from within the EU by the Product Licence Holder Delta Pharma (Europe) Ltd, 1 Colonial Way, P.O. Box 233, North Watford, Herts WD24 4EW and repackaged by O.P.D. Laboratories Ltd, Colonial Way, Watford, Herts WD24 4PR.

Leaflet revision and issue date (Ref) 18/02/2014.

Voltarol and Voltaren are registered Trademarks of Novartis AG, Switzerland.

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.