PACKAGE LEAFLET: INFORMATION FOR THE USER Diclofenac Sodium 25mg and 50mg Gastro-resistant Tablets

(Diclofenac Sodium)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Diclofenac Sodium Tablets are and what they are used for

2.    What you need to know before you take Diclofenac Sodium Tablets

3.    How to take Diclofenac Sodium Tablets

4.    Possible side effects

5.    How to store Diclofenac Sodium Tablets

6.    Contents of the pack and other information

1. What Diclofenac Sodium Tablets are and what they are used for

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

Diclofenac Sodium 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 Diclofenac Sodium Tablets are used to treat juvenile chronic

arthritis._

2. What you need to know before you take Diclofenac Sodium tablets

Do not take Diclofenac Sodium Tablets if:

•    you think you may be allergic to Diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Diclofenac Sodium Tablets (listed in section 6). 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 severe heart, kidney or liver failure

•    you are more than six months pregnant.

•    you have had stomach or bowel problems after you have taken other NSAIDs

Warnings and precautions

Talk to your doctor or pharmacist before taking Diclofenac Sodium Tablets

•    if you suffer from any stomach or bowel disorders including ulcerative colitis or Crohn's disease

•    if you have kidney or liver problems, or you are elderly

•    if you have a condition called porphyria

•    if 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.

•    if you ever had asthma

•    if you are breast-feeding

•    if you have heart problems, or previous stroke, or think that 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 should discuss your treatment with your doctor or pharmacist.

•    if you have Lupus (SLE) or any similar condition

Other medicines and Diclofenac Sodium Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or

might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking:

•    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)

•    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 betablockers or ACE inhibitors.

•    Sulfinpyrazone (a medicine used to treat gout) or 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, breast feeding and fertility

•    Although not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not take Diclofenac Sodium Tablets during the last 3 months of pregnancy as it may affect the baby's circulation.

•    Taking Diclofenac Sodium Tablets may make it more difficult to become pregnant. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant.

Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines

Very occasionally people have reported that Diclofenac Sodium 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.

Diclofenac Sodium Tablets contain

•    Lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

•    Sunset yellow FCF (E110) which may cause allergic reactions Other special warnings

•    You should take the lowest dose of Diclofenac Sodium Tablets for the shortest possible time, particularly if you are underweight or elderly.

•    Medicines such as Diclofenac Sodium Tablets may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

•    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, Diclofenac Sodium 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 Diclofenac Sodium Tablets.

•    The 50 mg tablets are not suitable for children aged under 12.

3. How to take Diclofenac Sodium Tablets Always take Diclofenac Sodium tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. 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 Diclofenac Sodium 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.

If you take more Diclofenac Sodium Tablets than you should 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.

If you forget to take Diclofenac Sodium Tablets 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 take a double dose to make up for a forgotten dose. Do not take more than 150 mg (three 50 mg tablets or six 25 mg tablets) in 24 hours.

|    4. Possible side effects    |

Like all medicines, Diclofenac Sodium Tablets can cause side effects, although not everybody gets them.

Some side effects can be serious

Stop taking Diclofenac Sodium 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) : and reported in less than 1 in 10,000 people include:

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 (menigitis), 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 Diclofenac Sodium Tablets without any problems.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet

5T How to store Diclofenac Sodium Tablets |

•    Keep out of the sight and reach of children

•    Do not use this medicine after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month.

•    Do not store above 25⁰C. Store in a dry place.

•    Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment_

6. Contents of the pack and other information

What Diclofenac Sodium Tablets contains

The active substance is diclofenac sodium. Each tablet contains either 25 mg (milligrams) or 50 mg of diclofenac sodium.

The other ingredients are anhydrous lactose, microcrystalline cellulose, maize starch, magnesium stearate, colloidal silicon dioxide, methylpropylhydroxycellulose phthalate, dibutyl phthalate, talc, Opaspray orange (K-1R-2433) contains E110 (sunset yellow FCF) and E171 (Titanium Dioxide), ethanol denatured, polyethylene glycol 6000.

What Diclofenac Sodium Tablets looks like and contents of the pack Diclofenac sodium tablets are orange round tablets marked ‘BL' on one side and ‘25' on the reverse for the 25mg and ‘BL' on one side and ‘50' on the reverse for 50mg strength.

Diclofenac sodium tablets come in blister packs containing 84 or 100 tablets and securitainers containing 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Name and address:    Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, UK Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

Email:    info@bristol-labs.co.uk

Diclofenac Sodium 25mg Gastro-resistant Tablets; PL 17907/0343 Diclofenac Sodium 50mg Gastro-resistant Tablets; PL 17907/0344 This leaflet was last revised in June 2012 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.