Please read this leaflet carefully before you start to take your medicine. This leaflet provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. The name of your medicine is Volsaid Retard 75 and Volsaid Retard 100.

There are two strengths of Volsaid Retard tablets, one contains 75 mg diclofenac sodium per tablet and the other contains 100 mg diclofenac sodium per tablet.

Other ingredients include: both strengths: talc, ethylcellulose, povidone, stearic acid, magnesium stearate, diethyl phthalate, hydroxypropyl methylcellulose, E171 and polyethylene glycol. Volsaid Retard 100 only: E172.

These tablets are supplied in packs of 28 or 56.

The active principle, diclofenac sodium, is a non-steroidal anti-inflammatory drug (NSAID) which relieves pain and inflammation in a variety of conditions and also has antipyretic (fever reducing) effects.

The Product Licence Holder is: Trinity Pharmaceuticals Limited, Tuition House, 27/37 St George's Road, Wimbledon, London, SW19 4EU.

The Manufacturer is: Valpharma SA, Via Ranco 112, 47031 Serravalle, Republic of San Marino,

Volsaid Retard tablets may be used in adults to treat pain and inflammation in a variety of conditions including: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, low back pain, pain from fractures and dislocations, injuries, stiff joints and frozen shoulder, inflammation of tendons and tendon sheaths, sprains and strains, and pain following orthopaedic, dental and other minor surgical procedures.

Volsaid Retard tablets are not suitable for children.

DO NOT take this medicine before telling your doctor if:

• You have ever reacted badly to diclofenac sodium before.
• You have or may have an active peptic ulcer or any past history of bleeding from the stomach.
• You have any bleeding from the gut or have passed black tarry stools.
• You are or may be pregnant.
• You have ever suffered asthma, urticaria or other allergic reactions after taking aspirin.
• You have ulcerative colitis or Crohn's disease.
• You have bleeding problems or other blood disorders.
• You have problems with your liver, kidney or heart.
• You have porphyria.
• You have recently undergone major surgery.
• You are taking other drugs including diuretics, lithium, digoxin, methotrexate, cyclosporin, anticoagulants, quinolone antibiotics, antidiabetic drugs, or other non-steroidal anti-inflammatory drugs.
• You have been taking this medicine or similar NSAIDs for a long time, your doctor may want to perform regular tests to monitor your condition.
• You should not drive or operate machinery if you experience any dizziness while taking this medicine.

The normal daily dose in adults and healthy patients is one 100 mg tablet a day or one 75 mg tablet once or twice a day. Frail and elderly patients may need to take a lower dose.

The duration of treatment will depend on the condition being treated. Your doctor may decide to change your dose and it is always important to follow your doctor's advice about when and how to take your medicine.

If you have forgotten to take your medicine do not make up for this by taking an extra tablet. Continue with your usual routine and take your next tablet at the prescribed time. If you are at all concerned about this you should consult your doctor or pharmacist.

If you have accidentally taken too many tablets you must obtain assistance from your doctor or local casualty department, as soon as possible.

It is possible that while you are taking Volsaid Retard tablets you may experience sickness, diarrhoea, indigestion, loss of appetite, belching, abdominal cramps, vertigo and dizziness. If they cause you distress you should contact your doctor or pharmacist for advice.

Serious effects of diclofenac include stomach ulcers, bleeding from the intestine or bloody diarrhoea and rarely aggravation of ulcerative colitis or Crohn's disease, sore mouth and tongue, constipation, severe pains in the upper back, inflammation of the pancreas, ulcers around the mouth. Skin rashes sometimes with blistering have occurred and hair loss and sensitivity to sunlight have also been reported.

Rarely you may experience drowsiness, tiredness, impaired hearing, difficulty with sleeping, seizures, irritability, anxiety, depression, mood changes, tremor, memory disturbances, vertigo, disorientation, changes in vision, ringing in the ears, bad dreams, taste alteration, allergic reactions, swelling due to water retention, palpitations, chest pains, impotence or tightness in the chest.

If you experience any other unpleasant effects which you think could be caused by this medicine you should contact your doctor or pharmacist for advice.

Do not take this medicine after the expiry date shown on the label. These tablets should be stored in a dry place below 25°C protected from light. If you notice any defects or if the tablets are broken or chipped you must take them to your pharmacist for advice before taking them.

Keep all medicines out of the reach of children. Your medicines can harm them.

REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others, it may harm them even if their symptoms are the same as yours.

This leaflet only applies to Volsaid Retard 75 and Volsaid Retard 100 tablets.

Date of preparation: November 1995