Patient Information Leaflet

Ketocid™ 200 Capsules

(Ketoprofen 200 mg)

TP14416022/1/1

Please read this leaflet carefully before you start taking your medicine. It tells you the important points you should know about KETOCID 200.

WHAT'S IN YOUR MEDICINE

These capsules contain 200 mg of Ketoprofen, the active ingredient.

The capsules also contain the following inactive ingredients: polyethylene glycol, ethylcellulose, stearic acid, talc, polymers of methacrylic acid, acrylic acid esters and methacrylic acid esters, sucrose and corn starch. The capsule shell consists of gelatine and E 171 and E 127 as colourants.

The capsules have a clear body and a pink cap.

KETOCID 200 capsules are available in packs of' 28 capsules.

Name of Product Licence Holder: Lagap Pharmaceuticals Limited, Bordon, Hants., England .

Name of Manufacturer: Valpharma SA, Via Ranco, 47031 Serravalle, Republic of San Marino, Italy.

ABOUT YOUR MEDICINE

Ketoprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). You can only get it on prescription from a doctor. It is used for relief' of pain, stiffness and inflammation in a number of conditions affecting joints and muscles. It is also used to relieve pain and to reduce fever and inflammation, in a number of other conditions eg: period pain and gout.

BEFORE TAKING YOUR MEDICINE

Before you start taking the capsules, tell your doctor if:

Ketoprofen can cause nausea, drowsiness, dizziness and confusion (see 'After taking your

medicine'). If you have any of these effects, do not drive or operate machinery.

continued

HOW TO TAKE YOUR MEDICINE

Make sure you take the capsules exactly as directed by your doctor. This is particularly important if you are elderly. The usual adult dose of KETOCID 200 is one 200 mg capsule a day. Your doctor may change your dose. Exactly how many of the capsules and how often you must take them, will be written on the label. Please read the label carefully.

Capsules should be taken with a little water with meals. Swallow the capsules whole without chewing.

If you forget to take a dose, take the missed dose as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining capsules at the correct times.

WHAT TO DO IF AN OVERDOSE IS TAKEN

If you (or someone else) swallows a lot of the capsules, or if you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or doctor immediately.

AFTER TAKING YOUR MEDICINE

KETOCID 200 like most other medicines, may cause side effects in some patients. These may include indigestion, nausea, heartburn, stomach pain, constipation or diarrhoea. Other possible effects include headache, dizziness, confusion, drowsiness, swelling (due to water retention), mood changes and sleeplessness.

If you develop any of these side effects and they are severe or they get worse, or last for more than a few days, contact your doctor. Rarely, Ketoprofen can cause stomach ulcers, liver or kidney problems or changes in your blood. If you get any allergic reactions (cg: breathing difficulties or skin rashes), or if you have any other unexpected effects, tell your doctor immediately.

STORING YOUR MEDICINE

Do not take this medicine after the expiry date printed on the container. If you have any medicines which are out of date, return them to your pharmacist for disposal.

Keep your capsules in a safe place where children cannot reach them.

These capsules should be stored in a cool, dry place. Keep them in the pack they came in.

Do not transfer them to another container.

Do not keep any capsules you no longer need; give them back to your pharmacist for disposal.

FURTHER INFORMATION

Remember this medicine is only for you. Only a doctor can prescribe it for you. Never give it to anyone else, even if it sounds as though they have the same problem as you. It may harm them.

This leaflet provides only a summary of the information known about KETOCID 200. If you have any questions, want to know more about this medicine, or are unsure about anything, ask your doctor or pharmacist.

This information applies only to KETOCID 200 Capsules.

Date of Preparation: December 1994

™Trade Mark applied for.

Trinity Pharmaceuticals Ltd.,

Tuition House, 27/37, St. George’s Road,

Wimbledon, London SW19 4DS