(Fenbufen 300mg and 450mg)

This leaflet provides important information on your medicine. Please read it carefully before you start taking LEDERFEN tablets. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). Keep this leaflet while you are taking LEDERFEN tablets, you may want to read it again.

LEDERFEN tablets contain fenbufen. They belong to a group of medicines called "non-steroidal anti-inflammatory agents" which are usually taken to relieve pain, stiffness and inflammation.

LEDERFEN tablets come in two strengths. The 300mg tablet is capsule shaped and contains 300 mg of Fenbufen, it has the word LEDERFEN on one side, the other side is blank. The 450mg tablet is lozenge shaped and contains 450 mg of Fenbufen, it has the word LEDERFEN on one side and 450 on the other.

Other ingredients in these tablets are lactose, sodium starch glycolate, povidone, dioctyl sodium sulphosuccinate cellulose microcrystalline, magnesium stearate, stearic acid, polyethylene glycol and the colours indigo carmine (E132) and titanium dioxide (E171). The total sodium content per tablet is 1.58mg for 300mg tablet and 2.37mg for the 450mg tablet.

The product licences are held by: Cyanamid of Great Britain Ltd., Gosport, Hampshire, England.

The 300mg tablets are manufactured by: Lederle Laboratories, Gosport, England and Cyanamid GmbH, Wolfratshausen, Germany.

The 450mg tablets are manufactured by: Lederle Laboratories, Gosport, England.

The licensed pack sizes are:

300mg Tablets Blister Packs of 84, Bottles of 100 tablets.

450mg Tablets Blister Packs of 56, Bottles of 56, 100, 500.

LEDERFEN tablets are used to relieve some symptoms caused by arthritis or rheumatism such as inflammation, swelling, stiffness and joint pain. This medicine will not cure arthritis but will help you as long as you continue to take it. It may also be used to relieve other painful conditions of the joints or muscles.

• you are pregnant, or trying to become pregnant or breast-feeding.
• you have ever had a bad reaction, such as itching or breathing problems (wheezing or asthma) or stomach pains, after taking aspirin, Ibuprofen or other medicines used to treat painful conditions affecting the joints and muscles.
• you have or have ever had a stomach ulcer.
• you have liver, heart or kidney problems.
• you are taking warfarin (to prevent blood clots), certain antibiotics called quinolones, or lithium. Also if you are taking any drugs to lower your blood sugar (hypoglycaemics or sulphonylureas) aspirin or aspirin-like drugs or methotrexate.
• you are taking any other medicines or tablets including those you have bought without a prescription.

This medicine should not be given to children under the age of 14.

When you take LEDERFEN tablets you may have blurred vision. Do not drive or operate machinery if this happens to you.

The dosage for LEDERFEN varies from person to person depending on your individual condition. You will probably be asked to take either one tablet in the morning and one at night if you have the 450mg tablets or one in the morning and two at night if you are taking the 300mg tablets.

Your doctor may suggest a different dose depending on your condition. Always take the number of tablets your doctor has told you to take. This information will also be on the pharmacist s label.

Your pharmacist (chemist) may also help if you are not sure of how or when to take your tablets.

LEDERFEN tablets should be swallowed whole with a drink of water. The tablet should not be chewed or sucked.

If you accidentally take more than 4 tablets of either strength in one day (an overdose), contact your doctor or local casualty department immediately. Always take the labelled pack with you, even if there are no tablets left.

Take it as soon as you remember, and continue to take your medicine as usual providing you do not take more than 3 tablets of either strength in one day.

Take your medicine exactly as your doctor has told you. Like all medicines, LEDERFEN tablets may cause unwanted effects in some people. If you get a rash, wheezing or shortness of breath, STOP TAKING LEDERFEN tablets and see your doctor immediately.

Some other unwanted effects may sometimes be seen when you are taking LEDERFEN tablets, these are described below. If these or any other unusual symptoms become troublesome; please contact your doctor or pharmacist (chemist).

The following symptoms are occasionally seen in patients taking these tablets: vomiting, sometimes of blood, stomach pain, heartburn, diarrhoea, black stools, constipation, irritation, dryness or soreness of the mouth, loss of appetite, swelling of the face, feet or lower legs, dizziness, depression, trouble in steeping, numbness in your hands or feet, severe headache, tiredness or generally feeling unwell, disturbance in vision, ringing or buzzing in your ears or your skin may become more sensitive to sunlight.

The following may be seen rarely: unexplained sore throats, chills or fever, unexplained bleeding from the gums or nose, unusual bleeding or bruising, or jaundice (yellowing of skin), bloody or cloudy urine, a large increase or a sudden decrease in the amount of urine, increased sweating or flushing.

Check with your doctor before you take any other medicines.

If you have to have a blood test tell your doctor that you are taking LEDERFEN tablets as they may affect the outcome of the test. If you will be taking this medicine for more than 3 months, ask your doctor if you need to have regular check-ups.

If you still feel unwell at the end of the prescribed course of medicine, tell your doctor.

Keep your tablets in a dry place at room temperature (below 25°C).

Keep all medicines in a safe place, away from children.

If your doctor decides to stop treatment, return any LEDERFEN tablets you have left to your pharmacist (chemist). Medicines should not be put down the sink, toilet or fn the bin.

Do not use after the expiry date. This date is printed on your pack. Date of Preparation or last Review: April 1994.

This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure of anything, ask your doctor or pharmacist (chemist) who can give you more information. The information in this leaflet applies only to LEDERFEN tablets.

Lederfen 300 mg tablets PL 0095/0081

Lederfen 450 mg tablets PL 0095/0092

*Registered Trademark

© Copyright Cyanamid of Great Britain Limited - 1994