What you should know about

Fenopron 600

Please read this leaflet carefully before you start to take your medicine. It does not contain all the information about your medicine that you may need to know. Please ask your doctor or pharmacist if you have any questions. This leaflet only applies to Fenopron 600.

What is in your medicine?

Your medicine is Fenopron 600. It comes in bottles of 100 tablets. The active ingredient is fenoprofen calcium. Fenopron 600 are orange tablets shaped like capsules. Each one is marked Dista 4021.

Each Fenopron 600 tablet contains fenoprofen calcium equivalent to 600mg of fenoprofen. Fenopron 600 also contains the inactive ingredients calcium hydrogen phosphate, maize starch, polacrilin potassium, magnesium stearate and stearic acid. The coating contains hydroxypropylmethylcellulose, polyethylene glycol 8000 and propylene glycol. The colourings are E110 and E171.

Fenopron is an anti-inflammatory medicine which does not contain steroids (a non-steroidal anti-inflammatory medicine or NSAID). Anti-inflammatory medicines help to reduce swelling and bone damage if you have arthritis.

Fenopron 600 is made by Lilly S.A., Avda. de la Industria 30, 28100 Alcobenda, Madrid, Spain.

The product licence is held by Dista Products Limited, Dextra Court, Chapel Hill, Basingstoke, Hampshire, RG21 2SY

Why Fenopron?

Fenopron is used to treat rheumatoid arthritis, osteoarthritis and a back problem called ankylosing spondylitis. It is also used as a painkiller.

Before taking your medicine
Make sure it is safe for you to take Fenopron. You should not give Fenopron to children.

If you answer 'YES' to any of the following questions, or you are not sure, tell your doctor or pharmacist.

Have you ever had a rash or other allergic reaction to Fenopron? (An allergic reaction may include a rash, itching, swelling or breathing difficulties.)

Have you ever had symptoms of asthma, a runny nose, an allergic reaction or kidney or bladder problems after taking aspirin or another non-steroidal anti-inflammatory medicine?

Have you ever had a stomach ulcer or problems with indigestion or heartburn?

Do you have asthma or other allergies?

Are you pregnant or could you be?

Are you breast-feeding?

Are you being treated for high blood pressure or other heart problems? . Have you ever had kidney or liver problems? If so, you may need to go for tests from time to time.

Are you anaemic?

Do you have problems with your hearing?

Are you taking aspirin, water tablets or blood-thinning medicine?

Tell your doctor all the medicines that you are taking.

Fenopron can make some patients sleepy or dizzy, so take care if you drive or use machinery.

Fenopron can affect the results of thyroid tests, so if you have this test tell your doctor that you are taking this medicine.

Please read the back of this leaflet

What you should know about Fenopron 600 - continued

Taking your medicine

Follow your doctor's instructions. Check the label for how many tablets to take and how often to take them.

Dose

Fenopron 600: take 1 tablet 3 times a day.

This is the usual starting dose but your doctor may change your dose later. He or she may add an extra dose at night.

You should never take more than 5 Fenopron 600 a day.

If you are elderly you may be given a smaller dose.

If you are not sure how many tablets to take, ask your doctor or pharmacist.

Swallow the tablets with water or milk.

You may prefer to take the tablets at mealtimes, especially if you have indigestion or they make you feel sick.

You should take the tablets for as long as your doctor has told you to.

If you forget to take your tablet, wait and take it as your next dose.

Do not take more tablets than your doctor tells you to.

If you ever take too many, go to the nearest hospital casualty department or tell your doctor immediately.

While taking your medicine

Fenopron, like other anti-inflammatory medicines, can cause side effects such as:

Feeling or being sick, indigestion, stomach ache, diarrhoea, constipation, mouth ulcers, a dry mouth or a metallic taste in the mouth, headache, or feeling dizzy, sleepy, nervous or confused.

Tell your doctor if you are worried by any of these symptoms.

Fenopron can sometimes cause bleeding from an ulcer. If you notice blood when you vomit or you have black or bloody stools, tell your doctor.

Some patients have had fever, rashes, itching and other allergic symptoms, difficulty breathing, and kidney problems including blood in their urine or kidney pain. Tell your doctor if you notice any of these.

A few patients taking Fenopron have had liver problems (including hepatitis and jaundice), changes in the blood causing bruising, bleeding or anaemia, palpitations or other heart problems, increased sweating, difficulties seeing, ringing in the ears and swollen hands and feet.

If you have these or any other side effects, tell your doctor He or she has more information about Fenopron and will tell you what to do.

How to store your medicine

Do not take the tablets after the 'Use before' date.

Keep your tablets at room temperature (15º to 25ºC) in a safe place and where children cannot see or reach them. Your tablets could harm them.

If your doctor tells you to stop taking the tablets, please take them back to the pharmacist. Only keep the tablets if your doctor tells you to.

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.

Fenopron is a registered trademark of Dista Products Limited.

Date of Leaflet Preparation: June 1995