Modalim

Please read this carefully before you start to take your medicine. This leaflet provides a summary of the information about your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist.

The name of this medicine is Modalim tablets. Its active ingredient is ciprofibrate.

What is in this medicine7 Each Modalim tablet contains 100 mg ciprofibrate.

Each Modalim tablet also contains maize starch, lactose, microcrystalline cellulose, hydroxypropylmethyl cellulose, hydrogenated vegetable oil and sodium lauryl sulphate.

Modalim tablets are gluten free.

Modalim tablets are white, capsule shaped tablets with MODALIM stamped on one side. They are supplied in cartons of 28 tablets.

Modalim alters blood lipid (fat) levels in patients with hyperlipidaemia.

The Product Licence holder is: Sanofi Winthrop Ltd. One Onslow Street, Guildford, Surrey, GU1 4YS

The manufacturer is; Sanofi Winthrop Ltd., Edgefield Avenue, Fawdon, Newcastle upon Tyne, NE3 3TT.

What is this medicine for7

Modalim is used to treat a condition called hyperlipidaemia in which the level of lipid (fats) in the blood is too high. It is usually prescribed after a low fat diet has failed to correct blood lipid levels. Patients with high levels of blood lipid have been shown to be at higher risk from early heart disease.

Before taking this medicine

You should not take Modalim if you are pregnant or breast feeding or if you suffer from severe liver or kidney disease.

Special care is needed (check with your doctor) if you have an underactive thyroid gland.

Modalim should not usually be given to children under 12 years of age.

If taken with some other medicines the effects of Modalim or the effects of the other medicines may be changed. Please check with your doctor if you are taking any of the following:

anticoagulant therapy used to thin the blood (e.g.

warfarin)

antidiabetictherapy

oral contraceptives ("the pill")

other medicines used to treat high blood lipid (fat)

levels eg. pravastatin, simvastatin, fluvastatin, clofi

brate, fenofibrate or gemfibrozil.

Taking this medicine

The dose of Modalim is 100 mg a day. This dose should not be exceeded. Patients with kidney prob Iems should only take 100 mg every other day. The correct dose for you will have been decided by your doctor. Check the label and if you're not sure ask your doctor or pharmacist.

Swallow the tablets with a drink of water.

Keep taking your medicine until your doctor tells you to stop.

It is important whilst you are taking Modalim to continue to follow any special diet you have been given.

Make sure you keep any followup appointments. These are quite normal and are to check you r response to treatment.

As with all medicines an overdose could be dangerous. If you have taken an overdose tell your doctor or go to the nearest hospital casualty department immediately.

Whilst taking this medicine

Modalim may cause problems in some people These include headache, vertigo, rash, nausea, vomiting, diarrhoea and indigestion. Hair loss, impotence, dizziness, drowsiness and tiredness have been reported rarely. These effects are usually mild and happen early on in treatment. They happen less often as treatment progresses. If you experience any of these effects you need not worry but you should discuss it with your doctor particularly if any of these become troublesome.

Rarely Modalim can cause breathlessness, if this becomes a problem you should see your doctor as soon as possible.

Occasionally Modalim can cause muscle problems veryrarelythesecanleadontomoreseriousproblems including kidney failure. If you experience muscle aches, cramps or weakness or if you get any unusual symptoms tell your doctor immediately as it may be necessary for you to stop taking Modalim.

Your doctor may ask you to have periodic blood tests to check your liver function and check any problems with your muscles.

Donottakethismedicineaftertheexpirydatewhich you will find on the pack.

Date of last revision of leaflet April 1995.

This leaflet does not contain all the information about your medicine. Pharmaceutical companies are not able to discuss your personal medical case. If you have any questions or are not sure about anything ask your doctor or pharmacist.

Modalim is a registered trademark. t 1995 Sanofi Winthrop Ltd.