TPI 88290029/1

Patient Information Leaflet

MONOMAX™ sr 40 capsules

(Isosorbide-5-Mononltrate)

 

Please read this leaflet carefully before you start taking your medicine. It tells you the important points you should know about Monomax SR 40 Capsules.

WHAT'S IN YOUR MEDICINE?

MONOMAX SR 40 Capsules contain 40 mg of Isosorbide Mononitrate (ISMN).

ISMN is the active ingredient in MONOMAX SR 40 Capsules and is present in a special 'slow release' form. The capsules also contain lactose, sucrose, maize starch, shellac, talc and polymers of methacrylic acid, acrylic acid esters and methacrylic acid esters. The capsule shells are made of gelatin and also contain the colouring agent titanium dioxide (E171). The capsules are white in colour. MONOMAX SR 40 Capsules are marked with "ISMN SR 40", MONOMAX SR 40 Capsules are available in blister packs of 28.

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

Name of Manufacturer: Ethypharm Industries, 17-21 Rue Saint Matthieu, 78550 Houdan, France.

ABOUT YOUR MEDICINE

ISMN belongs to a group of medicines called nitrates. It is used to prevent the symptoms of angina (chest pain) from happening. Angina usually occurs as a pain or tightness in the chest although it may be felt in the neck or arm. The pain happens when the muscle in the heart does not receive enough oxygen for the work it has to do. ISMN works by improving the blood supply to the heart, by enlarging the blood vessels in the heart muscle.

BEFORE TAKING YOUR MEDICINE

If the answer to any of these questions is YES, do not take the capsules without consulting your doctor again.

If the answer to any of these questions is YES, tell your doctor or pharmacist.

 

Please read the back of this leaflet

continued

Be careful when drinking alcohol, it may affect you more than usual.

Be careful when driving or operating machinery, if the capsules make you feel dizzy.

MONOMAX SR 40 Capsules are used to prevent symptoms of angina from happening; they are not used for the treatment of an acute angina attack. You should use your tablets or spray under the tongue for treatment of acute attacks.

HOW TO TAKE YOUR MEDICINE

The usual dose of MONOMAX SR 40 Capsules for the treatment of angina is 40 mg per day.

Some people may require up to 60 mg per day to treat their angina.

Exactly how many capsules and how often you must take them will be written on the dispensing label. Please read the label carefully. It is very important that you follow the directions exactly because otherwise the medicine may not be so effective over a period of time.

Swallow the capsules whole with a glass of water. Do not chew them.

AFTER TAKING YOUR MEDICINE

ISMN, like most other medicines, may cause side-effects in some patients, particularly when you first start to take it.

If you develop skin troubles such as rash or itching for the first time or wheezing or shortness of breath STOP taking the capsules and tell your doctor immediately. They may be signs of allergy.

Side-effects which some people can get include headaches, flushing (reddening) of the skin, faintness or dizziness especially when getting up from Iying or sitting down, a fast heart beat or pulse and feelings of sickness.

These effects are often mild and may wear off after a few days' treatment. If they are severe or last for more than a few days tell your doctor or pharmacist.

Contact your doctor immediately if too much is taken.

STORING YOUR MEDICINE

Do not take the capsules 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 dry, cool place (below 25°C). Keep them in the pack they came in. Do not transfer them to another container.

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 MONOMAX SR 40 Capsules.

Date of Preparation: April 1996

Trinity Pharmaceuticals Ltd., Tuition House, 27/37 St. George's Road,

Wimbledon, London SW19 4EU

™Trade Mark applied for.