Please read this leaflet carefully before you start taking your medicine. It tells you the

important points you should know about ANGITIL SR Capsules.

These capsules contain either 90 mg, 120 mg or 180 mg of Diltiazem Hydrochloride USP, the

active ingredient, in a special 'slow release' form.

The capsules also contain the following inactive ingredients: sucrose, maize starch, povidone, ethyl cellulose, talc, dibutyl sebacate, cetyl alcohol, sodium lauryl sulphate, gelatin and the colourings E171 and E172.

The 120 mg capsules also contain the colouring E 132.

ANGITIL SR Capsules are the following colours and have the following codes:

ANGITIL SR 90 Capsules: white/clear printed with the code "90 MG"

ANGITIL SR 120 Capsules: brown/clear printed with the code "120 MG"

ANGITIL SR 180 Capsules: pale brown/clear printed with the code "180 MG" ANGITIL SR 90, 120 and 180 Capsules are available in blister packs of 56.

Name of Product Licence Holder: Laboratoires Ethypharm, 21 Rue Saint Matthieu, 78550 Houdan, France.

Name of Manufacturer: Laboratoires Ethypharm, 21 Rue Saint Matthieu, 78550 Houdan, France.

Diltiazem belongs to a group of medicines called calcium-channel blockers. It is used for treating high blood pressure and the chest pain called angina.

• Are you pregnant or may become pregnant, or are you breast-feeding?
• Have you taken ANGITIL SR Capsules before or any medicines containing diltiazem or other calcium-channel blockers (e.g nifedipine, verapamil) before and had an allergic reaction (rash, itching, shortness of breath)?
• Do you suffer from heart disease (e.g heart failure, a slow heart rate) or have you recently had a heart attack?
• Are you taking '‘Beta-blocker' medication (for high blood pressure, angina, palpitations or nervousness) AND you have been told that you suffer from an interference with normal heartbeat?

If the answer to any of these questions is YES, DO NOT TAKE the capsules without consulting your doctor again.

• Do you suffer from muscles which are rigid or go into spasm and you perhaps take a medicine called dantrolene for the condition?

If the answer to this question is YES then if you go into hospital for severe spasm of your muscles you must tell the doctor that you are taking diltiazem. If dantrolene is given by injection it can seriously interfere with diltiazem.

• Are you taking anti-arrhythmic medicines such as digoxin (for the treatment of palpitations or irregular heart beat), carbamazepine (for epilepsy), cyclosporin (for the treatment of psoriasis or to prevent rejection of an organ following a transplant), theophylline (for asthma or other breathing difficulties) or anti-ulcer drugs (for the treatment of stomach ulcers)?
• Are you taking other anti-hypertensive medicines (for the treatment of high blood pressure) such as '‘Beta-blockers' (e.g propranolol) or 'Alpha-blockers' (e.g prazosin)? Prazosin and other 'Alpha-blockers' are also used to treat a condition where the toes and fingers become very cold (Raynaud's disease).

It is best to let your doctor know if you are taking any other medicines, including ones you have bought yourself without a prescription.

• Do you have kidney or liver disease?
• Do you suffer from porphyria?

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

If you have an operation, tell the doctor or dentist that you are taking ANGITIL SR Capsules and the dose that you are taking

If you have any blood, urine or other tests - tell the doctor or medical staff that you are taking diltiazem because the medicine can interfere with the result.

If your doctor prescribes you to take ANGITIL SR Capsules together with another antihypertensive medicine (e.g a 'Beta-blocker', a water tablet, an ACE-inhibitor, an 'Alphablocker') it is likely that your condition will be monitored regularly.

The usual dose of ANGITIL SR Capsules for the treatment of angina or high blood pressure is 90 mg to be taken twice a day. Over a period of time, your doctor may increase your dose to 120 mg twice a day, or 180 mg to be taken twice a day.

If you are elderly or you suffer from liver or kidney disease your doctor is likely to prescribe you a low dose of diltiazem. You may previously have been prescribed diltiazem 60 mg tablets. Your doctor may very gradually increase your dose and is likely to check your condition regularly to start with.

Exactly how many capsules, which strength, and how often you must take them, will be written on the label. Please read the label carefully.

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

You should finish all the capsules your doctor has prescribed. Even if you feel better, you should still take all the capsules you have been given - it may be dangerous to stop taking the medicine without your doctor's advice.

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.

If you see another doctor or go into hospital, tell them what medicines you are taking

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

If you develop wheezing or shortness of breath or severe skin rashes or itching after taking ANGITIL SR Capsules for the first time, STOP taking the capsules and tell your doctor immediately.

Tell your doctor as soon as possible if you develop a change in your normal heartbeat (eg slowing of heart rate, which may cause you to become dizzy, feel faint or actually faint). More common side-effects which some people get include swelling of the legs and ankles headaches, stomach upsets, feeling of sickness, tiredness, flushing and milder skin rashes. Tell your doctor if you suffer badly from any of these side-effects.

Tell your doctor or pharmacist if you notice any other unwanted effects not mentioned above.

Do not take any 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 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.

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 ANGITIL SR Capsules. 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 ANGITIL SR 90, 120 and 180 Capsules.

Date of Preparation: June 1995