Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
DILTIAZEM HYDROCHLORIDE
Cephalon UK Limited
C08DB01
DILTIAZEM HYDROCHLORIDE
120 Milligram
Prolonged Release Capsules
Product subject to prescription which may be renewed (B)
Benzothiazepine derivatives
Authorised
2010-11-19
PACKAGE LEAFLET: INFORMATION FOR THE USER DILZEM SR 60 MG, 90 MG, 120 MG PROLONGED-RELEASE HARD CAPSULES (diltiazem hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. WHAT DILZEM SR IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DILZEM SR 3. HOW TO TAKE DILZEM SR 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DILZEM SR 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT DILZEM SR IS AND WHAT IT IS USED FOR DILZEM SR contains the active ingredient, diltiazem hydrochloride. Diltiazem belongs to a group of medicines called calcium channel blockers. These medicines work to lower blood pressure and ease anginal chest pain by preventing the narrowing of blood vessels. DILZEM SR is used to treat and control MILD TO MODERATELY HIGH BLOOD PRESSURE and to prevent and treat CHEST PAIN due to the narrowing of blood vessels in the heart. DILZEM SR is designed to release the active ingredient, diltiazem, in a controlled manner throughout the whole day so that blood pressure and angina are treated for a full 24 hour period. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DILZEM SR DO NOT TAKE DILZEM SR IF Y Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dilzem SR 120 mg Prolonged-release hard capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Dilzem SR 120 mg capsule contains diltiazem hydrochloride 120 mg. Excipients with known effect: Each capsules contains 25.2mg sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsules, hard Buff coloured hard gelatin capsules, printed with ‘120 mg’ and containing roughly spherical white to off-white beads. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dilzem SR is indicated in adults for: treatment of angina pectoris including Prinzmentals angina; treatment of mild to moderate hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ADULTS:_ Hypertension: The usual initial dose is 90 mg twice daily (corresponding to 180 mg of diltiazem hydrochloride). Depending upon clinical response the patient’s dosage may be increased to 180 mg twice daily if required. Angina Pectoris: The usual initial dose is 90 mg twice daily (corresponding to 180 mg of diltiazem hydrochloride). Depending upon clinical response the patient’s dosage may be increased to 180 mg twice daily if required. _ELDERLY:_ Dosage should commence at the lower level of 60 mg twice daily and be increased slowly. Do not increase the dose if the heart rate falls below 50 beats per minute. _PATIENTS WITH HEPATIC IMPAIRMENT:_ Dosage should commence at the lower level of 60 mg twice daily and be increased slowly. Do not increase the dose if the heart rate falls below 50 beats per minute. See section 4.4. _PATIENTS WITH RENAL IMPAIRMENT:_ Dosage should commence at the lower level of 60 mg twice daily and be increased slowly. Do not increase the dose if the heart rate falls below 50 beats Baca dokumen lengkap