Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Lercanidipine hydrochloride
Clonmel Healthcare Ltd
C08CA; C08CA13
Lercanidipine hydrochloride
20 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives; lercanidipine
Marketed
2010-03-19
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER LERCANIDIPINE CLONMEL 10MG FILM-COATED TABLETS LERCANIDIPINE CLONMEL 20MG FILM-COATED TABLETS ACTIVE SUBSTANCE: LERCANIDIPINE 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 Lercanidipine Clonmel is and what it is used for 2. What you need to know before you take Lercanidipine Clonmel 3. How to take Lercanidipine Clonmel 4. Possible side effects 5. How to store Lercanidipine Clonmel 6. Contents of the pack and other information 1. WHAT LERCANIDIPINE CLONMEL IS AND WHAT IT IS USED FOR Lercanidipine Clonmel is a selective calcium channel blocker belonging to a group of medicines called dihydropyridines. Selective calcium channel blockers reduce high blood pressure. They work by relaxing and thus widening the blood vessels. LERCANIDIPINE CLONMEL IS USED TO: treat mild to moderate high blood pressure (essential hypertension). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LERCANIDIPINE CLONMEL DO NOT TAKE LERCANIDIPINE CLONMEL if you are allergic to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6) if you have had allergic reactions to medicines closely related to Lercanidipine Clonmel (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine) if you are pregnant or breast-feeding or if you might become pregnant (see section 2. Pregnancy and breast-feeding) if you are suffering from certain heart diseases: uncontrolled cardiac failure Aqra d-dokument sħiħ
Health Products Regulatory Authority 31 July 2020 CRN009W4V Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lercanidipine Clonmel 20 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 20 mg of lercanidipine hydrochloride as lercanidipine hydrochloride hemihydrate. This is equivalent to 18.8 mg of lercanidipine. Excipient with known effect: Each film-coated tablet contains 73.1 mg lactose-monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film_-_coated tablet Pink, round, biconvex film-coated tablets of 8.1 mm with score line. The tablets can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lercanidipine is indicated for the treatment of mild to moderate essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: Oral use The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The recommended dosage is 10 mg once a day at least 15 minutes before meals (preferably before breakfast); the dose may be increased to 20 mg depending on the individual patient's response. The tablets can be divided into equal halves. The remaining tablet half should be stored protected from light. This remaining half should be taken with the next dose. Dose titration should be gradual, because it may take about 2 weeks before the maximal antihypertensive effect is apparent. Some individuals, not adequately controlled on a single antihypertensive agent, may benefit from the addition of lercanidipine to therapy with a beta-blocking agent (atenolol), a diuretic (hydrochlorothiazide) or an angiotensin converting enzyme inhibitor (captopril or enalapril). Since the dose-response curve is steep with a plateau at doses between 20-30 mg, it is unlikely that efficacy will be improved by higher doses; whereas side effects may increase. _Older people_ Although the pharmacokinetic data and clinical experience suggest that no adjustment of the daily dosage Aqra d-dokument sħiħ