מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Lercanidipine hydrochloride
McDermott Laboratories Ltd., T/A Gerard Laboratories
C08CA; C08CA13
Lercanidipine hydrochloride
20 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives; lercanidipine
Not marketed
2011-06-03
PAGE 1 OF 6 PACKAGE LEAFLET PAGE 2 OF 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LERCANIDIPINE MYLAN 10MG FILM-COATED TABLETS LERCANIDIPINE MYLAN 20MG FILM-COATED TABLETS 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 Mylan is and what it is used for 2. What you need to know before you take Lercanidipine Mylan 3. How to take Lercanidipine Mylan 4. Possible side effects 5. How to store Lercanidipine Mylan 6. Contents of the pack and other information 1. WHAT LERCANIDIPINE MYLAN IS AND WHAT IT IS USED FOR Lercanidipine Mylan contains the active ingredient lercanidipine. Lercanidipine belongs to a group of medicines called calcium channel blockers (dihydropyridine derivatives) which are used to treat high blood pressure (hypertension). Lercanidipine works by opening up the blood vessels and increasing the flow of blood through them, helping to reduce pressure. Lercanidipine Mylan is used to treat high blood pressure in adults over the age of 18 years (it is not recommended for children up to 18 years old). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LERCANIDIPINE MYLAN DO NOT TAKE LERCANIDIPINE MYLAN: if you are allergic to lercanipidine hydrochloride or any other ingredients of this medicine (listed in section 6). if you are suffering from certain heart diseases: o Untreated heart failure o Obstruction to flow of blood from the heart o Unstable angina (angina at rest or progressively increasing) o Within one month of heart attack if you have קרא את המסמך השלם
Health Products Regulatory Authority 31 March 2021 CRN00C31D Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lercanidipine Mylan 20mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of lercanidipine hydrochloride, which is equivalent to 18.8 mg of lercanidipine. Excipient with known effect: each film-coated tablet contains 50.0 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film_-_coated tablet. Pink, round, biconvex film-coated tablet, debossed with “LR over 2” on one side of the tablet and with a deep score line on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lercanidipine Mylan is indicated in adults for the treatment of mild to moderate essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dosage is 10 mg orally once a day at least 15 minutes before meals; the dose may be increased to 20 mg depending on the individual patient's response. 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 Mylan to therapy with a beta-adrenoreceptor blocking drug (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. _ _ _Elderly people_ Although the pharmacokinetic data and clinical experience suggest that no adjustment of the daily dosage is required, special care should be exercised when initiating treatment in the elderly. _Paediatric population_ The safety and efficacy of Lercanidipine Mylan קרא את המסמך השלם