Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
LERCANIDIPINE HYDROCHLORIDE
IMED Healthcare Ltd.
C08CA13
LERCANIDIPINE HYDROCHLORIDE
10 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives
Authorised
2009-04-03
PACKAGE LEAFLET: INFORMATION FOR THE USER _ZANIDIP _10 MG FILM-COATED TABLETS _ZANIDIP _20 MG FILM-COATED TABLETS lercanidipine hydrochloride _READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START _ _TAKING THIS MEDICINE: _ _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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist IN THIS LEAFLET: 1. What Zanidip is and what it is used for 2. Before you take Zanidip 3. How to take Zanidip 4. Possible side effects 5. How to store Zanidip 6. Further information _1. WHAT ZANIDIP IS AND WHAT IT IS USED FOR _ Zanidip belongs to a group of medicines called Calcium Channel Blockers (dihydropyridine derivatives). Zanidip is used to treat high blood pressure also known as hypertension in adults over the age of 18 years (it is not recommended for children under 18 years old). _2. BEFORE YOU TAKE ZANIDIP _ _ _ _DO NOT TAKE ZANIDIP AND TELL YOUR DOCTOR IF: _ • You are allergic (hypersensitive) to lercanidipine hydrochloride or to any other ingredients of Zanidip tablets • You have had allergic reactions to drugs closely related to Zanidip tablets (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine) • 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 With Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zanidip 10mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg lercanidipine hydrochloride equivalent to 9.4mg lercanidipine. Excipients : Lactose monohydrate 30.0 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet Product imported from the UK Yellow, circular, biconvex tablets, scored on one 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 Zanidip is indicated for the treatment of mild to moderate essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dosage is 10mg orally once a day at least 15 minutes before meals; the dose may be increased to 20mg 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 Zanidip to therapy with a beta-adrenoceptor 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. _USE IN THE ELDERLY: _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. _USE IN CHILDREN: _there is no experience in children. _USE IN RENAL OR HEPATIC DYSFUNCTION: _special care Belgenin tamamını okuyun