Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
LERCANIDIPINE HYDROCHLORIDE
Clear Pharmacy
C08CA13
LERCANIDIPINE HYDROCHLORIDE
10 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives
Authorised
2010-08-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zanidip 10mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg of lercanidipine hydrochloride equivalent to 9.4mg lercanidipine. Excipients: Lactose monohydrate 30.0mg 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 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 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 Pročitajte cijeli dokument