Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lercanidipine (lercanidipine hydrochloride)
Recordati Industria Chimica e Farmaceutica S.p.A.
C08CA13
lercanidipine (lercanidipine hydrochloride)
10mg
tablets film-coated
(28/2x14/) in blister, (28/1x28/) in blister, (56/4x14/) in blister
Prescription
Registered
2021-10-08
Zanidip 10 mg SmPC_November 2018 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ZANIDIP-RECORDATI 10 mg film-coated tablets _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg lercanidipine hydrochloride (equivalent to 9.4 mg lercanidipine). One film-coated tablet contains 30 mg of lactose monohydrate. For the full list of excipients, see section 6.1 _._ 3. PHARMACEUTICAL FORM Film _-_ coated tablet. round-shaped biconvex tablet with a light yellow film coating, with a breaking line on one side, light yellow at the fracture surface _. _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZANIDIP 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 ZANIDIP to therapy with a beta-adrenoceptor blocking drug (atenolol), a diuretic (hydrochlorothiazide) or an angiotensin converting enzyme inhibitor (captopril or enalapril). Zanidip 10 mg SmPC_November 2018 2 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 patients:_ 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 ZANIDIP in children aged up to 18 years have not been established. No data are available. _Patients with renal or hepatic impairment:_ special care should be exercised when treatment is commenc Прочитать полный документ