ZANIDIP 10 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
LERCANIDIPINE
Available from:
Chemilines Healthcare (Ireland) Limited
ATC code:
C08CA13
INN (International Name):
LERCANIDIPINE
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Dihydropyridine derivatives
Authorization status:
Authorised
Authorization date:
2013-08-02
Summary of Product characteristics
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 of lercanidipine hydrochloride equivalent to 9.4mg lercanidipine.
Excipients: contains lactose monohydrate 30.0 mg
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Greece and the United Kingdom:_
Yellow, circular, biconvex tablets, scored on one side.
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 expereince in children.
_USE IN RENAL OR HEPATIC DYSFUNCTION_: special care should be exercised when treatment is commenced in patients with
mild to m
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