ZANIDIP 20 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-05-2024
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Active ingredient:
LERCANIDIPINE HYDROCHLORIDE
Available from:
Clear Pharmacy
ATC code:
C08CA13
INN (International Name):
LERCANIDIPINE HYDROCHLORIDE
Dosage:
20 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:
2010-08-27
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zanidip 20mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20mg of lercanidipine hydrochloride equivalent to 18.8mg lercanidipine.
Excipients: Lactose monohydrate 60.0mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet.
_Product imported from _the UK:
Pink, circular, biconvex tablets, scored on one side.
The scoreline 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 car
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