Zanidip-Recordati tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

lercanidipine (lercanidipine hydrochloride)

Available from:

Recordati Industria Chimica e Farmaceutica S.p.A.

ATC code:

C08CA13

INN (International Name):

lercanidipine (lercanidipine hydrochloride)

Dosage:

20mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/2x14/) in blister, (56/4x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-10-08

Summary of Product characteristics

Zanidip 20 mg SmPC_November 2018
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1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ZANIDIP-RECORDATI 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg lercanidipine hydrochloride
(equivalent to 18.8 mg
lercanidipine).
One film-coated tablet contains 60 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 pink to dark pink 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
Zanidip 20 mg SmPC_November 2018
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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.
_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
commence