Alkadipin

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amlodipine (amlodipine besilate)

Available from:

Alkaloid AD-Skopje

INN (International Name):

amlodipine (amlodipine besilate)

Dosage:

5mg

Pharmaceutical form:

tablets

Prescription type:

Prescription

Summary of Product characteristics

ALKADIPIN
®
5 and 10 mg tablets
Module
1.3.1.1
Summary of product characteristics SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ALKADIPIN

5 mg tablets
ALKADIPIN

10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALKADIPIN

5 mg tablets
Each tablet contains 6,934 mg of amlodipine besilate equivalent to 5
mg amlodipine.
ALKADIPIN

10 mg tablets
Each tablet contains 13,869 mg of amlodipine besilate equivalent to 10
mg amlodipine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_*_
Tablets
_ _
ALKADIPIN

5 mg tablets
Round, biconvex and white tablets with bisection line on one side.
The tablet can be divided into two equal halves.
ALKADIPIN

10 mg tablets
Round, biconvex and white tablets with bisection line 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
Hypertension;
Chronic stable angina pectoris;
Vasospastic (Prinzmetal's) angina.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
IN ADULTS_ _
For both hypertension and angina the usual initial dose is 5mg
amlodipine once daily which
may be increased to a maximum dose of 10 mg depending on the
individual patient's
response.
In hypertensive patients, amlodipine has been used in combination with
a thiazide diuretic,
alpha blocker, beta blocker, or an angiotensin converting enzyme
inhibitor. For angina,
ALKADIPIN may be used as monotherapy or in combination with other
antianginal
ALKADIPIN
®
5 and 10 mg tablets
Module
1.3.1.1
Summary of product characteristics
medicinal products in patients with angina that is refractory to
nitrates and/or to adequate
doses of beta blockers.
No dose adjustment of amlodipine is required upon concomitant
administration of thiazide
diuretics, beta blockers, and angiotensin-converting enzyme
inhibitors.
USE IN CHILDREN
Children with hypertension from 6 years to 17 years of age. The
recommended
antihypertensive oral dose in paediatric patients ages 6-17 y