Alkadipin tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amlodipine (amlodipine besilate)

Available from:

Alkaloid AD Skopje

ATC code:

C08CA01

INN (International Name):

amlodipine (amlodipine besilate)

Dosage:

10mg

Pharmaceutical form:

tablets

Units in package:

(30/2x15/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-04-06

Summary of Product characteristics

Alkadipin

5 mg and 10 mg tablets
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.
Excipient(s) with known effect: each tablet contains 37.290 mg lactose
monohydrate.
Alkadipin

10 mg tablets
Each tablet contains 13,869 mg of amlodipine besilate equivalent to 10
mg amlodipine.
Excipient(s) with known effect: each tablet contains 90 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM

Tablets
_ _
Alkaipin

5 mg tablets
White, round, biconvex tablets with break-mark on one side.
The tablet can be divided into two equal doses.
Alkaipin

10 mg tablets
White, round, biconvex tablets with break-mark on one side.
The break-mark 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.
Alkadipin

5 mg and 10 mg tablets
Summary of Product Characteristics
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_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 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.
Special populations
_