Amlodigamma

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amlodipine (amlodipine besilate)

Available from:

Woerwag Pharma GmbH & Co. KG

INN (International Name):

amlodipine (amlodipine besilate)

Dosage:

10mg

Pharmaceutical form:

tablets

Prescription type:

Prescription

Summary of Product characteristics

AMLODIGAMMA
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amlodipine besilate 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Amlodipine besilate 10 mg tablets: _
Each tablet contains 10 mg of amlodipine (as amlodipine besilate).
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet.
Amlodipine besilate 10 mg tablets:
White round tablets with a break score on both sides. The tablet can
be divided into equal halves._ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Chronic stable angina pectoris
Vasospastic (Prinzmetal´s) angina
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
_ _
_Adults _
For both hypertension and angina the usual initial dose is 5 mg
Amlodigamma once daily which may
be increased to a maximum dose of 10 mg depending on the individual
patient's response.
In hypertensive patients, Amlodigamma has been used in combination
with a thiazide diuretic, alpha
blocker, beta blocker, or an angiotensin converting enzyme inhibitor.
For angina, Amlodigamma 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 Amlodigamma is required upon concomitant
administration of thiazide
diuretics, beta blockers, and angiotensin-converting enzyme
inhibitors.
Special populations
_Elderly _
Amlodigamma used at similar doses in elderly or younger patients is
equally well tolerated. Normal
dosage regimens are recommended in the elderly, but increase of the
dosage should take place with
care (see sections 4.4 and 5.2).
_Hepatic impairment _
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Dosage recommendations have not been established in patients with mild
to moderate hepatic
impairment; therefore dose selection should be cautious and should
start at the lower end of
the dosing range (see sections 4.4 and 5.2). The pharmacokinetics of
amlodipine have not
been studied in severe hepatic impairment. Amlodipine should be
initiated at