Amlodipine tablets

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

amlodipine (amlodipine besilate)

Tilgængelig fra:

Arpimed LLC

ATC-kode:

C08CA01

INN (International Name):

amlodipine (amlodipine besilate)

Dosering:

5mg

Lægemiddelform:

tablets

Enheder i pakken:

(30/3x10/) in blister

Recept type:

Prescription

Autorisation status:

Registered

Autorisation dato:

2020-09-25

Produktets egenskaber

SUMMARY PRODUCT CHARACTERISTIC (SPC)
AMLODIPINE
5 MG AND 10 MG TABLETS
1.1 BRAND NAME – AMLODIPINE
1.2 INTERNATIONAL NON-PROPERTY NAME - AMLODIPINE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of “Amlodipine, 5 mg tablets” contains:
active ingredient: amlodipine (as besylate) – 5 mg;
_For a full list of excipients, see section 6.1 _
Each tablet of “Amlodipine, 10 mg tablets” contains:
active ingredient: amlodipine (as besylate) – 10 mg;
_For a full list of excipients, see section 6.1 _
3. PHARMACEUTICAL FORM
_Amlodipine, 5 mg tablets _
White or off white flat scored tablets.
_Amlodipin, 10 mg tablets _
White or off white biconvex scored tablets.
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
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, Amlodipine 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
_Elderly patients_
Amlodipine 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).
_Patients with hepatic impairment_
Dosage recommendations have not been established in patients with mild
to moderate hepatic
impairment; therefore dose selection should be cautious and shou