Normodipine tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amlodipine (amlodipine besilate)

Available from:

Gedeon Richter PLC

ATC code:

C08CA01

INN (International Name):

amlodipine (amlodipine besilate)

Dosage:

5mg

Pharmaceutical form:

tablets

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-10-21

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Normodipine 5 mg tablets
Normodipine 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Normodipine 5 mg tablets
Each tablet contains 5.00 mg amlodipine (as 6.944 mg amlodipine
besylate).
Normodipine 10 mg tablets
Each tablet contains 10.00 mg amlodipine (as 13.889 mg amlodipine
besylate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Normodipine 5 mg tablets
White or almost white, oblong, biconvex tablets with an engraved mark
“5” on one side.
Normodipine 10 mg tablets
White or almost white, oblong, biconvex tablets with an engraved mark
“10” on one side and a score
line on the reverse side. The tablet can be divided 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
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, Normodipine has been used in combination
with a thiazide diuretic, alpha
blocker, beta blocker, or an angiotensin converting enzyme inhibitor.
For angina, Normodipine 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 Normodipine is required upon concomitant
administration of thiazide
diuretics, beta blockers, and angiotensin converting enzyme
inhibitors.
_Special populations _
_Elderly patients_
Normodipine 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
2
care (see sections 4.4 and 5.2).
_Patients with hepatic impairment _
Dosage recommendations have not been established in patients with mild
to moderate hepa