Each tablet of “Amlodipine, 5 mg tablets” contains:

active ingredient: amlodipine (as besylate) – 5 mg;

For a full list of excipients, see section List of excipients

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 Special warnings and precautions for use and Pharmacokinetic properties).

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 should start at the lower end of the dosing range (see sections Special warnings and precautions for use and Pharmacokinetic properties). The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in patients with severe hepatic impairment.

Patients with renal impairment

Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Amlodipine is not dialysable.

Paediatric population

Children and adolescents with hypertension from 6 years to 17 years of age

The recommended antihypertensive oral dose in paediatric patients ages 6-17 years is 2.5 mg once daily as a starting dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks. Doses in excess of 5 mg daily have not been studied in paediatric patients (see sections Pharmacodynamic properties and Pharmacokinetic properties).

Children under 6 years old

No data are available.

Method of administration

Tablet for oral administration.

Pharmacotherapeutic group: Calcium channel blockers, selective calcium channel blockers with mainly vascular effects.

ATC Code: C08CA01.

List of excipients

Calcium phosphate dibasic,

Microcrystalline cellulose,

Sodium starch glycolate,

Magnesium stearate.

For more detailed information about the drug, click: http://pharm.cals.am/pharm/data/drug_134425/1736329537406.pdf