Country: Арменија
Језик: Енглески
Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
amlodipine (amlodipine besilate)
Alkaloid AD Skopje
C08CA01
amlodipine (amlodipine besilate)
10mg
tablets
(30/2x15/) in blister
Prescription
Registered
2020-04-06
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 _ Прочитајте комплетан документ