Država: Armenija
Jezik: angleščina
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
amlodipine (amlodipine besilate)
Gedeon Richter PLC
C08CA01
amlodipine (amlodipine besilate)
5mg
tablets
(30/3x10/) in blister
Prescription
Registered
2020-10-21
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 Preberite celoten dokument