দেশ: আর্মেনিয়া
ভাষা: ইংরেজি
সূত্র: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
amlodipine (amlodipine besilate)
Arpimed LLC
C08CA01
amlodipine (amlodipine besilate)
10mg
tablets
(30/3x10/) in blister
Prescription
Registered
2019-09-25
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 সম্পূর্ণ নথি পড়ুন