Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
AMLODIPINE MALEATE
Pinewood Laboratories Ltd,
5 Milligram
Tablets
2005-07-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amlid 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg amlodipine (as amlodipine maleate). Excipients: Each 5 mg tablet also contains 144 mg lactose. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet The tablets are white, round and biconvex. 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 once daily which may be increased to a maximum dose of 10 mg depending on the individual patient's response. In hypertensive patients, Amlid has been used in combination with a thiazide diuretic, alpha blocker, beta blocker, or an angiotensin converting enzyme inhibitor. For angina, Amlid 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 Amlid is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/03/2012_ _CRN 2108030_ _page number: 1_ Special populations Elderly Amlid 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). Hepatic impairment Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore d Read the complete document