Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
AMLODIPINE MALEATE
McDermott Laboratories Ltd t/a Gerard Laboratories
10 Milligram
Tablets
2004-11-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amlist 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of amlodipine (as amlodipine maleate). Excipient(s): 145.20 mg Lactose monohydrate For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round tablets with a break score on both sides. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension. Chronic stable and vasospastic angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _In adults_ For treatment of both hypertension and angina pectoris the usual initial dose is 5 mg once daily. If the desired therapeutic effect cannot be achieved within 2-4 weeks, this dose may be increased to a maximum dose of 10 mg daily (as single dose) depending on the individual patient’s response. Amlodipine may be used either as monotherapy or in combination with other antianginal drugs in patients with angina. _Children 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 section 5.1 Pharmacodynamic Properties and section 5.2 Pharmacokinetic Properties). The effect of amlodipine on blood pressure in patients less than 6 years of age is not known The 2.5 mg dose cannot be obtained with Amlodipine tablets 5 mg as these tablets are not manufactured to break into two equal halves _In the elderly_ Normal dosage regimens are recommended in the elderly, but caution should be exercised when increasing th Aqra d-dokument sħiħ