Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE INDAPAMIDE
Glenmark Pharmaceuticals Europe Limited
PERINDOPRIL TERT-BUTYLAMINE INDAPAMIDE
2/0.625 mg/mg
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2014-09-10
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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril tert-butylamine/Indapamide Glenmark 2 mg/0.625 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg perindopril tert-butylamine salt, equivalent to 1.669 mg perindopril and 0.625mg indapamide. Excipient: each tablet contains 58.47mg of lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, rod shaped tablets having ‘P’ and ‘I’ engraved on either side of score line on one side and score line on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension for patients whose blood pressure is not adequately controlled on perindopril alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral use It is recommended that one Perindopril tert-butylamine/Indapamide Glenmark 2 mg/0.625 mg Tablet is taken daily, preferably in the morning before a meal. The dose should be adjusted according to the patient profile and blood pressure response. If blood pressure is not adequately controlled the dose may be increased to one erindopril tert- butylamine/Indapamide Glenmark 4 mg/1.25 mg Tablet daily. When clinically appropriate, direct change from monotherapy with perindopril to Perindopril tert- butylamine/Indapamide Glenmark may be considered. Individual dose titration with the components may be required. Elderly (See 4.4) Treatment should be initiated at a dose of 2 mg/0.625 mg daily with consideration of the blood pressure response and renal function. Patients with renal impairment (See 4.3 & 4.4) In severe renal failure, (creatinine clearance below 30ml/min) treatment is contraindicated. In patients with moderate renal impa Læs hele dokumentet