국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE SALT INDAPAMIDE
Les Laboratoires Servier
4mg/1.25 Milligram
Tablets
1998-08-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bi Preterax 4mg/1.25mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 3.338 mg perindopril corresponding to 4 mg perindopril tert-butylanine and 1.25 mg indapamide. Excipient: 61.55 mg lactose monohydrate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. White, rod-shaped tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension, Bi Preterax 4 mg/1.25 mg Tablets is indicated in patients whose blood pressure is not adequately controlled on perindopril alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral route One Bi Preterax 4 mg/1.25 mg tablet per day as a single dose, preferably to be taken in the morning, and before a meal. When possible individual dose titration with the components is recommended. Bi Preterax 4 mg/1.25 mg tablet should be used when blood pressure is not adequately controlled on Preterax 2 mg/0.625 mg Tablets (where available).When clinically appropriate, direct change from monotherapy to Bi Preterax 4 mg/1.25 mg Tablets tablet may be considered. _Elderly (see section 4.4)_ Treatment should be initiated after considering blood pressure response and renal function. _Patients with renal impairment (see section 4.4)_ In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contraindicated. In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), it is recommended to start treatment with the adequate dosage of the free combination. In patients with creatinine clearance greater than or equal to 60 ml/min, no dose modification is required. Usual medical follow-up will include frequent monitoring of creatinine and potassium. _Patients with hepatic impairment (see sections 4.3 전체 문서 읽기