Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE SALT INDAPAMIDE
Les Laboratoires Servier
2mg/0.625 Milligram
Tablets
2002-02-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril -Indapamide 2 mg/0.625 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 1.669 mg perindopril corresponding to 2 mg perindopril tert-butylamine and 0.625 mg indapamide. Excipient : 64.175 mg lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, rod-shaped tablet, scored on each side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. The usual dose is one Perindopril-Indapamide 2 mg/0.625 mg tablet per day as a single dose, preferably to be taken in the morning and before a meal. If blood pressure is not controlled after one month of treatment, the dose can be doubled_._ _Elderly (see section 4.4)_ Treatment should be started at the normal dose of one Perindopril-Indapamide 2 mg/0.625 mg tablet per day. _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), the maximum dose should be one tablet of Perindopril-Indapamide 2 mg/0.625 mg per day. 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, 4.4 and 5.2)_ In severe hepatic impairment, treatment is contraindicated. In patients with moderate hepatic impairment, no dose modification is required. _Children and adolescents_ Perindopril-Indapamide 2 mg/0.625 mg should not be used in children and adolescent Izlasiet visu dokumentu