Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE
Les Laboratoires Servier
C09BA04
PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE
8/2.5 mg/mg
Tablets
Product subject to prescription which may be renewed (B)
ACE inhibitors and diuretics
Authorised
2009-08-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril tert-butylamine /Indapamide Servier 8mg/2.5mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 6.676 mg perindopril equivalent to 8 mg perindopril tert-butylamine and 2.5 mg indapamide. Excipient : lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perindopril tert-butylamine /Indapamide Servier 8 mg /2.5mg is indicated as substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril and indapamide given concurrently at the same dose level. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral route One Perindopril tert-butylamine /Indapamide Servier 8 mg /2.5mg tablet per day as a single dose, preferably to be taken in the morning, and before a meal. _Elderly (see section 4.4)_ In elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated if renal function is normal and after considering blood pressure response. _Patients with renal impairment (see section 4.4)_ In severe and moderate renal impairment (creatinine clearance below 60 ml/min), treatment is contraindicated. 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 tert-butylamine /Indapamide Servier 8 mg /2.5mg should not be used in children and adolescents as the efficacy and tolerability of perindopril in children and adolescents, alone or in Izlasiet visu dokumentu