Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ARGININE INDAPAMIDE
Les Laboratoires Servier
PERINDOPRIL ARGININE INDAPAMIDE
10/2.5 mg/mg
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Teraxans 10mg/2.5mg film coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 6.79 mg perindopril equivalent to 10 mg perindopril arginine and 2.5 mg indapamide. Excipient : lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, round film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Teraxans 10mg/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 Teraxans 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_ Teraxans should not be used in children and adolescents as the efficacy and tolerability of perindopril in children and adolescents, alone or in combination, have not been established. 4.3 CONTRAINDICATIONS _Linked to perindopril:_ _- _Hypersensitivity to perindopril or any other Przeczytaj cały dokument