Country: Indónesía
Tungumál: indónesíska
Heimild: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 6 BLISTER @ 5 TABLET PELEPASAN LAMBAT
2022-07-11
NAME OF THE MEDICINAL PRODUCT Natexam 1.5 mg / 5 mg modified-release tablets Natexam 1.5 mg / 10 mg modified-release tablets QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 1.5 mg indapamide and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine. One tablet contains 1.5 mg indapamide and 13.87 mg amlodipine besilate equivalent to 10 mg amlodipine. Excipient with known effect: 104.5 mg lactose monohydrate. PHARMACEUTICAL FORM Modified-release tablet. White, round, film-coated, bilayered, modified- release tablet of 9 mm diameter engraved with on one face. Pink, round, film-coated, bilayered, modified-release tablet of 9 mm diameter engraved with on one face. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Natexam is indicated as substitution therapy for treatment of essential hypertension in patients already controlled with indapamide and amlodipine given concurrently at the same dose level. POSOLOGY AND METHOD OF ADMINISTRATION Posology One tablet per day as single dose, preferably to be taken in the morning, to be swallowed whole with water and not chewed. The fixed dose combination is not suitable for initiation therapy. If a change of the posology is required, titration should be done with the individual components. Special populations _Paediatric population _ The safety and efficacy of Natexam in children and adolescents have not been established._ _ No data are available. _Patients _ _with _ _renal _ _impairment _ _(see _ _sections _ _Contraindications _ _and _ _Special _ _warnings _ _and _ _precautions for use): _ In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contraindicated. In patients with mild to moderate renal impairment, no dose adjustment is needed. _Older _ _people _ _(see _ _section _ _Special _ _warnings _ _and _ _precautions for use and Pharmacokinetic properties): _ Older people can be treated with Natexam according to renal function. _Patients _ _with _ _hepatic _ _impairment _ _(see _ _sections _ _Contraindications _ _and _ _Special _ _warnin Lestu allt skjalið