Nazione: Indonesia
Lingua: indonesiano
Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
IRBESARTAN, HYDROCHLOROTHIAZIDE
AVENTIS PHARMA - Indonesia
IRBESARTAN, HYDROCHLOROTHIAZIDE
150 MG /12.5 MG
TABLET SALUT SELAPUT
DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT
SANOFI WINTHROP INDUSTRIE - France
2021-07-22
BASED ON COAPROVEL-EU SMPC (22 APRIL 2021) 1 RANCANGAN LEAFLET IRBESARTAN /HYDROCHLOROTIAZIDE COMPOSITION COAPROVEL 150 MG /12.5 MG FILM COATED TABLETS Each film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide. COAPROVEL 300 MG/12.5 MG FILM COATED TABLETS Each film-coated tablet contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide. PHARMACEUTICAL FORM 150 MG/12.5 MG FILM COATED TABLET Film-coated tablet: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number «2875» engraved on the other side. 300 MG/12.5 MG FILM COATED TABLET Film-coated tablet: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number «2876» engraved on the other side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Treatment of essential hypertension. This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. This fixed dose combination is also indicated as initial treatment when hypertension is severe and rapid control of blood pressure (within days to weeks) is of primary clinical importance (see “ Pharmacodynamic Properties ”). POSOLOGY AND METHOD OF ADMINISTRATION Posology CoAprovel can be taken once daily, with or without food. Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended. When clinically appropriate direct change from monotherapy to the fixed combinations may be considered: ▪ CoAprovel 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; ▪ CoAprovel 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg. ▪ CoAprovel 300 mg/25 mg may be administered in patients insufficiently controlled by CoAprovel 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, CoAprovel may be adm Leggi il documento completo