COAPROVEL

מדינה: אינדונזיה

שפה: אינדונזית

מקור: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

מרכיב פעיל:

IRBESARTAN, HYDROCHLOROTHIAZIDE

זמין מ:

AVENTIS PHARMA - Indonesia

INN (שם בינלאומי):

IRBESARTAN, HYDROCHLOROTHIAZIDE

כמות:

150 MG /12.5 MG

טופס פרצבטיות:

TABLET SALUT SELAPUT

יחידות באריזה:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

תוצרת:

SANOFI WINTHROP INDUSTRIE - France

תאריך אישור:

2021-07-22

מאפייני מוצר

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