Pays: Singapour
Langue: anglais
Source: HSA (Health Sciences Authority)
HYDROCHLOROTHIAZIDE; IRBESARTAN
MEDOCHEMIE SINGAPORE PTE. LTD.
C09DA04
TABLET, FILM COATED
HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150.0MG
ORAL
Prescription Only
MEDOCHEMIE LTD - CENTRAL FACTORY
ACTIVE
2018-03-23
spcirbehydrtabs1.6_SG 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Converide 150 mg/12.5 mg film-coated tablets Converide 300mg/12.5mg film-coated tablets Converide 300mg/25mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Converide 150 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Converide 300mg/12.5mg film-coated tablets: Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Converide 300mg/25mg film-coated tablets: Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide. Excipient with known effect: lactose monohydrate. Converide 150 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 26.65 mg of lactose (as lactose monohydrate) Converide 300mg/12.5mg film-coated tablets: Each film-coated tablet contains 65.8 mg of lactose (as lactose monohydrate) Converide 300mg/25mg film-coated tablets: Each film-coated tablet contains 53.3 mg of lactose (as lactose monohydrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Converide 150 mg/12.5 mg film-coated tablets: White, round, convex, film- coated tablets with diameter 9.5 mm. spcirbehydrtabs1.6_SG 2 Converide 300mg/12.5mg film-coated tablets: Pink, convex, film coated capsule-shaped tablets, scored on one side, embossed “MC” on the other side, with dimensions 17.5 x 8 mm. Converide 300mg/25mg film-coated tablets: White, convex, film coated capsule-shaped tablets, scored on one side, embossed “MC” on the other side, with dimensions 17.5 x 8 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. This fixed dose combination is also Lire le document complet