CONVERIDE FILM COATED TABLET 300MG12.5MG

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

Hydrochlorothiazide; Irbesartan

Disponibil de la:

MEDOCHEMIE SINGAPORE PTE. LTD.

Codul ATC:

C09DA04

Forma farmaceutică:

TABLET, FILM COATED

Compoziție:

Hydrochlorothiazide 12.5mg; Irbesartan 300.0mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

Prescription Only

Produs de:

Medochemie Ltd - Central Factory

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

2018-03-23

Caracteristicilor produsului

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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.
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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