COAPROVEL FILM-COATED TABLET 15012.5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

HYDROCHLOROTHIAZIDE; IRBESARTAN

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

C09DA04

Dosage:

12.50 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

HYDROCHLOROTHIAZIDE 12.50 mg; IRBESARTAN 150.00 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

SANOFI WINTHROP INDUSTRIE

Authorization status:

ACTIVE

Authorization date:

2001-08-28

Patient Information leaflet

 
 COAPROVEL 
®

irbesartan/hydrochlorothiazide 

[sanofi logo] 

COMPOSITION 
COAPROVEL 150/12.5 MG FILM-COATED TABLETS 
Each film-coated tablet contains 150 mg irbesartan and 12.5 mg
hydrochlorothiazide. 
Excipient: Each film-coated tablet contains 38.5 mg of lactose (as
lactose monohydrate). 
For a full list of excipients, see _List of excipients_. 

COAPROVEL 300/12.5 MG FILM-COATED TABLETS 
Each film-coated tablet contains 300 mg irbesartan and 12.5 mg
hydrochlorothiazide. 
Excipient: Each film-coated tablet contains 89.5 mg of lactose (as
lactose monohydrate). 
For a full list of excipients, see _List of excipients_. 

COAPROVEL

300/25 MG FILM-COATED TABLETS 
Each film-coated tablet contains 300 mg of irbesartan and 25 mg
of hydrochlorothiazide. 
Excipient: Each film-coated tablet contains 53.3 mg of lactose (as
lactose monohydrate). 
For a full list of excipients, see _List of excipients_. 

PREGNANCY AND LACTATION 

USE IN PREGNANCY: 
Should exposure to angiotensin-II receptor antagonists have occurred
from 
the second trimester of pregnancy, ultrasound check of renal
function and skull is 
recommended. 
Infants whose mothers have taken angiotensin-II
receptor antagonists should be closely 
observed for
hypotension (see also _Contraindications_ and _Special warnings
and special _
_precautions for use_
). 

Although there is no experience with CoAprovel in pregnant
women, _in utero_ exposure to 
angiotensin converting enzyme inhibitors given to pregnant women
during the second and third 
trimesters has been reported to cause injury and death to the
developing foetus. As for any drug 
that also acts directly on the renin-angiotensin-aldosterone system,
CoAprovel should not be 
used during pregnancy. 

Thiazides cross the placental barrier and appear in cord blood.
They may cause foetal 
electrolyte disturbances and possibly other reactions that have
occurred in the adults. Cases o

Summary of Product characteristics

SG/COA/0822/SmPC0222 COAPROVEL
®
irbesartan/hydrochlorothiazide
[sanofi logo]
QUALITATIVE AND QUANTITATIVE COMPOSITION
COAPROVEL 150/12.5 MG FILM-COATED TABLETS
Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
Excipient with known effect: Each film-coated tablet contains 38.5 mg
of lactose (as lactose
monohydrate).
For a full list of excipients, see _List of excipients_.
COAPROVEL 300/12.5 MG FILM-COATED TABLETS
Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
Excipient with known effect: Each film-coated tablet contains 89.5 mg
of lactose (as lactose
monohydrate).
For a full list of excipients, see _List of excipients_.
COAPROVEL
300/25 MG FILM-COATED TABLETS
Each film-coated tablet contains 300 mg of irbesartan and 25 mg of
hydrochlorothiazide.
Excipient with known effect: Each film-coated tablet contains 53.3 mg
of lactose (as lactose
monohydrate).
For a full list of excipients, see _List of excipients_.
PHARMACEUTICAL FORM
COAPROVEL 150 MG/12.5 MG FILM-COATED TABLET
Peach, biconvex, oval-shaped, with a heart debossed on one side and
the number 2875 engraved
on the other side.
COAPROVEL 300 MG/12.5 MG FILM-COATED TABLET
Peach, biconvex, oval-shaped, with a heart debossed on one side and
the number 2876 engraved
on the other side.
COAPROVEL 300 MG/25 MG FILM-COATED TABLET
Pink, biconvex, oval-shaped, with a heart debossed on one side and the
number 2788 engraved on
the other side.
CLINICAL PARTICULARS
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 indicated as initial therapy in
patients with moderate to severe
essential hypertension for whom the benefit of a prompt blood pressure
reduction exceeds the risk
of initiating combination therapy in these patients (see
_Pharmacodynamic properties_).
POSOLOGY AND METHOD OF ADMINISTRATION