APROVEL FILM-COATED TABLET 300 mg

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

IRBESARTAN

Διαθέσιμο από:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Φαρμακολογική κατηγορία (ATC):

C09CA04

Δοσολογία:

300.00 mg

Φαρμακοτεχνική μορφή:

TABLET, FILM COATED

Σύνθεση:

IRBESARTAN 300.00 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

SANOFI WINTHROP INDUSTRIE

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

1999-04-06

Φύλλο οδηγιών χρήσης

APROVEL 
 LOGO _[75mg, 150mg, 300mg]_ 
Film-coated tablet 
Irbesartan 

_[SANOFI LOGO] _

COMPOSITION

APROVEL 75 MG FILM-COATED TABLETS

Each film-coated tablet contains 75 mg irbesartan. 
APROVEL 150 MG FILM-COATED TABLETS

Each film-coated tablet contains 150 mg irbesartan. 
APROVEL 300 MG FILM-COATED TABLETS

Each film-coated tablet contains 300 mg irbesartan. 

PHARMACEUTICAL FORM

75 MG FILM-COATED TABLET

White to off-white, biconvex, and oval-shaped with
a heart debossed on one side and the number 2871 
engraved on the other side. 
150 MG FILM-COATED TABLET

White to off-white, biconvex, and oval-shaped with
a heart debossed on one side and the number 2872 
engraved on the other side. 
300 MG FILM-COATED TABLET

White to off-white, biconvex, and oval-shaped with
a heart debossed on one side and the number 2873 
engraved on the other side. 

CLINICAL PARTICULARS

THERAPEUTIC INDICATIONS

Treatment of essential hypertension. 
Treatment of renal disease in patients with hypertension and type
2 diabetes mellitus as part of an 
antihypertensive drug regimen _(see Pharmacodynamic properties)._ 

POSOLOGY AND METHOD OF ADMINISTRATION

The usual recommended initial and maintenance dose is 150 mg once
daily, with or without food. Aprovel 
at a dose of 150 mg once daily generally provides a better 24 hour
blood pressure control than 75 mg. 
However, initiation of therapy with 75 mg could be considered,
particularly in haemodialysed patients and 
in the elderly over 75 years. 

In patients insufficiently controlled with 150 mg once daily, the
dose of Aprovel can be increased to 300 
mg, or other anti-hypertensive agents can be added. In particular,
the addition of a diuretic such as 
hydrochlorothiazide has been shown to have an additive effect with
Aprovel _(see Interaction with other _
_medicinal products and other forms of interaction). _

In hypertensive type 2 diabetic patients

Αρχείο Π.Χ.Π.

SG/APR/1121/SmPC0421
APROVEL 150 MG FILM-COATED TABLETS
APROVEL 300 MG FILM-COATED TABLETS
Irbesartan
_[SANOFI LOGO] _
QUALITATIVE AND QUANTITATIVE COMPOSITION
APROVEL 150 MG FILM-COATED TABLETS
Each film-coated tablet contains 150 mg of irbesartan.
Excipient with known effect: 51.00 mg of lactose monohydrate per
film-coated tablet.
For the full list of excipients, see _List of excipients_.
APROVEL 300 MG FILM-COATED TABLETS
Each film-coated tablet contains 300 mg of irbesartan.
Excipient with known effect: 102.00 mg of lactose monohydrate per
film-coated tablet.
For the full list of excipients, see _List of excipients_.
PHARMACEUTICAL FORM
150 MG FILM-COATED TABLET
White to off-white, biconvex, and oval-shaped with a heart debossed on
one side and the number 2872
engraved on the other side.
300 MG FILM-COATED TABLET
White to off-white, biconvex, and oval-shaped with a heart debossed on
one side and the number 2873
engraved on the other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Treatment of renal disease in patients with hypertension and type 2
diabetes mellitus as part of an
antihypertensive drug regimen (see _Pharmacodynamic properties_).
POSOLOGY AND METHOD OF ADMINISTRATION
The usual recommended initial and maintenance dose is 150 mg once
daily, with or without food.
Aprovel at a dose of 150 mg once daily generally provides a better 24
hour blood pressure control than
75 mg. However, initiation of therapy with 75 mg could be considered,
particularly in haemodialysed
patients and in the elderly over 75 years.
In patients insufficiently controlled with 150 mg once daily, the dose
of Aprovel can be increased to 300
mg, or other anti-hypertensive agents can be added. In particular, the
addition of a diuretic such as
hydrochlorothiazide has been shown to have an additive effect with
Aprovel _(see Interaction with other _
_medicinal products and other forms of interaction). _
In hypertensive type 2 diabetic patients, therapy should be initiated
at 150 mg irbesartan once