COVERSYL 10mg tablet

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

perindopril arginine 10mg eqv to perindopril

Available from:

SERVIER (S) PTE LTD

ATC code:

C09AA04

Dosage:

6.790 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

perindopril arginine 10mg eqv to perindopril 6.790 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

LES LABORATOIRES SERVIER INDUSTRIE [LSI]

Authorization status:

ACTIVE

Authorization date:

2008-07-16

Patient Information leaflet

_ _

COVERSYL
®

1. 
NAME OF THE MEDICINAL PRODUCT 

Coversyl 5 mg, film-coated tablets 
Coversyl 10 mg, film-coated tablets 

2. QUALITATIVE 
AND 
QUANTITATIVE 
COMPOSITION 

_Coversyl 5 mg: _
One film-coated tablet contains 3.395 mg of perindopril
corresponding to 5 mg of perindopril arginine. 
Excipient with known effect: 72.58 mg lactose monohydrate. 

_Coversyl 10 mg: _
One film-coated tablet contains 6.790
mg of perindopril corresponding to 10 mg of perindopril arginine. 
Excipient with known effect: 145.16 mg lactose monohydrate. 

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM

_ _
_Coversyl 5 mg _
Film-coated tablet, light green, rod-shaped, engraved with 
on one face and scored on both 
edges. The tablet can be divided into equal halves doses. 

_Coversyl 10 mg: _
Film-coated tablet, green, round, biconvex, engraved with 
on one face and 
on the other. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
_ _
_Coversyl 5 mg and 10 mg _

Hypertension 
Treatment of hypertension 

Stable coronary artery disease 
Reduction of risk of cardiac events in patients with a history
of myocardial infarction and/or 
revascularisation. 
_ _
_Coversyl 5 mg_

Heart failure 
Treatment of symptomatic_ _heart failure 

4.2     POSOLOGY AND METHOD OF ADMINISTRATION 

_METHOD OF ADMINISTRATION _
_ _
For oral use. 
COVERSYL is recommended to be taken once daily
in the morning before a meal. 
_ _
_POSOLOGY _
2/14 
_ _
_  _
The dose should be individualised according to the patient
profile (see section 4.4) and blood pressure 
response. 

Hypertension 
COVERSYL may be used in
monotherapy or in combination with other classes of
antihypertensive 
therapy. 

The recommended starting dose is 5 mg given once daily_ _in
the morning._  _
_ _
Patients wi

Summary of Product characteristics

COVERSYL

1.
NAME OF THE MEDICINAL PRODUCT
Coversyl 5 mg, film-coated tablets
Coversyl 10 mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Coversyl 5 mg: _
One film-coated tablet contains 3.395 mg of perindopril corresponding
to 5 mg of perindopril arginine.
Excipient with known effect: 72.58 mg lactose monohydrate.
_Coversyl 10 mg: _
One film-coated tablet contains 6.790 mg of perindopril corresponding
to 10 mg of perindopril arginine.
Excipient with known effect: 145.16 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_Coversyl 5 mg _
Film-coated tablet, light green, rod-shaped, engraved with
on one face and scored on both
edges. The tablet can be divided into equal halves doses.
_Coversyl 10 mg: _
Film-coated tablet, green, round, biconvex, engraved with
on one face and
on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Coversyl 5 mg and 10 mg _
_ _
Hypertension
Treatment of hypertension
Stable coronary artery disease
Reduction of risk of cardiac events in patients with a history of
myocardial infarction and/or
revascularisation.
_Coversyl 5 mg _
_ _
Heart failure
Treatment of symptomatic heart failure
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION _
_ _
For oral use.
COVERSYL is recommended to be taken once daily in the morning before a
meal.
_POSOLOGY _
2/16
_ _
The dose should be individualised according to the patient profile
(see section 4.4) and blood pressure
response.
Hypertension
COVERSYL may be used in monotherapy or in combination with other
classes of antihypertensive
therapy (see sections 4.3, 4.4, 4.5 and 5.1).
The recommended starting dose is 5 mg given once daily in the morning.
Patients with a strongly activated renin-angiotensin-aldosterone
system (in particular, renovascular
hypertension, salt and/or volume depletion, cardiac decompensation or
severe hypertension) may
experience an excessive drop in blood pressure following the initial
dose. A starting dose of 2.5 mg is
recommended in