COVERSYL TABLET 4 mg

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

PERINDOPRIL

Saatavilla:

SERVIER (S) PTE LTD

ATC-koodi:

C09AA04

Annos:

4 mg

Lääkemuoto:

TABLET

Koostumus:

PERINDOPRIL 4 mg

Antoreitti:

ORAL

Prescription tyyppi:

Prescription Only

Valmistaja:

LES LABORATOIRES SERVIER INDUSTRIE

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

1990-05-29

Pakkausseloste

_ _

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

Valmisteyhteenveto

1. NAME OF THE MEDICINAL PRODUCT
Coversyl 4 mg
Coversyl 8 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
4 mg perindopril tert-butylamine salt, equivalent to 3.338 mg of
perindopril
8 mg perindopril tert-butylamine salt, equivalent to 6.676 mg
perindopril
Excipients: Microcrystalline cellulose, lactose monohydrate,
Hydrophobic
colloidal silica, magnesium stearate, aluminium copper complexes of
chlorophyllins (E141 ii) lake
3. PHARMACEUTICAL FORM
Coversyl 4 mg: Tablets, light green, oblong, engraved with
on one
face and scored on both edges.
Coversyl 8 mg Tablets: Tablets, green, round, biconvex, engraved with
on one face and
on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of hypertension
Heart Failure
Treatment of symptomatic heart failure
Stable coronary artery disease:
Reduction of risk of cardiac events in patients with a history of
myocardial
infarction and/or revascularisation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
It is recommended that COVERSYL is taken once daily in the morning
before
a meal.
The dose should be individualised according to the patient profile
(see 4.4
“Special warnings and special precautions for use”) 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 4 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 mg is recommended in such patients and the initiation of
treatment
should take place under medical supervision.
The dose may be increased to 8 mg once daily after one month of
treatment.
Symptomatic hypotension may occur following initiation of therapy with
COVERSYL; this is more likely in patients who are being treated
concur-
rently wit