COVERSYL TABLET 8 mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

Perindopril tert-butylamine

Tilgængelig fra:

SERVIER (S) PTE LTD

ATC-kode:

C09AA04

Dosering:

8 mg

Lægemiddelform:

TABLET

Sammensætning:

Perindopril tert-butylamine 8 mg

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

Les Laboratoires Servier Industrie

Autorisation status:

ACTIVE

Autorisation dato:

2004-12-23

Indlægsseddel

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 b

Produktets egenskaber

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