COVERSYL orodispersible Tablet 5mg

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Perindopril 3.395 mg eqv Perindopril arginine

Διαθέσιμο από:

SERVIER (S) PTE LTD

Φαρμακολογική κατηγορία (ATC):

C09AA04

Δοσολογία:

5 mg

Φαρμακοτεχνική μορφή:

TABLET, ORALLY DISINTEGRATING

Σύνθεση:

Perindopril 3.395 mg eqv Perindopril arginine 5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

SERVIER (IRELAND) INDUSTRIES LTD. [ SII]

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2012-07-04

Φύλλο οδηγιών χρήσης

PACKAGE INSERT 

COVERSYL ORODISPERSIBLE 2.5 MG TABLETS 
COVERSYL ORODISPERSIBLE 5 MG TABLETS 
COVERSYL ORODISPERSIBLE 10 MG TABLETS 

1. NAME OF THE MEDICINAL PRODUCT 

COVERSYL orodispersible 2.5 mg tablets 
COVERSYL orodispersible 5 mg tablets 
COVERSYL orodispersible 10 mg tablets 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Perindopril arginine. 

COVERSYL orodispersible 2.5 mg tablets 
One orodispersible tablet contains 1.698 mg perindopril
corresponding to 2.5 mg perindopril arginine. 
Excipients with known effect: 
31.365 mg lactose, 0.1 mg aspartame. 

COVERSYL orodispersible 5 mg tablets 
One orodispersible tablet contains 3.395 mg perindopril
corresponding to 5 mg perindopril arginine. 
Excipients with known effect: 
62.73 mg lactose, 0.2 mg aspartame. 

COVERSYL orodispersible 10 mg tablets 
One orodispersible tablet contains 6.790 mg perindopril
corresponding to 10 mg perindopril arginine. 
Excipients with known effect: 
125.46 mg lactose, 0.4 mg aspartame. 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 

Orodispersible tablet. 
White, round, tablet. 

4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

_COVERSYL orodispersible 2.5 mg, 5 mg and 10 mg tablets_ 

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 orodispersible 2.5 mg and 5 mg tablets_ 

Heart failure: 
Treatment of symptomatic heart failure. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 

_METHOD OF ADMINISTRATION _

For oral use. 
COVERSYL orodispersible tablet is recommended to be taken once
daily in the morning before a meal. 
The tablet should be placed on the tongue for disintegration and
swallowed with saliva. Alternatively, 
patients can disperse the tablet in a glass of water and drink the
resulting suspension.

Αρχείο Π.Χ.Π.

PACKAGE INSERT
COVERSYL ORODISPERSIBLE 2.5 MG TABLETS
COVERSYL ORODISPERSIBLE 5 MG TABLETS
COVERSYL ORODISPERSIBLE 10 MG TABLETS
1. NAME OF THE MEDICINAL PRODUCT
COVERSYL orodispersible 2.5 mg tablets
COVERSYL orodispersible 5 mg tablets
COVERSYL orodispersible 10 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril arginine.
COVERSYL orodispersible 2.5 mg tablets
One orodispersible tablet contains 1.698 mg perindopril corresponding
to 2.5 mg perindopril arginine.
Excipients with known effect:
31.365 mg lactose, 0.1 mg aspartame.
COVERSYL orodispersible 5 mg tablets
One orodispersible tablet contains 3.395 mg perindopril corresponding
to 5 mg perindopril arginine.
Excipients with known effect:
62.73 mg lactose, 0.2 mg aspartame.
COVERSYL orodispersible 10 mg tablets
One orodispersible tablet contains 6.790 mg perindopril corresponding
to 10 mg perindopril arginine.
Excipients with known effect:
125.46 mg lactose, 0.4 mg aspartame.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Orodispersible tablet.
White, round, tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_COVERSYL orodispersible 2.5 mg, 5 mg and 10 mg tablets_
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 orodispersible 2.5 mg and 5 mg tablets_
Heart failure:
Treatment of symptomatic heart failure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION _
For oral use.
COVERSYL orodispersible tablet is recommended to be taken once daily
in the morning before a meal.
The tablet should be placed on the tongue for disintegration and
swallowed with saliva. Alternatively,
patients can disperse the tablet in a glass of water and drink the
resulting suspension.
_ _
_POSOLOGY _
The dose should be individualised according to the patient profile
(see section 4.4) and blood pressure
response.
Hypertension
COVERSYL orodispersible tablets may be used in mon