COVERSYL orodispersible Tablet 10mg

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
10-07-2014
Ciri produk Ciri produk (SPC)
26-08-2019

Bahan aktif:

Perindopril 6.79 mg eqv Perindopril arginine

Boleh didapati daripada:

SERVIER (S) PTE LTD

Kod ATC:

C09AA04

Dos:

10 mg

Borang farmaseutikal:

TABLET, ORALLY DISINTEGRATING

Komposisi:

Perindopril 6.79 mg eqv Perindopril arginine 10 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

SERVIER (IRELAND) INDUSTRIES LTD. [ SII]

Status kebenaran:

ACTIVE

Tarikh kebenaran:

2012-07-04

Risalah maklumat

                                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.
                                
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Ciri produk

                                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
                                
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