COVERSYL PLUS Tablet 10mg2.5mg

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

Indapamide; Perindopril arginine (corresponding to perindopril 6.79mg)

可用日期:

SERVIER (S) PTE LTD

ATC代码:

C09BA04

剂量:

2.5mg

药物剂型:

TABLET, FILM COATED

组成:

Indapamide 2.5mg; Perindopril arginine (corresponding to perindopril 6.79mg) 10mg

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

LES LABORATOIRES SERVIER INDUSTRIE [LSI]

授权状态:

ACTIVE

授权日期:

2010-07-02

资料单张

EU SPC 08.2012 (French MA amendment: 21st August 2012) 
Page 1 of 17 

PACKAGE INSERT 
COVERSYL PLUS 2.5MG/0.625MG 
COVERSYL PLUS 5MG/1.25MG 
COVERSYL PLUS 10MG/2.5MG 

1. NAME OF THE MEDICINAL PRODUCT  

COVERSYL PLUS 2.5mg/0.625mg film-coated tablets  
COVERSYL PLUS 5mg/1.25mg film-coated tablets  
COVERSYL PLUS 10mg/2.5mg film-coated tablets  

2. QUALITATIVE AND QUANTITATIVE COMPOSITION  

COVERSYL PLUS 2.5mg/0.625mg  
One film-coated tablet contains 1.6975 mg perindopril corresponding
to 2.5 mg perindopril arginine and 
0.625 mg indapamide.  

COVERSYL PLUS 5mg/1.25mg  
One film-coated tablet contains 3.395
mg perindopril corresponding to 5 mg perindopril arginine
and 1.25 
mg indapamide.  

COVERSYL PLUS 10mg/2.5mg  
One film-coated tablet contains 6.79 mg perindopril equivalent
to 10 mg perindopril arginine and 2.5 mg 
indapamide.  
Excipient: lactose monohydrate  
For a full list of excipients, see section 6.1.  

3. PHARMACEUTICAL FORM  

Film-coated tablet.  
COVERSYL PLUS 5mg/1.25mg: White, rod-shaped film-coated tablet.  
COVERSYL PLUS 2.5mg/0.625mg: White, rod-shaped film-coated tablet
with an embossed line on both 
faces.  
COVERSYL PLUS 10mg/2.5mg: White, round film-coated tablet.  

4. CLINICAL PARTICULARS  

4.1 THERAPEUTIC INDICATIONS  

COVERSYL PLUS 2.5mg/0.625mg  
Essential hypertension.  

COVERSYL PLUS 5mg/1.25mg  
Treatment of essential hypertension, COVERSYL PLUS 5mg/1.25mg
film-coated tablet is indicated in 
patients whose blood pressure is not adequately controlled
on perindopril alone.  

COVERSYL PLUS 10mg/2.5mg  
COVERSYL PLUS 10mg/2.5mg tablet is indicated as substitution
therapy for treatment of essential 
hypertension, in patients already controlled with
perindopril and indapamide given concurrently at the 
same dose level.  

4.2 POSOLOGY AND METHOD OF ADMINISTRATION  
_ _
EU SPC 08.2012 (French MA amendment: 21st August 2012) 
Page 2 of 17 

_Oral

产品特点

PACKAGE INSERT
COVERSYL PLUS 5MG/1.25MG
COVERSYL PLUS 10MG/2.5MG
1. NAME OF THE MEDICINAL PRODUCT
COVERSYL PLUS 5mg/1.25mg film-coated tablets
COVERSYL PLUS 10mg/2.5mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
COVERSYL PLUS 5mg/1.25mg
One film-coated tablet contains 3.395 mg perindopril corresponding to
5 mg perindopril arginine and 1.25 mg
indapamide.
COVERSYL PLUS 10mg/2.5mg
One film-coated tablet contains 6.79 mg perindopril equivalent to 10
mg perindopril arginine and 2.5 mg
indapamide.
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
COVERSYL PLUS 5mg/1.25mg: White, rod-shaped film-coated tablet.
COVERSYL PLUS 10mg/2.5mg: White, round film-coated tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
COVERSYL PLUS 5mg/1.25mg
Treatment of essential hypertension in adults, COVERSYL PLUS
5mg/1.25mg film-coated tablet is indicated
in patients whose blood pressure is not adequately controlled on
perindopril alone.
COVERSYL PLUS 10mg/2.5mg
COVERSYL
PLUS
10mg/2.5mg
tablet
is
indicated
as
substitution
therapy
for
treatment
of
essential
hypertension, in adult patients already controlled with perindopril
and indapamide given concurrently at the
same dose level.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
COVERSYL PLUS 5mg/1.25mg
One COVERSYL PLUS 5mg/1.25mg tablet per day as a single dose,
preferably to be taken in the morning and
before
a
meal.
When
clinically
appropriate,
direct
change
from
monotherapy
to
COVERSYL
PLUS
5mg/1.25mg film-coated tablet may be considered.
COVERSYL PLUS 10mg/2.5mg
One COVERSYL PLUS 10mg/2.5mg tablet per day as a single dose,
preferably to be taken in the morning,
and before a meal.
_ _
Special populations
_ _
_Elderly (see section 4.4) _
Treatment should be initiated after considering blood pressure
response and renal function.
In elderly, the plasma creatinine must be adjusted in relation to age,
weight and gender. Elderly patients can be
treated with COVERSYL PL