COVERSYL PLUS TABLET 2.5mg0.625mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Indapamide; PERINDOPRIL 1.6975 mg EQV PERINDOPRIL ARGININE

Available from:

SERVIER (S) PTE LTD

ATC code:

C09BA04

Dosage:

0.625mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Indapamide 0.625mg; PERINDOPRIL 1.6975 mg EQV PERINDOPRIL ARGININE 2.5 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

LES LABORATOIRES SERVIER INDUSTRIE [LSI]

Authorization status:

ACTIVE

Authorization date:

2009-04-24

Patient Information leaflet

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

Summary of Product characteristics

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 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 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 in adults.
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 2.5mg/0.625mg
Treatment may be started on one COVERSYL PLUS 2.5mg/0.625mg tablet per
day as a single dose,
preferably to be taken in the morning and before a meal.
COVERSYL PLUS 5mg/1.25mg
If blood pressure is not controlled after one month of treatment, the
dose should be titrated to one
COVER