COVERAM Tablet 5mg5mg

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

AMLODIPINE BESILATE 6.935 mg EQV AMLODIPINE; PERINDOPRIL 3.395 mg EQV PERINDOPRIL ARGININE

Διαθέσιμο από:

SERVIER (S) PTE LTD

Φαρμακολογική κατηγορία (ATC):

C09BB04

Δοσολογία:

5mg

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

AMLODIPINE BESILATE 6.935 mg EQV AMLODIPINE 5mg; PERINDOPRIL 3.395 mg EQV PERINDOPRIL ARGININE 5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

LES LABORATOIRES SERVIER INDUSTRIE [LSI]

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2010-07-08

Φύλλο οδηγιών χρήσης

1 
_ _

SUMMARY OF PRODUCT CHARACTERISTICS 

1.   NAME OF THE MEDICINAL PRODUCT 

COVERAM 5mg/5mg tablets 
COVERAM 5mg/10mg tablets 
COVERAM 10mg/5mg tablets 
COVERAM 10mg/10mg tablets 

2.   QUALITATIVE AND QUANTITATIVE COMPOSITION 

COVERAM  5mg/5mg  tablets:  One  tablet  contains  3.395  mg  perindopril  equivalent  to  5  mg  perindopril 
arginine and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine 
COVERAM  5mg/10mg  tablets:  One  tablet  contains  3.395  mg  perindopril  equivalent  to  5  mg  perindopril 
arginine and 13.870 mg amlodipine besilate equivalent to 10 mg amlodipine 
COVERAM  10mg/5mg  tablets:  One  tablet  contains  6.790  mg  perindopril  equivalent  to  10  mg  perindopril 
arginine and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine 
COVERAM  10mg/10mg  tablets:  One  tablet  contains  6.790  mg  perindopril  equivalent  to  10  mg  perindopril 
arginine and 13.870 mg amlodipine besilate equivalent to 10 mg amlodipine 

Excipient : lactose monohydrate  
For the complete list of excipients, see section 6.1. 

3.   PHARMACEUTICAL FORM 

Tablet. 
COVERAM 5mg/5mg tablets: White, rod-shaped tablet engraved with 5/5 on one face and 
 on the other 
face. 
COVERAM 5mg/10mg tablets: White, square-shaped tablet engraved with 5/10 on one face and 
 on the 
other face. 
COVERAM  10mg/5mg tablets: White, triangular-shaped tablet engraved with 10/5 on one face and 
 on 
the other face. 
COVERAM 10mg/10mg tablets: White, round tablet engraved with 10/10 on one face and 
 on the other 
face. 

4.   CLINICAL DATA  

4.1 
THERAPEUTIC INDICATIONS 
COVERAM is indicated as substitution therapy for treatment of essential hypertension and/or stable coronary 
artery disease

Αρχείο Π.Χ.Π.

1
1.
NAME OF THE MEDICINAL PRODUCT
Coveram 5mg/5mg tablets
Coveram 5mg/10mg tablets
Coveram 10mg/5mg tablets
Coveram 10mg/10mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Coveram 5mg/5mg tablets: One tablet contains 3.395 mg perindopril
equivalent to 5 mg perindopril arginine
and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine
Coveram 5mg/10mg tablets: One tablet contains 3.395 mg perindopril
equivalent to 5 mg perindopril arginine
and 13.870 mg amlodipine besilate equivalent to 10 mg amlodipine
Coveram 10mg/5mg tablets: One tablet contains 6.790 mg perindopril
equivalent to 10 mg perindopril
arginine and 6.935 mg amlodipine besilate equivalent to 5 mg
amlodipine
Coveram 10mg/10mg tablets: One tablet contains 6.790 mg perindopril
equivalent to 10 mg perindopril
arginine and 13.870 mg amlodipine besilate equivalent to 10 mg
amlodipine
Excipient with known effect: lactose monohydrate
For the complete list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Coveram 5mg/5mg tablets: White, rod-shaped tablet engraved with 5/5 on
one face and
on the other
face.
Coveram 5mg/10mg tablets: White, square-shaped tablet engraved with
5/10 on one face and
on the
other face.
Coveram 10mg/5mg tablets: White, triangular-shaped tablet engraved
with 10/5 on one face and
on the
other face.
Coveram 10mg/10mg tablets: White, round tablet engraved with 10/10 on
one face and
on the other
face.
4.
CLINICAL DATA
4.1
THERAPEUTIC INDICATIONS
Coveram is indicated as substitution therapy for treatment of
essential hypertension and/or stable coronary
artery disease, in patients already controlled with perindopril and
amlodipine given concurrently at the same
dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Posology _
Oral route.
One tablet per day as a single dose, preferably to be taken in the
morning and before a meal.
The fixed dose combination is not suitable for initial therapy.
If a change of posology is required, the dose of Coveram could be
modified or individual titration with free
combination