COVERSYL PLUS TABLETS

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

INDAPAMIDE; PERINDOPRIL TERT-BUTYLAMINE

Available from:

SERVIER (S) PTE LTD

ATC code:

C09BA04

Dosage:

1.25 mg

Pharmaceutical form:

TABLET

Composition:

INDAPAMIDE 1.25 mg; PERINDOPRIL TERT-BUTYLAMINE 4 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

LES LABORATOIRES SERVIER INDUSTRIE

Authorization status:

ACTIVE

Authorization date:

1999-03-24

Patient Information leaflet

1
QUALITATIVE AND QUANTITATIVE COMPOSITION
Boxes of 30 tablets dosed at 4 mg of perindopril tert-
butylamine and 1.25 mg of indapamide.
THERAPEUTIC INDICATIONS
Treatment of essential hypertension. COVERSYL PLUS 
is indicated for patients whose blood pressure is insuffi-
ciently controlled by perindopril alone.
DOSAGE AND METHOD OF ADMINISTRATION
Oral route
One tablet of COVERSYL PLUS per day as a single dose,
preferably taken in the morning and before a meal. If 
necessary, dose titration with the individual components
may be recommended. In appropriate clinical cases, a
direct change from monotherapy to COVERSYL PLUS may
be considered.
_RENAL INSUFFICIENCY (SEE SPECIAL WARNINGS AND SPECIAL_
_PRECAUTIONS FOR USE)._
In cases of severe renal insufficiency (creatinine clearance
below 30 ml/min), treatment is contra-indicated. In patients
with a creatinine clearance greater than or equal to 
30 ml/min and less than 60 ml/min, it is recommended to
start the treatment with the adequate dosage of the free
combination. It is not necessary to change the dose when
the creatinine clearance is greater than 60 ml/min. The 
normal medical practice includes periodic control for 
creatinine and potassium.
_CHILDREN_
COVERSYL PLUS should not be used in children as the
efficacy and tolerability of perindopril in children, alone
or in combination, have not been established.
CONTRA-INDICATIONS
_LINKED TO PERINDOPRIL_
This drug SHOULD NEVER be used in cases of:
•
hypersensitivity to perindopril, or to any other
angiotensin converting enzyme inhibitor,
•
previous history of angineurotic oedema (Quincke's
oedema) linked to treatment with an angiotensin 
converting enzyme inhibitor,
•
hereditary or idiopathic angioneurotic oedema,
•
pregnancy,
•
lactation.
This drug is generally not recommended in:
•
combinations with potassium-sparing diuretics,
potassium salts, lithium (See Interactions with other
drugs and other forms of interactions),
•
bilateral renal artery stenosis or single functioning
kidney

Summary of Product characteristics

1
QUALITATIVE AND QUANTITATIVE COMPOSITION
Boxes of 30 tablets dosed at 4 mg of perindopril tert-
butylamine and 1.25 mg of indapamide.
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
COVERSYL PLUS
is indicated for patients whose blood pressure is insuffi-
ciently controlled by perindopril alone.
DOSAGE AND METHOD OF ADMINISTRATION
Oral route
One tablet of COVERSYL PLUS per day as a single dose,
preferably taken in the morning and before a meal. If
necessary, dose titration with the individual components
may be recommended. In appropriate clinical cases, a
direct change from monotherapy to COVERSYL PLUS may
be considered.
_RENAL INSUFFICIENC_
_Y (SEE SPECIAL WARNINGS AND SPECIAL_
_PRECAUTIONS FOR USE)._
In cases of severe renal insufficiency (creatinine clearance
below 30 ml/min), treatment is contra-indicated. In patients
with a creatinine clearance greater than or equal to
30 ml/min and less than 60 ml/min, it is recommended to
start the treatment with the adequate dosage of the free
combination. It is not necessary to change the dose when
the creatinine clearance is greater than 60 ml/min. The
normal medical practice includes periodic control for
creatinine and potassium.
_CHILDREN_
COVERSYL PLUS should not be used in children as the
efficacy and tolerability of perindopril in children, alone
or in combination, have not been established.
CONTRA-INDICATIONS
_LINKED TO PERINDOPRIL_
This drug SHOULD NEVER be used in cases of:
• hypersensitivity
to
perindopril,
or
to
any
other
angiotensin converting enzyme inhibitor,
• previous history of angineurotic oedema (Quincke's
oedema) linked to treatment with an angiotensin
converting enzyme inhibitor,
• hereditary or idiopathic angioneurotic oedema,
• pregnancy,
• lactation.
This drug is generally not recommended in:
• combinations with potassium-sparing diuretics,
potassium salts, lithium (See Interactions with other
drugs and other forms of interactions),
• bilateral renal artery stenosis or single functioning
kidney,
• hyperkalaemia
_LINKE