COVERSYL PLUS TABLETS

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

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Ficha técnica Ficha técnica (SPC)
03-02-2004

Ingredientes activos:

INDAPAMIDE; PERINDOPRIL TERT-BUTYLAMINE

Disponible desde:

SERVIER (S) PTE LTD

Código ATC:

C09BA04

Dosis:

1.25 mg

formulario farmacéutico:

TABLET

Composición:

INDAPAMIDE 1.25 mg; PERINDOPRIL TERT-BUTYLAMINE 4 mg

Vía de administración:

ORAL

tipo de receta:

Prescription Only

Fabricado por:

LES LABORATOIRES SERVIER INDUSTRIE

Estado de Autorización:

ACTIVE

Fecha de autorización:

1999-03-24

Información para el usuario

                                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
                                
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Ficha técnica

                                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
                                
                                Leer el documento completo