PRETERAX 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:

0.625 mg

Pharmaceutical form:

TABLET

Composition:

INDAPAMIDE 0.625 mg; PERINDOPRIL TERT-BUTYLAMINE 2 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 scored tablets dosed at 2 mg of perindopril
tert-butylamine and 0.625 mg of indapamide.
THERAPEUTIC INDICATION
Essential hypertension.
POSOLOGY AND METHOD OF ADMINISTRATION
Oral route.
One PRETERAX tablet per day as a single dose, prefer-
ably to be taken in the morning and before a meal. If blood
pressure is inadequately controlled, the dose should be
doubled using two tablets of PRETERAX.
_ELDERLY_
Treatment should be started at the normal dose of one
PRETERAX tablet per day.
Patients with renal insufficiency (see section on special
warnings and special precautions for use).
In cases of severe renal insufficiency (creatinine clear-
ance < 30 ml/min), treatment is contra-indicated. In
patients with moderate renal insufficiency (creatinine
clearance 30-60 ml/min), the maximum dose should be
one tablet of PRETERAX per day. In patients with creati-
nine clearance greater than or equal to 60 ml/min, no
dose modification is required.
Usual medical follow-up will include frequent monitoring
of creatinine and potassium.
_CHILDREN_
PRETERAX should not be used in children as the efficacy
and tolerability of perindopril in children, alone or in com-
bination, 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 inhibitors,
•
previous history of angioneurotic 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 section on Interactions
with other drugs and other forms of interaction),
•
bilateral renal artery stenosis or single functioning 
kidney,
•
hyperkalaemia
_LINKED TO INDAPAMIDE_
This drug SHOULD NEVER be used in cases of:
•
hypersensitivity to sulphon

Summary of Product characteristics

1
QUALITATIVE AND QUANTITATIVE COMPOSITION
Boxes of 30 scored tablets dosed at 2 mg of perindopril
tert-butylamine and 0.625 mg of indapamide.
THERAPEUTIC INDICATION
Essential hypertension.
POSOLOGY AND METHOD OF ADMINISTRATION
Oral route.
One PRETERAX tablet per day as a single dose, prefer-
ably to be taken in the morning and before a meal. If blood
pressure is inadequately controlled, the dose should be
doubled using two tablets of PRETERAX.
_ELDERLY_
Treatment should be started at the normal dose of one
PRETERAX tablet per day.
Patients with renal insufficiency (see section on special
warnings and special precautions for use).
In cases of severe renal insufficiency (creatinine clear-
ance < 30 ml/min), treatment is contra-indicated. In
patients with moderate renal insufficiency (creatinine
clearance 30-60 ml/min), the maximum dose should be
one tablet of PRETERAX per day. In patients with creati-
nine clearance greater than or equal to 60 ml/min, no
dose modification is required.
Usual medical follow-up will include frequent monitoring
of creatinine and potassium.
_CHILDREN_
PRETERAX should not be used in children as the efficacy
and tolerability of perindopril in children, alone or in com-
bination, 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 inhibitors,
• previous history of angioneurotic 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 section on Interactions
with other drugs and other forms of interaction),
• bilateral renal artery stenosis or single functioning
kidney,
• hyperkalaemia
_LINKED TO INDAPAMIDE_
This drug SHOULD NEVER be used in cases of:
• hypersensitivity to sulphonamides,
• severe r