Preterax 2mg/0.625mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PERINDOPRIL TERT, BUTYLAMINE SALT, INDAPAMIDE

Available from:

Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France

ATC code:

C09BA04

INN (International Name):

INDAPAMIDE 0.625 mg PERINDOPRIL TERT-BUTYLAMINE SALT 2 mg

Pharmaceutical form:

TABLET

Composition:

INDAPAMIDE 0.625 mg PERINDOPRIL TERT-BUTYLAMINE SALT 2 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2005-10-10

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRETERAX 2MG/0.625MG TABLETS
perindopril tert-butylamine/indapamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any of the side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
:
1.
What Preterax 2mg/0.625mg is and what it is used for
2.
What you need to know before you take Preterax 2mg/0.625mg
3.
How to take Preterax 2mg/0.625mg
4.
Possible side effects
5.
How to store Preterax 2mg/0.625mg
6.
Contents of the pack and other information
1.
WHAT PRETERAX 2MG/0.625MG IS AND WHAT IT IS USED FOR
Preterax 2mg/0.625mg is a combination of two active ingredients,
perindopril and indapamide. It is an anti-
hypertensive and is used in the treatment of high blood pressure
(hypertension) in adults.
Perindopril belongs to a class of medicines called ACE inhibitors.
These work by widening the blood
vessels, which makes it easier for your heart to pump blood through
them. Indapamide is a diuretic. Diuretics
increase the amount of urine produced by the kidneys. However,
indapamide is different from other
diuretics, as it only causes a slight increase in the amount of urine
produced. Each of the active ingredients
reduces blood pressure and they work together to control your blood
pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRETERAX 2MG/0.625MG
DO NOT TAKE PRETERAX 2MG/0.625MG
-
if you are allergic to perindopril or any other ACE inhibitor, or to
indapamide or any other sulphonamides
or any of the other ingredients of this medicine (listed in section
6),
-
if you have experienced symptoms such as wheezing, swe

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Preterax 2mg/0.625mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 1.669 mg perindopril corresponding to 2 mg
perindopril tert-butylamine and 0.625 mg
indapamide.
Excipient with known effect: 64.175 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, rod-shaped tablet, scored on each side. The tablet can be
divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Preterax 2mg/0.625mg tablets is indicated in essential hypertension in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual dose is
_ _
one Preterax 2mg/0.625mg tablet per day as a single dose, preferably
to be taken in the
morning and before a meal. If blood pressure is not controlled after
one month of treatment, the dose can be
doubled
_. _
Special populations
_Elderly (see section 4.4)_
Treatment should be started at the normal dose of one Preterax
2mg/0.625mg tablet per day.
_Renal impairment (see section 4.4) _
In severe renal impairment (creatinine clearance below 30 ml/min),
treatment is contraindicated.
In patients with moderate renal impairment (creatinine clearance 30-60
ml/min), the maximum dose should
be one tablet of Preterax 2mg/0.625mg per day.
In patients with creatinine 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.
_Hepatic impairment (see sections 4.3, 4.4 and 5.2) _
In severe hepatic impairment, treatment is contraindicated.
In patients with moderate hepatic impairment, no dose modification is
required.
_Paediatric population _
The safety and efficacy of perindopril tert-butylamine/indapamide in
the paediatric population have not yet
been established. No data are available.
Preterax 2mg/0.625mg should not be used in children and adolescents.
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Method of administration
Oral use
4.3
CONTRAINDICATIONS
_Linked to perindopril: _