Preterax Arginine 2.5mg/0.625mg film coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PERINDOPRIL ARGININE, INDAPAMIDE

Available from:

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

ATC code:

C09BA04

INN (International Name):

PERINDOPRIL ARGININE 2.5 mg INDAPAMIDE 0.625 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PERINDOPRIL ARGININE 2.5 mg INDAPAMIDE 0.625 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2007-07-11

Patient Information leaflet

PAGE 1 OF 8
B. PACKAGE LEAFLET
PAGE 2 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRETERAX ARGININE 2.5MG/0.625MG FILM-COATED TABLETS
perindopril arginine/indapamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What PRETERAX ARGININE 2.5mg/0.625mg is and what it is used for
2.
Before you take PRETERAX ARGININE 2.5mg/0.625mg
3.
How to take PRETERAX ARGININE 2.5mg/0.625mg
4.
Possible side effects
5.
How to store PRETERAX ARGININE 2.5mg/0.625mg
6.
Further information
1.
WHAT PRETERAX ARGININE 2.5MG/0.625MG IS AND WHAT IT IS USED FOR
WHAT IS PRETERAX ARGININE 2.5MG/0.625MG ?
PRETERAX ARGININE 2.5mg/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).
WHAT IS PRETERAX ARGININE 2.5MG/0.625MG USED FOR ?
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.
BEFORE YOU TAKE PRETERAX ARGININE 2.5MG/0.625MG
DO NOT TAKE PRETERAX ARGININE 2.5MG/0.625MG
a.
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 PRETERAX ARGININE
2.5mg/0.625

Summary of Product characteristics

PAGE 1 OF 20
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 20
1.
NAME OF THE MEDICINAL PRODUCT
PRETERAX ARGININE 2.5mg/0.625mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 1.6975 mg perindopril corresponding to
2.5 mg perindopril arginine
and 0.625 mg indapamide.
Excipient: 74.455 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, rod-shaped film-coated tablet with an embossed line on both
faces.
The score line is not intended for breaking the tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual dose is_ _ one PRETERAX ARGININE 2.5mg/0.625mg film-coated
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_._
_Elderly (see section 4.4)_
Treatment should be started at the normal dose of one PRETERAX
ARGININE 2.5mg/0.625mg
film-coated tablet per day.
_Patients with 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 ARGININE 2.5mg/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.
_Patients with hepatic impairment (see sections 4.3, 4.4 and 5.2) _
PAGE 3 OF 20
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 arginine/indapamide in the
paediatric population have not yet
been established.
PRETERAX ARGININE 2.5mg/0.625mg should not be used in children and
adolescents
Metho