bi Preterax Argenine 5mg/1.25mg film-coated Tablets
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
26-06-2023
Summary of Product characteristics
(SPC)
26-06-2023
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 5 mg INDAPAMIDE 1.25 mg
Pharmaceutical form:
FILM-COATED TABLET
Composition:
PERINDOPRIL ARGININE 5 mg INDAPAMIDE 1.25 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Withdrawn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
BIPRETERAX ARGININE 5MG/1.25MG 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 BIPRETERAX ARGININE 5mg/1.25mg is and what it is used for
2.
Before you take BIPRETERAX ARGININE 5mg/1.25mg
3.
How to take BIPRETERAX ARGININE 5mg/1.25mg
4.
Possible side effects
5.
How to store BIPRETERAX ARGININE 5mg/1.25mg
6.
Further information
1.
WHAT BIPRETERAX ARGININE 5MG/1.25MG IS AND WHAT IT IS USED FOR
WHAT IS BIPRETERAX ARGININE 5MG/1.25MG ?
BIPRETERAX ARGININE 5mg/1.25mg 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 BIPRETERAX ARGININE 5MG/1.25MG 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 BIPRETERAX ARGININE 5MG/1.25MG
DO NOT TAKE BIPRETERAX ARGININE 5MG/1.25MG
-
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 BIPRETERAX ARGININE
5mg/1.25mg,
-
if you
Read the complete document
Summary of Product characteristics
PAGE 1 OF 20
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 20
1.
NAME OF THE MEDICINAL PRODUCT
BIPRETERAX ARGININE 5mg/1.25mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 3.395 mg perindopril corresponding to
5 mg perindopril arginine
and 1.25 mg indapamide.
Excipient: 71.33 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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension, BIPRETERAX ARGININE 5mg/1.25mg
film-coated tablet is
indicated in patients whose blood pressure is not adequately
controlled on perindopril alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One BIPRETERAX ARGININE 5mg/1.25mg film-coated tablet per day as a
single dose, preferably
to be taken in the morning, and before a meal.
When possible individual dose titration with the components is
recommended. BIPRETERAX
ARGININE 5mg/1.25mg film-coated tablet should be used when blood
pressure is not adequately
controlled on PRETERAX ARGININE 2.5mg/0.625mg film-coated tablet
(where available).When
clinically appropriate, direct change from monotherapy to BIPRETERAX
ARGININE 5mg/1.25mg
film-coated tablet may be considered.
_Elderly (see section 4.4) _
Treatment should be initiated after considering blood pressure
response and renal function.
_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), it is recommended
to start treatment with the adequate dosage of the free combination.
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) _
In severe hepatic impairment, treatment is contrain
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