Preterax 2mg/0.625mg tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Perindopril tert-butylamine salt; Indapamide

Saatavilla:

Les Laboratoires Servier

ATC-koodi:

C09BA; C09BA04

INN (Kansainvälinen yleisnimi):

Perindopril tert-butylamine salt; Indapamide

Annos:

2 mg/0.625 milligram(s)

Lääkemuoto:

Tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

ACE inhibitors and diuretics; perindopril and diuretics

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2001-12-03

Pakkausseloste

1
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, swelling of the
face or

Valmisteyhteenveto

Health Products Regulatory Authority
07 October 2019
CRN008ZGK
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
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 is indicated in essential hypertension in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual dose isone Preterax2mg/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
Preterax2mg/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
Preterax2mg/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..
Method of administration
Oral use
He