PERINDOPRIL TERT-BUTLYAMINE/INDAPAMIDE SERVIER 8/2.5 mg/mg Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
15-05-2018
Summary of Product characteristics
(SPC)
15-05-2018
Active ingredient:
PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE
Available from:
Les Laboratoires Servier
ATC code:
C09BA04
INN (International Name):
PERINDOPRIL TERT-BUTYLAMINE, INDAPAMIDE
Dosage:
8/2.5 mg/mg
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
ACE inhibitors and diuretics
Authorization status:
Authorised
Authorization date:
2009-08-14
Patient Information leaflet
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERINDOPRIL TERT-BUTYLAMINE / INDAPAMIDE SERVIER 8MG/2.5MG 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 side effects , talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4. .
WHAT IS IN THIS LEAFLET
:
1.
What Perindopril Tert-butylamine / Indapamide Servier is and what it
is used for
2.
What you need to know before you take Perindopril Tert-butylamine /
Indapamide Servier
3.
How to take Perindopril Tert-butylamine / Indapamide Servier
4.
Possible side effects
5.
How to store Perindopril Tert-butylamine / Indapamide Servier
6.
Contents of the pack and other information
1.
WHAT PERINDOPRIL TERT-BUTYLAMINE / INDAPAMIDE SERVIER IS AND WHAT IT
IS USED FOR
Perindopril Tert-butylamine / Indapamide Servier 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).
Perindopril Tert-butylamine / Indapamide Servier is prescribed for
patients already receiving perindopril 8
mg and indapamide 2.5 mg from separate tablets, these patients may
instead receive one tablet of Perindopril
Tert-butylamine / Indapamide Servier which contains both ingredients.
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 th
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril Tert-butylamine / Indapamide Servier 8mg/2.5mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 6.676 mg perindopril equivalent to 8 mg
perindopril tert-butylamine and 2.5 mg indapamide.
Excipient with known effect : lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Perindopril Tert-butylamine / Indapamide Servier is indicated as
substitution therapy for treatment of essential
hypertension, in patients already controlled with perindopril and
indapamide given concurrently at the same dose level.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Perindopril Tert-butylamine / Indapamide Servier
tablet per day as a single dose, preferably to be taken in the
morning, and before a meal.
Special populations
_Elderly (see section 4.4)_
In elderly, the plasma creatinine must be adjusted in relation to age,
weight and gender. Elderly patients can be treated
if renal function is normal and after considering blood pressure
response.
_Renal impairment (see section 4.4)_
In severe and moderate renal impairment (creatinine clearance below 60
ml/min), treatment is contraindicated.
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
Servier in children and adolescents have not yet
been established. No data are available Perindopril Tert-butylamine /
Indapamide Servier should not be used in children
and adolescents.
Method of administration
Oral use.
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