Percarnil Indapamide 2.5mg/0.625mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PERINDOPRIL ARGININE, INDAPAMIDE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

C09BA04

INN (International Name):

PERINDOPRIL ARGININE 2.5 mg INDAPAMIDE .625 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PERINDOPRIL ARGININE 2.5 mg INDAPAMIDE .625 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2015-12-22

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PERCARNIL INDAPAMIDE 2.5 MG/0.625 MG FILM-COATED TABLETS
perindopril arginine/indapamide hemihydrate
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 Percarnil indapamide is and what it is used for
2.
What you need to know before you take Percarnil indapamide
3.
How to take Percarnil indapamide
4.
Possible side effects
5.
How to store Percarnil indapamide
6.
Contents of the pack and other information
1.
WHAT PERCARNIL INDAPAMIDE IS AND WHAT IT IS USED FOR
Percarnil indapamide is a combination of two active ingredients,
perindopril and indapamide. It is
an antihypertensive and is used in the treatment of high blood
pressure (hypertension).
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 PERCARNIL INDAPAMIDE
DO NOT TAKE PERCARNIL INDAPAMIDE
-
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 whee

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Percarnil indapamide 2.5 mg/0.625 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg perindopril arginine
corresponding to 1.6975 mg
perindopril and 0.625 mg indapamide hemidydrate.
Excipient with known effect:
Each film-coated tablet contains 87 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Percarnil indapamide 2.5 mg/0.625 mg film-coated tablets are white,
8.5 mm x 4.3 mm oval
and biconvex.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Percarnil indapamide 2.5 mg/0.625 mg 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 Percarnil
indapamide 2.5 mg/0.625 mg
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
contra-indicated.
In patients with moderate renal impairment (creatinine clearance 30-60
ml/min), the maximum
dose should be one tablet of Percarnil indapamide 2.5 mg/0.625 mg per
day.
In patients with creatinine clearance greater than or equal to 60
ml/min, no dose modification
is required.
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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 contraindicated.
In patients with moderate hepatic impairment, no dose modification is
required.
_ _
_Paediatric population _
Percarnil indapamide should not be used in children and adolescents as
the efficacy and
tolerability of perindopril in children and adolescents, alone or in
combination, hav