Percarnil Indapamide 5mg / 1.25mg 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 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Withdrawn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:

2015-12-22

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PERCARNIL INDAPAMIDE 5 MG/1.25 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 wheezin

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Percarnil indapamide 5 mg/1.25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg perindopril arginine
corresponding to 3.395 mg perindopril
and 1.25 mg indapamide hemidydrate.
Excipient with known effect:
Each film-coated tablet contains 84 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Percarnil indapamide 5 mg/1.25 mg film-coated tablets are blue, 8.5 mm
x 4.3 mm oval, biconvex
with horizontal line on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension, Percarnil indapamide 5 mg/1.25 mg
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 Percarnil indapamide 5 mg/1.25 mg 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. Percarnil indapamide
5 mg/1.25 mg film-coated tablet should be used when blood pressure is
not adequately controlled on
Percarnil
indapamide
2.5 mg/0.625 mg
film-coated
tablet
(where
available).
When
clinically
appropriate, direct change from monotherapy to Percarnil indapamide 5
mg/1.25 mg 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 contra-indicated.
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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 i