Percanil Indapamide Tablets 4mg/1.25

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PERINDOPRIL TERT, BUTYLAMINE SALT, INDAPAMIDE

Available from:

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

ATC code:

C09BA04

INN (International Name):

PERINDOPRIL TERT-BUTYLAMINE SALT 4 mg INDAPAMIDE 1.25 mg

Pharmaceutical form:

TABLET

Composition:

PERINDOPRIL TERT-BUTYLAMINE SALT 4 mg INDAPAMIDE 1.25 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2016-01-29

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
PERCANIL INDAPAMIDE 4 MG/1.25 MG 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 Percanil Indapamide is and what it is used for
2.
What you need to know before you take Percanil Indapamide
3.
How to take Percanil Indapamide
4.
Possible side effects
5.
How to store Percanil Indapamide
6.
Contents of the pack and other information
1.
WHAT PERCANIL INDAPAMIDE IS AND WHAT IT IS USED FOR
WHAT ARE PERCANIL INDAPAMIDE TABLETS?
Percanil Indapamide is a combination of two active substances,
perindopril and indapamide. It
is an anti-hypertensive medicine used in the treatment of high blood
pressure (hypertension).
WHAT ARE PERCANIL INDAPAMIDE TABLETS 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 substances reduces
blood pressure and they
work together to control your blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERCANIL INDAPAMIDE
DO NOT TAKE PERCANIL INDAPAMIDE:
-
if you are allergic to perindopril, indapamide or any of the other
ingredients of this
medicine (listed in section 6)
-
if you are allergic to other ACE inhibitors o

Summary of Product characteristics

Page 1 of 20
1.
NAME OF THE MEDICINAL PRODUCT
Percanil Indapamide 4 mg/1.25 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.338 mg perindopril corresponding to 4 mg
perindopril _tert_-butylamine
and 1.25 mg indapamide.
Excipient with known effect: 68.75 mg lactose monohydrate/tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, capsule-shaped tablet, embossed with ‘I 4’ on
one side and ‘>’ on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension, Percanil Indapamide 4 mg/1.25 mg
tablets is indicated in
patients whose blood pressure is not adequately controlled on
perindopril alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one Percanil Indapamide 4 mg/1.25 mg 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. Percanil
Indapamide 4 mg/1.25 mg tablet should be used when blood pressure is
not adequately
controlled on Percanil Indapamide 2 mg/0.625 mg tablets (where
available).When clinically
appropriate, direct change from monotherapy to Percanil Indapamide 4
mg/1.25 mg tablets
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.
Page 2 of 20
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,