Percarnil Arginine 5 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Perindopril arginine

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

C09AA; C09AA04

INN (International Name):

Perindopril arginine

Dosage:

5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors, plain; perindopril

Authorization status:

Not marketed

Authorization date:

2016-01-29

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PERCARNIL ARGININE 5 MG FILM-COATED TABLETS
Perindopril arginine
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 Arginine is and what it is used for
2.
What you need to know before you take Percarnil Arginine
3.
How to take Percarnil Arginine
4.
Possible side effects
5.
How to store Percarnil Arginine
6.
Contents of the pack and other information
1.
WHAT PERCARNIL ARGININE IS AND WHAT IT IS USED FOR
Percarnil Arginine is an angiotensin converting enzyme (ACE)
inhibitor. These work by widening the
blood vessels, which makes it easier for your heart to pump blood
through them.
Percarnil Arginine is used:
-
to treat high blood pressure (hypertension)
-
to treat heart failure (a condition where the heart is unable to pump
enough blood to meet the
body’s needs)
-
to reduce the risk of cardiac events, such as heart attack, in
patients with stable coronary artery
disease (a condition where the blood supply to the heart is reduced or
blocked) and who have
already had a heart attack and/or an operation to improve the blood
supply to the heart by
widening the vessels that supply it
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERCARNIL ARGININE
DO NOT TAKE PERCARNIL ARGININE
-
if you are allergic to perindopril, to any other ACE inhibitor 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, tongue or throat,
intense itching or severe skin rashes with previous ACE

Summary of Product characteristics

Health Products Regulatory Authority
25 February 2020
CRN009KRH
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Percarnil Arginine 5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film‑coated tablet contains 5 mg perindopril arginine
equivalent to 3.395 mg perindopril.
Excipient with known effect:
Each film‑coated tablet contains 70.78 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film‑coated tablet.
Perindopril arginine Actavis 5 mg film‑coated tablets are white, 8 x
4 mm oval, biconvex with side scores and with two dots on
one side. The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension:
Treatment of hypertension.
Heart failure:
Treatment of symptomatic heart failure.
Stable coronary artery disease:
Reduction of risk of cardiac events in patients with a history of
myocardial infarction and/or revascularisation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be individualised according to the patient profile
(see section 4.4) and blood pressure response.
_Hypertension:_
Percarnil Arginine may be used in monotherapy or in combination with
other classes of anti‑hypertensive therapy (see sections
4.3, 4.4, 4.5 and 5.1).
The recommended starting dose is 5 mg given once daily in the morning.
Patients with a strongly activated renin‑angiotensin‑aldosterone
system (in particular, renovascular hypertension, salt and/or
volume depletion, cardiac decompensation or severe hypertension) may
experience an excessive drop in blood pressure
following the initial dose. A starting dose of 2.5 mg is recommended
in such patients and the initiation of treatment should
take place under medical supervision.
The dose may be increased to 10 mg once daily after one month of
treatment.
Symptomatic hypotension may occur following initiation of therapy with
Percarnil Arginine; this is more likely in patients who
are being treated concurrently with diur