COVERSYL ARGININE 10 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PERINDOPRIL ARGININE

Available from:

Clear Pharmacy

ATC code:

C09AA04

INN (International Name):

PERINDOPRIL ARGININE

Dosage:

10 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors, plain

Authorization status:

Authorised

Authorization date:

2010-11-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL® ARGININE 10MG FILM-COATED TABLETS
perindopril arginine
WHAT IS IN THIS LEAFLET:
1.
What Coversyl arginine is and what it is used for
2.
What you need to know before you take Coversyl arginine
3.
How to take Coversyl arginine
4.
Possible side effects
5.
How to store Coversyl arginine
6.
Content of the pack and other information
1. WHAT COVERSYL ARGININE IS AND WHAT IT IS USED FOR
Coversyl 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.
Coversyl arginine is used:
•
to treat
_HIGH BLOOD PRESSURE _
(hypertension),
•
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 COVERSYL ARGININE
DO NOT TAKE COVERSYL ARGININE
•
if you are allergic to perindopril or any of the other ingredients of
this
medicine (listed in Section 6), or to any other ACE inhibitor
•
if you have experienced symptoms such as wheezing, swelling of the
face,
tongue or throat, intense itching or severe skin rashes with previous
ACE
inhibitor treatment or if you or a member of your family have had
these
symptoms in any other circumstances (a condition called angioedema).
•
if you are more than 3 months pregnant (It is also better to avoid
Coversyl
arginine in early pregnancy - see pregnancy section).
•
if you have diabetes or impaired kidney function and you are treated
with a
blood pressure lowering medicine containing aliskiren.
WARNING AND PRECAUTION
If any of the following apply to you please talk to your doctor or
pharmacist or
nurse before taking Coversyl arginine if you:
•
have aortic stenosis (narrowing of the main blood vessel leading from
the
heart)

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coversyl Arginine 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril arginine.
One film-coated tablet contains 6.790 mg perindopril corresponding to
10 mg perindopril arginine.
Excipient: lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Hungary and Poland:_
Green, round, biconvex, film-coated tablet engraved with [heart
graphic] on one face and the [Servier logo] on the
other face.
4 CLINICAL PARTICULARS
As per PA0568/002/006
5 PHARMACOLOGICAL PROPERTIES
As per PA0568/002/006
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Magnesium stearate
Maltodextrin
Hydrophobic colloidal silica
Sodium starch glycolate (type A)
Glycerol
Hypromellose
Copper chlorophyllin
Macrogol
Titanium dioxide
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer carton of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Keep the container tightly closed in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
30 tablets in a white tablet container equipped with a flow reducer
an