Coversyl Arginine 10 mg film-coated tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Perindopril arginine

Pieejams no:

PCO Manufacturing Ltd.

ATĶ kods:

C09AA; C09AA04

SNN (starptautisko nepatentēto nosaukumu):

Perindopril arginine

Deva:

10 milligram(s)

Zāļu forma:

Film-coated tablet

Receptes veids:

Product subject to prescription which may be renewed (B)

Ārstniecības joma:

ACE inhibitors, plain; perindopril

Autorizācija statuss:

Authorised

Autorizācija datums:

2007-08-31

Lietošanas instrukcija

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL
® ARGININE 10 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, pharmacist or
nurse

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 or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
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

Produkta apraksts

Health Products Regulatory Authority
14 January 2020
CRN009FPG
Page 1 of 2
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
10mg perindopril arginine.
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Greece, The UK, Poland, and Hungary:_
Green, round, biconvex film-coated tablet engraved with the Servier
logo on one face and a heart 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
_Core:_
Lactose monohydrate
Magnesium stearate
Maltodextrin
Hydrophobic colloidal silica
Sodium starch glycolate (type A)
_Film-coating: _
Glycerol (E422a)
Hypromellose (E464)
Copper chlorophyllin (E141 ii)
Macrogol
Magnesium stearate
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the countainer and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
14 January 2020
CRN009FPG
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package. Keep the container tightly closed in
order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
_Product imported from the UK and Greece:_
30 tablets in a white polypropylene tablet container equipped with a
polyethylene flow reducer and a green opaque stopper
containing a dessicant gel, contained in an overlabelled carton.
_Product imported from Poland:_
30 tablets in a white polypropylene tablet container equipped with a
polyethylene flow reducer and a red opaque stopper
containing a dessicant gel.
_Product imported from Hungary:_
30 tablets in a white polypropylene tablet container equipped with a
poly