Coversyl Arginine 5 mg film-coated tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Perindopril arginine

Saatavilla:

PCO Manufacturing Ltd.

ATC-koodi:

C09AA; C09AA04

INN (Kansainvälinen yleisnimi):

Perindopril arginine

Annos:

5 milligram(s)

Lääkemuoto:

Film-coated tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

ACE inhibitors, plain; perindopril

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2007-08-31

Pakkausseloste

_ _
_ _
_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL
® 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, 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 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 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 th

Valmisteyhteenveto

Health Products Regulatory Authority
14 January 2020
CRN009FPG
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coversyl Arginine 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril arginine.
One film-coated tablet contains 3.395mg perindopril corresponding to
5mg 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, Poland, Hungary and the UK:_
Light-green, rod-shaped film-coated tablet engraved with the Servier
logo on one face and scored on both edges.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
As per PA0568/002/005
5 PHARMACOLOGICAL PROPERTIES
As per PA0568/002/005
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
Health Products Regulatory Authority
14 January 2020
CRN009FPG
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
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 Greece, UK & Poland:_
30 tablets in a white polypropylene tablet container equipped with a
polyethylene flow reducer and a green opaque stopper
containing a dessicant gel.
_Product imported from Hungary:_
30 tablets in a white polypropylene tablet container equipped with a
polyethylene flow reducer and a white opaque stopper
containing a dessicant gel.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER