Coversyl Arginine 5mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Gebrauchsinformation Gebrauchsinformation (PIL)
16-08-2018
Fachinformation Fachinformation (SPC)
13-06-2018

Wirkstoff:

Perindopril arginine

Verfügbar ab:

Servier Laboratories Ltd

ATC-Code:

C09AA04

INN (Internationale Bezeichnung):

Perindopril arginine

Dosierung:

5mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 02050501; GTIN: 5017476171207

Gebrauchsinformation

                                Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL
® ARGININE 5MG TABLETS
(perindopril arginine)
Your medicine is available using the name Coversyl Arginine
10mg Tablets but it will be referred to as Coversyl Arginine
throughout this leaflet. Other strengths 2.5mg and 10mg are
also available.
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 t
                                
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Fachinformation

                                OBJECT 1
COVERSYL ARGININE
Summary of Product Characteristics Updated 13-Sep-2017 | Servier
Laboratories Limited
1. Name of the medicinal product
Coversyl Arginine 2.5 mg film-coated tablets
Coversyl Arginine 5 mg film-coated tablets
Coversyl Arginine 10 mg film-coated tablets
2. Qualitative and quantitative composition
Perindopril arginine.
2.5mg
One film-coated tablet contains 1.6975 mg perindopril corresponding to
2.5 mg perindopril
arginine.
Excipient with known effect: 36.29 mg lactose monohydrate.
5mg
One film-coated tablet contains 3.395 mg perindopril corresponding to
5 mg perindopril
arginine.
Excipient with known effect: 72.58 mg lactose monohydrate.
10mg
One film-coated tablet contains 6.790 mg perindopril corresponding to
10 mg perindopril
arginine.
Excipient with known effect: 145.16 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
2.5 mg
White, round, convex, film-coated tablet.
5mg
Light-green, rod-shaped film-coated tablet engraved with
on one face and scored on
both edges. The tablet can be divided into equal doses.
10mg
Green, round, biconvex, film-coated tablet engraved with
on one face and
on the other face.
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:
Coversyl Arginine may be used in monotherapy or in combination with
other classes of antihypertensive
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, 
                                
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