COVERSYL ARGININE 2.5 Milligram Orodispersible Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
22-04-2015
Summary of Product characteristics
(SPC)
03-09-2016
Active ingredient:
PERINDOPRIL ARGININE
Available from:
Les Laboratoires Servier
ATC code:
C09AA04
INN (International Name):
PERINDOPRIL ARGININE
Dosage:
2.5 Milligram
Pharmaceutical form:
Orodispersible Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
ACE inhibitors, plain
Authorization status:
Authorised
Authorization date:
2010-07-09
Patient Information leaflet
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL ARGININE 2.5 MG ORODISPERSIBLE 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),
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to treat _heart failure_ (a condition where the heart is unable to pump enough blood to meet the body’s
needs),
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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
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coversyl Arginine 2.5 mg orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One orodispersible tablet contains 1.698 mg perindopril corresponding to 2.5 mg perindopril arginine.
Excipients with known effect: 31.365 mg lactose, 0.1 mg aspartame.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
White, round tablet.
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, 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 Coversyl arginine; this is more likely in
patients who are being treated concurrently with diuretics. Caution is therefore recommended
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