COVERSYL ARGININE 5mg orodispersible Tablets
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
26-06-2023
Summary of Product characteristics
(SPC)
26-06-2023
Active ingredient:
PERINDOPRIL ARGININE
Available from:
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
ATC code:
C09AA04
INN (International Name):
PERINDOPRIL ARGININE 5 mg
Pharmaceutical form:
ORODISPERSIBLE TABLET
Composition:
PERINDOPRIL ARGININE 5 mg
Prescription type:
POM
Therapeutic area:
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorization status:
Withdrawn
Authorization date:
2010-07-20
Patient Information leaflet
Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL ARGININE 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),
-
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 throat,
intense itching
Read the complete document
Summary of Product characteristics
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Coversyl Arginine 5 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One orodispersible tablet contains 3.395 mg perindopril corresponding
to 5 mg perindopril arginine.
Excipients with known effect: 62.73 mg lactose,
0.2 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.
Page 2 of 17
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 since these patients may be volume and/or salt depleted.
If possible, the diuretic should be discontinued 2 to 3 days before
beginning therapy with Coversyl
Arginine Arginine (see section 4.4
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