Coversyl 5mg film-coated Tablets
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
01-11-2021
Summary of Product characteristics
(SPC)
01-06-2021
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:
FILM-COATED TABLET
Composition:
PERINDOPRIL ARGININE 5 mg
Prescription type:
POM
Therapeutic area:
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorization status:
Authorised
Authorization date:
2005-10-14
Patient Information leaflet
1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL 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 is and what it is used for
2.
What you need to know before you take Coversyl
3.
How to take Coversyl
4.
Possible side effects
5.
How to store Coversyl
6.
Content of the pack and other information
1. WHAT COVERSYL IS AND WHAT IT IS USED FOR
Coversyl 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 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
DO NOT TAKE COVERSYL
-
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 yo
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Summary of Product characteristics
1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Coversyl 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril arginine.
One film-coated tablet contains 3.395 mg perindopril corresponding to
5 mg perindopril arginine.
Excipient with known effect : 72.58 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
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.
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 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; 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
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