Coversyl 2.5mg film-coated Tablets

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

PERINDOPRIL ARGININE

Disponibbli minn:

Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France

Kodiċi ATC:

C09AA04

INN (Isem Internazzjonali):

PERINDOPRIL ARGININE 2.5 mg

Għamla farmaċewtika:

FILM-COATED TABLET

Kompożizzjoni:

PERINDOPRIL ARGININE 2.5 mg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

L-istatus ta 'awtorizzazzjoni:

Withdrawn

Data ta 'l-awtorizzazzjoni:

2005-10-14

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL 2.5 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 your family
have

Karatteristiċi tal-prodott

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Coversyl 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril arginine.
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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, convex, film-coated 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
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
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19
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 to 3 days before
beginning therapy with
Coversyl
(see section 4.4).
In