Coversyl 4mg tablets

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

PERINDOPRIL TERT, BUTYLAMINE SALT

זמין מ:

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

קוד ATC:

C09AA04

INN (שם בינלאומי):

PERINDOPRIL TERT-BUTYLAMINE SALT 4 mg

טופס פרצבטיות:

TABLET

הרכב:

PERINDOPRIL TERT-BUTYLAMINE SALT 4 mg

סוג מרשם:

POM

איזור תרפויטי:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

מצב אישור:

Authorised

תאריך אישור:

2006-01-30

עלון מידע

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL
® 4 MG TABLETS
perindopril tert-butylamine
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 4 mg is and what it is used for
2.
What you need to know before you take Coversyl 4 mg
3.
How to take Coversyl 4 mg
4.
Possible side effects
5.
How to store Coversyl 4 mg
6.
Content of the pack and other information
1.
WHAT COVERSYL 4 MG IS AND WHAT IT IS USED FOR
Coversyl 4 mg 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 4 mg 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 4 MG
DO NOT TAKE COVERSYL 4 MG
-
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

מאפייני מוצר

1
1.
NAME OF THE MEDICINAL PRODUCT
Coversyl 4 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril tert-butylamine.
One tablet contains 3.338 mg perindopril corresponding to 4 mg
perindopril tert-butylamine.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, rod-shaped, scored on both faces. The tablet can be divided
into equal halves.
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
4
mg
may
be
used
in
monotherapy
or
in
combination
with
other
classes
of
antihypertensive therapy.
The recommended starting dose is 4 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 mg is
recommended in such patients and the initiation of treatment should
take place under medical
supervision.
The dose may be increased to 8 mg once daily after one month of
treatment.
Page 2 of 17
Symptomatic hypotension may occur following initiation of therapy with
Coversyl 4 mg; 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
4 mg (see section 4.4).
In hypertensive patients in whom the diuretic cannot be discontinued,
therapy with C