Coversyl 10mg film-coated Tablets

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

PERINDOPRIL ARGININE

제공처:

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

ATC 코드:

C09AA04

INN (International Name):

PERINDOPRIL ARGININE 10 mg

약제 형태:

FILM-COATED TABLET

구성:

PERINDOPRIL ARGININE 10 mg

처방전 유형:

POM

치료 영역:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

승인 상태:

Authorised

승인 날짜:

2005-10-14

환자 정보 전단

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL 10 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 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 had these symptoms in any other circumstances (a condition called
angioedema).
-
if you are more tha

제품 특성 요약

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Coversyl 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril arginine.
One film-coated tablet contains 6.790 mg perindopril corresponding to
10 mg perindopril arginine.
Excipient with known effect: 145.16 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Green, round, biconvex, film-coated tablet engraved with
on one face and
on the other face..
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension:
Treatment of hypertension.
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 to 3 days before
beginning therapy with Coversyl
(see
section 4.4).
In hypertensive patients in whom