COVERSYL 8 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
15-05-2018
Summary of Product characteristics
(SPC)
15-05-2018
Active ingredient:
PERINDOPRIL TERT-BUTYLAMINE SALT
Available from:
Les Laboratoires Servier
ATC code:
C09AA09
INN (International Name):
PERINDOPRIL TERT-BUTYLAMINE SALT
Dosage:
8 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
ACE inhibitors, plain
Authorization status:
Authorised
Authorization date:
2004-06-25
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL TABLETS 8 MG_ _
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 of the side effects, talk to your doctor, 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 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 than 3 months pregnant
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coversyl Tablets 8 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Coversyl Tablets 8 mg:
Each tablet contains 8 mg perindopril tert-butylamine salt, equivalent
to 6.676 mg perindopril
Excipient with known effect: lactose.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Green, round, biconvex tablet, engraved with
on one face and
on the other.
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 4.4 “Special warnings and special precautions
for use”) 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 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.
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
“Special warnings and special precautions for use”).
In hypertensive patients i
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