BIOCOVERSYL PLUS 10/2,5 TABLET

Country: Afrika Selatan

Bahasa: Inggeris

Sumber: South African Health Products Regulatory Authority (SAHPRA)

Boleh didapati daripada:

Servier Laboratories South Africa (Pty) Ltd

Dos:

See ingredients

Borang farmaseutikal:

TABLET

Komposisi:

EACH TABLET CONTAINS INDAPAMIDE 2,5 mg PERINDOPRIL ARGININE 10,0 mg

Status kebenaran:

Registered

Tarikh kebenaran:

2015-06-08

Risalah maklumat

Page 1 of 14
Approved PIL
Applicant:
Servier Laboratories SA (Pty) Ltd
Product:
Coversyl Plus
Date:
9 April 2020
PATIENT INFORMATION LEAFLET
COVERSYL PLUS TABLET
perindopril tert-butylamine and indapamide
Contains sugar (lactose)
SCHEDULING STATUS: S3
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING COVERSYL
PLUS.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

COVERSYL PLUS has been prescribed to you personally and you should not
share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET

1. What COVERSYL PLUS is and what it is used for

2. What you need to know before you take COVERSYL PLUS

3. How to take COVERSYL PLUS

4. Possible side effects

5. How to store COVERSYL PLUS

6. Contents of the pack and other information
1.
WHAT COVERSYL PLUS IS AND WHAT IT IS USED FOR
COVERSYL PLUS is a combination of two active ingredients, perindopril
and indapamide. It is an anti-
hypertensive and is used in the treatment of high blood pressure
(hypertension) in adults.
Perindopril belongs to a class of medicines called ACE-inhibitors.
These work by widening the
blood vessels, which makes it easier for your heart to pump blood
through them. Indapamide is a
diuretic. Diuretics increase the amount of urine produced by the
kidneys. However, indapamide is
Page 2 of 14
Approved PIL
Applicant:
Servier Laboratories SA (Pty) Ltd
Product:
Coversyl Plus
Date:
9 April 2020
different from other diuretics, as it only causes a slight increase in
the amount of urine produced.
Each of the active ingredients reduces blood pressure and they work
together to control your blood
pressure.
COVERSYL PLUS is used to treat high blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE TAKING COVERSYL PLUS
DO NOT TAKE COVERSYL PLUS:

if you are hypersensitive (allergic) to perindopril or any other
ACE-inhibitor, or to indapamide or
any other sulphonamides or any of the other

Ciri produk

Page 1 of 40
Approved PI
Applicant:
Servier Laboratories SA (Pty) Ltd
Product:
Coversyl Plus
Date:
9 April 2020
COVERSYL
® PLUS
SCHEDULING STATUS: S3
1.
NAME OF MEDICINE
COVERSYL
® PLUS, tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg of perindopril tert-butylamine salt and 1,25
mg of
indapamide.
Excipient with known effect: 61,55 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White, 8-mm x 4-mm rod-shaped tablets.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
COVERSYL
® PLUS is indicated for the treatment of essential hypertension, in
patients
where blood pressure is not adequately controlled and where fixed
combination is
considered more appropriate than monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage regimen depends upon the individual requirements of the
patient and
is at the discretion of the medical doctor. One COVERSYL
® PLUS tablet per day as a
single dose, preferably to be taken in the morning before a meal.
Page 2 of 40
Approved PI
Applicant:
Servier Laboratories SA (Pty) Ltd
Product:
Coversyl Plus
Date:
9 April 2020
Special populations
ELDERLY (SEE SECTION 4.4):
It is recommended to start the treatment with only one of the
constituents.
PATIENTS WITH RENAL FAILURE (SEE SECTION 4.4):
In cases of severe renal failure (creatinine clearance below 30
ml/min), treatment
is contra-indicated. In patients with a creatinine clearance greater
than or equal to
30 ml/min and less than 60 ml/min, it is recommended to start the
treatment with
only one of the constituents. It is not necessary to change the dose
when the
creatinine clearance is greater than 60 ml/min.
Method of administration
Oral use.
4.3 CONTRAINDICATIONS
This medicine is contraindicated in the following circumstances:
Linked to indapamide:
•
Hypersensitivity to any of the ingredients of COVERSYL
® PLUS or any other
ACE-inhibitor.
•
A history of angioedema related to previous therapy with
ACE-inhibitors or
angiotensin receptor bloc