Coversyl Plus 5mg/1.25mg film-coated tablets
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
01-05-2023
Summary of Product characteristics
(SPC)
11-06-2021
Active ingredient:
PERINDOPRIL ARGININE, INDAPAMIDE
Available from:
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
ATC code:
C09BA04
INN (International Name):
PERINDOPRIL ARGININE 5 mg INDAPAMIDE 1.25 mg
Pharmaceutical form:
FILM-COATED TABLET
Composition:
PERINDOPRIL ARGININE 5 mg INDAPAMIDE 1.25 mg
Prescription type:
POM
Therapeutic area:
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorization status:
Authorised
Authorization date:
2010-02-16
Patient Information leaflet
1
PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL PLUS 5MG/1.25MG FILM-COATED TABLETS
perindopril arginine/indapamide
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 or pharmacist.
-
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. This
includes any possible side effects
not listed in this leaflet. See section 4.,
WHAT IS IN THIS LEAFLET
:
1.
What Coversyl Plus 5mg/1.25mg is and what it is used for
2.
What you need to know before you take Coversyl Plus 5mg/1.25mg
3.
How to take Coversyl Plus 5mg/1.25mg
4.
Possible side effects
5.
How to store Coversyl Plus 5mg/1.25mg
6.
Contents of the pack and other information
1.
WHATCOVERSYL PLUS 5MG/1.25MG IS AND WHAT IT IS USED FOR
Coversyl Plus 5mg/1.25mg 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 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COVERSYL PLUS 5MG/1.25MG
DO NOT TAKE COVERSYL PLUS 5MG/1.25MG
-
if you are allergic to perindopril or any other ACE inhibitor, or to
indapamide or any other sulphonamides
or any of the other ingredients of this medicine (listed in section
6),
-
if you have e
Read the complete document
Summary of Product characteristics
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SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Coversyl Plus 5mg/1.25mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 3.395 mg perindopril corresponding to
5 mg perindopril arginine and 1.25
mg indapamide.
Excipient with known effect: 71.33 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, rod-shaped film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults, Coversyl Plus
5mg/1.25mg film-coated tablet is indicated in
patients whose blood pressure is not adequately controlled on
perindopril alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Coversyl Plus 5mg/1.25mg film-coated tablet per day as a single
dose, preferably to be taken in the
morning, and before a meal.
When possible individual dose titration with the components is
recommended. Coversyl Plus 5mg/1.25mg
film-coated tablet should be used when blood pressure is not
adequately controlled on Preterax Arginine
2.5mg/0.625mg
film-coated
tablet
(where
available).When
clinically
appropriate,
direct
change
from
monotherapy to Coversyl Plus 5mg/1.25mg film-coated tablet may be
considered.
Special populations
_Elderly (see section 4.4) _
Treatment should be initiated after considering blood pressure
response and renal function.
_Renal impairment (see section 4.4) _
In severe renal impairment (creatinine clearance below 30 ml/min),
treatment is contraindicated.
In patients with moderate renal impairment (creatinine clearance 30-60
ml/min), it is recommended to start
treatment with the adequate dosage of the free combination.
In patients with creatinine clearance greater than or equal to 60
ml/min, no dose modification is required.
Usual medical follow-up will include frequent monitoring of creatinine
and potassium.
_Hepatic impairment (see sections 4.3, 4.4 and 5.2) _
In severe hepatic impairment, treatment is contraindicated.
In patients with mode
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