COVERSYL PLUS 10mg/2.5mg film-coated Tablets
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
26-06-2023
Summary of Product characteristics
(SPC)
26-06-2023
Active ingredient:
PERINDOPRIL ARGININE, INDAPAMIDE
Available from:
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
ATC code:
C09BA04
INN (International Name):
INDAPAMIDE 2.5 mg PERINDOPRIL ARGININE 10 mg
Pharmaceutical form:
FILM-COATED TABLET
Composition:
INDAPAMIDE 2.5 mg PERINDOPRIL ARGININE 10 mg
Prescription type:
POM
Therapeutic area:
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorization status:
Authorised
Authorization date:
2010-07-29
Patient Information leaflet
Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL PLUS 10MG/2.5MG 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 10mg/2.5mg is and what it is used for
2.
What you need to know before you take Coversyl Plus 10mg/2.5mg
3.
How to take Coversyl Plus 10mg/2.5mg
4.
Possible side effects
5.
How to store Coversyl Plus 10mg/2.5mg
6.
Contents of the pack and other information
1.
WHAT COVERSYL PLUS 10MG/2.5MG IS AND WHAT IT IS USED FOR
Coversyl Plus 10mg/2.5mg 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). Coversyl
Plus 10mg/2.5mg is prescribed for patients already receiving
perindopril 10 mg and indapamide 2.5
mg from separate tablets, these patients may instead receive one
tablet of Coversyl Plus 10mg/2.5mg
which contains both ingredients.
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 10MG/2.5MG
DO NOT TAKE
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Summary of Product characteristics
Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Coversyl Plus 10mg/2.5mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 6.79 mg perindopril equivalent to 10
mg perindopril arginine and 2.5 mg
indapamide.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Coversyl Plus 10mg/2.5mg
_ _
is indicated as substitution therapy for treatment of essential
hypertension, in
patients already controlled with perindopril and indapamide given
concurrently at the same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Coversyl Plus 10mg/2.5mg
_ _
tablet per day as a single dose, preferably to be taken in the
morning,
and before a meal.
Special populations
_Elderly (see section 4.4) _
In elderly, the plasma creatinine must be adjusted in relation to age,
weight and gender. Elderly patients
can be treated if renal function is normal and after considering blood
pressure response.
_Renal impairment (see section 4.4) _
In
severe
and
moderate
renal
impairment
(creatinine
clearance
below
60
ml/min),
treatment
is
contraindicated.
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.
Page 2 of 24
In patients with moderate hepatic impairment, no dose modification is
required.
_Paediatric population _
The safety and efficacy of Coversyl Plus 10mg/2.5mg in children and
adolescents have not yet been
established. No data are available. Coversyl Plus 10mg/2.5mg
_ _
should not be used in children and
adolescents.
Method of administration
Oral use.
4.3
CONTRAINDICATIONS
_Linked to perindopril: _
-
Hypersensitivity to the active substance or to any other ACE inhibitor
-
History of angioedema (Quincke’s oedema) associated with previo
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