Coversyl Arginine Plus 10mg/2.5mg film-coated tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Perindopril arginine; Indapamide

Fáanlegur frá:

Les Laboratoires Servier

ATC númer:

C09BA; C09BA04

INN (Alþjóðlegt nafn):

Perindopril arginine; Indapamide

Skammtar:

10 mg/2.5 milligram(s)

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

ACE inhibitors and diuretics; perindopril and diuretics

Leyfisstaða:

Marketed

Leyfisdagur:

2009-08-14

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERSYL ARGININE 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 Arginine Plus 10mg/2.5mg is and what it is used for
2.
What you need to know before you take Coversyl Arginine Plus
10mg/2.5mg
3.
How to take Coversyl Arginine Plus 10mg/2.5mg
4.
Possible side effects
5.
How to store Coversyl Arginine Plus 10mg/2.5mg
6.
Contents of the pack and other information
1.
WHAT COVERSYL ARGININE PLUS 10MG/2.5MG IS AND WHAT IT IS USED FOR
Coversyl Arginine 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 Arginine
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 Arginine 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.
WHA

Vara einkenni

Health Products Regulatory Authority
20 June 2023
CRN00DKJZ
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coversyl Arginine 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 Arginine 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 Arginine 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.
In patients with moderate hepatic impairment, no dose modification is
required.
_Paediatric population_
The safety and efficacy ofCoversyl Arginine Plus 10mg/2.5mg in
children and adolescents have not yet been established. No
data are available. Coversyl Arginine 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
inhibito