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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Indapamide; Perindopril arginine

Available from:

LTT Pharma Limited

ATC code:

C09BA; C09BA04

INN (International Name):

Indapamide; Perindopril arginine

Dosage:

10/2.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors and diuretics; perindopril and diuretics

Authorization status:

Authorised

Authorization date:

2017-03-01

Patient Information leaflet

LEAFLET DETAILS
Licence Number:
PPA1562/063/002
Leaflet size:
210mm x 345mm, Portrait double sided - 2 columns on each side
Column width:
97.5mm
Text Free Border:
5mm (around edge & between columns)
Font:
Arial
Font Size:
Title = 15pt
Generic Name = 12pt
Main Section Headings = 10pt
Sub Headings = 8pt
Main Text = Font 8pt / Leading 9pt
Statement for Blind = 12pt
Colour:
Black print on white paper
Irish Leaflet:
Servier, October 2014
LTT Revision date:
23/09/2016
Ref: 063/002/230916/1/F & Ref: 063/002/230916/1/B =
Coversyl Arginine Plus 10mg/ 2.5mg Film-coated Tablets (Front & Back)
_This is the final mock-up._
_This leaflet has been user tested._
COVERSYL ARGININE PLUS 10MG/ 2.5MG FILM-COATED TABLETS
(perindopril arginine/ indapamide)
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
*
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. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours.
*
If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
What COVERSYL ARGININE PLUS 10mg/2.5mg is and what it is used
for
Before you take COVERSYL ARGININE PLUS 10mg/2.5mg
How to take COVERSYL ARGININE PLUS 10mg/2.5mg
Possible side effects
How to store COVERSYL ARGININE PLUS 10mg/2.5mg
Further information
WHAT COVERSYL ARGININE PLUS 10MG/2.5MG IS AND
WHAT IT IS USED FOR
WHAT IS COVERSYL ARGININE PLUS 10MG/2.5MG?
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 ARGININ

Summary of Product characteristics

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: lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Hungary_
White, round film-coated tablet
4 CLINICAL PARTICULARS
As per PA0568/022/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0568/022/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Core:_
lactose monohydrate
maltodextrin
magnesium stearate (E470B)
anhydrous colloidal silica
Sodium starch glycolate type A
_Film-coating:_
gylcerol (E422)
hypromellose (E464)
macrogol 6000
titanium dioxide (E171)
magnesium stearate (E470B)
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Keep the container tightly closed in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
30 tablets in polypropylene tablet container equipped with a low
density polyethylene flow reducer
and a low