Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Indapamide; Perindopril arginine
LTT Pharma Limited
C09BA; C09BA04
Indapamide; Perindopril arginine
10/2.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors and diuretics; perindopril and diuretics
Authorised
2017-03-01
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 Read the complete document
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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _2_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _1_ _9_ _4_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 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 Read the complete document