Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Perindopril arginine; Indapamide
McDermott Laboratories Ltd., T/A Gerard Laboratories
C09BA; C09BA04
Perindopril arginine; Indapamide
2.5 mg/0.625 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors and diuretics; perindopril and diuretics
Not marketed
2011-08-19
PAGE 1 OF 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERINDOPRIL ARGININE/INDAPAMIDE MYLAN 2.5 MG/0.625 MG FILM-COATED TABLETS PERINDOPRIL ARGININE/INDAPAMIDE MYLAN 5 MG/1.25 MG FILM-COATED TABLETS perindopril arginine and 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 Perindopril Arginine/Indapamide Mylan is and what it is used for 2. What you need to know before you take Perindopril Arginine/Indapamide Mylan 3. How to take Perindopril Arginine/Indapamide Mylan 4. Possible side effects 5. How to store Perindopril Arginine/Indapamide Mylan 6. Contents of the pack and other information 1. WHAT PERINDOPRIL ARGININE/INDAPAMIDE MYLAN IS AND WHAT IT IS USED FOR Perindopril Arginine/Indapamide Mylan 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). Perindopril belongs to a group of medicines known as angiotensin converting enzyme (ACE) inhibitors, which widen the blood vessels, and therefore it is easier for the heart to pump blood through them. Indapamide is a diuretic, which is a type of medicine that increases the amount of urine produced by the kidneys. These two active ingredients work together to reduce and control your blood pressure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERINDOPRIL ARGININE/INDAPAMIDE MYLAN DO NOT TAKE PERINDOPRIL ARGININE/INDAPAMIDE MYLAN: if you are allergic to perindopril or any other ACE inhibitor, indapamide or any other sulphona Read the complete document
Health Products Regulatory Authority 22 July 2020 CRN009SVR Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril Arginine/Indapamide Mylan 2.5 mg/0.625 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1.6975 mg perindopril corresponding to 2.5 mg perindopril arginine and 0.625 mg indapamide. Excipients with known effect: contains lecithin (soya) Each tablet contains 33.325 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, capsule shaped, biconvex, film-coated tablets debossed with a ‘P’, score line and ‘I’ on one side and an ‘M’, score line and ‘1’ on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perindopril Arginine/Indapamide Mylan 2.5 mg/0.625 mg is indicated for essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual dose is one Perindopril Arginine/Indapamide Mylan 2.5 mg/0.625 mg film-coated tablet per day as a single dose. If blood pressure is not controlled with Perindopril Arginine/Indapamide Mylan 2.5 mg/0.625 mg after one month of treatment, the dose can be doubled. _Elderly (see section 4.4)_ Treatment should be started at the normal dose of one Perindopril Arginine/Indapamide Mylan 2.5 mg/0.625 mg film-coated tablet per day. _Patients with 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 the treatment with an appropriate dose of the free combination. The maximum dose of perindopril arginine should be 2.5 mg per day. 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 cr Read the complete document