Country: Malta
Language: English
Source: Medicines Authority
PERINDOPRIL ARGININE, INDAPAMIDE
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
C09BA04
PERINDOPRIL ARGININE 2.5 mg INDAPAMIDE 0.625 mg
FILM-COATED TABLET
PERINDOPRIL ARGININE 2.5 mg INDAPAMIDE 0.625 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2007-07-11
PAGE 1 OF 8 B. PACKAGE LEAFLET PAGE 2 OF 8 PACKAGE LEAFLET: INFORMATION FOR THE USER PRETERAX ARGININE 2.5MG/0.625MG FILM-COATED TABLETS perindopril arginine/indapamide 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: 1. What PRETERAX ARGININE 2.5mg/0.625mg is and what it is used for 2. Before you take PRETERAX ARGININE 2.5mg/0.625mg 3. How to take PRETERAX ARGININE 2.5mg/0.625mg 4. Possible side effects 5. How to store PRETERAX ARGININE 2.5mg/0.625mg 6. Further information 1. WHAT PRETERAX ARGININE 2.5MG/0.625MG IS AND WHAT IT IS USED FOR WHAT IS PRETERAX ARGININE 2.5MG/0.625MG ? PRETERAX ARGININE 2.5mg/0.625mg 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). WHAT IS PRETERAX ARGININE 2.5MG/0.625MG USED FOR ? 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. BEFORE YOU TAKE PRETERAX ARGININE 2.5MG/0.625MG DO NOT TAKE PRETERAX ARGININE 2.5MG/0.625MG a. if you are allergic to perindopril or any other ACE inhibitor, or to indapamide or any other sulphonamides or any of the other ingredients of PRETERAX ARGININE 2.5mg/0.625 Read the complete document
PAGE 1 OF 20 SUMMARY OF PRODUCT CHARACTERISTICS PAGE 2 OF 20 1. NAME OF THE MEDICINAL PRODUCT PRETERAX ARGININE 2.5mg/0.625mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 1.6975 mg perindopril corresponding to 2.5 mg perindopril arginine and 0.625 mg indapamide. Excipient: 74.455 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, rod-shaped film-coated tablet with an embossed line on both faces. The score line is not intended for breaking the tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual dose is_ _ one PRETERAX ARGININE 2.5mg/0.625mg film-coated tablet per day as a single dose, preferably to be taken in the morning and before a meal. If blood pressure is not controlled 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 PRETERAX ARGININE 2.5mg/0.625mg 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), the maximum dose should be one tablet of PRETERAX ARGININE 2.5mg/0.625mg 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 creatinine and potassium. _Patients with hepatic impairment (see sections 4.3, 4.4 and 5.2) _ PAGE 3 OF 20 In severe hepatic impairment, treatment is contraindicated. In patients with moderate hepatic impairment, no dose modification is required. Paediatric population The safety and efficacy of perindopril arginine/indapamide in the paediatric population have not yet been established. PRETERAX ARGININE 2.5mg/0.625mg should not be used in children and adolescents Metho Read the complete document