Riik: Malta
keel: inglise
Allikas: Malta Medicines Authority
PERINDOPRIL ARGININE, INDAPAMIDE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
C09BA04
PERINDOPRIL ARGININE 10 mg INDAPAMIDE 2.5 mg
FILM-COATED TABLET
PERINDOPRIL ARGININE 10 mg INDAPAMIDE 2.5 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2015-12-22
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER PERCARNIL INDAPAMIDE 10 MG/2.5 MG FILM-COATED TABLETS perindopril arginine/indapamide hemihydrate 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 Percarnil indapamide is and what it is used for 2. What you need to know before you take Percarnil indapamide 3. How to take Percarnil indapamide 4. Possible side effects 5. How to store Percarnil indapamide 6. Contents of the pack and other information 1. WHAT PERCARNIL INDAPAMIDE IS AND WHAT IT IS USED FOR Percarnil indapamide is a combination of two active ingredients, perindopril and indapamide. It is an antihypertensive and is used in the treatment of high blood pressure (hypertension). Percarnil indapamide 10 mg/2.5 mg 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 Percarnil indapamide 10 mg/2.5 mg 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERCARNIL INDAPAMIDE DO NOT Lugege kogu dokumenti
Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Percarnil indapamide 10 mg/2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg perindopril arginine corresponding to 6.79 mg perindopril and 2.5 mg indapamide hemidydrate. Excipient with known effect: Each film-coated tablet contains 167 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Percarnil indapamide 10 mg/2.5 mg film-coated tablets are white, 8.5 mm round and biconvex. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Percarnil indapamide 10 mg/2.5 mg 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 Percarnil indapamide 10 mg/2.5 mg tablet per day as a single dose, preferably to be taken in the morning, and before a meal. _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. _Patients with 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. _Patients with hepatic impairment (see sections 4.3, 4.4 and 5.2) _ In severe hepatic impairment, treatment is contraindicated. Page 2 of 20 In patients with moderate hepatic impairment, no dose modification is required. _ _ _Paediatric population _ Percarnil indapamide should not be used in children and adolescents as the efficacy and tolerability of perindopril in children and adolescents, alone or in combination, have not been established. Method of administration Oral use. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active su Lugege kogu dokumenti