Pajjiż: Olanda
Lingwa: Olandiż
Sors: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
INDAPAMIDE 0-WATER 1,25 mg/stuk ; PERINDOPRILTOSILAAT 5 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 3,4 mg/stuk
INDAPAMIDE 0-WATER 1,25 mg/stuk ; PERINDOPRILTOSILAAT 5 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 3,4 mg/stuk
Filmomhulde tablet
LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; POLYVINYLALCOHOL (E 1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERINDOPRIL TOSILAAT/INDAPAMIDE DOC 5 MG/1,25 MG, FILMOMHULDE TABLETTEN perindopril tosilate/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 [Product name] 5 mg/1.25 mg is and what it is used for 2. What you need to know before you take [Product name] 5 mg/1.25 mg 3. How to take [Product name] 5 mg/1.25 mg 4. Possible side effects 5. How to store [Product name] 5 mg/1.25 mg 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] 5 MG/1.25 MG IS AND WHAT IT IS USED FOR [Product name] 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) in adults. 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 [PRODUCT NAME] 5 MG/1.25 MG DO NOT TAKE [PRODUCT NAME] 5 MG/1.25 MG - if you are allergic to perindopril or any other ACE inhibitor, or to indapamide or any other sulfonamide or any of the other ingredients of this medicine (listed in section 6) Aqra d-dokument sħiħ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Perindopril tosilaat/Indapamide DOC 5 mg/1,25 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg perindopril tosilate corresponding to 3.408 mg perindopril, converted in situ to perindopril sodium, and 1.25 mg indapamide. Excipient with known effect : Each film-coated tablet contains 141 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White, capsule shaped biconvex film-coated tablet of approximately 5 mm width and 10 mm length, debossed “P”, “I” and breakline on one side and plain on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults, Perindopril tosilaat/Indapamide DOC 5 mg/1.25 mg film- coated tablet is indicated in patients whose blood pressure is not adequately controlled on perindopril alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One Perindopril tosilaat/Indapamide DOC 5 mg/1.25 mg film-coated tablet per day as a single dose, preferably to be taken in the morning, and before a meal. When possible individual dose titration with the components is recommended. Perindopril tosilaat/Indapamide DOC 5 mg/1.25mg film-coated tablet should be used when blood pressure is not adequately controlled on Perindopril tosilaat/Indapamide DOC 2.5 mg/0.625 mg film-coated tablet (where available). When clinically appropriate, direct change from monotherapy to Perindopril tosilaat/Indapamide DOC 5 mg/1.25 mg film-coated tablet may be considered. Special populations _Elderly (see section 4.4) _ Treatment should be initiated after considering blood pressure response and renal function. _ _ _Renal impairment (see section 4.4) _ In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contraindicated. 2 In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), it is recommended to st Aqra d-dokument sħiħ