Kraj: Holandia
Język: niderlandzki
Źródło: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
INDAPAMIDE 0-WATER 2,5 mg/stuk ; PERINDOPRILTOSILAAT 10 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 6,8 mg/stuk
INDAPAMIDE 0-WATER 2,5 mg/stuk ; PERINDOPRILTOSILAAT 10 mg/stuk SAMENSTELLING overeenkomend met ; PERINDOPRIL 6,8 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 10 MG/2,5 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] 10 mg/2.5 mg is and what it is used for 2. What you need to know before you take [Product name] 10 mg/2.5 mg 3. How to take [Product name] 10 mg/2.5 mg 4. Possible side effects 5. How to store [Product name] 10 mg/2.5 mg 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] 10 MG/2.5 MG IS AND WHAT IT IS USED FOR [Product name] 10 mg/2.5 mg 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. [Product name] 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 [Product name] 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 BEF Przeczytaj cały dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Perindopril tosilaat/Indapamide DOC 10 mg/2,5 mg, filmomhulde tabletten. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg perindopril tosilate corresponding to 6.816 mg perindopril, converted in situ to perindopril sodium, and 2.5 mg indapamide. Excipient with known effect: Each film-coated tablet contains 281 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, round and biconvex film-coated tablet of approximately 10 mm diameter, plain on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perindopril tosilaat/Indapamide DOC 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 Perindopril tosilaat/Indapamide DOC 10 mg/2.5 mg film-coated tablet per day as a single dose, preferably to be taken in the morning and before a meal. Special populations _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. _ _ _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. _ _ _Hepatic impairment (see sections 4.3, 4.4 and 5.2) _ In severe hepatic impairment, treatment is contraindicated. In patients with moderate hepatic impairment, no dose modification is required. _ _ _Paediatric population _ 2 The safety and efficacy of Perindopril tosilaat/Indapamide DOC 10 mg/2.5 mg in children and adolescents have not yet been established. No data are available. Perindopril tosilaat/Indapamide DOC 10 mg/2.5 mg should not be use Przeczytaj cały dokument