देश: नीदरलैंड
भाषा: डच
स्रोत: 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
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)
C09BA04
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, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Perindopril And Diuretics
Hulpstoffen: LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMWATERSTOFCARBONAAT (E 500 (II)); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
Perindopril tosilate/indapamide 5 mg/1.25 mg, NL/H/2475/002, 19.01.2023 Approved within IB026, IB028, IA030: shaded in turquoise Day 20 comments: shaded in yellow Day 20 second round: shaded in green rvg 110917 EU PIL IB/033 met NL info-clean versie 3 PACKAGE LEAFLET: INFORMATION FOR THE USER PERINDOPRIL TOSILAAT/INDAPAMIDE RATIOPHARM 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] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR WHAT IS [PRODUCT NAME]? [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. WHAT IS [PRODUCT NAME] 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE पूरा दस्तावेज़ पढ़ें
Perindopril tosilate/indapamide 5 mg/1.25 mg, NL/H/2475/002, 19.01.2023 Approved within IB026, IB028, IA030: shaded in turquoise Day 20 comments: shaded in yellow Day 20 second round: shaded in green 1 rvg 110917 EU SPC IB/033 met NL info-clean versie 3 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Perindopril Tosilaat/Indapamide ratiopharm 5 mg/1,25 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 3.408 mg perindopril corresponding to 5 mg perindopril tosilate, converted _in situ _ to perindopril sodium, and 1.25 mg indapamide. Excipient with known effect: Each film-coated tablet contains 148.112 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White, capsule shaped biconvex film-coated tablet of approx. 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, [Product name] is indicated in patients whose blood pressure is not adequately controlled on perindopril alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One [Product name] 5mg/1.25mg 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. [Product name] 5mg/1.25mg film-coated tablet should be used when blood pressure is not adequately controlled on Perindopril/Indapamide 2.5mg/0.625mg film-coated tablet (where available).When clinically appropriate, direct change from monotherapy to [Product name] 5mg/1.25mg film-coated tablet may be considered. _ _ Special populations Perindopril tosilate/indapamide 5 mg/1.25 mg, NL/H/2475/002, 19.01.2023 Approved within IB026, IB028, IA030: shaded in turquoise Day 20 comments: shaded in yellow Day 20 second round: shaded in green 2 rvg 110917 EU SPC IB/033 met NL info-cle पूरा दस्तावेज़ पढ़ें