Země: Nizozemsko
Jazyk: nizozemština
Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PERINDOPRILTOSILAAT SAMENSTELLING overeenkomend met ; PERINDOPRIL
Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM
C09AA04
PERINDOPRILTOSILAAT COMPOSITION corresponding to ; PERINDOPRIL
Filmomhulde tablet
BRILJANTBLAUW FCF ALUMINIUMLAK (E133) ; CHINOLINEGEEL ALUMINIUMLAK (E 104) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; 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
Hulpstoffen: BRILJANTBLAUW FCF ALUMINIUMLAK (E133); CHINOLINEGEEL ALUMINIUMLAK (E 104); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); 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);
2013-06-12
Perindopril tosilate, film-coated tablets, NL/H/2473/001-003, 07.03.2019 Changes due CMDh:without shading Changes due to Excipients Guideline and QRD: shaded in turquoise 1 BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER PERINDOPRIL TOSILAAT TEVA 2,5 MG, FILMOMHULDE TABLETTEN PERINDOPRIL TOSILAAT TEVA 5 MG, FILMOMHULDE TABLETTEN PERINDOPRIL TOSILAAT TEVA 10 MG, FILMOMHULDE TABLETTEN perindopril tosilate 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 Perindopril Tosilate is and what it is used for 2. What you need to know before you take Perindopril Tosilate 3. How to take Perindopril Tosilate 4. Possible side effects 5. How to store Perindopril Tosilate 6. Contents of the pack and other information 1. WHAT PERINDOPRIL TOSILATE IS AND WHAT IT IS USED FOR Perindopril Tosilate is an angiotensin converting enzyme (ACE) inhibitor. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. Perindopril Tosilate is used: - to treat _high blood pressure_ (hypertension), - [2.5 mg and 5 mg strengths]to treat _heart failure_ (a condition where the heart is unable to pump enough blood to meet the body’s needs), - to reduce the risk of cardiac events, such as heart attack, in patients with _stable coronary _ _artery disease_ (a condition where the blood supply to the heart is reduced or blocked) and who have already had a heart attack and/or an operation to improve the blood supply to the heart by widening the vessels that supply it. 2. WHAT YOU NEED TO KNOW BEFORE Přečtěte si celý dokument
Perindopril tosilate, film-coated tablets, NL/H/2473/001-003, 07.03.2019 Changes due CMDh:without shading Changes due to Excipents Guideline and QRD: shaded in turquoise 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Perindopril Tosilaat Teva 2,5 mg, filmomhulde tabletten Perindopril Tosilaat Teva 5 mg, filmomhulde tabletten Perindopril Tosilaat Teva 10 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril tosilate 2.5 mg Each film-coated tablet contains 1.704 mg perindopril corresponding to 2.5 mg perindopril tosilate converted _in situ_ to perindopril sodium. Excipient with known effect: Each film-coated tablet contains 35.981 mg lactose monohydrate. 5 mg Each film-coated tablet contains 3.408 mg perindopril corresponding to 5 mg perindopril tosilate converted _in situ_ to perindopril sodium. Excipient with known effect: Each film-coated tablet contains 71.962 mg lactose monohydrate. 10 mg Each film-coated tablet contains 6.816 mg perindopril corresponding to 10 mg perindopril tosilate converted _in situ_ to perindopril sodium. Excipient with known effect: Each film-coated tablet contains 143.924 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 2.5 mg White, round, biconvex, film-coated tablet of approx. 5 mm diameter, debossed “T” on one side and plain on the other. 5 mg Light green, capsule shape, biconvex film-coated tablet of approx. 4 mm width and 8 mm length, debossed “T” on one side, plain on the other side with breaklines on both edges. The tablet can be divided into equal doses. 10 mg Green, round, biconvex, film-coated tablet of approx. 8 mm diameter, debossed “10” on one side and “T” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 2 Hypertension: Treatment of hypertension. [2.5 mg and 5 mg strengths] Heart failure: Treatment of symptomatic heart failure. Stable coronary artery disease: Reduction of risk of cardiac events in patients with a history of myoc Přečtěte si celý dokument