Nazione: Paesi Bassi
Lingua: olandese
Fonte: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IRBESARTAN
Torrent Pharma GmbH
C09CA04
IRBESARTAN
Filmomhulde tablet
CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Irbesartan
Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); POLYETHYLEENGLYCOL (E 1521); POVIDON K 30 (E 1201); TITAANDIOXIDE (E 171);
2011-11-03
Irbesartan Torrent, 75-150-300 mg, film-coated tablets – NL/H/2066/001-003/DC Page 1 NL pl NL/p/008/16/2 1 PACKAGE LEAFLET: INFORMATION FOR THE USER IRBESARTAN TORRENT 75 MG FILMOMHULDE TABLETTEN IRBESARTAN TORRENT 150 MG FILMOMHULDE TABLETTEN IRBESARTAN TORRENT 300 MG FILMOMHULDE TABLETTEN Irbesartan 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 Irbesartan Torrent is and what it is used for 2. What you need to know before you take Irbesartan Torrent 3. How to take Irbesartan Torrent 4. Possible side effects 5 How to store Irbesartan Torrent 6. Contents of the pack and other information 1. WHAT IRBESARTAN TORRENT IS AND WHAT IT IS USED FOR Irbesartan Torrent belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan Torrent prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan Torrent slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Irbesartan Torrent is used in adult patients - to treat high blood pressure (_essential hypertension_) - to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRBESARTAN TORRENT DO NOT TAKE IRBESARTAN TORRENT - if you are ALLERGI Leggi il documento completo
Irbesartan Torrent, 75-150-300 mg, film-coated tablets – NL/H/2066/001-003/DC Page 1 NL spc NL/s/005/16/2 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Irbesartan Torrent 75 mg filmomhulde tabletten. Irbesartan Torrent 150 mg filmomhulde tabletten. Irbesartan Torrent 300 mg filmomhulde tabletten. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75/150/300 mg of irbesartan. Excipients with known effect: Irbesartan Torrent 75 mg: This medicine contains 63.50 mg of lactose monohydrate and less than 1 mmol sodium (23 mg) per film-coated tablet Irbesartan Torrent 150 mg: This medicine contains 127.00 mg of lactose monohydrate and less than 1 mmol sodium (23 mg) per film-coated tablet Irbesartan Torrent 300 mg: This medicine contains 254.00 mg of lactose monohydrate and less than 1 mmol sodium (23 mg) per film-coated tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Irbesartan Torrent 75 mg film-coated tablets: White to off-white, oval-shaped, biconvex film-coated tablets debossed with “L172” on one side and “75” on the other side. Irbesartan Torrent 150 mg film-coated tablets: White to off-white, oval-shaped, biconvex film-coated tablets debossed with “L173” on one side and “150” on the other side. Irbesartan Torrent 300 mg film-coated tablets: White to off-white, oval-shaped, biconvex film-coated tablets debossed with “L174” on one side and “300” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irbesartan Heumann is indicated in adults for the treatment of essential hypertension. It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1). Irbesartan Torrent, 75-150-300 mg, film-coated tablets – NL/H/2066/001-003/DC Page 2 NL spc NL/s/005/16/2 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The usual recommende Leggi il documento completo