Land: Nederland
Språk: nederlandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IRBESARTAN 150 mg/stuk
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
C09CA04
IRBESARTAN 150 mg/stuk
Filmomhulde tablet
COPOVIDON (E 1208) ; CROSCARMELLOSE (E 468) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), COPOVIDON ; CROSCARMELLOSE (E 468) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), COPOVIDON ; CROSCARMELLOSE (E 468) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Irbesartan
Hulpstoffen: COPOVIDON; CROSCARMELLOSE (E 468); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER IRBESARTAN STADA 75 MG, FILMOMHULDE TABLETTEN. IRBESARTAN STADA 150 MG, FILMOMHULDE TABLETTEN. IRBESARTAN STADA 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 STADA is and what it is used for 2. What you need to know before you take Irbesartan STADA 3. How to take Irbesartan STADA 4. Possible side effects 5. How to store Irbesartan STADA 6. Contents of the pack and other information 1. WHAT IRBESARTAN STADA IS AND WHAT IT IS USED FOR Irbesartan STADA 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 STADA prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan STADA slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. Irbesartan STADA is used in adult patients to: • treat high blood pressure (essential hypertension) • 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 STADA DO NOT TAKE IRBESARTAN STADA • if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) • if you are MORE THAN 3 MONTHS PREGNAN Les hele dokumentet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Irbesartan STADA 75 mg, filmomhulde tabletten. Irbesartan STADA 150 mg, filmomhulde tabletten. Irbesartan STADA 300 mg, filmomhulde tabletten. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 75 mg film-coated tablet contains 75 mg of irbesartan. Each 150 mg film-coated tablet contains 150 mg of irbesartan. Each 300 mg film-coated tablet contains 300 mg of irbesartan. Excipient with known effect Each 75 mg film-coated tablet contains 17.08 mg of lactose monohydrate. Each 150 mg film-coated tablet contains 34.16 mg of lactose monohydrate. Each 300 mg film-coated tablet contains 68.32 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets 75 mg film-coated tablets are white, biconvex, oval-shaped and approximately 10 mm in length. 150 mg film-coated tablets are white, biconvex, oval-shaped and approximately 13 mm in length. 300 mg film-coated tablets are white, biconvex, oval-shaped and approximately 16 mm in length. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irbesartan STADA 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology This medicinal product is available in 3 strengths: 75 mg, 150 mg and 300 mg. The usual recommended initial and maintenance dose is 150 mg once daily. Irbesartan STADA at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan STADA can be increased to 300 mg, or other antihypertensive agents can be added (see sect Les hele dokumentet