מדינה: הולנד
שפה: הולנדית
מקור: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; IRBESARTAN 300 mg/stuk
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
C09DA04
HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; IRBESARTAN 300 mg/stuk
Filmomhulde tablet
COPOVIDON (E 1208) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Irbesartan And Diuretics
Hulpstoffen: COPOVIDON; CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
PL Irbesartan/HCT NL1919 PACKAGE LEAFLET: INFORMATION FOR THE USER IRBESARTAN/HYDROCHLOORTHIAZIDE STADA 150/12,5 MG, FILMOMHULDE TABLETTEN IRBESARTAN/HYDROCHLOORTHIAZIDE STADA 300/12,5 MG, FILMOMHULDE TABLETTEN IRBESARTAN/HYDROCHLOORTHIAZIDE STADA 300/25 MG, FILMOMHULDE TABLETTEN irbesartan/hydrochlorothiazide 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. Whatis and what it is used for 2. What you need to know before you take קרא את המסמך השלם3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR is a combination of two active substances, irbesartan and hydrochlorothiazide. Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure. The two active ingredients in work together to lower blood pressure further than if either was given alone. IS USED TO TREAT HIGH BLOOD PRESSURE, when treatment with irbesartan or hydrochlorothiazide alone d
SmPC Irbesartan/HCT NL1919 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Irbesartan/Hydrochloorthiazide STADA 150/12,5 mg, filmomhulde tabletten Irbesartan/Hydrochloorthiazide STADA 300/12,5 mg, filmomhulde tabletten Irbesartan/Hydrochloorthiazide STADA 300/25 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _150 mg/12.5 mg film-coated tablets _ Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. _ קרא את המסמך השלם300 mg/12.5 mg film-coated tablets _ Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. _ 300 mg/25 mg film-coated tablets _ Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide. Excipient(s) with known effect _ 150 mg/12.5mg film-coated tablets _ Each film-coated tablet contains 34.16 mg lactose (as lactose monohydrate). _ 300 mg/12.5 mg and 300 mg/25 mg film-coated tablets _ Each film-coated tablet contains 68.32 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _ 150 mg/12.5 mg film-coated tablet _ Pink, oblong, biconvex film-coated tablet and approximately 13 mm in length. _ 300 mg/12.5 mg film-coated tablet _ Pink, oblong, biconvex film-coated tablet and approximately 16 mm in length. _ 300 mg/25 mg film-coated tablet _ Red, oblong, biconvex film-coated tablet and approximately 16 mm in length. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology can be taken once daily, with or without food. Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended. SmPC Irbesartan/HCT NL1