Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; IRBESARTAN 150 mg/stuk
Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)
C09DA04
HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; IRBESARTAN 150 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Irbesartan And Diuretics
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2010-03-22
Hexal AG Page 1 Irbesartan comp HEXAL 150/12,5 mg, filmomhulde tabletten V12 Augustus 2021 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IRBESARTAN COMP HEXAL 150/12,5 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. What [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR_ _ [Nationally completed name] is a combination of two active substances, irbesartan and hydrochlorothiazide. IRBESARTAN belongs to a group of medicines called angiotensin-II receptor antagonists. These work by widening the blood vessels which in turn lowers the blood pressure. HYDROCHLOROTHIAZIDE belongs to a group of medicines called diuretics (water tablets). The two active substances in [Nationally completed name] work together to lower blood pressure further than if either was given alone. [Nationally completed name] is used in the treatment of high blood pressure (hypertension), when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]_ _ DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU: • are ALLERGIC TO IRBESARTAN, HYDROCHLOROTHIAZIDE OR ANY OF THE Lees het volledige document
Hexal AG Page 1 Irbesartan comp HEXAL 150/12,5 mg, filmomhulde tabletten. V13 1.3.1.1 Summary of Product Characteristics Augustus 2021 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Irbesartan comp HEXAL 150/12,5 mg, filmomhulde tabletten. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Excipient with known effect Each film-coated tablet contains 7.8 mg lactose (as monohydrate). _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Apricot, oval biconvex film-coated tablet, debossed with 150H on one side. 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 [Nationally completed name] can be taken once daily, with or without food. Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended. When clinically appropriate direct change from monotherapy to the fixed combinations may be considered: • [Nationally completed name 150 mg/12.5 mg] may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone. • [Nationally completed name 300 mg/12.5 mg] may be administered in patients insufficiently controlled by irbesartan 300 mg or by [nationally completed name 150 mg/12.5 mg]. • [Nationally completed name 300 mg/25 mg] may be administered in patients insufficiently controlled by [nationally completed name 300 mg/12.5 mg]. Hexal AG Page 2 Irbesartan comp HEXAL 150/12,5 mg, filmomhulde tabletten. V13 1.3.1.1 Summary of Product Characteristics Augustus 2021 Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, [Nationally completed name] may be a Lees het volledige document