Země: Nizozemsko
Jazyk: nizozemština
Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ANASTROZOL 1 mg/stuk
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)
L02BG03
ANASTROZOL 1 mg/stuk
Filmomhulde tablet
HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171), HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Anastrozole
Hulpstoffen: HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 400; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); TITAANDIOXIDE (E 171);
1900-01-01
Anastrozole, NL/H/0834/001, 30.06.2021 Consolidation IB/023 + IA/024 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Anastrozol ratiopharm 1 mg, filmomhulde tabletten anastrozole 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 /.../ is and what it is used for 2. What you need to know before you take /.../ 3. 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 /.../ contains a substance called anastrozole. This belongs to a group of medicines called ‘aromatase inhibitors’. /.../ is used to treat breast cancer in women who have gone through the menopause. /.../ works by cutting down the amount of the hormone called estrogen that your body makes. It does this by blocking a natural substance (an enzyme) in your body called ‘aromatase’. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE /.../ DO NOT TAKE /.../ - if you are allergic to anastrozole or any of the other ingredients of this medicine (listed in section 6). - if you are pregnant or breast-feeding (see the section called ‘Pregnancy and breast-feeding’). Do not take /.../ if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking /.../. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking /.../ - if you still have menstrual periods and have not yet gone through the menopause. - if you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see the section Přečtěte si celý dokument
Anastrozole, NL/H/0834/001, 30.06.2021 Consolidation IB/023 + IA/024 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Anastrozol ratiopharm 1 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg anastrozole. Excipient(s) with known effect: Each film-coated tablet contains 87 mg lactose monohydrate (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off-white, film-coated round-shaped tablet, debossed with numbers "93" on one side and "A10" on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS /.../ is indicated for the: • Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women. • Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women. • Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of anastrozole for adults including the elderly is one 1 mg tablet once a day. For postmenopausal women with hormone receptor-positive early invasive breast cancer, the recommended duration of adjuvant endocrine treatment is 5 years. Special populations _Paediatric population_ Anastrozole is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.4 and 5.1). _ _ _Renal impairment_ Anastrozole, NL/H/0834/001, 30.06.2021 Consolidation IB/023 + IA/024 2 No dose change is recommended in patients with mild or moderate renal impairment. In patients with severe renal impairment, administration of anastrozole should be performed with caution (see sections 4.4 and 5.2). _Hepatic impairment _ No dose change is recommended in patients with mild hepatic disease. Caution is advised in patients with moderate to severe hepatic impairment (see section 4.4). Method of administ Přečtěte si celý dokument