País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Anastrozole
Bluefish Pharmaceuticals AB
L02BG; L02BG03
Anastrozole
1 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Aromatase inhibitors; anastrozole
Marketed
2011-03-25
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ANASTROZOLE BLUEFISH 1 MG FILM-COATED TABLETS 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 or nurse. - 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 or nurse.This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Anastrozole Bluefish is and what it is used for 2. What you need to know before you take Anastrozole Bluefish 3. How to take Anastrozole Bluefish 4. Possible side effects 5. How to store Anastrozole Bluefish 6. Contents of the pack and other information 1. WHAT ANASTROZOLE BLUEFISH IS AND WHAT IT IS USED FOR Anastrozole Bluefish contains a substance called anastrozole. This belongs to a group of medicines called ‘aromatase inhibitors’. Anastrozole Bluefish is used to treat breast cancer in women who have gone through the menopause. Anastrozole Bluefish 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’. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANASTROZOLE BLUEFISH DO NOT TAKE ANASTROZOLE BLUEFISH - 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 Anastrozole Bluefish if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Anastrozole Bluefish. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist or nurse before Leer el documento completo
Health Products Regulatory Authority 02 July 2021 CRN00CD2Z Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anastrozole Bluefish 1 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg anastrozole Excipient with known effect: Each tablet contains 93 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, round, biconvex tablet of diameter 6.0 - 6.2mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anastrozole Bluefish is indicated for the: Treatment of hormone receptor –positive advanced breast cancer in postmenopausal women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Anastrozole Bluefish for adults including the elderly is 1 mg tablet once a day. Special population Paediatric population Anastrozole Bluefish 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 No dose change is recommended in patients with mild and moderate renal impairment. In patients with severe renal impairment, administration of Anastrozole Bluefish should be performed with caution (see section 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 administration Anastrozole should be taken orally. 4.3 CONTRAINDICATIONS Anastrozole Bluefish is contraindicated in: - pregnant or breast-feeding women, - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE General Health Products Regulatory Authority 02 July 2021 CRN00CD2Z Page 2 of 9 Anastrozole should not be used in premenopausal women. The menopause should be defined biochemically (luteinizing-hormone [LH], follicle stimulating hormone [FSH], and/or estradiol levels) in any patient where there is doub Leer el documento completo