Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Anastrozole
Clonmel Healthcare Ltd
L02BG; L02BG03
Anastrozole
1 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Aromatase inhibitors; anastrozole
Marketed
2009-07-24
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER AMIDEX 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. − 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. IN THIS LEAFLET 1. What Amidex is and what it is used for 2. What you need to know before you take Amidex 3. How to take Amidex 4. Possible side effects 5. How to store Amidex 6. Contents of the pack and other information 1. WHAT AMIDEX IS AND WHAT IT IS USED FOR Amidex contains a substance called anastrozole. This belongs to a group of medicines called ‘aromatase inhibitors’. Amidex is used to treat breast cancer in women who have gone through the menopause. Amidex works by cutting down the amount of the hormone called oestrogen 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 AMIDEX DO NOT TAKE AMIDEX • 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 Amidex if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Amidex. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Amidex • 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 oestrogen (see the section called ‘Other medicines and Amidex’) • if you have read_full_document
Health Products Regulatory Authority 30 September 2021 CRN00CJJW Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amidex 1 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 1 mg of anastrozole. Excipient(s) with known effect Each tablet contains 92.75 mg lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex tablet with imprint A1 on one side and strength on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amidex 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 Amidex 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 _ Amidex 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 or moderate renal impairment. In patients with severe renal impairment, administration of Amidex 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 Amidex should be taken orally. Health Products Regulatory Authority 30 September 2021 CRN00CJJW Page 2 of 11 4.3 CONTRAINDICATIONS Anastrozole is contraindi read_full_document