Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Anastrozole
Zaphyr Pharmaceuticals Ireland Limited
L02BG; L02BG03
Anastrozole
1 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Aromatase inhibitors; anastrozole
Marketed
2009-11-27
ZAPHYR PHARMACEUTICALS IRELAND LIMITED DCP NO.: IE/H/189/001/DC PA 1914/001/001 ANASTROZOLE ZAPHYR PHARMACEUTICALS 1MG FILM- COATED TABLETS. MODULE 1 1 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER ANASTROZOLE ZAPHYR PHARMACEUTICALS 1MG FILM-COATED TABLETS. Anastrozole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What ANASTROZOLE ZAPHYR PHARMACEUTICALS is and what it is used for 2. Before you take ANASTROZOLE ZAPHYR PHARMACEUTICALS 3. How to take ANASTROZOLE ZAPHYR PHARMACEUTICALS 4. Possible side effects 5. How to store ANASTROZOLE ZAPHYR PHARMACEUTICALS tablets. 6. Further information 1. WHAT ANASTROZOLE ZAPHYR PHARMACEUTICALS IS AND WHAT IT IS USED FOR ANASTROZOLE ZAPHYR PHARMACEUTICALS contains a substance called anastrozole. This belongs to a group of medicines called aromatase inhibitors. ANASTROZOLE ZAPHYR PHARMACEUTICALS is used to treat breast cancer in women who have gone through the menopause. ANASTROZOLE ZAPHYR PHARMACEUTICALS works by cutting down the amount of hormone called estrogen that your body makes. It does this by blocking a natural substance (an enzyme) in your body calles “aromatase”. 2. BEFORE YOU TAKE ANASTROZOLE ZAPHYR PHARMACEUTICALS DO NOT TAKE ANASTROZOLE ZAPHYR PHARMACEUTICALS - if you are allergic (hypersensitive) to anastrozole or any of the other ingredients of ANASTROZOLE ZAPHYR PHARMACEUTICALS (see section 6:Further information).. - if you are pregnant or breast feeding (see the sectin called ‘Pregnancy and breast-feeding’). Do not Take ANASTROZOLE ZAPHYR PHARMACEUTICALS if any of the above apply to you. If you are Read the complete document
Health Products Regulatory Authority 17 May 2021 CRN00C939 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anastrozole Zaphyr Pharmaceuticals 1 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg anastrozole Excipient with known effect: Each film-coated tablet contains 90.3 mg lactose (as lactose monohydrate) (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex, film-coated tablets. Debossed with ‘1’ on one side and plain on the reverse side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anastrozole 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 for adults including the elderly is one 1 mg tablet once a day. _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_ 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 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 is contraindicated in: • Pregnant or breast-feeding women • Patients with known hypersensitivity to anastrozole or to any of the excipients as referenced in section 6.1. Health Products Regulatory Authority 17 May 2021 CRN00C939 Page 2 of 10 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE General Anastrozole should not be used in premenopausal women. The menopause should be defined biochemically (lutein Read the complete document