País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
ANASTROZOLE
Ranbaxy Ireland Limited
ANASTROZOLE
1 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-10-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anastrozole 1 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg anastrozole. Excipient(s): Each tablet contains 65 mg of Lactose monohydrate (see section 4.4) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, round film-coated tablet with a diameter of 6.6 mm approximately 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anastrozole Tablets are 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_ 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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/07/2012_ _CRN 2103768_ _page number: 1_ 4.3 CONTRAINDICATIONS Anastrozole 1mg Tablets are 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 4.4 SPEC Llegiu el document complet