ANASTROZOLE

Posology The recommended dose of anastrozole for adults including the elderly is one 1 mg tablet once a day. 1). Renal impairment No dose change is recommended in patients with mild or moderate renal impairment. 2). Hepatic impairment No dose change is recommended in patients with mild hepatic disease.

4). Method of administration Anastrozole should be taken orally.

The following table presents adverse reactions from clinical trials, post- marketing studies or spontaneous reports. Unless specified, the frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in 9,366 postmenopausal women with operable breast cancer given adjuvant treatment for five years (the Anastrozole, Tamoxifen, Alone or in Combination [ATAC] study).

Adverse reactions listed below are classified according to frequency and System Organ Class (SOC). Frequency groupings are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000), and very rare (<1/10,000).

The most frequently reported adverse reactions were headache, hot flushes, nausea, rash, arthralgia, joint stiffness, arthritis, and asthenia. Table 1 Adverse reactions by System Organ Class and frequency Adverse reactions by SOC and frequency Common Anorexia Hypercholesterolaemia Metabolism and nutrition disorders Uncommon Hypercalcaemia (with or without an increase in parathyroid hormone) Psychiatric disorders Very common Depression Very common Headache Common Somnolence Carpal Tunnel Syndrome* Sensory disturbances (including paraesthesia, taste loss and taste perversion) Nervous system disorders Not known Memory impairment Eye disorders Not known Dry eye Vascular disorders Very common Hot flushes Very common Nausea Gastrointestinal disorders Common Diarrhoea Vomiting Common Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferaseHepatobiliary disorders Uncommon Increases in gamma-GT and bilirubin Hepatitis Very common Rash Common Hair thinning (alopecia) Allergic reactions Uncommon Urticaria Rare Erythema multiforme Anaphylactoid reaction Cutaneous vasculitis (including some reports of Henoch- Schönlein purpura)** Very rare Stevens-Johnson syndrome Angioedema Skin and subcutaneous tissue disorders Not known Lichenoid eruption Very common Arthralgia/joint stiffness Arthritis Osteoporosis Common Bone pain Myalgia Uncommon Trigger finger Musculoskeletal and connective tissue disorders Not known Tendonitis Tendon rupture Reproductive system and breast disorders Common Vaginal dryness Vaginal bleeding *** General disorders and administration site conditions Very common Asthenia * Events of Carpal Tunnel Syndrome have been reported in patients receiving anastrozole treatment in clinical trials in greater numbers than those receiving treatment with tamoxifen.

However, the majority of these events occurred in patients with identifiable risk factors for the development of the condition. 1%) based on the worst value of the point estimate. *** Vaginal bleeding has been reported commonly, mainly in patients with advanced breast cancer during the first few weeks after changing from existing hormonal therapy to treatment with anastrozole.

If bleeding persists, further evaluation should be considered. The table below presents the frequency of pre-specified adverse events in the ATAC study after a median follow-up of 68 months, irrespective of causality, reported in patients receiving trial therapy and up to 14 days after cessation of trial therapy.

6%) Fracture rates of 22 per 1,000 patient-years and 15 per 1,000 patient-years were observed for the anastrozole and tamoxifen groups, respectively, after a median follow-up of 68 months. The observed fracture rate for anastrozole is similar to the range reported in age-matched postmenopausal populations.

3% in patients treated with tamoxifen. It has not been determined whether the rates of fracture and osteoporosis seen in ATAC in patients on anastrozole treatment reflect a protective effect of tamoxifen, a specific effect of anastrozole, or both.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

General 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 doubt about menopausal status.

There are no data to support the use of anastrozole with LHRH analogues. 1). 8). Women with osteoporosis or at risk of osteoporosis, should have their bone mineral density formally assessed at the commencement of treatment and at regular intervals thereafter.

Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored. g. 8). Hepatic impairment Anastrozole has not been investigated in breast cancer patients with moderate or severe hepatic impairment.

2). Treatment should be based on a benefit-risk evaluation for the individual patient. Renal impairment Anastrozole has not been investigated in breast cancer patients with severe renal impairment. 2). 1). Anastrozole should not be used in boys with growth hormone deficiency in addition to growth hormone treatment.

1). Since anastrozole reduces estradiol levels, Anastrozole must not be used in girls with growth hormone deficiency in addition to growth hormone treatment. Long- term safety data in children and adolescents are not available. Hypersensitivity to lactose This product contains lactose.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Sodium content This medicine contains less than 1 mmol sodium (23 mg) per each film-coated tablet, that is to say essentially ‘sodium-free’.

Anastrozole is contraindicated in: • Pregnant or breastfeeding women. 1.