Accord Anastrozole 1 mg Tablets

u2022 Treatment of early breast cancer in postmenopausal women.

u2022 Treatment of advanced breast cancer in postmenopausal women.

u2022 Efficacy has not been demonstrated in oestrogen receptor negative patients unless they have had a previous positive clinical response to tamoxifen

Adults including the elderly

The dose of Accord Anastrozole is one 1 mg tablet taken once a day. S4

Special populations

Renal impairment: no dose adjustment required in patients with mild or moderate renal impairment.

Hepatic impairment: no dose adjustment with mild hepatic impairment.

Paediatric population

Not recommended for use in children.

Method of administration

For oral use.

u2022 Accord Anastrozole is contra-indicated in any patient who has shown a hypersensitivity reaction to anastrozole or to any of the excipients (see section 6.1).

u2022 Pre-menopausal women

u2022 Patients with severe renal impairment (creatinine clearance less than 20 ml/min)

u2022 Pregnant and lactating women

u2022 Patients with moderate or severe hepatic disease

As Accord Anastrozole lowers circulating oestrogen levels it may cause a reduction in bone mineral density with a consequent increased risk of fracture. The increased risk should be managed according to treatment guidelines for managing bone health in postmenopausal women.

Women with osteoporosis or osteopenia, or at risk of osteoporosis or osteopenia, should have their bone mineral density formally assessed at the commencement of treatment and at regular intervals thereafter. Treatment or prophylaxis for osteoporosis or osteopenia should be initiated as appropriate and carefully monitored, as per local guidelines. The use of specific treatments, e.g. bisphosphonates, may stop further bone mineral loss caused by Accord Anastrozole in postmenopausal women and could be considered (see section 4.8).

Accord Anastrozole is contra-indicated in pre-menopausal. 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 hormonal status. There are no data to support the use of anastrozole with LHRH analogues.

Co-administration of tamoxifen or estrogen-containing therapies with Accord Anastrozole should be avoided as this may diminish its pharmacological action (see section 4.5 and 5.1).

Hepatic impairment

There is no data to support the safe use of Accord Anastrozole in patients with moderate or severe hepatic impairment. Exposure to anastrozole can be increased in subjects with hepatic impairment (see section 5.2); administration of Accord Anastrozole in patients with moderate and severe hepatic impairment should be performed with caution (see section 4.2).

Renal impairment

There is no data to support the safe use of Accord Anastrozole in patients with severe impairment of renal function (creatinine clearance less than 20 ml/min) (see section 4.3).

Paediatric population

Accord Anastrozole is not recommended for use in children as safety and efficacy has not been established in these groups of patients.

Lactose monohydrate

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

u2022 Anastrozole inhibits CYPs 1A2, 2C8/9 and 3A4 in vitro. Antipyrine, warfarin and cimetidine clinical interaction studies indicate that co-administration of Accord Anastrozole with other medicines is unlikely to result in clinical significant interactions mediated by cytochrome P450.

u2022 There is no clinical information to date on the use of anastrozole in combination with other anti-cancer medicines.

u2022 Tamoxifen and/or oestrogen containing therapies should not be co-administered with Accord Anastrozole as it would diminish its pharmacological action.

Accord Anastrozole is contra-indicated in pregnant and lactating women (see section 4.3).

Asthenia, somnolence and dizziness have been reported with the use of Accord Anastrozole and caution should be observed when driving or operating machinery while such symptoms persist.

Summary of the safety profile

The most frequently reported adverse reactions were headache, hot flushes, nausea, rash, arthralgia, joint stiffness, arthritis, and asthenia.

Tabulated summary of adverse reactions

System organ class Frequency Adverse reaction

Blood and lymphatic system disorders Less frequent Frequency unknown Leucopenia

Immune system disorders Less frequent Allergic reactions including angioedema, urticaria and anaphylaxis

Metabolism and nutrition disorders Frequent Anorexia, Hypercholesterolaemia Less frequent Hypercalcaemia (with or without an increase in parathyroid hormone)

Psychiatric disorders Frequent Depression

Nervous system disorders Frequent Headache, Carpal Tunnel Syndrome, dizziness, drowsiness, sensory disturbances (including paraesthesia, taste loss and taste perversion) Less frequent Somnolence

Vascular disorders Frequent Hot flushes, oedema Frequency unknown Thrombophlebitis

Gastro-intestinal disorders Frequent Nausea, diarrhoea, vomiting

Hepato-biliary disorders Frequent Increased alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase Less frequent Increased gamma-GT and bilirubin, hepatitis

Skin and subcutaneous tissue disorders Frequent Hair thinning (alopecia), rash, allergic reactions Less frequent Erythema multiforme, Stevens-Johnson syndrome, anaphylactoid reaction, cutaneous vasculitis (including some reports of Henoch-Schu00f6nlein purpura), angioedema

Musculoskeletal, connective tissue and bone disorders Frequent Arthralgia, joint pain/stiffness, arthritis, osteoporosis, myalgia, bone pain Less frequent Trigger finger

Reproductive system and breast disorders Frequent Vaginal bleeding, vaginal dryness

General disorders and administration site conditions Frequent Asthenia, fever, flu-like syndrome

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the Med Safety App (Medsafety X SAHPRA) and eReporting platform (who- umc.org) found on the SAHPRA website.

Refer to side effects for symptoms of overdosage. There is no specific antidote to overdosage and treatment must be symptomatic. In the management of an overdose, consider that multiple medicines may have been taken. Vomiting may be induced if the patient is alert. Dialysis may be helpful because Accord Anastrozole is not highly protein bound. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.