Mylan Anastrozole 1 mg Film-coated tablets

Treatment of early breast cancer in postmenopausal women. Treatment of advanced breast cancer in postmenopausal women. Efficacy has not been demonstrated in oestrogen receptor-negative patients unless they have had a previous positive clinical response to tamoxifen.

Posology
Adults including the elderly: One 1 mg tablet to be taken orally once a day.
Children: Not recommended for use in children.
Renal impairment: No dose change is recommended in patients with mild or moderate renal impairment.
Hepatic impairment: No dose change is recommended in patients with mild hepatic disease.
Method of administration
MYLAN ANASTROZOLE 1 mg should be taken orally.

MYLAN ANASTROZOLE 1 mg is contra-indicated in:
u2212 patients with hypersensitivity to the active substance or to any of the excipients of MYLAN ANASTROZOLE 1 mg (see section 6.1),
u2212 pre-menopausal women,
u2212 pregnant or lactating women (see section 4.6)
u2212 patients with severe renal impairment (creatinine clearance less than 20 ml/min),
u2212 patients with moderate or severe hepatic disease.

As MYLAN ANASTROZOLE 1 mg lowers circulating oestrogen levels it may cause a reduction in bone mineral density with a consequent increased risk of fracture. This increased risk should be managed according to treatment guidelines for managing bone health in postmenopausal women.
MYLAN ANASTROZOLE 1 mg is not recommended for use in children or in pre-menopausal women as safety and efficacy have not been established in this group of patients.
The menopause should be defined biochemically in any patient where there is doubt about hormonal status.
There are no data to support the safe use of MYLAN ANASTROZOLE 1 mg in patients with moderate or severe hepatic impairment, or patients with severe impairment of renal function (creatinine clearance less than 20 ml/min).
Lactose: MYLAN ANASTROZOLE 1 mg contains lactose. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption or fructose intolerance should not take MYLAN ANASTROZOLE 1 mg.

Antipyrine and cimetidine clinical interaction studies indicate that the co-administration of MYLAN ANASTROZOLE 1 mg with other medicines is unlikely to result in clinically significant interactions mediated by cytochrome P450. A review of the clinical trial safety database did not reveal evidence of clinically significant interaction in patients treated with MYLAN ANASTROZOLE 1 mg who also received other commonly prescribed medicines. There were no clinically significant interactions with bisphosphonates.
There is no clinical information to date on the use of MYLAN ANASTROZOLE 1 mg in combination with other anti-cancer medicines. Tamoxifen and/or oestrogen-containing therapies should not be co-administered with MYLAN ANASTROZOLE 1 mg as they would diminish its pharmacological action.

Pregnancy
There are no data from the use of MYLAN ANASTROZOLE 1 mg in pregnant women. MYLAN ANASTROZOLE 1 mg is contraindicated in pregnant women (see section 4.3).
Breastfeeding
There are no data on the use of MYLAN ANASTROZOLE 1 mg during lactation. MYLAN ANASTROZOLE 1 mg is contraindicated during breastfeeding (see section 4.3).
Fertility
The effects of MYLAN ANASTROZOLE 1 mg on fertility in humans have not been studied.

Asthenia and somnolence have been reported with the use of MYLAN ANASTROZOLE 1 mg 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 list of adverse reactions
System organ class Frequency Adverse reactions
Blood and the lymphatic system disorders Less Frequent Anaemia; leucopenia with or without infection; thromboembolism and thrombophlebitis
Metabolism and nutrition disorders Frequent Anorexia; hypercholesterolaemia; increased appetite
Less Frequent Hypercalcaemia (with or without an increase in parathyroid hormone), weight gain
Psychiatric disorders Frequent Depression
Nervous system disorders Frequent Headache; dizziness; drowsiness; carpal tunnel syndrome; somnolence; sensory disturbances (including paraesthesia, taste loss and taste perversion)
Less Frequent Insomnia; nervousness; anxiety; confusion
Vascular disorders Frequent Hot flushes; flushing; peripheral oedema
Less Frequent Hypertension
Respiratory, thoracic and mediastinal disorders Frequent Chest pain; dyspnoea; cough; pharyngitis
Less Frequent Bronchitis; sinusitis; rhinitis
Gastrointestinal disorders Frequent Nausea; vomiting; diarrhoea; constipation; abdominal pain; dry mouth
Hepato - biliary disorders Frequent Increase in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase
Less Frequent Increase in gamma-GT and bilirubin; hepatitis
Skin and subcutaneous tissue disorders Frequent Hair thinning (alopecia); rash; sweating; allergic reactions including pruritus
Less Frequent Erythema multiforme; Stevens-Johnson syndrome; angioedema; urticaria and anaphylaxis; cutaneous vasculitis (including some reports of Henoch-Schu00f6nlein purpura)
Musculoskeletal, connective tissue and bone disorders Frequent Arthralgia; joint pain/stiffness; myalgia; back and bone pain; arthritis; osteoporosis
Less Frequent Trigger finger; breast pain; bone fractures
Reproductive system and breast disorders Frequent Vaginal dryness; vaginal bleeding *
General disorders and administration site conditions Frequent Asthenia; pain; pelvic pain
Less Frequent Flu syndrome
* Vaginal bleeding has been reported in patients with advanced breast cancer, previously receiving other hormonal therapy. This reflects changes in oestrogen status. If bleeding persists, further evaluation should be considered
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. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

There is no specific antidote to overdosage and treatment must be symptomatic. In the management of an overdose, consideration should be given to the possibility that multiple medicines may have been taken. Vomiting may be induced if the patient is alert. Dialysis may be helpful because MYLAN ANASTROZOLE 1 mg is not highly protein bound. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.