Anastrozole Sandoz 1mg FC Tablet

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.

Adults: Take one ANASTROZOLE SANDOZ 1 mg tablet orally once a day.

Paediatric population: ANASTROZOLE SANDOZ 1 mg is not recommended for use in children 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.

Hepatic impairment: No dose change is recommended in patients with mild hepatic disease.

ANASTROZOLE SANDOZ 1 mg is contraindicated in:

• patients with hypersensitivity to anastrozole or to any of the excipients listed in section 6.1
• premenopausal women
• pregnant or lactating women
• patients with severe renal impairment (creatinine clearance less than 20 ml/min)
• patients with moderate or severe hepatic disease

General: ANASTROZOLE SANDOZ 1 mg should not be used in premenopausal women. The menopause should be defined biochemically (luteinising-hormone (LH), follicle stimulating hormone (FSH), and/or oestradiol levels) in any patient where there is doubt about menopausal status. There are no data to support the use of ANASTROZOLE SANDOZ 1 mg with LHRH analogues.

Co-administration of tamoxifen or oestrogen-containing therapies with ANASTROZOLE SANDOZ 1 mg should be avoided as this may diminish its pharmacological action (see section 4.5 and 5.1).

Vaginal bleeding: If bleeding persists, further evaluation should be considered.

Effect on bone mineral density: As anastrozole lowers circulating oestrogen levels it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture (see section 4.8). 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. The use of specific treatments, e.g., bisphosphonates, may stop further bone mineral loss caused by ANASTROZOLE SANDOZ 1 mg in postmenopausal women and could be considered (see section 4.8).

Hepatic impairment: ANASTROZOLE SANDOZ 1 mg has not been investigated in breast cancer patients with moderate or severe hepatic impairment. Exposure to anastrozole can be increased in subjects with hepatic impairment (see section 5.2); administration of ANASTROZOLE SANDOZ 1 mg in patients with moderate and severe hepatic impairment is contraindicated.

Renal impairment: ANASTROZOLE SANDOZ 1 mg has not been investigated in breast cancer patients with severe renal impairment (creatinine clearance less than 20 ml/min). In patients with severe renal impairment, administration of ANASTROZOLE SANDOZ 1 mg is contraindicated.

Paediatric population: ANASTROZOLE SANDOZ 1 mg is not recommended for use in children and adolescents as safety and efficacy have not been established in these groups of patients (see section 5.1). ANASTROZOLE SANDOZ 1 mg should not be used in boys with growth hormone deficiency in addition to growth hormone treatment. In the pivotal clinical trial, efficacy was not demonstrated and safety was not established (see section 5.1). Since anastrozole reduces estradiol levels, ANASTROZOLE SANDOZ 1 mg 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.

Lactose intolerance: ANASTROZOLE SANDOZ 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 ANASTROZOLE SANDOZ 1 mg. ANASTROZOLE SANDOZ 1 mg contains lactose, which may have an effect on the glycaemic control of patients with diabetes mellitus.

Anastrozole inhibits CYPs 1A2, 2C8/9 and 3A4 in vitro. Clinical studies with antipyrine and warfarin showed that anastrozole at a 1 mg dose did not significantly inhibit the metabolism of antipyrine and R u2013 and S - warfarin, indicating that the co-administration of ANASTROZOLE SANDOZ 1 mg with other medicines is unlikely to result in clinically significant medicine interactions mediated by CYP enzymes. The enzymes mediating metabolism of anastrozole have not been identified. Cimetidine, a weak, unspecific inhibitor of CYP enzymes, did not affect the plasma concentrations of anastrozole. The effect of potent CYP inhibitors is unknown. A review of the clinical trial safety database did not reveal evidence of clinically significant interaction in patients treated with anastrozole who also received other commonly prescribed medicines. There were no clinically significant interactions with bisphosphonates (see section 5.1). There is no clinical information to date on the use of ANASTROZOLE SANDOZ 1 mg in combination with other anti-cancer agents. Co-administration of tamoxifen or oestrogen-containing therapies with ANASTROZOLE SANDOZ 1 mg should be avoided, as this may diminish its pharmacological action (see section 4.4 and 5.1).

Pregnancy: There are no data from the use of anastrozole in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). ANASTROZOLE SANDOZ 1 mg is contraindicated during pregnancy.

Breastfeeding: There are no data on the use of anastrozole during lactation. ANASTROZOLE SANDOZ 1 mg is contraindicated during breastfeeding (see section 4.3).

Fertility: The effects of anastrozole on fertility in humans have not been studied. Studies in animals have shown reproductive toxicity (see section 5.3).

ANASTROZOLE SANDOZ 1 mg has no or negligible influence on the ability to drive and use machines. However, asthenia and somnolence have been reported with the use of ANASTROZOLE SANDOZ 1 mg and caution should be observed when driving or operating machinery while such symptoms persist.

Side effects have been arranged according to their system organ class and the frequency of their occurrence according to the following convention: Frequent and less frequent. Some of the side effects may be attributed to the pharmacological action of ANASTROZOLE SANDOZ 1 mg. The most frequently reported adverse reactions were headache, hot flushes, nausea, rash, arthralgia, joint stiffness, arthritis, and asthenia.

Metabolism and nutrition disorders: Frequent: Anorexia, hypercholesterolemia. Less Frequent: Hypercalcaemia (with or without an increase in parathyroid hormone).

Nervous system disorders: Frequent: Headache, somnolence, carpal tunnel syndrome, depression.

Vascular disorders: Frequent: Hot flushes.

Gastrointestinal disorders: Frequent: Nausea, diarrhoea, vomiting.

Hepatobiliary disorders: Frequent: Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. Less Frequent: Increases in gamma-GT and bilirubin, hepatitis.

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

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

Reproductive system and breasts disorders: Frequent: Vaginal dryness, vaginal bleeding*. * 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.

General disorders and administration site conditions: Frequent: Asthenia.

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 Suspected side effects can also be reported directly to the HCR via [email protected].

Clinical experience is limited regarding over dosage of ANASTROZOLE SANDOZ 1 mg. In animal studies, anastrozole demonstrated low acute toxicity. Clinical trials have been conducted with various dosages of anastrozole, up to 60 mg in a single dose given to healthy male volunteers, and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were well tolerated. A single dose of ANASTROZOLE SANDOZ 1 mg that results in life threatening symptoms has not been established. Refer to section 4.8 for possible symptoms of overdosage.

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