Anzonat Special Precautions

General: Anastrozole tablets 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 tablets with LHRH analogues.
Co-administration of tamoxifen or estrogen-containing therapies with anastrozole tablets should be avoided as this may diminish its pharmacological action. Effect on bone mineral density: As anastrozole tablets lowers circulating estrogen levels it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture.
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 tablets in postmenopausal women and could be considered.
Hepatic impairment: Anastrozole tablets 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 administration of anastrozole tablets in patients with moderate and severe hepatic impairment should be performed with caution. Treatment should be based on a benefit-risk evaluation for the individual patient.
Renal impairment: Anastrozole tablets has not been investigated in breast cancer patients with severe renal impairment. Exposure to anastrozole is not increased in subjects with severe renal impairment (GRF<30ml/min) in patients with severe renal impairment, administration of anastrozole tablets should be performed with caution.
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 tablet, that is to say essentially 'sodium-free'.
Use in Children: Anastrozole tablets are not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients.
Anastrozole tablets 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. Since anastrozole reduces estradiol levels, Anastrozole tablets 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.