Anastro-cell Special Precautions

Anastrozole is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients.
Anastrozole 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 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.
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 Anastrozole in patients with moderate or severe hepatic impairment, or patients with severe impairment of renal function (creatinine clearance less than 20 mL/min).
Women with osteoporosis or at risk of osteoporosis, should have their bone mineral density formally assessed by bone densitometry e.g. DEXA (dual energy x-ray absorptiometry) scanning at the commencement of treatment and at regular intervals thereafter. Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored.
There are no data available for the use of Anastrozole with LHRH (luteinizing hormone-releasing hormone) analogues. This combination should not be used outside clinical trials.
As Anastrozole lowers circulating oestrogen levels, it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture. The use of bisphosphonates may stop further bone mineral loss caused by Anastrozole in postmenopausal women and could be considered.
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Effects on ability to drive and use machines: Anastrozole is unlikely to impair the ability of patients to drive and operate machinery. However, asthenia and somnolence have been reported with the use of Anastrozole and caution should be observed when driving or operating machinery while such symptoms persist.