Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Aromasin should not be administered to women with pre-menopausal endocrine status.
Therefore, whenever clinically appropriate, the post-menopausal status should be ascertained by assessment of LH, FSH and oestradiol levels.
Aromasin should be used with caution in patients with hepatic or renal impairment.
Aromasin tablets contain sucrose and should not be administered to patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase- isomaltase insufficiency.
Aromasin tablets contain methyl -parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Aromasin is a potent oestrogen lowering agent, and a reduction in bone mineral density (BMD) and an increased fracture rate have been observed following administration (see section 5.1). At the commencement of adjuvant treatment with Aromasin, women with osteoporosis or at risk of osteoporosis should have treatment baseline bone mineral health assessment based on current clinical guidelines and practice. Patients with advanced disease should have their bone mineral density assessed on a case-by-case basis. Although adequate data to show the effects of therapy in the treatment of the bone mineral density loss caused by Aromasin are not available, patients treated with Aromasin should be carefully monitored and treatment for, or prophylaxis of, osteoporosis should be initiated in at risk patients.
Routine assessment of 25 hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be considered, due to the high prevalence of severe deficiency in women with early breast cancer. Women with Vitamin D deficiency should receive supplementation with Vitamin D.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Effects on Driving

4.7 Effects on ability to drive and use machines
Exemestane has moderate influence on the ability to drive and use machines.
Drowsiness, somnolence, asthenia and dizziness have been reported with the use of exemestane. Patients should be advised that, if these events occur, their physical and/or mental abilities required for operating machinery or driving a car may be impaired.