• For the treatment of postmenopausal symptoms, hormone replacement therapy (HRT) should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually, and HRT should only be continued as long as the benefit outweighs the risk.
• Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women.
Medical examination/follow-up • Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use.
During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see section “Breast cancer” below).
g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual. 5 mg/g vaginal cream. Conditions which need supervision • If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
g. g. liver adenoma) – Diabetes mellitus with or without vascular involvement – Cholelithiasis – Migraine or (severe) headache – Systemic lupus erythematosus – A history of endometrial hyperplasia (see below) – Epilepsy – Asthma – Otosclerosis Reasons for immediate withdrawal of therapy Therapy should be discontinued in case a contraindication is discovered and in the following situations: – Jaundice or deterioration in liver function – Significant increase in blood pressure – New onset of migraine-type headache – Pregnancy Endometrial hyperplasia and carcinoma • In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when systemic oestrogens are administered alone for prolonged periods.
• For oestrogen products for vaginal application of which the systemic exposure to oestrogen remains within the normal postmenopausal range, it is not recommended to add a progestogen. • Endometrial safety of long-term (more than one year) or repeated use of local vaginally administered oestrogen is uncertain.