• Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women.
• Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. Posology and method of administration
Oestrogel is an oestrogen-only product indicated only for women without a uterus. Oestrogel should be administered daily on a continuous basis.
In women with an intact uterus it is recommended to add a progestogen (e.g. a progesterone) for at least 12 days of each month, in accordance with the manufacturers' recommendations.
Menopausal and postmenopausal symptoms:
Each metered dose (1 pump actuation) from the dispenser is 1.25 g of Oestrogel. Two pumps (2.5 g) of Oestrogel once daily (1.5 mg 17ß-oestradiol) is the usual starting dose, which in the majority of women will provide effective relief of symptoms. If after one month's treatment effective relief is not obtained, the dosage may be increased accordingly to a maximum of four pumps (5 g) of Oestrogel daily (3.0 mg 17ß-oestradiol). The lowest effective dose should be used for maintenance therapy.
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.
The minimum effective dose is 2.5 g of Oestrogel once daily for most patients.
Use with progestogen:
In women with an intact uterus the recommended dose of a progestogen should be administered for at least 12 days of each month, in accordance with the manufacturers recommendations. Oestrogel should be administered daily on a continuous sequential basis.
Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.
Initiation of treatment:
Women who have never taken HRT and are post-menopausal or have very infrequent menstrual cycles: treatment with Oestrogel can be started on any day."