Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE
Post menopausal symptoms due to estrogen deficiency.
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.
Palliative treatment of prostatic cancer.
Hormone replacement therapy for failure of ovarian development e.g. in patients with gonadal dysgenesis where initial estrogen therapy is later followed by combined estrogen/progestogen therapy.
Disorders of menstruation, given in conjunction with a progestogen.
(See also Section 4.4).
Ethinylestradiol Tablets is an estrogen-only preparation of hormone replacement therapy (HRT) for oral administration.
Post menopausal symptoms due to estrogen deficiency including prevention of postmenopausal osteoporosis: 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 usual dose range is 10 to 50 micrograms daily, usually on a cyclical basis (e.g. 3 weeks on and 1 week off).
For women without a uterus, who did not have endometriosis diagnosed, it is not recommended to add a progestogen.
In women with an intact uterus (or in endometriosis when endometrial foci may be present despite hysterectomy), where a progestogen is necessary, it should be added for at least 12-14 days every month/28 day cycle to reduce the risk to the endometrium.
The benefits of the lower risk of endometrial hyperplasia and endometrial cancer due to adding progestogen should be weighed against the increased risk of breast cancer (see Sections 4.4 and 4.8).
Therapy with Ethinylestradiol Tablets may start at any time in women with established amenorrhoea or who are experiencing long intervals between spontaneous menses. In women who are menstruating, it is advised that therapy starts on the first day of bleeding. As Ethinylestradiol Tablets are usually taken on a cyclical basis direct switching from other estrogen-only HRT preparations taken cyclically is possible.
Palliative treatment of prostatic cancer: 150 micrograms to 1.5 mg daily. Larger dose Ethinylestradiol Tablets are available.
Hormone replacement therapy for failure of ovarian development e.g. in patients with gonadal dysgenesis: 10 to 50 micrograms daily, usually on a cyclical basis. Initial estrogen therapy should be followed by combined estrogen/progestogen therapy.
Disorders of menstruation: 20 to 50 micrograms daily from day 5 to day 25 of each cycle. A progestogen is given daily in addition, either throughout the cycle or from days 15 to 25 of the cycle.
If a dose is forgotten it should be taken as soon as it is remembered. If it is nearly time for the next dose then the patient should wait until then. Two doses should not be taken together. Forgetting a dose may increase the likelihood of break-through bleeding and spotting.
Acute overdose of ethinylestradiol may cause nausea and vomiting and may result in withdrawal bleeding in females.
Shelf life: 36 months.
Store below 25°C.
Pigmented polypropylene container fitted with a tamper evident closure containing 21 or 100 tablets. All pack sizes may not be marketed.
Not applicable.
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