Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Theramex HQ UK LTD, Sloane Square House, 1 Holbein Place, London SW1W 8NS UK
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in peri- and post-menopausal women.
Evorel 50, 75 and 100 only:
Prevention of osteoporosis in post-menopausal women at high risk of future fractures who are intolerant of, or contra- indicated for, other medicinal products approved for the prevention of osteoporosis. (See Section 4.4).
The experience of treating women older than 65 years is limited.
Evorel is an oestrogen-only HRT patch applied to the skin twice weekly.
For initiation and continuation of treatment of menopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4) should be used.
For women with an intact uterus progestogen should normally be added to Evorel for the prevention of adverse endometrial effects, eg hyperplasia and cancer. The regimen may be either cyclic or continuous sequential.
Only progestogens approved for addition to oestrogen treatment may be prescribed (eg oral norethisterone, 1mg/day or medroxyprogesterone acetate, 2.5mg/day) and should be added for at least 12-14 days every month/28 day cycle.
Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.
Therapy should be started with one Evorel 50 patch (delivering 50 micrograms of estradiol/24 hours) and the dose adjusted after the first month if necessary depending on efficacy and signs of over-oestrogenisation (eg breast tenderness). For maintenance therapy the lowest effective dose should be used; a maximum dose of 100 micrograms of estradiol/24 hours should not be exceeded.
Prevention of post-menopausal osteoporosis:
Therapy should be started with Evorel 50. The dose may be adjusted depending on efficacy and signs of over-oestrogenisation (eg breast tenderness). Note, however, that the efficacy of Evorel 25 for the prevention of post- menopausal osteoporosis has not been demonstrated. For maintenance therapy, the lowest effective dose should be used. A dose of 100micrograms of estradiol/24 hours should not be exceeded.
Guidance on how to start therapy:
Post-menopausal women currently not on HRT may start Evorel at any time.
Peri-menopausal women who are still having regular menstrual cycles and are not currently on HRT should start Evorel within 5 days of the start of bleeding. Peri-menopausal women with irregular menstrual cycles, for whom pregnancy has been excluded, can start Evorel at any time.
The switch from another oestrogen-only therapy in post-menopausal women to Evorel may occur at any time.
Women on a continuous combined regimen wishing to switch from another oestrogen to Evorel may do so at any time.
Women on a cyclic or continuous sequential regimen wishing to switch from a sequential combined HRT preparation to Evorel may do so at the end of a cycle of the current therapy or after a 7 day hormone free interval.
Evorel should be applied to the skin as soon as it is removed from the wrapper. Recommended application sites are on clean, dry, healthy, intact skin and each application should be made to a slightly different area of skin on the trunk below waistline. Evorel should not be applied on or near the breasts.
Evorel should remain in place during bathing and showering. Should it fall off during bathing or showering the patient should wait until cutaneous vasodilation ceases before applying a replacement patch to avoid potential excessive absorption. Should a patch fall off at other times it should be replaced immediately.
Patients can be advised to use baby oil to help remove any gum/glue which may remain on their skin after patch removal.
If the patient forgets to change their patch, they should change it as soon as possible and apply the next one at the normal time. However, if it is almost time for the next patch, the patient should skip the missed one and go back to their regular schedule. Only one patch should be applied at a time.
There is an increased likelihood of break-through bleeding and spotting when a patch is not replaced at the normal time.
Evorel is not indicated in children.
Data are insufficient in regard to the use of Evorel in the elderly (>65 years old).
Transdermal use.
By virtue of the mode of administration of Evorel, overdosage is unlikely, but effects can if necessary be reversed by removal of the patch. The most commonly observed symptoms of overdose with oestrogen therapy are breast pain or tenderness, nausea, vomiting and breakthrough bleeding, abdominal cramps or bloating. There is no specific antidote and treatment should be symptomatic.
24 months for the product as packed for sale.
Do not store above 25°C.
Evorel should be kept away from children and pets.
Each Evorel patch size is presented in a sealed protective pouch. The pouches are packed in a cardboard carton.
None.
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