Posology : מינונים

4.2 Posology and method of administration

Adults
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, e.g. hyperplasia and cancer. The regimen may be either cyclic or continuous sequential.

Only progestogens approved for addition to oestrogen treatment may be prescribed (e.g. 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.

Treatment of oestrogen deficiency symptoms

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 (e.g. breast tenderness).
For maintenance therapy the lowest effective dose should be used; For woman with a uterus, doses of oestradiol above 50 µg/day have not been studied and are therefore not recommended. For women without a uterus, a maximum dose of 100 micrograms 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.
Switching from other HRT

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 days hormone free interval.

Method of Administration

The EVOREL transdermal delivery system (TDS) should be placed on a clean, dry, healthy, intact area of skin, on the trunk of the body below the waist. Creams, lotions or powders may interfere with the adhesive properties of the patch. Evorel should not be applied on or near the breasts. The area of application should be changed, with an interval of at least one week allowed between applications to a particular site. The skin area selected should not be damaged or irritated. The waistline should not be used because excessive rubbing of the TDS may occur.

The TDS should be used immediately after opening the sachet. Remove one part of the protecting foil. Apply the exposed part of adhesive to the application site from the edge to the middle; avoid wrinkling of the TDS. The second part of the protective foil should now be removed and the freshly exposed adhesive applied. Wrinkling should again be avoided and the palm of the hand used to press the TDS onto the skin and to bring the TDS to skin temperature at which the adhesive effect is optimized.

The patient should avoid contact between fingers and the adhesive part of the TDS during application.

Should a patch fall off, a new patch should be applied immediately. However, the usual day of changing patches should be maintained. It is not necessary to remove the patch during bathing or showering. It is recommended, however, that the patch be removed prior to a sauna bath, and that a new patch is applied immediately thereafter.

To remove a patch, peel away an edge of the patch and pull smoothly away from the skin.
(See Instructions for Use and Handling, Section 6.6.)

Any adhesive that remains on the skin after removal of the patch may be removed by washing with soap and water or rubbing it off with the fingers or use baby oil.

Missed dose

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.
Children

Evorel is not indicated in children.

Elderly
Data are insufficient in regard to the use of Evorel in the elderly (> 65 years old.) Route of administration

Transdermal use.