FEMSEVEN Transdermal patch Ref.[28030] Active ingredients: Estradiol

FemSeven is an oestrogen-only patch that should be applied to the skin once weekly on a continuous basis, i.e. each patch is replaced with a new one after 7 days.

In women with an intact uterus, the addition of a progestagen for at least 12 to 14 days every month/28 day cycle is essential to help prevent any endometrial hyperplasia induced by the oestrogen. For more detailed information, please refer to section 4.4 (Special warnings and precautions for use - “Endometrial hyperplasia”).

Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women.

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. Therefore, therapy should normally be started with one FemSeven patch (delivering 50 micrograms of estradiol in 24 hours). If the prescribed dose does not eliminate the menopausal symptoms, the dose should be adjusted stepwise after the first few months by using a transdermal patch delivering 75 or 100 micrograms estradiol per day. A maximum of 100 micrograms estradiol per day should not be exceeded. If there are persistent signs of overdose, such as breast tenderness, the dose should be reduced accordingly.

Hysterectomised women not taking HRT or transferring from another HRT product may start treatment with FemSeven on any convenient day. The same holds true for non-hysterectomised women not taking HRT or transferring from a continuous combined HRT product. In non-hysterectomised women switching from sequential HRT regimens, treatment with FemSeven should start after the previous treatment regimen has ended.

Consecutive new patches should be applied to different sites. It is recommended that sites are chosen below the waist where little wrinkling of the skin occurs e.g., buttocks, hip or abdomen. FemSeven must not be applied on or near the breasts. The patch should be applied to clean, dry, healthy and intact skin. The patch should be applied to the skin as soon as it is removed from its wrapping. The patch is applied by removing both parts of the protective liner and then holding it in contact with the skin for at least 30 seconds (warmth is essential to ensure maximal adhesive strength).

Should part or all of a patch detach prematurely (before 7 days) it should be removed and a new patch applied. To aid compliance it is recommended the patient then continues to change the patch on the usual day. This advice also applies if a patient forgets to change the patch on schedule. Forgetting a patch may increase the likelihood of break-through bleeding or spotting.

The mode of administration makes significant overdose unlikely; removal of the patches is all that is required should it occur.

3 years.

Do not store above 30°C.

The container (primary packaging) consists of a sealed laminated sachet. This comprises layers of food grade paper/polyethylene/aluminium/ethylene copolymer.

Package sizes: Carton of 4 and 12 patches.

After removal from the laminated sachet, peel off the two part protective liner. Try to avoid touching the adhesive. Stick the adhesive side down to the upper left or right buttock on a clean and dry area of skin. Hold the applied patch to the skin with the palm of the hand for at least 30 seconds, in order to ensure optimal adhesion to the skin.

Recommended application sites are clean, dry and intact areas of skin on the trunk below the waistline. FemSeven should not be applied on or near the breasts. After removal the used patch should be folded and disposed of with the normal household solid waste.