Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Rottapharm Ltd, Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in women at least 6 months since last menses. The experience treating women older than 65 years is limited.
DERMESTRIL-Septem is an oestrogen-only patch applied to the skin once weekly in order to ensure a continuous supply of estradiol to the body; thus each used system is removed after seven days and replaced by a new one. Three strengths of DERMESTRIL-Septem are available, i.e. DERMESTRIL-Septem 25, 50, 75.
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. Treatment is usually initiated with DERMESTRIL-Septem 25. If after a treatment of 1-2 months with DERMESTRIL-Septem 25 applied once weekly the symptoms of oestrogen deficiency appear not to be neutralised, a higher dosage can be given. In case of undesirable effects or symptoms of overdose (e.g. breast tenderness and/or vaginal bleeding), the dose should be reduced.
In women with an intact uterus, a progestagen approved for addition to oestrogen treatment must be additionally administered for at least 12-14 days every month/28 day cycle to oppose the development of an oestrogen-stimulated hyperplasia of the endometrium (see Section 4.4 Special Warnings and Special Precautions for Use).
Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women. The treatment with DERMESTRIL-Septem may be initiated at any convenient time for women who are not currently on any oestrogen therapy. Women currently using cyclic or sequential oestrogen/progestagen therapy should complete the on-going treatment cycle before beginning treatment with DERMESTRIL-Septem; the appropriate time to begin treatment with DERMESTRIL-Septem would be the first day of a withdrawal bleeding.
Women who are already using continuous combined oestrogen/progestagen therapy may be switched to DERMESTRIL-Septem directly.
Apply DERMESTRIL-Septem to the skin of the hip, upper quadrant of the buttock, lumbar region or abdomen and press firmly over the whole surface and along the edges to ensure good adhesion. The absorption capacity of the skin is the rate-determining factor in the release of estradiol from DERMESTRIL-Septem. The application on another (higher) skin region than on the mentioned preferred regions is not recommended, as this might have an influence on the release of estradiol. The skin of the application site should be clean, dry, not-greasy and free of redness or irritation. Areas of the body which form folds or are subject to friction during movement should be avoided.
DERMESTRIL-Septem should not be applied on or near the breasts.
Patches should not be applied twice consecutively to the same skin site.
If the patch is correctly applied, it will adhere to the skin for the required one-week period without problems. In the event that a patch does come off, it should be replaced with a new patch for the rest of the one-week dosing period. The patch should then be changed again at the regular time to re-establish the patient’s routine schedule. Similarly, if the patch is not changed on the scheduled day, it should be replaced as soon as possible and changed again on the next scheduled day. Forgetting to apply a new patch at the scheduled timemay increase the likelihood of break-through bleeding and spotting.
If the patch is correctly applied, the patient may bathe or shower. However, the patch may become detached after a very hot bath or sauna. If this occurs, the patch should be replaced with a new one (as described above). Possibly the sauna should be planned for a day scheduled for the change of the patch.
Overdosage is unlikely with transdermal application. Nausea, vomiting, sleepiness, dizziness and withdrawal bleeding may occur in some women. There is no specific antidote and treatment should be symptomatic. The patch(es) should be removed. Aforementioned information is also applicable for overdosing in children.
Two years.
Do not store above 25°C.
DERMESTRIL-Septem should be stored in an intact sachet.
DERMESTRIL-Septem 25 is packed in a cardboard box containing 4 or 12 transdermal delivery systems sealed individually in protective sachets consisting of 4 layers: Surlyn, heat-sealable material (inner layer), aluminium foil, polyethylene and paper (outer layer).
Not all pack sizes may be marketed.
Tear open the sachet at the indentation (do not use scissors to avoid damaging the patch) and remove the patch. Hold the patch between the thumb and index finger at the corner of the pull-off-tag. Detach the protective liner with the other hand and discard it.
Do not touch the adhesive side of the patch. Apply the patch to the skin holding between the thumb and index finger the part still covered by the protective liner. Detach the remaining part of the protective liner and press firmly for about 10 seconds on the whole surface of the patch.
Pass a finger along the edges to assure good adhesion.
After use, the patch should be folded with the adhesive part inside and discarded. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
