ESTRADOT Transdermal patch Ref.[7705] Active ingredients: Estradiol

Dosage

The transdermal patch is applied twice weekly, i.e. every three to four days.

Oestrogen deficiency symptoms

Estradot is available in five strengths: 25, 37.5, 50, 75 and 100. 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. Depending on the clinical response the dose can then be adjusted to the patient’s individual needs. If, after three months, there is insufficient response in the form of alleviated symptoms, the dose can be increased. If symptoms of overdose arise (e.g. tender breasts) the dose must be decreased.

General instructions

Estradot is administered as continuous therapy (uninterrupted application twice weekly).

In women with an intact uterus, Estradot should be combined with a progestagen approved for addition to oestrogen treatment in a continuous sequential dosing scheme: the oestrogen is dosed continuously. The progestagen is added for at least 12 to 14 days of every 28-day cycle, in a sequential manner.

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

In women who are not taking HRT or women transferring from a continuous combined HRT product, treatment may be started on any convenient day. In women transferring from a sequential HRT regimen, treatment should begin the day following completion of the prior regimen.

Method of administration

The adhesive side of Estradot should be placed on a clean, dry area of the abdomen. Estradot should not be applied to the breasts.

Estradot should be replaced twice weekly. The site of application must be rotated, with an interval of at least 1 week allowed between applications to a particular site. The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may dislodge the patch. The patch should be applied immediately after opening the sachet and removing the protective liner. The patch should be pressed firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact, especially around the edges.

In the event that a patch should fall off, the same patch may be reapplied. If necessary, a new patch may be applied. In either case, the original treatment schedule should be continued. The patch may be worn during bathing.

If a woman has forgotten to apply a patch, she should apply a new patch as soon as possible. The subsequent patch should be applied according to the original treatment schedule. The interruption of treatment might increase the likelihood of irregular bleeding and spotting.

Acute overdose is unlikely due to the method of administration. The most common symptoms of overdose in clinical use are breast tenderness and/or vaginal bleeding. If such symptoms occur, a reduction in dosage should be considered. The effects of overdose can be rapidly reversed by removal of the patch.

2 years.

Do not refrigerate or freeze.

Store in the original pouch and carton.

Each Estradot patch is individually sealed in an aluminium laminate sachet.

Sachets may be provided in cartons of 2, 8, 24 and 26.

Not all pack sizes may be marketed.

Used transdermal patches should be folded in half with the adhesive side inwards, and discarded safely and out of the reach and sight of children. Any used or unused transdermal patches should be disposed of in accordance with local requirements or returned to the pharmacy, preferably in the original packaging.