1. Name of the medicinal product
Estradot® 50 micrograms/24 hours, transdermal patch. Also sold under brandname Estraderm
2. Qualitative and quantitative composition
5 cm2 patch containing 0.78 mg estradiol (as hemihydrate) with a release rate of 50 micrograms estradiol per 24 hours.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Rectangular patch with rounded corners, comprising a pressure-sensitive adhesive layer containing estradiol, with a translucent polymeric backing on one side and a protective liner on the other.
4. Clinical particulars4.1 Therapeutic indications
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women.
Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis (for Estradot 50, 75 and 100 only).
The experience treating women older than 65 years is limited.
4.2 Posology and method of administration
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.
Prevention of postmenopausal osteoporosis:
Estradot is available in three strengths: 50, 75 and 100. Treatment must be initiated with an Estradot 50 microgram/24 hours patch. Adjustments can be made by using Estradot 50, 75 and 100 microgram patches.
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.