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
Transdermal patch.
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 particulars
- 4.1 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