ESTRACOMBI TTS 50/50/250 Microgram/day Transdermal Patch
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
ESTRADIOL HEMIHYDRATE NORETHISTERONE ACETATE ESTRADIOL HEMIHYDRATE
Available from:
Novartis Pharmaceuticals UK Ltd
INN (International Name):
ESTRADIOL HEMIHYDRATE NORETHISTERONE ACETATE ESTRADIOL HEMIHYDRATE
Dosage:
50/50/250 Microgram/day
Pharmaceutical form:
Transdermal Patch
Authorization status:
Withdrawn
Authorization date:
2009-08-31
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Estracombi TTS Transdermal Patches.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Estracombi TTS is comprised of an Estraderm TTS 50 patch and an Estragest TTS patch.
i.
Estraderm TTS system contains 4 mg estradiol (as hemihydrate) with an absorption rate of approximately 50
micrograms of estradiol per day from a drug releasing area of 10cm
2
.
ii.
Estragest TTS system contains 10 mg estradiol (as hemihydrate) and 30 mg norethisterone acetate. The
absorption rates from the system are approximately 50 micrograms of estradiol per day and 250 micrograms of
norethisterone acetate per day from a drug releasing area of 20cm
2
.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal Patch.
Estraderm TTS 50: a self-adhesive, circular, transparent, transdermal therapeutic system (patch) marked ‘CG DWD’.
Estragest TTS: a self-adhesive, goggle-shaped, transparent, transdermal therapeutic system (patch) marked ‘CG FNF’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As hormone replacement therapy in patients with an intact uterus and with disorders due to natural or surgically
induced menopause.
Prevention of osteoporosis in post menopausal women at high risk of future fractures who are intolerant of, or
contraindicated for, other medicinal products approved for the prevention of osteoporosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
ADULTS AND ELDERLY: For initiation and continuation of treatment of post-menopausal symptoms, the lowest effective
dose for the shortest duration (see also section 4.4, Special warnings and precautions for use) should be used.
Estracombi TTS provides continuous oestrogen and sequential progestogen therapy to women with an intact uterus.
One tre
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