Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ESTRADIOL HEMIHYDRATE NORETHISTERONE ACETATE ESTRADIOL HEMIHYDRATE
Novartis Pharmaceuticals UK Ltd
50/50/250 Microgram/day
Transdermal Patch
1993-03-25
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 Read the complete document