Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
Norethisterone acetate; Oestradiol
Novartis Pharmaceuticals Australia Pty Ltd
Medicine Registered
ESTALIS ® CONTINUOUS _oestradiol / norethisterone acetate (NETA)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about the menopause (the "change of life"), hormone replacement therapy and Estalis Continuous. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP-TO-DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP-TO- DATE LEAFLET FROM WWW.NOVARTIS.COM.AU. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHEN YOU MUST NOT USE ESTALIS CONTINUOUS DO NOT USE ESTALIS CONTINUOUS OR OTHER OESTROGENS, WITH OR WITHOUT A PROGESTOGEN TO PREVENT HEART ATTACKS, STROKE OR DEMENTIA. A study called the Women's Health Initiative indicated increased risk of heart attack, stroke, breast cancer, and blood clots in the legs or lungs in women receiving treatment with a product containing conjugated oestrogens 0.625 mg and the progestogen medroxyprogesterone acetate (MPA). The researchers stopped the study after 5 years when it was determined the risks were greater than the benefits in this group. The Women's Health Initiative Memory Study indicated increased risk of dementia in women aged 65-79 years taking conjugated oestrogens and MPA. There are no comparable data currently available for other doses of conjugated oestrogens and MPA or other combinations of oestrogens and progestogens. Therefore, you should ass Прочетете целия документ
1 ESTALIS CONTINUOUS (OESTRADIOL/NORETHISTERONE ACETATE) TRANSDERMAL MATRIX PATCH WARNING Oestrogens and progestogens should not be used for the prevention of cardiovascular disease or dementia. The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with conjugated oestrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo (See CLINICAL TRIALS and PRECAUTIONS). The WHI study reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years of treatment with conjugated oestrogens (0.625 mg) relative to placebo (See CLINICAL TRIALS and PRECAUTIONS). The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 to 5.2 years of treatment with conjugated oestrogens, with or without medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women (See CLINICAL TRIALS and PRECAUTIONS). Other doses of conjugated oestrogens and medroxyprogesterone acetate, and other combinations and dosage forms of oestrogens and progestogens were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, oestrogens with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. NAME OF THE MEDICINE Oestradio Прочетете целия документ