Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
estradiol hemihydrate, Quantity: 2.32 mg (Equivalent: estradiol, Qty 2.25 mg)
Juno Pharmaceuticals Pty Ltd
Drug delivery system, transdermal
Excipient Ingredients: polyethylene terephthalate; isopropyl palmitate; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane
Transdermal
8, 24, 2 starter pack
(S4) Prescription Only Medicine
Menopausal symptoms: Short-term treatment of signs and symptoms of oestrogen deficiency due to menopause, whether natural or surgically induced. In women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (Refer to section 5.1 Pharmacodynamic properties - Clinical Trials and section 4.2 Dose and method of administration). Prevention of post-menopausal bone mineral density loss: Estraderm MX 50, 75 and 100 may be used for prevention of post-menopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. When prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of bone mineral density loss. Lifestyle modifications and the risk-benefit profile of Estraderm MX should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing (See section 4.4 Special warnings and precautions for use and section 4.2 Dose and method of administration). Combination HRT should not be used in hysterectomised women because it is not needed in these women and it may increase risk of breast cancer.
Visual Identification: A translucent, colourless system, about 6.1cm in diameter, square, with rounded corners, on an oversized transparent protective liner. The backing film is imprinted with code "CG HKH".; Container Type: Sachet; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2000-09-22
ESTRADERM MX 1 ESTRADERM MX _oestradiol _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about the menopause ("change of life"), hormone replacement therapy and Estraderm MX. 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 ESTRADERM MX DO NOT USE ESTRADERM MX 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 assume the risks will be similar for other medicines containing oestr Read the complete document
Australian Product Information Juno Pharmaceuticals Pty Ltd Estraderm PI Page | 1 AUSTRALIAN PRODUCT INFORMATION _ESTRADERM MX _ _(ESTRADIOL) TRANSDERMAL PATCH _ _ _ WARNING Estrogens with or without progestogens should not be used for the prevention of cardiovascular disease or dementia. The Women’s Health Initiative (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 estrogens (0.625 mg) relative to placebo (See SECTION 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS and SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). The 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 estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo (See SECTION 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS and SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 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 estrogens, with or without medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women (See SECTION 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS and SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens 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, estrogens with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and ris Read the complete document