Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
estradiol hemihydrate, Quantity: 2.07 mg (Equivalent: estradiol, Qty 2 mg); norethisterone acetate, Quantity: 1 mg
Novo Nordisk Pharmaceuticals Pty Ltd
estradiol hemihydrate,Norethisterone acetate
Tablet, film coated
Excipient Ingredients: lactose monohydrate; maize starch; hyprolose; purified talc; magnesium stearate; hypromellose; triacetin
Oral
28 tablets
(S4) Prescription Only Medicine
Short term symptomatic treatment of oestrogen deficiency associated with natural or artificial menopause (see DOSAGE AND ADMINISTRATION and CLINICAL TRIALS).
Visual Identification: 10 white tablets, 6 millimetres in diameter engraved 'Novo/281'.; Container Type: Dial Dispenser Pack; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-01-11
Trisequens ® tablets Trisequens cmi-v10 Page 1 of 2 TRISEQUENS ® _Estradiol/Norethisterone acetate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET WHEN YOU MUST NOT USE TRISEQUENS ® .................................. 1 WHAT TRISEQUENS ® IS USED FOR ..... 1 BEFORE YOU TAKE TRISEQUENS ® ...... 1 HOW TO TAKE TRISEQUENS ® ............ 4 WHILE YOU ARE TAKING TRISEQUENS ® ....................................................... 4 SIDE EFFECTS .................................... 5 STORAGE .......................................... 6 PRODUCT DESCRIPTION .................... 7 FURTHER INFORMATION .................... 7 USER INSTRUCTIONS .......................... 8 This leaflet answers some common questions about Trisequens ® . It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Trisequens ® against the benefits they expect it will have for you. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. Trisequens ® is available only by prescription at pharmacies. WHEN YOU MUST NOT USE TRISEQUENS ® DO NOT USE TRISEQUENS ® OR OTHER ESTROGENS, WITH OR WITHOUT A PROGESTAGEN 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 estrogens 0.625 mg and the progestagen 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 estrogens and MPA. There are no comparable data currently available for other doses of conjugated estrogens and MPA o Aqra d-dokument sħiħ
Trisequens-pi-v13 Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION TRISEQUENS ® ESTRADIOL TABLETS AND NORETHISTERONE ACETATE PLUS ESTRADIOL TABLETS DIAL DISPENSER PACK. WARNING Estrogens and progestagens 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 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 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 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 progestagens 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 progestagens should be prescribed at the lowest effective doses and for the shortest duratio Aqra d-dokument sħiħ