البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
estradiol hemihydrate, Quantity: 1.033 mg (Equivalent: estradiol, Qty 1 mg); drospirenone, Quantity: 2 mg
Bayer Australia Ltd
Drospirenone,estradiol hemihydrate
Tablet, film coated
Excipient Ingredients: povidone; hypromellose; magnesium stearate; lactose monohydrate; purified talc; macrogol 6000; titanium dioxide; pregelatinised maize starch; maize starch; iron oxide red
Oral
28 tablets, 84 tablets, 112 tablets, 7 Tablets (Starter Pack), 56 tablets
(S4) Prescription Only Medicine
Hormone Replacement therapy (HRT) for use in the short-term treatment in postmenopausal women with an intact uterus of the climacteric syndrome caused by deficient endogenous oestrogen production due to natural menopause, hypogonadism, castration or primary ovarian failure.
Visual Identification: Small, round, medium red tablet, one side embossed with the letter DL in a regular hexagon.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2004-11-30
ANGELIQ® 1/2 CMI V1.0 1 ANGELIQ® 1/2 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I USING ANGELIQ® 1/2? ANGELIQ® 1/2 contains the active ingredients estradiol and drospirenone. ANGELIQ® 1/2 provides hormone replacement therapy (HRT) for the treatment of menopausal complaints in postmenopausal women. ANGELIQ® 1/2 IS NOT A CONTRACEPTIVE. IT WILL NOT PREVENT YOU FROM FALLING PREGNANT. For more information, see Section 1. Why am I using ANGELIQ® 1/2? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ANGELIQ® 1/2? Do not use if you have ever had an allergic reaction to estradiol, drospirenone, or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT, PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use ANGELIQ® 1/2? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with ANGELIQ® 1/2 and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ANGELIQ® 1/2? Take one tablet daily at about the same time each day. Swallow the tablets whole with a full glass of water. It does not matter if you take this medicine before or after food. More instructions can be found in Section 4. How do I use ANGELIQ® 1/2? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ANGELIQ® 1/2? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using ANGELIQ® 1/2. • Check your breasts each month and report any changes promptly to your doctor. THINGS YOU SHOULD NOT DO • Do not take ANGELIQ® 1/2 to treat any other complaints unless your doctor tells you to. • Do not اقرأ الوثيقة كاملة
ANGELIQ ® 1/2 PI V1.0 CCDS 12 1 AUSTRALIAN PRODUCT INFORMATION ANGELIQ ® 1/2 (ESTRADIOL, DROSPIRENONE) TABLETS 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 sub-study 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 risks for the individual woman. 1 NAME OF THE MEDICINE E اقرأ الوثيقة كاملة