Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
raloxifene hydrochloride, Quantity: 60 mg
Arrotex Pharmaceuticals Pty Ltd
Raloxifene hydrochloride
Tablet, film coated
Excipient Ingredients: hypromellose; crospovidone; macrogol 400; microcrystalline cellulose; magnesium stearate; titanium dioxide; povidone; citric acid monohydrate; polysorbate 80
Oral
28, 7
(S4) Prescription Only Medicine
Raloxifene is indicated for the prevention and treatment of osteoporosis in post-menopausal women.
Visual Identification: White to off-white, elliptical, film-coated tablets debossed with 'X' on one side and '57' on other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-09-26
AURO-RALOXIFENE CONSUMER MEDICINE INFORMATION Ver 1.1 Page 1 of 3 AURO-RALOXIFENE 60 Raloxifene hydrochloride CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet is designed to provide you with answers to some common questions about this medicine. It does not contain all the available information and does not take the place of talking with your doctor. All medicines have risks and benefits. Your doctor has more information about this medicine than is contained in this leaflet. Also, your doctor has had the benefit of taking a full and detailed history from you and is in the best position to make an expert judgement to meet your individual needs. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THIS MEDICINE. You may need to read it again. WHAT AURO-RALOXIFENE IS USED FOR AURO-RALOXIFENE belongs to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators (SERMs). When a woman reaches menopause, the level of the female sex hormone, oestrogen, goes down. AURO- RALOXIFENE mimics some of the beneficial effects of oestrogen after menopause. AURO-RALOXIFENE is used to prevent and treat osteoporosis in women after menopause. Osteoporosis causes your bones to become thin and fragile - it is especially common in women after menopause. While osteoporosis may have no symptoms at first, it makes your bones more likely to break, especially in your spine, hips and wrists. Osteoporosis may also cause back pain, loss of height and a curved back. Fractures may occur during normal, everyday activity, such as lifting, or from minor injury that would not ordinarily fracture normal bone. Your doctor may have prescribed AURO-RALOXIFENE for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY AURO- RALOXIFENE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE AURO-RALOXIFENE TELL YOUR DOCTOR IF YOU HAVE ANY OF THE FOLLOWING CONDITIONS OR IF YOU HAVE EVER EXPERIENCED AN Read the complete document
Product Information: AURO-RALOXIFENE (Raloxifene Hydrochloride Tablets 60 mg) Ver 1.1 Page 1 of 17 PRODUCT INFORMATION AURO-RALOXIFENE 60 (60 MG RALOXIFENE HYDROCHLORIDE TABLETS) NAME OF THE MEDICINE The active ingredient in AURO-RALOXIFENE tablets is raloxifene hydrochloride. CHEMICAL NAME: methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1- piperidinyl)ethoxy]phenyl], hydrochloride MOLECULAR FORMULA: C 28 H 27 NO 4 S•HCl MOLECULAR WEIGHT: 510.05 The CAS number for raloxifene hydrochloride is 82640-04-8. The CAS number for raloxifene free base is 84449-90-1. DESCRIPTION Raloxifene hydrochloride is an off-white to pale-yellow solid that is very slightly soluble or practically insoluble in water and in acetone. Each AURO-RALOXIFENE film coated tablet contains 60 mg raloxifene hydrochloride, which is equivalent to 56 mg raloxifene free base. AURO-RALOXIFENE tablets contain following inactive ingredients: microcrystalline cellulose, povidone, polysorbate 80, crospovidone, magnesium stearate, hypromellose, macrogol 400 , citric acid monohydrate & titanium dioxide. PHARMACOLOGY LONGTERM POST-MENOPAUSAL HEALTH AND THE ROLE OF OESTROGEN Oestrogen exerts agonistic effects on a number of bodily tissues. For example, oestrogen affects the structure and integrity of bone. Decreases in oestrogen levels after oophorectomy or menopause lead to increases in bone resorption, accelerated bone loss and increased risk of fracture. Bone is initially lost rapidly because the compensatory increase in bone formation is inadequate to offset resorptive losses. This imbalance between resorption and formation is related to loss of oestrogen, and may also Product Information: AURO-RALOXIFENE (Raloxifene Hydrochloride Tablets 60 mg) Ver 1.1 Page 2 of 17 involve age-related impairment of osteoblasts or their precursors. Vertebral fractures are the most common type of osteoporotic fracture in post-menopausal women. These fractures are associated with substantial morbidity and impairment in quality of life. Managing post-me Read the complete document