Țară: Singapore
Limbă: engleză
Sursă: HSA (Health Sciences Authority)
RALOXIFENE HCl
LOTUS INTERNATIONAL PTE. LTD.
G03XC01
60 mg
TABLET, FILM COATED
RALOXIFENE HCl 60 mg
ORAL
Prescription Only
LILLY SA
ACTIVE
1999-04-09
BONE LOSS I. NAME OF PRODUCT EVISTA® tablets 60mg II. DESCRIPTION OF PRODUCT EVISTA® tablets are white, oval shaped and film coated. Each EVISTA® tablet has the identicode ‘ALV’ debossed on one side. Each tablet of EVISTA® contains 60mg of the active ingredient called Raloxifene. The tablet also contains: Tablet Core: Povidone, polysorbate 80, anhydrous lactose, lactose monohydrate, crospovidone, magnesium stearate. Tablet Coating: Titanium dioxide (E 171), hydroxypropyl methylcellulose 2910, 3 cps, hydroxypropyl methylcellulose 2910, 6 cps, macrogol 400, polysorbate 80, carnauba wax. Ill. WHAT IS THE MEDICINE? EVISTA® belongs to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators. When a woman reaches menopause, the level of the female sex hormone, oestrogen, goes down. EVISTA® mimics some of the beneficial effects of oestrogen after menopause. Estrogen is a female hormone that affects your bones as well as other parts of the body. With the onset of menopause, a woman's body produces up to 80% less 1 estrogen. A reduction in estrogen has a high impact on bones. It causes bones to become thinner and weaker and may result in a condition called osteoporosis. Osteoporosis 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. EVISTA Ra l oxi f ene HCI YOUR DOCTOR HAS RECOMMENDED EVISTA® (RALOXIFENE HCI) FOR YOU. THIS LEAFLET WILL PROVIDE ANSWERS TO SOME COMMON QUESTIONS ABOUT THIS MEDICINE, TO BETTER UNDERSTAND HOW EVISTA® CAN HELP YOU COPE WITH THE EFFECTS OF MENOPAUSE. 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 INFORMAT Citiți documentul complet
EVISTA ® 60MG FILM COATED TABLETS RALOXIFENE HYDROCHLORIDE 1. NAME OF THE MEDICINAL PRODUCT EVISTA 60 MG film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base. Excipients with known effect: Each tablet contains lactose (149.40 mg). For excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Film coated tablets for oral use. Elliptically shaped, white tablets imprinted with the code 4165. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. For those postmenopausal women taking EVISTA for osteoporosis treatment, EVISTA has been to shown to reduce the risk of invasive breast cancer. When determining the choice of EVISTA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see Section 5.1). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The recommended posology is one tablet daily by oral administration, which may be taken at any time of the day without regard to meals. Due to the nature of this disease process, EVISTA is intended for long term use. Generally calcium and vitamin D supplements are advised in women with a low dietary intake. Elderly No dose adjustment is necessary for the elderly. Renal impairment EVISTA should not be used in patients with severe renal impairment (see section 4.3). In patients with moderate and mild renal impairment, EVISTA should be used with caution. Hepatic impairment EVISTA should not be used in patients with hepatic impairment (see section 4.3 and 4.4). Paediatric population EVISTA should not be used in children of any age. There is no relevant use of EVISTA in the paediatric population. 4.3. CONTRAINDICATIONS Hypersensitivi Citiți documentul complet