Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
alendronate sodium
Generic Health Pty Ltd
alendronate sodium
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CONSUMER MEDICINE INFORMATION ALENDROBELL (ALENDRONATE SODIUM) UNCOATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Alendrobell (alendronate). 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 taking Alendrobell against the benefits they expect it will have for you. If you have any concerns about using/taking this medicine, ask your doctor or pharmacist. Keep this leaflet with this medicine. You may need to read it again. WHAT ALENDROBELL IS USED FOR Alendrobell is used to treat osteoporosis. This condition is caused by changes in the way bone is normally maintained. _UNDERSTANDING BONE _ Bone is living, growing tissue. Throughout life, our bodies are breaking down old bone and rebuilding new bone in a continuous cycle. Until our late 20s, while bones are still developing, we gain bone by building more than we lose. From then until about age 35 the process is usually in balance, so that the amount of bone lost is about equal to the amount that is replaced. After about age 35 this balance is disturbed, with bone loss occurring at a slightly faster rate than it can be replaced. In women, after menopause, hormonal changes cause bone loss at an even faster rate. When bone loss is excessive, bones can become thinner and weaker, and therefore are more likely to break. _OSTEOPOROSIS _ _ _ _Osteo_ means bone, and _porosis _ means something that has holes in it, like a sponge. Therefore, osteoporosis is a disease, which causes bones to become more porous, gradually making them weaker, more brittle and likely to break. Osteoporosis is common in postmenopausal women. Menopause occurs when the ovaries virtually stop producing the female hormone, oestrogen, or are removed (which may occur, for example, at the time of a hysterectomy). At this time, bone is removed faster than it is formed, so bone loss occurs and bones become weaker. The earlier Read the complete document
AUSTRALIAN PRODUCT INFORMATION – ALENDROBELL (ALENDRONATE SODIUM) UNCOATED TABLET 1 NAME OF THE MEDICINE Alendronate sodium. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Alendrobell 10 mg tablet contains alendronate sodium equivalent to 10 mg alendronic acid. Each Alendrobell 70 mg tablet contains alendronate sodium equivalent to 70 mg alendronic acid. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Alendrobell 10 mg tablets are white to off-white tablets, debossed with “A3” on one side and with a deep breakline on other side. Alendrobell 70 mg tablets are white to off-white circular tablets, debossed with “A” on one side and “4” on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alendrobell is indicated for the treatment of osteoporosis, including glucocorticoid-induced osteoporosis (see SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION). Prior to treatment, osteoporosis must be confirmed by: • the finding of low bone mass of at least 2 standard deviations below the gender specific mean for young adults; or by • the presence of osteoporotic fracture. Alendrobell is also indicated for the prevention of: • osteoporosis in postmenopausal women with low bone mass (at least 1 standard deviation below the mean for young adults). • glucocorticoid-induced osteoporosis in those patients on long term corticosteroid therapy (see SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION for specific uses of Alendrobell tablets)._ _ 4.2 DOSE AND METHOD OF ADMINISTRATION Alendrobell must be taken at least 30 minutes before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food and some medications are likely to reduce the absorption of alendronate (see SECTION 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS). Alendrobell v4 Page 2 of 21 (alendronate sodium) uncoated tablet Alendrobell should only be taken upon arising for the day. To facilitate delivery to the stomach and Read the complete document