Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
colecalciferol, Quantity: 0.14 mg; alendronate sodium, Quantity: 91.37 mg (Equivalent: alendronic acid, Qty 70 mg)
Dr Reddys Laboratories Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: magnesium stearate; povidone; sucrose; butylated hydroxytoluene; croscarmellose sodium; microcrystalline cellulose; Gelatin; medium chain triglycerides; colloidal anhydrous silica
Oral
4 Tablets, 1 Tablet
(S4) Prescription Only Medicine
ALENDRONATE PLUS D3 70 mg/140 microgram APOTEX are indicated for the treatment of: Osteoporosis in select patients where vitamin D supplementation is recommended, 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
Visual Identification: White to off-white, modified capsule-shaped uncoated tablet, debossed with ADC on one side and 56 on the 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; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-11-16
ALENDRONATE PLUS D3 APOTEX _Alendronate sodium and colecalciferol _ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 095 055 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Alendronate Plus D3 APOTEX. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR Alendronate Plus D3 APOTEX contains both alendronate and colecalciferol (vitamin D). It is used to treat osteoporosis and to provide additional vitamin D. Alendronate belongs to a group of medicines called bisphosphonates. Vitamin D is an essential nutrient required for calcium absorption and healthy bones. _UNDERSTANDING BONE _ Throughout life, old bone is being broken down and rebuilt as 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 age 35 this balance is disturbed, with bone loss occurring at a slightly faster rate than it can be replaced. After menopause, hormonal changes in women cause bone loss at an even faster rate. Excessive bone loss causes bones to become thinner and weaker, and therefore more likely to break. _OSTEOPOROSIS _ 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. The earlier a woman reaches the menopause, the greater the risk of osteoporosis. Osteoporosis also occurs in men but is less common than in women. Early osteoporosis usua Lire le document complet
AUSTRALIAN PRODUCT INFORMATION– ALENDRONATE PLUS D3 70 MG/70 µ G APOTEX (ALENDRONATE SODIUM AND COLECALCIFEROL) ALENDRONATE PLUS D3 70 MG/140 µ G APOTEX (ALENDRONATE SODIUM AND COLECALCIFEROL) 1 NAME OF THE MEDICINE Alendronate sodium and colecalciferol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Alendronate Plus D3 70 mg/70 µ g APOTEX contains 91.37 mg of alendronate sodium, which is the molar equivalent to 70 mg of alendronic acid, and 70 microgram of colecalciferol equivalent to 2800 IU vitamin D. Each tablet of Alendronate Plus D3 70 mg/140 µ g APOTEX contains 91.37 mg of alendronate sodium, which is the molar equivalent to 70 mg of alendronic acid, and 140 microgram of colecalciferol equivalent to 5600 IU vitamin D. EXCIPIENTS WITH KNOWN EFFECT Sucrose For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM Alendronate Plus D3 70 mg/ 70 µ g APOTEX once weekly tablet is a white to off-white, modified capsule- shaped uncoated tablet, debossed with 'ADC' on one side and '28' on the other side. Alendronate Plus D3 70 mg/ 140 µ g APOTEX once weekly tablet is a white to off-white, modified capsule- shaped uncoated tablet, debossed with 'ADC' on one side and '56' on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alendronate Plus D3 70 mg/70 µ g APOTEX and Alendronate Plus D3 70 mg/140 µ g APOTEX are indicated for the treatment of: • Osteoporosis in select patients where vitamin D supplementation is recommended 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 1 4.2 DOSE AND METHOD OF ADMINISTRATION Alendronate Plus D3 (70 mg/70 microgram or 70 mg/140 microgram) Treatment of osteoporosis in patients where vitamin D3 supplementation is recommended The recommended dose is one tablet of Alendronate Plus D3 (70 mg/70 microgram or 70 mg/140 microgram) once weekly. The optimal du Lire le document complet