Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
risedronate sodium hemipentahydrate, Quantity: 40.5 mg (Equivalent: risedronate sodium, Qty 35 mg)
Arrotex Pharmaceuticals Pty Ltd
Risedronate sodium
Tablet, film coated
Excipient Ingredients: hypromellose; titanium dioxide; macrogol 8000; lactose; magnesium stearate; iron oxide red; crospovidone; hyprolose; colloidal anhydrous silica; iron oxide yellow
Oral
4, 12, 8, 30
(S4) Prescription Only Medicine
- Treatment of osteoporosis. - Treatment of glucocorticoid-induced osteoporosis. - Preservation of bone mineral density in patients on long term corticosteroid therapy.
Visual Identification: Orange, round, biconvex coated tablets, engraved "APO" on one side, "RIS" over "35" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2010-11-11
1 AUSTRALIAN PRODUCT INFORMATION APO-RISEDRONATE (RISEDRONATE SODIUM HEMIPENTAHYDRATE) TABLETS 1 NAME OF THE MEDICINE Risedronate sodium hemipentahydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 35, 75 or 150 mg risedronate sodium as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Contains sugars as Lactose For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM FILM COATED TABLETS: 35 MG TABLETS Orange, round, biconvex coated tablets, engraved “APO” on one side, “RIS” over “35” on the other side. 75 MG TABLETS Dark pink, round, biconvex coated tablet, engraved “APO” on one side, “RIS” over “75” on the other side. 150 MG TABLETS Blue, round, biconvex coated tablet, engraved “APO” on one side, “RIS” over “150” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of osteoporosis • Treatment of glucocorticoid-induced osteoporosis. • Preservation of bone mineral density in patients on long-term corticosteroid therapy. 2 4.2 DOSE AND METHOD OF ADMINISTRATION Risedronate tablets are intended for oral administration. DOSAGE Risedronate must only be taken with PLAIN WATER. Plain water is the only drink that should be taken with risedronate tablets. Note that some mineral waters or water from regional areas may have a higher concentration of calcium and therefore should not be used. Risedronate must be taken 30 minutes before the first food or drink other than water. To facilitate delivery to the stomach, risedronate should be taken while the patient is in an upright position and the patients should avoid lying down for 30 minutes. Patients should not chew or suck the tablet because of the potential for oropharyngeal irritation. OSTEOPOROSIS The recommended dose is either: • 5 mg daily; • 35 mg once-a-week, taken on the same day each week; • 75 mg taken for two consecutive days on the same dates each month; or • 150 mg taken once-a-month. The tablet should be taken on the same date ea Lire le document complet