Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
risedronate sodium hemipentahydrate, Quantity: 86.7 mg
Arrotex Pharmaceuticals Pty Ltd
Risedronate sodium hemipentahydrate
Tablet, film coated
Excipient Ingredients: hypromellose; titanium dioxide; macrogol 8000; iron oxide red; colloidal anhydrous silica; hyprolose; magnesium stearate; crospovidone; lactose
Oral
30
Medicine Registered
(S4) Prescription Only Medicine
The treatment of osteoporosis,The treatment of glucocorticoid-induced osteoporosis,The preservation of bone-mineral density in patients on long term corticosteroid therapy
Visual Identification: Dark pink, round, biconvex coated tablet. Engraved "APO" on one side, "RIS" over "75" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2012-03-08
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 Preberite celoten dokument