Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
risedronate sodium, Quantity: 30 mg (Equivalent: risedronic acid, Qty 27.84 mg)
Theramex Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: crospovidone; hypromellose; macrogol 400; hyprolose; titanium dioxide; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; macrogol 8000; lactose monohydrate
Oral
28 tablets, 14 tablets
(S4) Prescription Only Medicine
Treatment of Paget's disease of bone.
Visual Identification: Oval white film-coated tablets with RSN embossed on one side and 30mg on the other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2000-08-14
ACTONEL ® A C T O N E L ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING ACTONEL? Actonel contains the active ingredient risedronate sodium. Actonel is used to treat bone disease and belongs to a group of medicines called bisphosphonates. For more information, see Section 1. Why am I using Actonel? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ACTONEL Do not use if you have ever had an allergic reaction to Actonel or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Actonel? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Actonel and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ACTONEL? For osteoporosis, the usual dose is one 5mg tablet each day or one 150mg tablet once a month. For Paget's disease of the bone, the usual dose is one 30 mg tablet each day for 2 months. More instructions can be found in Section 4. How do I use Actonel? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ACTONEL? THINGS YOU SHOULD DO • Tell any doctors, dentists and pharmacists who are treating you that you are taking Actonel. • If you require a dental procedure tell your dentist that you are taking Actonel. Invasive dental procedures should be avoided where possible. • If you become pregnant while taking Actonel tell your doctor or pharmacist. • If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking Actonel. THINGS YOU SHOULD NOT DO • Do not stop using this medicine without checking with your doctor or pharmacist. • Do not lie down for 30 minutes after taking Acton Přečtěte si celý dokument
ACTONEL ® (Risedronate sodium) Theramex Australia Pty Ltd Version 1.1 1 AUSTRALIAN PRODUCT INFORMATION – ACTONEL ® AND ACTONEL ® ONCE-A-MONTH (RISEDRONATE SODIUM) FILM- COATED TABLETS 1 NAME OF THE MEDICINE Risedronate sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Actonel tablet contains the equivalent of 5 or 30 mg of risedronate sodium. Each Actonel Once-a-Month tablet contains the equivalent of 150 mg of risedronate sodium. Excipients with known effect: • Sugars as lactose (5 or 30 mg tablets only) For the full list of excipients, see Section 6.1 - List of Excipients. 3 PHARMACEUTICAL FORM Film-coated tablet Actonel 5 mg tablets: oval, yellow film-coated tablets with RSN embossed on one side and 5 mg on the other side. Actonel 30 mg tablets: oval, white film-coated tablets with RSN embossed on one side and 30 mg on the other side. Actonel 150 mg Once-a-Month tablets: oval, light-blue film-coated tablets with RSN engraved on one side and 150 mg on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Actonel 5 mg and 150 mg Tablets • Treatment of osteoporosis • Treatment of glucocorticoid-induced osteoporosis • Preservation of bone mineral density in patients on long term corticosteroid therapy Actonel 30 mg Tablet • Treatment of Paget’s disease of bone ACTONEL ® (Risedronate sodium) Theramex Australia Pty Ltd Version 1.1 2 4.2 DOSE AND METHOD OF ADMINISTRATION Actonel must only be taken with plain water. Plain water is the only drink that should be taken with Actonel tablets. Please note that some mineral waters or water from regional areas may have a higher concentration of calcium and therefore should not be used. Actonel must be taken 30 minutes before the first food or drink other than water. To facilitate delivery to the stomach, Actonel should be taken in an upright position and the patient should avoid lying down for 30 minutes. Patients should not chew or suck on the tablet because of the potential for oropharyngeal irritation. OSTEOPOROSIS: _Actonel 5 mg _ The r Přečtěte si celý dokument