Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
meloxicam, Quantity: 15 mg
Arrotex Pharmaceuticals Pty Ltd
Meloxicam
Capsule
Excipient Ingredients: titanium dioxide; sunset yellow FCF; magnesium stearate; maize starch; sodium citrate dihydrate; Gelatin; lactose monohydrate; brilliant blue FCF; quinoline yellow
Oral
20, 30, 100, 10
(S4) Prescription Only Medicine
Meloxicam is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis.
Visual Identification: Light green/light yellow, size '2' hard gelatin capsules filled with light yellow coloured granules.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2011-10-18
APO-MELOXICAM 1 APO-MELOXICAM _CAPSULES _ _Meloxicam _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about meloxicam. 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 meloxicam 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 Meloxicam is used to treat the symptoms of osteoarthritis and rheumatoid arthritis. These conditions mainly affect the joints, causing pain and swelling. _HOW IT WORKS _ Meloxicam belongs to a group of medicines called non- steroidal anti- inflammatory drugs (NSAIDs). These medicines work by relieving pain and inflammation. Although meloxicam can relieve symptoms of pain and inflammation, it will not cure your condition. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR'S PRESCRIPTION. THERE IS NOT ENOUGH INFORMATION TO RECOMMEND THE USE OF THIS MEDICINE FOR CHILDREN UNDER THE AGE OF 18 YEARS. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • meloxicam • aspirin or any other NSAIDs • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • rash, itching or hives on the skin • swelling of the face, lips, tongue, or other parts of the body • shortness of breath • wheezing or difficulty breathing DO NOT TAKE THIS MEDICINE IF YOU HAVE ANY OF THE FOLLOWING MEDICAL CONDITIONS: • coronary artery bypass graft surgery • heart disease with sh Belgenin tamamını okuyun
1 AUSTRALIAN PRODUCT INFORMATION APO-MELOXICAM (MELOXICAM) CAPSULES 1 NAME OF THE MEDICINE Meloxicam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains either 7.5 mg or 15 mg meloxicam as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate, gelatin. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 7.5 MG CAPSULES Light green/light green, size ‘2’ hard gelatin capsules filled with light yellow coloured granules. 15 MG CAPSULES Light green/light yellow, size ‘2’ hard gelatin capsules filled with light yellow coloured granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Meloxicam is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Meloxicam capsules are intended for oral administration. DOSAGE Meloxicam should be used at the lowest dose and for the shortest duration consistent with effective treatment. The maximum recommended daily dose of meloxicam is 15 mg. A dose of 15 mg/day should not be exceeded. As a dose for children has not been established, use should be restricted to adults (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE - PAEDIATRIC USE). The dose of meloxicam in patients with end-stage renal failure on haemodialysis should not exceed 7.5 mg/day (see section 5.2 PHARMACOKINETIC PROPERTIES – RENAL IMPAIRMENT AND HAEMODIALYSIS). No dose reduction is required in patients with mild or moderate renal impairment (i.e., in patients with a creatinine clearance of greater than 25 mL/min) nor in patients with mild to moderate hepatic impairment. In non-dialysed patients with severe renal impairment meloxicam is contraindicated (see section 4.3 CONTRAINDICATIONS). In patients with increased risks of adverse reactions e.g. a history of gastrointestinal disease or risk factors for cardiovascular disease, treatment should be started at dose of 7.5 mg/day and increased to 15 mg/day only if clinically justified. Patients on long term treatment Belgenin tamamını okuyun