Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
meloxicam, Quantity: 7.5 mg
Sandoz Pty Ltd
Meloxicam
Capsule, hard
Excipient Ingredients: lactose monohydrate; maize starch; sodium citrate dihydrate; magnesium stearate; Gelatin; titanium dioxide; sunset yellow FCF; brilliant blue FCF
Oral
30
(S4) Prescription Only Medicine
Meloxicam is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis.
Visual Identification: Light green/light green, 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; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2013-04-11
MELOXICAM SANDOZ CMI V2 1 MELOXICAM SANDOZ ® _MELOXICAM CAPSULES _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Meloxicam Sandoz. 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 Sandoz 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 The name of your medicine is Meloxicam Sandoz. It contains the active ingredient meloxicam. It is used to treat the symptoms of • osteoarthritis • rheumatoid arthritis. Both diseases mainly affect the joints causing pain and swelling. Although meloxicam can relieve symptoms such as pain and inflammation, it will not cure your condition. Meloxicam Sandoz belongs to a family of medicines called Non- Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by relieving pain and inflammation. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. There is no evidence that this medicine is addictive. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE MELOXICAM SANDOZ IF YOU HAVE AN ALLERGY TO: • any medicine containing meloxicam • any of the ingredients listed at the end of this leaflet • any other similar medicines (such as aspirin or any other NSAIDs). Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF YOU: • are about to undergo a coronary artery bypass graft surgery • Прочитайте повний документ
210823-meloxicam-sandoz-pi Page 1 of 21 AUSTRALIAN PRODUCT INFORMATION MELOXICAM SANDOZ ® (MELOXICAM) CAPSULES 1 NAME OF THE MEDICINE Meloxicam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Meloxicam Sandoz ® 7.5 mg capsule contains 7.5 mg meloxicam. Each Meloxicam Sandoz ® 15 mg capsule contains 15 mg meloxicam. _Excipient with known effect:_ Lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Meloxicam Sandoz 7.5 mg capsules are light green/light green, size ‘2’ hard gelatin capsules filled with light yellow coloured granules. Meloxicam Sandoz 15 mg capsules are light green/light yellow, size ‘2’ hard gelatin capsules filled with light yellow coloured granules. _Not all strengths may be marketed in Australia. _ 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Meloxicam Sandoz is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. 4.2 D OSE AND METHOD OF 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). In patients with increased risks of adverse reactions, e.g. a history of gastrointestinal disease or risk factors for cardiovascular disease, the treatment should be started at 7.5 mg/day and increased to 15 mg/day only if clinically justified. _OSTEOARTHRITIS _ The recommended dose of meloxicam is 7.5 mg once daily, to be swallowed with fluid, in conjunction with food. Depending on the adequacy of response, the severity of the arthritic condition and the patient’s concomitant diseases, the dose may be increased to 15 mg/day. Patients should generally be maintained on the lowest dose consistent with achieving a satisfactory therapeutic response. 210823-meloxicam-san Прочитайте повний документ