Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
MELOXICAM
Boehringer Ingelheim International GmbH Binger Strasse 173, 55216 Ingelheim am Rhein, Germany
M01AC06
MELOXICAM 7.5 mg
TABLET
MELOXICAM 7.5 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Withdrawn
2007-04-19
PACKAGE LEAFLET: INFORMATION FOR THE USER MOBIC ® 7.5 MG TABLETS Meloxicam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What MOBIC is and what it is used for 2. What you need to know before you take MOBIC 3. How to take MOBIC 4. Possible side effects 5. How to store MOBIC 6. Contents of the pack and other information 1. WHAT MOBIC IS AND WHAT IT IS USED FOR MOBIC contains the active substance meloxicam. Meloxicam belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) which are used to reduce inflammation and pain in joints and muscles. MOBIC is used for the: - short-term treatment of flare-ups of osteoarthritis - long-term treatment of - rheumatoid arthritis - ankylosing spondylitis (also known as Bechterew’s Disease) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOBIC DO NOT TAKE MOBIC: - allergy to meloxicam or any of the other ingredients of this medicine (listed in section 6) - during the last three months of pregnancy - children and adolescents under 16 years of age - allergy (hypersensitivity) to aspirin or other anti-inflammatory medicines (NSAIDs) - any of the following signs after taking aspirin or other NSAIDs: - wheezing, chest tightness, breathlessness (asthma) - nasal blockage due to swellings in the lining in your nose (nasal polyps) - skin rashes/nettle rash (urticaria) - sudden skin or mucosal swelling, such as swelling around the eyes, face, lips, mouth or throat, possibly making breathing difficult (angioneurotic oedema) - after previous therapy with NSAIDs and his Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Mobic 7.5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 7.5 mg of Meloxicam. Excipient(s) with known effect Each tablet contains 22.3 mg lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Light yellow round tablet with the logotype of the company on one side and a score with 59D/59D on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Short-term symptomatic treatment of exacerbations of osteoarthrosis. - Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The total daily amount should be taken as a single dose. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis. - Exacerbations of osteoarthrosis: 7.5 mg/day (one 7.5 mg tablet). If necessary, in the absence of improvement, the dose may be increased to 15 mg/day (two 7.5 mg tablets). - Rheumatoid arthritis, ankylosing spondylitis: 15 mg/day (two 7.5 mg tablets). (see also section ‘Special populations’ below) According to the therapeutic response, the dose may be reduced to 7.5 mg/day (one 7.5 mg tablet). DO NOT EXCEED THE DOSE OF 15 MG/DAY. Special populations _Elderly patients and patients with increased risks for adverse reaction (see section 5.2): _ The recommended dose for long term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly patients is 7.5 mg per day. Patients with increased risks for adverse reactions should start treatment with 7.5 mg per day (see section 4.4). _Renal impairment (see section 5.2): _ In dialysis patients with severe renal failure, the dos Διαβάστε το πλήρες έγγραφο