Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Meloxicam
Chanelle Medical Unlimited Company
M01AC; M01AC06
Meloxicam
7.5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Oxicams; meloxicam
Not marketed
2005-12-02
ID: PL 55/56 M VERSION: 16 REVIEW DATE: 17/05/2023 PAGE 8 OF 8 PACKAGE LEAFLET: INFORMATION FOR THE USER MELOXICAM CHANELLE MEDICAL 7.5 MG TABLETS MELOXICAM CHANELLE MEDICAL 15 MG TABLETS Meloxicam IN THIS LEAFLET: 1. What Meloxicam Chanelle Medical tablets are and what they are used for. 2. What you need to know before you take Meloxicam Chanelle Medical 3. How to take Meloxicam Chanelle Medical tablets. 4. Possible side effects. 5. How to store Meloxicam Chanelle Medical tablets. 6. Contents of the pack and other information Meloxicam 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. Meloxicam Chanelle Medical tablets is used for: • short-term treatment of flare-ups of osteoarthrosis • long-term treatment of - rheumatoid arthritis - ankylosing spondylitis DO NOT TAKE MELOXICAM CHANELLE MEDICAL TABLETS: • during the last three months of pregnancy. • children and adolescents under 16 years of age. • if you are allergic to meloxicam, aspirin or other anti-inflammatory medicines (NSAIDs) • if you are allergic to any of the other ingredients of this medicine (listed in section 6) • 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 history of - bleeding in your stomach or intestines - holes (perforations) in your stomach or intestines • ulcers or bleeding in your stomach or intestines • recent or history of stomach or peptic ulcers or bleeding (ulceration or bleeding occurring at least twice) • severely impaired liver function • non dialysed severe kidney failure Прочитајте комплетан документ
Health Products Regulatory Authority 12 January 2024 CRN00DM09 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Meloxicam Chanelle Medical 7.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: 7.5 mg meloxicam. Excipient: Each tablet contains 40.85 mg lactose (as lactose monohydrate). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet Pale yellow coloured round tablet with a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Meloxicam Chanelle Medical is indicated in adults and children above 16 years. - 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 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 (see section 5.2): _ _The recommended dose for long term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly patients is 7.5 mg _ _daily (see also sections 4.2 "Patients at increased risk of adverse reactions" and 4.4)_ Health Products Regulatory Authority 12 January 2024 CRN00DM09 Page 2 of 13 _ _ _Patients at increased risk of adv Прочитајте комплетан документ