País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Meloxicam
McDermott Laboratories Ltd., T/A Gerard Laboratories
M01AC; M01AC06
Meloxicam
15 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Oxicams; meloxicam
Not marketed
2004-09-17
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ARELOGER 7.5 MG TABLETS ARELOGER 15 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Areloger is and what it is used for 2. What you need to know before you take Areloger 3. How to take Areloger 4. Possible side effects 5. How to store Areloger 6. Contents of the pack and other information 1. WHAT ARELOGER IS AND WHAT IT IS USED FOR Areloger contains the active ingredient meloxicam. Meloxicam belongs to the group of non- steroidal anti-inflammatory drugs (NSAIDs) used for the treatment of pain and inflammation in muscles and joints. Areloger can be used by adults and adolescents over 16 years of age for: • the short-term treatment of flare-ups of osteoarthrosis (a disease of the joints) • the long-term treatment of pain in connection with rheumatoid arthritis (inflammation of the joints) • the long-term treatment of a similar condition called ankylosing spondylitis (inflammation of the spine). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARELOGER DO NOT TAKE ARELOGER • during the last three months of pregnancy • if you are a child or adolescent under 16 years of age • if you are allergic to meloxicam or any of the _ _ other ingredients of this medicine (listed in section 6) • if you are allergic to acetylsalicylic acid (e.g. aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs) Page 2 of 9 • if you have previously had symptoms of wheezing, chest tightness, breathlessness (asthma), swelling Leer el documento completo
Health Products Regulatory Authority 13 November 2023 CRN00DV84 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Areloger 15 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15.0 mg of meloxicam. Excipient with known effect Each tablet contains 81.7 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Pale yellow, round, flat bevelled tablet with a break line on one side. Approximately 10 mm in diameter. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Areloger is indicated in adults and adolescents over 16 years of age for: - 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 tablet of 7.5 mg or half a 15 mg tablet). If necessary, in the absence of improvement, the dose may be increased to 15 mg/day (two tablets of 7.5 mg or 1 tablet of 15 mg). _Rheumatoid arthritis, ankylosing spondylitis_: 15 mg/day (two tablets of 7.5 mg or 1 tablet of 15 mg) (see also “Special populations”). According to the therapeutic response, the dose may be reduced to 7.5 mg/day (one tablet of 7.5 mg or half a 15 mg tablet). DO NOT EXCEED THE DOSE OF 15 MG/DAY. SPECIAL POPULATIONS _Elderly patients and patients with increased risks for adverse reactions (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 Leer el documento completo