País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
LORNOXICAM
Takeda UK Limited
LORNOXICAM
8 Milligram
Film Coated Tablet
Authorised
0000-00-00
Produkt Xefo 8mg Maße / Code 148 x 420 mm Ident-Nr. IRL F.1/0213/xxxxxxx Farben schwarz Code Art der Änderung: name change Nycomed GmbH Plant Oranienburg Lehnitzstrasse 70-98 16515 Oranienburg Gut zum Druck TMA/A. Dohmen lIIIIIlIlI lIIIIIlIlI READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Xefo is and what it is used for 2. Before you take Xefo 3. How to take Xefo 4. Possible side effects 5. How to store Xefo 6. Further information 1. WHAT XEFO IS AND WHAT IT IS USED FOR Xefo is a non-steroidal anti-inflammatory drug (NSAID) and antirheumatic drug of the oxicam class. It is intended for SHORT TERM TREATMENT OF ACUTE MILD TO MODERATE PAIN AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS SUCH AS PAIN AND INFLAMMATION OF JOINTS. 2. BEFORE YOU TAKE XEFO DO NOT TAKE XEFO • if you are allergic (hypersensitive) to lornoxicam or any of the other ingredients of Xefo 8 mg film-coated tablets; • if you are taking other NSAIDs such as acetylsalicylic acid (for instance, aspirin), ibuprofen and COX-2 inhibitors; • if you are hypersensitive to other NSAIDs including acetylsalicylic acid (for instance, aspirin); • if you suffer from thrombocytopenia (low blood platelet count which increases risk of bleeding or bruising); • if you suffer from severe heart failure; • if you suffer from gastrointestinal bleeding, rupture and Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xefo 8 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 8 mg lornoxicam Excipients: 90 mg Lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to yellowish oblong film-coated tablet with imprint “L08”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Short-term relief of acute mild to moderate pain - Symptomatic relief of pain and inflammation in osteoarthritis. - Symptomatic relief of pain and inflammation in rheumatoid arthritis 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For all patients the appropriate dosing regimen should be based upon individual response to treatment. Pain 8-16 mg lornoxicam daily divided into 2 or 3 doses. Maximum recommended daily dose is 16 mg. Osteoarthritis and Rheumatoid arthritis Initial recommended dose is 12 mg lornoxicam daily divided into 2 or 3 doses. Maintenance dose should not exceed 16 mg lornoxicam daily. Xefo film-coated tablets are supplied for oral use and should be taken with a sufficient quantity of liquid. Additional information on special populations Children and adolescents Lornoxicam is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy. Elderly No special dosage modification is required for elderly patients above age 65 unless renal or hepatic function is impaired. Lornoxicam should be administered with precaution as gastrointestinal adverse effects are less well tolerated in this group (see section 4.4). Renal impairment For patients with mild to moderate renal impairment the maximum recommended daily dose is 12 mg divided in 2 or 3 doses (see section 4.4). Hepatic impairment IRISH MEDICINES Leer el documento completo