מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tenoxicam
Sigma Pharmaceuticals Plc
M01AC02
Tenoxicam
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
TENOXICAM 20 MG TABLETS Patient Information Leaflet READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE • Please 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 becomes severe, of if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. _ _ IN THIS LEAFLET: 1. WHAT TENOXICAM TABLETS ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU TAKE TENOXICAM TABLETS 3. HOW TO TAKE TENOXICAM TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TENOXICAM TABLETS 6. FURTHER INFORMATION 1. WHAT TENOXICAM TABLETS ARE AND WHAT THEY ARE USED FOR Tenoxicam belongs to a group of medicines called non-steroidal anti- inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in the joints and muscles and also reduce a fever. Tenoxicam Tablets are used to treat: • osteoarthritis and rheumatoid arthritis; • short-term injuries such as sprains and strains and other soft-tissue injuries. 2. BEFORE YOU TAKE TENOXICAM TABLETS DO NOT TAKE THIS MEDICINE IF: • you are ALLERGIC to tenoxicam or any of the other ingredients; • you have previously taken another NSAID (e.g. ibuprofen) or aspirin and had an ALLERGIC REACTION. This reaction may have been signs of asthma (e.g. wheeziness), runny nose, swelling of the skin or itching; • you have, or have ever had an ULCER OF THE STOMACH or duodenum (gut); • you have ever suffered from BLEEDING in the stomach or intestines (gastrointestinal bleeding) or bleeding in the brain (cerebrovascular bleeding) or you have a bleeding disorder; • you are taking a medication to prevent the blood clotting (e.g. WARFARIN); • you have severe LIVER, KIDNEY OR HEART FAILURE; • you are PREGNANT or planning to become pregnant, or are you breast- feeding; • your doctor tells you that you current קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tenoxicam 20mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20mg Tenoxicam. Also contains lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Round, yellowish film-coated tablet._ _ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tenoxicam tablets are for the treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis. It is also indicated for short term treatment of acute musculoskeletal disorders including strains, sprains and other soft-tissue injuries. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The tablets are for oral use and should be taken with water or other fluid, preferably with or after food. Adults: The recommended dosage is a single daily dose of 20mg taken at the same time each day. As there is no significantly greater therapeutic effect at higher doses, and higher doses may result in an increase of adverse events, oral doses greater than recommended should be avoided. Tenoxicam 20 mg Tablets should only be used for up to a maximum of 2 weeks in cases of severe acute musculoskeletal disorders. Usually treatment of up to 7 days is sufficient. Elderly: The elderly are at increased risk of the serious consequences of adverse reactions. They are also more likely to be receiving concomitant medication or to have impaired hepatic, renal or cardiovascular function. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding for 4 weeks following initiation of NSAID therapy. Children: Tenoxicam 20mg Tablets should not be used in children until sufficient data become available. Use in renal and hepatic insufficiency: CREATININE CLEARANCE DOSAGE REGIMEN Greater than 25ml/min Usual dosage but monitor patients carefully (see section 4.4) Less than 25ml/min Insufficient data to make dosage recommendations Because of the high pla קרא את המסמך השלם