Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nabumetone
Viatris UK Healthcare Ltd
M01AX01
Nabumetone
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 7317510000011 5060035249190
Patient Information Leaflet Relifex 500 mg & 1 g Film-coated Tablets Nabumetone 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. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • In this leaflet, Relifex 500 mg & 1 g Film-coated Tablets will be called Relifex. What is in this leaflet: 1. What Relifex is and what it is used for 2. What you need to know before you take Relifex 3. How to take Relifex 4. Possible side effects 5. How to store Relifex 6. Contents of the pack and other information 1. What Relifex is and what it is used for Relifex belongs to a group of medicines called non-steroi- dal anti-inflammatory drugs (known as NSAIDs). It works by reducing the production of some natural chemicals found in the body. These chemicals (prosta- glandins) cause the symptoms of inflammation such as pain and swelling. Relifex is used to treat the pain, stiffness and swelling of joints which are affected by osteoarthritis or rheumatoid arthritis. 2. What you need to know before you take Relifex Do not take Relifex if: • You are allergic to nabumetone • You are allergic to any of the other ingredients of Relifex (see section 6) • You have ever had an allergic reaction like a rash, itchy, runny or bleeding nose, or become short of breath when you have taken aspirin or other NSAID medicines. Such medicines include ibuprofen, acetylsalicylic acid, diclofenac or naproxen. Some people who have had previous allergic reactions to NSAID medicines have very serious, sometimes fatal reactions if they take this kind of medicine again. • You have, or have ever had a stomach ( Leggi il documento completo
OBJECT 1 RELIFEX 500MG Summary of Product Characteristics Updated 19-Apr-2018 | Meda Pharmaceuticals 1. Name of the medicinal product Relifex 500 mg Film-coated Tablets 2. Qualitative and quantitative composition Each tablet contains 500 mg nabumetone. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Dark red, film-coated tablets marked Relifex on one side and "500" on the other. 4. Clinical particulars 4.1 Therapeutic indications Nabumetone is a non-acidic non-steroidal anti-inflammatory agent which is a relatively weak inhibitor of prostaglandin synthesis. However, following absorption from the gastrointestinal tract it is rapidly metabolised in the liver to the principal active metabolite, 6-methoxy-2-naphthylacetic acid (6-MNA), a potent inhibitor of prostaglandin synthesis. It is indicated for the treatment of osteoarthritis and rheumatoid arthritis requiring anti-inflammatory and analgesic treatment. 4.2 Posology and method of administration For oral administration. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Relifex 500 mg film-coated tablets should be taken preferably with or after food. ADULTS The recommended daily dose is two tablets (1 g) taken as a single dose at bedtime. For severe or persistent symptoms, or during acute exacerbations, an additional one or two tablets (500 mg-1 g) may be given as a morning dose. ELDERLY In common with many drugs, blood levels may be higher in elderly patients. The recommended daily dose of two tablets (1 g) should not be exceeded in this age group and in some cases one tablet (500 mg) may give satisfactory relief. The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patients should be monitored for gastrointestinal bleeding during NSAID therapy. CHILDREN There are no clinical data to recommend Leggi il documento completo