Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sulindac
DE Pharmaceuticals
M01AB02
Sulindac
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
PAGE 1 OF 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SULINDAC 100 MG AND 200 MG TABLETS (sulindac) 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 Sulindac is and what it is used for 2. What you need to know before you take Sulindac 3. How to take Sulindac 4. Possible side effects 5. How to store Sulindac 6. Contents of the pack and other information 1. WHAT SULINDAC IS AND WHAT IT IS USED FOR Sulindac belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is a painkiller and antipyretic (reduces fever). Sulindac works by reducing inflammation and relieving pain, swelling and stiffness in the joints and muscles. There are a number of painful conditions that can affect your joints and muscles, which can be helped by taking Sulindac. These conditions include: - Rheumatoid arthritis - Osteoarthritis - Ankylosing spondylitis (arthritis in the spine) - Gout - Musculo-skeletal disorders such as sprains, strains and other injuries. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SULINDAC DO NOT TAKE SULINDAC IF YOU - are allergic to sulindac or any of the other ingredients of this medicine (listed in section 6) - have taken an NSAID in the past (e.g. ibuprofen, aspirin) and suffered an allergic reaction or had problems such as bleeding or ulcers - have a stomach or gut ulcer, bleeding in your stomach or know that you have suffered with ulcers, stomach bleeding or perforation in the past - have severe heart failure - have severe liver or kidney problems - are already tak Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sulindac 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of sulindac Excipients with known effect: Each tablet contains 18 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM 8mm flat bevel-edged orange yellow tablet marked “SD” breakline “100” on one side and “ α ” on the reverse. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Sulindac is a non-steroidal anti-inflammatory drug with analgesic and antipyretic activity and is indicated in rheumatoid arthritis, osteoarthritis, acute gouty arthritis, ankylosing spondylitis and musculoskeletal and periarticular disorders such as tendinitis, tenosynovitis, and bursitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: For oral administration. Sulindac should always be taken with fluids either with food or immediately after food and is normally taken twice a day. The usual adult dosage is 400 mg a day and doses above this level are not recommended. Lower doses may be found sufficient. Seven days treatment is usually sufficient for acute gouty arthritis. For peri-articular disorders treatment should be no longer than 7 to 10 days. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). _ _ _Paediatric population _ Not recommended. _ _ _Older people _ Older people 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 patient should be monitored regularly for GI bleeding during NSAID therapy. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. NSAIDS are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin Read the complete document