Land: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indometacin
Kent Pharma (UK) Ltd
M01AB01
Indometacin
25mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
PATIENT INFORMATION LEAFLET INDOMETACIN 25MG CAPSULES INFLAMID 25MG CAPSULES READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE AS IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have further questions, ask your doctor or your 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. IN THIS LEAFLET 1. What Indometacin Capsules are and what they are used for 2. What you need to know before you take Indometacin Capsules 3. How to take Indometacin Capsules 4. Possible side effects 5. How to store Indometacin Capsules 6. Contents of the pack and other information 1. WHAT INDOMETACIN CAPSULES ARE AND WHAT THEY ARE USED FOR Indometacin belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Indometacin works by reducing inflammation and relieving pain, swelling and stiffness in the joints and muscles. Indometacin is used to relieve some symptoms caused by: • gout (pain and inflammation of the joints) • rheumatoid arthritis • osteoarthritis • acute musculoskeletal disorders (e.g. sprains, strains and other injuries, such as backache and neck ache) • lower back pain • ankylosing spondylitis (arthritis of the spine) • degenerative hip disease • pain following bone and joint surgery • period pain 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDOMETACIN CAPSULES DO NOT TAKE INDOMETACIN CAPSULES IF YOU: • are allergic (hypersensitive) to indometacin or any other ingredients in these capsules. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue • suffer from severe heart failure, a disease of the heart that causes shortness of breath and swelling of the feet or legs due to fluid build up • Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Indometacin Capsules BP 25 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 25 mg of indometacin For excipients, see 6.1 3 PHARMACEUTICAL FORM lndometacin capsules are presented as size 3, ivory opaque shells printed with ‘IND 25’ and company logo. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indometacin capsules are indicated for the pain and inflammation associated with the following conditions. Active stages of rheumatoid arthritis. Osteoarthritis. Ankylosing spondylitis. Degenerative joint disease of the hip. Acute musculoskeletal disorders. Low back pain. Acute gout. Inflammation, pain and oedema following orthopaedic procedures. Pain and associated symptoms of primary dysmenorrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. To be taken preferably with or after food, milk or an antacid. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Chronic conditions Adults: 25 mg two to four times daily increased if required, up to 200 mg daily. The recommended oral dose range is 50 – 200 mg daily in divided doses. Acute gouty arthritis Adults: 150 – 200 mg daily in divided doses until all signs and symptoms subside. Dysmenorrhoea Up to 75 mg daily until the symptoms subside. Paediatric dosage: Not established Elderly: 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 patient should be monitored regularly for GI bleeding during NSAID therapy. 4.3 CONTRAINDICATIONS • Hypersensitivity to indometacin or to any of the excipients. • NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs Lestu allt skjalið