البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indometacin
Crescent Pharma Ltd
M01AB01
Indometacin
25mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5017123072130
PACKAGE LEAFLET: INFORMATION FOR THE USER INDOMETACIN 25 MG & 50 MG CAPSULES 1. WHAT INDOMETACIN IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDOMETACIN 3. HOW TO TAKE INDOMETACIN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE INDOMETACIN 6. CONTENTS OF THE PACK AND OTHER INFORMATION Indometacin capsules belongs to a group of medicines called non-steroidal anti-Inflammatory drugs (NSAIDs). These medicines are pain killers which reduce swelling. Indometacin capsules are for: inflammatory disease of the joints such as rheumatoid arthritis, osteoarthritis and degenerative hip disease pain and stiffness in the backbone (ankylosing spondylitis) sprain and strains (acute muscle and bone disorders) low back pain pain and swelling following muscle or bone surgery period pain gout If you are not sure why you have been prescribed this medicine then please ask your doctor. DO NOT TAKE INDOMETACIN CAPSULES IF YOU: are in the LAST THREE MONTHS OF PREGNANCY are ALLERGIC (HYPERSENSITIVE) TO INDOMETACIN or any of the ingredients of Indometacin capsules (see Section 6) are ALLERGIC (HYPERSENSITIVE) TO ASPIRIN, IBUPROFEN OR OTHER NSAIDS or you have developed signs of asthma (wheezing), runny nose, swelling of the face, lips, tongue or throat or a skin rash with pale or red irregular raised patches with severe itching, when taking these medicines are taking other NSAIDS (e.g. naproxen) including COX II INHIBITORS (e.g. celecoxib) suffer with ANGIONEUROTIC OEDEMA (swelling of the face, lips, tongue or throat) have or have had a history of two or more episodes of PEPTIC ULCERS (ulcer in your stomach or duodenum) OR BLEEDING IN YOUR STOMACH or INTESTINES in the past. Symptoms may include vomiting particles that look like coffee-grounds, black tarry stools and blood in your faeces (stools/motions) have severe LIVER, KIDNEY or HEART problems have NASAL OBSTRUCTION (nasal polyps). WARNING AND PRECAUTIONS If you are elderly or you have previously had stomach ulc اقرأ الوثيقة كاملة
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 اقرأ الوثيقة كاملة