Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indometacin
Sandoz Ltd
M01AB01
Indometacin
25mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
SAME SIZE ARTWORK 430 x 140 mm Front • Lower back pain • Pain, inflammation and swelling following muscle or bone surgery • Period pain • Disease of the hip joint In addition, Indometacin capsules may be prescribed for acute gouty arthritis. 2. What you need to know before you take Indometacin Capsules Do not take Indometacin capsules if you: • are allergic to indometacin or any of the other ingredients of this medicine (listed in section 6), for example, if you have experienced breathing difficulties, skin rashes which look like nettle rash, or a runny nose or if you are hypersensitive to aspirin or another non steroidal anti-inflammatory medicine. • If you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two episodes of peptic ulcers, stomach bleeding or perforation. • If you have polyps in your nose, associated with itching, nettle rash, wheezing, or swelling of the face, lips, tongue and/or throat or difficulties in swallowing or breathing. • If you are in the third trimester of pregnancy or while you are breastfeeding (see pregnancy, breast feeding and fertility) Warnings and Precautions Talk to your doctor or pharmacist before taking Indometacin Capsules if y o u : • are epileptic • have Parkinson’s disease • have a psychiatric problem • have heart disease, high blood pressure or have a tendency for fluid retention • are being treated for infection or you have a fever • know you suffer from asthma, digestive tract, liver or kidney disease, diabetes or heart failure • have a problem with your blood clotting. 140 mm 430 mm Package leaflet: Information for the user INDOMETACIN 25 MG CAPSULES Indometacin 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 ma Přečtěte si celý dokument
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 Přečtěte si celý dokument