País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indometacin
A A H Pharmaceuticals Ltd
M01AB01
Indometacin
100mg
Suppository
Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
INDOMETACIN 100MG SUPPOSITORIES READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell 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 symptoms are the same as yours. IN THIS LEAFLET: 1. WHAT INDOMETACIN SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU USE INDOMETACIN SUPPOSITORIES 3. HOW TO USE INDOMETACIN SUPPOSITORIES 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE INDOMETACIN SUPPOSITORIES 6. FURTHER INFORMATION 1. WHAT INDOMETACIN SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR Indometacin suppositories belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines are pain killers which reduce swelling. Indometacin suppositories are for: inflammatory diseases of the joints such as rheumatoid arthritis, osteoarthritis and degenerative hip disease pain and stiffness in the backbone (ankylosing spondylitis) sprains and strains (acute muscle and bone disorders) lower back pain pain and swelling following muscle or bone surgery period pain gout. 2. BEFORE YOU USE INDOMETACIN SUPPOSITORIES DO NOT USE INDOMETACIN SUPPOSITORIES IF YOU: are in the LAST THREE MONTHS OF PREGNANCY are ALLERGIC (HYPERSENSITIVE) TO INDOMETACIN or any of the ingredients of Indometacin suppositories (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) or COX II INHIBITORS (e.g. Celecoxib) suffer with ANGIONEUROTIC OEDEMA (swelling of t Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Indometacin Suppositories BP 100mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains 100mg Indometacin 3 PHARMACEUTICAL FORM Yellow suppositories 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indometacin has non-steroidal analgesic and anti-inflammatory properties. It is indicated for the following conditions: • active stages of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, degenerative joint disease of the hip, acute musculoskeletal disorders, gout and lumbago • inflammation, pain and oedema following orthopaedic procedures • treatment of pain and associated symptoms of primary dysmenorrhoea Since indometacin is not a simple analgesic, its use should be limited to the above conditions. Indometacin suppositories may be used where night pain and morning stiffness are prominent. One suppository at bedtime frequently gives relief from pain and stiffness for 13-16 hours after administration. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults only_: To be inserted rectally. One suppository (100mg) to be inserted at night and repeated in the morning, if necessary. _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. _Children_:_ _Safety for use in children has not been established. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). _Method of Administration _ For rectal administration 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-inf Leia o documento completo