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Indometacin 25Mg and 50Mg Capsules - speech disorder, fits or seizures, worsening of By reporting side effects you can help provide more epilepsy, disorder of the nerves causing tingling information on the safety of this medicine. and numbness, pins and needles - uncontrolled movements, worsening of 5 How to store Indometacin capsules parkinsonism (tremor, stiffness and shuffling). Keep out of the sight and reach of children. • Heart: Store below 25°C in a dry place. Protect from light. - fluid retention causing swelling, chest pain, heart Do not take Indometacin capsules after the expiry Indometacin 25mg failure (symptoms include shortness of breath, date which is stated on the label/carton/bottle. tiredness, increased heart rate, flushing, swelling - Medicines should not be disposed of via wastewater and 50mg capsules especially of the ankles) or household waste. Ask your pharmacist how to - high and low blood pressure (symptoms include dispose of medicines no longer required. These dizziness, fainting, light-headedness, nausea, measures will help to protect the environment. heart attack) Read all of this leaflet carefully before 2 What you need to know before you take - racing heart beat, irregular heart beat, 6 Contents of the pack and other you start taking this medicine because it Indometacin capsules palpitations. Do not take Indometacin capsules if you: • Blood vessels: information contains important information for you. • Keep this leaflet. You may need to read it • are in the last three months of pregnancy or - flushing. What Indometacin capsules contain while you are breast-feeding (see “Pregnancy • Breathing: • The active substance (the ingredient that makes the again. and breast-feeding”) - increase in the number of white blood cells in the medicine work) is indometacin PhEur. Each capsule • If you have any further questions, ask your • are allergic (hypersensitive) to indometacin or lungs contains either 25mg or 50mg indometacin. any of the ingredients of Indometacin capsules (see - narrowing of the airways in those who have a • The other ingredients are starch 1500, powdered doctor or pharmacist. • This medicine has been prescribed for you section 6) history of asthma or allergic disease. cellulose, colloidal silicon dioxide, magnesium • are allergic (hypersensitive) to aspirin, ibuprofen • Stomach and intestines: stearate, yellow iron oxide (E172), titanium dioxide only. Do not pass it on to others. It may or other NSAIDs or you have developed signs of - loss of appetite (E171), gelatin, shellac glaze, iron oxide black (E172), harm them, even if their signs of illness are asthma (wheezing), runny nose, swelling of the - development or worsening of ulcerative colitis or propylene glycol. the same as yours. face, lips, tongue or throat, or a skin rash with pale Crohn’s disease or red irregular raised patches with severe itching, - inflammation of the pancreas causing pain What Indometacin capsules look like and • If you get any side effects, talk to your contents of the pack when taking these medicines and tenderness in the abdomen and back doctor or pharmacist. This includes any • are taking other NSAIDs (e.g. naproxen) including (pancreatitis). Indometacin capsules are ivory, hard, gelatin capsules. Pack size is 28. possible side effects not listed in this leaflet. COX II inhibitors (e.g. celecoxib) • Skin: See section 4. • suffer with angioneurotic oedema (swelling of the - inflammation of blood vessels Marketing Authorisation Holder and face, lips, tongue or throat) - sensitivity to sunlight or artificial light (e.g. sun Manufacturer • have or have had a history of two or more beds) Accord, Barnstaple, EX32 8NS, UK. What is in this leaflet: episodes of peptic ulcer (ulcer in your stomach - tender red lumps usually on the legs (erythema 1 What Indometacin capsules are and or duodenum) or bleeding in your stomach or nodosum) This leaflet was last revised in November 2019 what they are used for intestines in the past. Symptoms may include - hair loss, sweating vomiting particles that look like coffee-grounds, - worsening of psoriasis (itchy scaly pink patches 2 What you need to know before you take Indometacin capsules black tarry stools and blood in your faeces (stools/ on the elbows, knees, scalp and other parts of the motions) body). 3 How to take Indometacin capsules • have severe liver, kidney or heart problems • Liver: 4 Possible side effects • have nasal obstruction (nasal polyps). - blocked bile flow (pale coloured stools, dark urine, itching). 5 How to store Indometacin capsules Indometacin capsules must not be used in • Muscle and bone: If you would like a 6 Contents of the pack and other children. - muscle weakness, increased breakdown of leaflet with larger information Warnings and precautions cartilage. Talk to your doctor before taking • Kidneys: text, please contact Indometacin capsules if you are: - blood in the urine 1 What Indometacin capsules are and what they are used for • elderly (see “Other warnings”) - nephrotic syndrome (increased protein in urine 01271 385257. • to have a vaccination with a live vaccine and fluid retention) Indometacin capsules belong to a group of medicines called non-steroidal anti-inflammatory drugs • a woman trying to become pregnant or - too much protein in the urine undergoing investigation for infertility. - inflammation of the kidneys, reduced kidney (NSAIDs). These medicines are pain killers which reduce swelling. Indometacin may make it more difficult to become function or kidney failure. pregnant. You should inform your doctor if you • Reproductive system: are planning to become pregnant or if you have - bleeding from the vagina Indometacin capsules are for: • inflammatory diseases of the joints such problems becoming pregnant - breast enlargement or tenderness, enlarged • taking medicines poisonous to the kidneys such breasts in men. as rheumatoid arthritis, osteoarthritis and degenerative hip disease as cisplatin or vancomycin. Reporting of side effects • pain and stiffness in the backbone (ankylosing If you get any side effects, talk to your doctor, spondylitis) or if you have: pharmacist or nurse. This includes any possible side • sprains and strains (acute muscle and bone • a history of high blood pressure or congestive effects not listed in this leaflet. disorders) heart failure You can also report side effects directly via • lower back pain • a bleeding or blood clotting disorder the Yellow Card Scheme at: • pain and swelling following muscle or bone surgery • a mental health problem e.g. mood changes www.mhra.gov.uk/yellowcard or search for • period pain • epilepsy MHRA Yellow Card in the Google Play or Apple App • gout. • Parkinson’s Disease (tremor, stiffness and Store. shuffling) • an infection or sepsis (severe infection) 50967738 BBBA4736 296x210 Leaflet Reel Fed Bi Fold Profile (BST) page 4 page 1 Indometacine 25mg & 50mg 28 Tabs PIL - UK Indometacin Hard Capsules 25, approved for print/date Item number: BBBA4736 Colours Non Printing Colours 50mg x 28’s (UK) 1. 1. Originator: RH Dimensions: 296x210 Black Profile JDE No.: 50967738 Origination Date: 09-05-19 Min Body Text Size: 10pt 2. 2. Revision Date: 11-11-19 Supplier: Accord Barnstaple 3. 3. Dimensions: 296x210 (Reel Fed) Revised By: RH 4. Component: Leaflet for Blisters 5. Proof Round Pharmacode: 4453 Technical Date sent: NA 6. 05 Approval Date received: NA Date Sent: 01/05/19 [email protected] Technologist: T. Hull Technically Approved FMD info NA (not a carton) No Yes Details * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 2 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 01.11.2017 • any liver, kidney or heart problems irregular heart beat) - Sudden worsening of a chronic disorder: up to • effects on the stomach such as feeling or being • fluid retention which may be caused by diseases • ciclosporin, tacrolimus or muromonab-CD3 (to 150-200mg a day. Your doctor will decide on the sick, inflammation of the stomach lining, small of the heart or kidneys suppress the immune system) best dose for you. intestine or mouth, constipation, diarrhoea, • asthma or a history of asthma • corticosteriods e.g. prednisolone (used in many - Acute muscle and bone disorders: initially wind, perforation of previous intestinal damage, • have or have a history of gastrointestinal diseases different diseases) 50mg two or three times a day for 10-14 days. narrowing of or blockage in the intestine such as ulcerative colitis or Crohn’s disease • cyclophosphamide or methotrexate (to treat some Your doctor will decide on the best dose for you, • abnormal liver function (as seen in blood tests) • systemic lupus erythematosus (SLE) or other types of cancer and rheumatoid arthritis) depending on the severity of your condition. • liver disease: yellowing of the skin or whites of the connective tissue disorders • desmopressin (for diabetes insipidus and frequent - Lower back pain: 50mg two or three times a day eyes (jaundice), inflammation of the liver (hepatitis) • diabetes urination during the night) for 5-10 days. Your doctor will decide on the best causing fatigue, weakness, loss of appetite, weight • a decreased amount of fluid around the cells of • diuretics (water tablets) such as triamterene, dose for you, depending on the severity of your loss, abdominal pain, fever the body (extracellular volume depletion) thiazides (e.g. bendroflumethiazide) or furosemide condition. • skin reactions such as itching, pale or
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