Indometacin 25Mg and 50Mg Capsules

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- 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 red • peripheral arterial disease (a problem with the • lithium (for some mental health problems) - Acute attack of gout: 50mg three or four times a irregular raised patches with severe itching (hives), circulation in the legs). • mifepristone (for termination of pregnancy). day until symptoms decrease. disorder characterised by blood spots, bruising Indometacin capsules should not be taken within - After muscle or bone surgery: 100-150mg a and discolouring of the skin (purpura), blisters or Other warnings 8-12 days of taking mifepristone day in divided doses, to be taken until symptoms skin that is red, flaky or peeling such as severe rash If you are elderly or you have previously had • baclofen (a muscle relaxant) decrease. involving reddening, peeling and swelling of the stomach ulcers, you have a higher risk of getting • pentoxifylline (for blood vessel disease and leg - Period pain: up to 75mg daily, continuing for as skin that resembles severe burns (toxic epidermal side effects, especially from the stomach. Your doctor ulcers) long as symptoms last. necrolysis), circular, irregular red patches on the should therefore prescribe the lowest dose that gives • probenecid (for gout) skin of the hands and arms (erythema multiforme), you sufficient relief. If you experience any unusual • antacids (used to relieve heartburn, upset stomach • Elderly: severe form of skin rash with flushing, fever, blisters symptoms from the stomach, you must tell your or acid indigestion) If you are elderly, your doctor will give you the or ulcers (Stevens Johnson syndrome) doctor about it. • tiludronic acid (for Paget’s disease of bone). lowest effective dose for the shortest amount of • aseptic meningitis (stiff neck, headache, feeling or Medicines such as indometacin may be associated time. being sick, fever, disorientation) especially in those with a small increased risk of heart attack Pregnancy and breast-feeding who already have an auto-immune disease such as Do not take Indometacin capsules if you are in the • Children: (“myocardial infarction”) or stroke. Any risk is more Indometacin capsules must not be used in children. systemic lupus erythematosus or mixed connective likely with high doses and prolonged treatment. Do last three months of pregnancy. You should only tissue disease. not exceed the recommended dose or duration of take Indometacin capsules in the first six months of If you take more Indometacin capsules than pregnancy or if you are breast-feeding under medical Medicines such as Indometacin may be associated treatment. you should with a small increased risk of heart attack (“myocardial supervision. Always ask your doctor before taking any It is important not to take too many capsules. Contact If you have heart problems, previous stroke or think medicine. infarction”) or stroke (see Section 2 ‘Other warnings’). you might be at risk of these conditions (for example your doctor or nearest hospital casualty department immediately, if you have taken more capsules than Tell your doctor or pharmacist if you notice any of if you have high blood pressure, diabetes or high Driving and using machines the following side effects: cholesterol or are a smoker) you should discuss your Indometacin capsules may make you feel, drowsy, you should or a child accidentally swallows any. Symptoms of overdose are headache, feeling or • Eyes: treatment with your doctor or pharmacist. dizzy, tired or affect your vision. Make sure you are - blurred and double vision not affected before you drive or operate machinery. being sick, stomach pain, bleeding in the stomach Taking painkillers for headaches too often or for too or intestines, diarrhoea, disorientation, excitement, - inflammation of the optic nerve (which may long can make them worse. Tests coma, drowsiness, dizziness, ringing or buzzing in cause eye pain and loss of vision) Other medicines and Indometacin capsules Your doctor may want to carry out tests to monitor the ears, fainting, fits or seizures, kidney failure, liver - eye pain your kidney and liver function, the levels of blood damage. - changes in your sight. Please tell your doctor or pharmacist if you are • Ear: taking, or have recently taken, any other medicines, cells and the effects on your stomach and intestines (especially if you are elderly). If you have or have had If you forget to take Indometacin capsules - ringing or buzzing in the ears including medicines obtained without a prescription, If you forget to take your capsules, take the missed - hearing disturbances including deafness. particularly: a history of high blood pressure or heart failure your doctor may also want to monitor you. If you have dose as soon as you remember, unless it is nearly • Blood: • other non-steroidal anti-inflammatory drugs time for your next dose. Do not take a double dose to - small purple red spots, nosebleeds, bruising, (NSAIDs) including aspirin, naproxen or COX II rheumatoid arthritis you may be advised to have make up for one you have missed. disorder characterised by blood spots, blood inhibitors (e.g. celecoxib) or diflunisal (for pain and regular eye tests to check your sight. clotting throughout the body, disturbance of inflammation) Surgery blood count, reduction in blood cell production • quinolone antibiotics e.g. ciprofloxacin (to treat 4 Possible side effects If you are about to have, or have recently had by the bone marrow. If you notice increased infections) Like all medicines, Indometacin capsules can cause surgery, please contact your doctor before using this bruising, nosebleeds, sore throats, infections, • medicines which thin the blood or which prevent side effects, although not everybody gets them. medicine. excessive tiredness, breathlessness on exertion, blood clotting, such as warfarin or antiplatelet STOP TAKING the medicine and seek immediate or abnormal paleness of the skin, you should tell drugs such as clopidogrel medical help if you develop any of the following your doctor who may want you to have a blood • selective serotonin reuptake inhibitors (SSRIs) e.g. 3 How to take Indometacin capsules test. fluoxetine (for depression) Always take Indometacin capsules exactly as your at any time during your treatment: • Metabolism: • metformin or sulfonylureas e.g. gliclazide (for doctor has told you. If you are not sure, check with • signs of bleeding in the stomach: diabetes) your doctor or pharmacist. - Pass blood in your faeces (stools/motions) - high blood sugar - Pass black tarry stools - sugar in the urine • phenytoin (for epilepsy) Swallow the capsules with or immediately after food, • diazepam (for anxiety, difficulty sleeping, alcohol - Vomit any blood or dark particles that look like - high blood levels of potassium (muscle cramps or with milk or antacids (indigestion remedy) to coffee grounds or pain, irregular heart beat, unusual tiredness or withdrawal, seizures and muscle spasm) reduce side effects on the stomach and intestines. • medicines used to treat high blood pressure such • signs of an allergic reaction: weakness). - difficulty breathing or swallowing, asthma, • Nervous system: as beta blockers (e.g. atenolol), alpha blockers (e.g. Dose prazosin), ACE inhibitors (e.g. lisinopril), angiotensin sudden decrease in blood pressure - headache, dizziness, lightheadedness, spinning • Adults: - swelling of the face, lips, tongue or throat. sensation (vertigo), tiredness, fainting, a feeling of II receptor antagonists (e.g. valsartan), hydralazine - Acute rheumatoid arthritis: initially 25mg two or (vasodilator) or nifedipine general discomfort and illness, drowsiness, coma, three times a day. STOP TAKING the medicine and tell your doctor if fluid in the brain causing swelling • haloperidol (an antipsychotic drug) - Chronic joint disorders: 25mg two or three • zalcitabine, zidovudine or ritonavir (for HIV you experience: - depression, nervousness, confusion, times a day. Your doctor may increase your dose • indigestion or heartburn hallucinations, anxiety and other mental health infection) depending on your response, up to a maximum of • cardiac glycosides e.g. digoxin (for heart failure and • abdominal pain (pains in your stomach) or other problems, a feeling of unreality (that the mind is 200mg a day. abnormal stomach symptoms separated from the body), difficulty sleeping

296x210 Leaflet Reel Fed Bi Fold Profile (BST) page 2 page 3 Indometacine 25mg & 50mg 28 Tabs PIL - UK

296x210 Leaflet Reel Fed Bi Fold Profile (BST) page 4 page 1 Indometacine 25mg & 50mg 28 Tabs PIL - UK