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Home , Indometacin

• Blood: • : - small purple red spots, nosebleeds, bruising, - blocked bile flow (pale coloured stools, dark , disorder characterised by blood spots, blood itching). clotting throughout the body, disturbance of • Muscle and bone: blood count, reduction in blood cell production - muscle weakness, increased breakdown of by the bone marrow. If you notice increased cartilage. bruising, nosebleeds, sore throats, infections, • Kidneys: Indometacin 25mg excessive tiredness, breathlessness on exertion, - blood in the urine or abnormal paleness of the skin, you should tell - (increased protein in urine your doctor who may want you to have a blood and fluid retention) and 50mg capsules test. - too much protein in the urine • Metabolism: - of the kidneys, reduced - high blood sugar function or . Read all of this leaflet carefully before you - sugar in the urine • Reproductive system: 2 Before you take Indometacin capsules - high blood levels of (muscle cramps - bleeding from the vagina start taking this medicine. Do not take Indometacin capsules if you: or , irregular heart beat, unusual tiredness or - breast enlargement or tenderness, enlarged • Keep this leaflet. You may need to read it • are in the last three months of pregnancy weakness). breasts in men. again. • are allergic (hypersensitive) to indometacin or any of the ingredients of Indometacin capsules (see • Nervous system: If you notice any of these side effects, or they get • If you have any further questions, ask your - , dizziness, lightheadedness, spinning section 6) worse or you notice any side effects not listed, doctor or pharmacist. • are allergic (hypersensitive) to , sensation (vertigo), tiredness, fainting, a feeling of please tell your doctor or pharmacist. general discomfort and illness, drowsiness, coma, • If any of the side effects gets serious or or other NSAIDs or you have developed signs of fluid in the brain causing swelling asthma (wheezing), runny nose, swelling of the face, 5 How to store Indometacin capsules if you notice any side effects not listed - depression, nervousness, confusion, in this leaflet, please tell your doctor or lips, tongue or throat, or a skin rash with pale or red hallucinations, anxiety and other mental health Keep out of the reach and sight of children. irregular raised patches with severe itching, when problems, a feeling of unreality (that the mind is Store below 25°C in a dry place. Protect from light. pharmacist. taking these medicines separated from the body), difficulty sleeping Do not take Indometacin capsules after the expiry • This medicine has been prescribed for you. • are taking other NSAIDs (e.g. ) including - speech disorder, fits or seizures, worsening of date which is stated on the label/carton/bottle. Do not pass it on to others. It may harm COX II inhibitors (e.g. ) Medicines should not be disposed of via wastewater , disorder of the nerves causing tingling them, even if their symptoms are the same • suffer with angioneurotic oedema (swelling of the and numbness, pins and needles or household waste. Ask your pharmacist how to face, lips, tongue or throat) - uncontrolled movements, worsening of dispose of medicines no longer required. These as yours. • have or have had a history of two or more parkinsonism (tremor, stiffness and shuffling). measures will help to protect the environment. episodes of peptic ulcer (ulcer in your • Heart: In this leaflet: or duodenum) or bleeding in your stomach or intestines in the past. Symptoms may include - fluid retention causing swelling, chest pain, heart 6 Further information 1 What Indometacin capsules are and failure vomiting particles that look like coffee-grounds, What Indometacin capsules contain what they are used for black tarry stools and blood in your faeces (stools/ - high and low blood pressure • The active substance (the ingredient that makes the - racing heart beat, irregular heart beat, 2 Before you take Indometacin capsules motions) medicine work) is indometacin PhEur. Each capsule • have severe liver, kidney or heart problems palpitations contains either 25mg or 50mg indometacin. 3 How to take Indometacin capsules • Blood vessels: • have nasal obstruction (nasal polyps). • The other ingredients are starch 1500, powdered 4 Possible side effects - flushing. Indometacin capsules must not be used in cellulose, colloidal silicon dioxide, magnesium 5 How to store Indometacin capsules • Breathing: stearate, yellow iron oxide (E172), titanium dioxide children. - increase in the number of white blood cells in the 6 Further information (E171), gelatin, shellac glaze, iron oxide black (E172), Check with your doctor before taking lungs propylene glycol. - narrowing of the airways in those who have a 1 What Indometacin capsules are and Indometacin capsules if you are: history of asthma or allergic disease. What Indometacin capsules look like and • elderly (see “Other warnings”) • Stomach and intestines: what they are used for • to have a vaccination with a live vaccine contents of the pack Indometacin capsules belong to a group of medicines - loss of appetite Indometacin capsules are ivory, hard, gelatin capsules. • a woman trying to become pregnant or called non-steroidal anti-inflammatory drugs - development or worsening of ulcerative colitis or Pack size is 28. undergoing investigation for infertility (NSAIDs). These medicines are pain killers which Crohns disease Indometacin may make it more difficult to become reduce swelling. - inflammation of the pancreas causing pain Marketing Authorisation Holder and Manufacturer pregnant. You should inform your doctor if you and tenderness in the abdomen and back Actavis, Barnstaple, EX32 8NS, UK. Indometacin capsules are for: are planning to become pregnant or if you have (pancreatitis). • inflammatory diseases of the joints such problems becoming pregnant • Skin: This leaflet was last revised as , and • taking medicines poisonous to the kidneys such - inflammation of blood vessels in July 2013. degenerative hip disease as cisplatin or vancomycin. - sensitivity to sunlight or artificial light (e.g. sun If you would like a • pain and stiffness in the backbone (ankylosing or if you have: beds) spondylitis) • a history of high blood pressure or congestive - tender red lumps usually on the legs (erythema leaflet with larger • sprains and strains (acute muscle and bone heart failure nodosum) text, please contact disorders) • a bleeding or blood clotting disorder - hair loss, sweating • lower back pain • a mental health problem e.g. mood changes - worsening of psoriasis (itchy scaly pink patches 01271 311257. • pain and swelling following muscle or bone surgery • epilepsy on the elbows, knees, scalp and other parts of the • period pain • Parkinson’s Disease (tremor, stiffness and body). • . shuffling) • an infection or sepsis (severe infection) AAAF5110 50740411 AAAF5110 50740411

page 4 Actavis, Barnstaple, EX32 8NS, UK 296x210 reel fed bi-fold leaflet profile UK BST (DR/RW/MC 10.02.11) page 1

Indomentacin Capsules 25mg & 50mg 28 Capsules PIL - UK colours/plates: 1. Black

item no: AAAF5110 50740411 dimensions: 296x210 Reel fed 2. 3. print proof no: 2 pharmacode: 3691 4. origination date: 18.06.13 min pt size: 5. R.Wrey (BST Technical) originated by: SA 6. approved for print/date Non Printing Colours revision date: 31.07.13 Technical Approval 1. revised by: SA date sent: 05/06/13 2. supplier: Actavis UK technically app. date: 05/06/13 3. • any liver, kidney or heart problems • haloperidol (an antipsychotic drug) 3 How to take Indometacin capsules 4 Possible side effects • fluid retention which may be caused by diseases • zalcitabine, or ritonavir (for HIV Always take Indometacin capsules exactly as your Like all medicines, Indometacin capsules can cause of the heart or kidneys infection) doctor has told you. If you are not sure, check with side effects, although not everybody gets them. • asthma or a history of asthma • cardiac glycosides e.g. digoxin (for heart failure and your doctor or pharmacist. • have or have a history of gastrointestinal diseases irregular heart beat) STOP TAKING the medicine and seek immediate such as ulcerative colitis or Crohns disease • ciclosporin, tacrolimus or muromonab-CD3 (to Swallow the capsules with or after food, milk or medical help if you develop any of the following at • systemic erythematosus (SLE) or other suppress the immune system) antacids ( remedy) to reduce side effects any time during your treatment: connective tissue disorders • corticosteriods e.g. prednisolone (used in many on the stomach and intestines. • signs of bleeding in the stomach: • diabetes different diseases) Dose - Pass blood in your faeces (stools/motions) • a decreased amount of fluid around the cells of • cyclophosphamide or methotrexate (to treat some • Adults: - Pass black tarry stools the body (extracellular volume depletion) types of cancer and rheumatoid arthritis) - Acute rheumatoid arthritis: initially 25mg two or - Vomit any blood or dark particles that look like • peripheral arterial disease (a problem with the • desmopressin (for diabetes insipidus and frequent three times a day. coffee grounds circulation in the legs). urination during the night) - Chronic joint disorders: 25mg two or three • signs of an allergic reaction: • (water tablets) such as , times a day. Your doctor may increase your dose - difficulty breathing or swallowing, asthma, Other warnings thiazides (e.g. bendroflumethiazide) or furosemide sudden decrease in blood pressure If you are elderly or you have previously had depending on your response, up to a maximum of • (for some mental health problems) 200mg a day. - swelling of the face, lips, tongue or throat. stomach ulcers, you have a higher risk of getting • mifepristone (for termination of pregnancy). side effects, especially from the stomach. Your doctor - Sudden worsening of a chronic disorder: up to Indometacin capsules should not be taken within 150-200mg a day. Your doctor will decide on the STOP TAKING the medicine and tell your doctor if should therefore prescribe the lowest dose that gives 8-12 days of taking mifepristone you experience: you sufficient relief. If you experience any unusual best dose for you. • baclofen (a muscle relaxant) - Acute muscle and bone disorders: initially • indigestion or symptoms from the stomach, you must tell your • pentoxifylline (for blood vessel disease and leg • abdominal pain ( in your stomach) or other doctor about it. 50mg two or three times a day for 10-14 days. ulcers) Your doctor will decide on the best dose for you, abnormal stomach symptoms Medicines such as indometacin may be associated • (for gout) depending on the severity of your condition. • effects on the stomach such as feeling or being with a small increased risk of heart attack • tiludronic acid (for Paget’s disease of bone). - Lower back pain: 50mg two or three times a day sick, inflammation of the stomach lining, small (“myocardial infarction”) or stroke. Any risk is more intestine or mouth, constipation, diarrhoea, Pregnancy and breast-feeding for 5-10 days. Your doctor will decide on the best likely with high doses and prolonged treatment. Do dose for you, depending on the severity of your wind, perforation of previous intestinal damage, not exceed the recommended dose or duration of If you are in the last three months of pregnancy, you narrowing of or blockage in the intestine must not take Indometacin capsules. You should condition. treatment. - Acute attack of gout: 50mg three or four times a • abnormal liver function (as seen in blood tests) only take Indometacin capsules in the first six • liver disease: yellowing of the skin or whites of the If you have heart problems, previous stroke or think months of pregnancy or if you are breast-feeding day until symptoms decrease. you might be at risk of these conditions (for example - After muscle or bone surgery: 100-150mg a eyes (jaundice), inflammation of the liver () under medical supervision. Always ask your doctor causing fatigue, weakness, loss of appetite, weight if you have high blood pressure, diabetes or high before taking any medicine. day in divided doses, to be taken until symptoms cholesterol or are a smoker) you should discuss your decrease. loss, abdominal pain, treatment with your doctor or pharmacist. Driving and using machines • skin reactions such as itching, pale or red irregular Indometacin capsules may make you feel, drowsy, • Elderly: raised patches with severe itching (hives), disorder Taking pain killers for too often or for too If you are elderly, your doctor will give you the characterised by blood spots, bruising and long can make them worse. dizzy or affect your vision. Make sure you are not affected before you drive or operate machinery. lowest effective dose for the shortest amount of discolouring of the skin (purpura), blisters or skin Taking other medicines time. that is red, flaky or peeling such as severe rash Please tell your doctor or pharmacist if you are Tests involving reddening, peeling and swelling of the Your doctor may want to carry out tests to monitor • Children: skin that resembles severe burns (toxic epidermal taking, or have recently taken, any other medicines, Indometacin capsules must not be used in children. including medicines obtained without a prescription, your kidney and liver function, the levels of blood necrolysis), circular, irregular red patches on the particularly: cells and the effects on your stomach and intestines If you take more Indometacin capsules than skin of the hands and arms (erythema multiforme), • other non-steroidal anti-inflammatory drugs (especially if you are elderly). If you have or have had you should severe form of skin rash with flushing, fever, blisters (NSAIDs) including aspirin, naproxen or COX II a history of high blood pressure or heart failure your It is important not to take too many capsules. Contact or ulcers (Stevens Johnson syndrome) inhibitors (e.g. celecoxib) or (for pain and doctor may also want to monitor you. If you have your doctor or nearest hospital casualty department • aseptic meningitis (stiff neck, headache, feeling or inflammation) rheumatoid arthritis you may be advised to have immediately, if you have taken more capsules than being sick, fever, disorientation) especially in those • quinolone antibiotics e.g. ciprofloxacin (to treat regular eye tests to check your sight. you should or a child accidentally swallows any. who already have an auto-immune disease such as infections) Symptoms of overdose are headache, feeling or systemic lupus erythematosus or mixed connective Surgery tissue disease. • medicines which thin the blood or which prevent If you are about to have, or have recently had being sick, stomach pain, bleeding in the stomach blood clotting, such as warfarin or antiplatelet drugs surgery, please contact your doctor before using this or intestines, diarrhoea, disorientation, excitement, Medicines such as Indometacin may be associated such as clopidogrel medicine. coma, drowsiness, dizziness, ringing or buzzing in with a small increased risk of heart attack (“myocardial • selective serotonin reuptake inhibitors (SSRIs) e.g. the ears, fainting, fits or seizures, kidney failure, liver infarction”) or stroke (see Section 2 ‘Other warnings’). fluoxetine (for depression) damage. Tell your doctor or pharmacist if you notice any of • metformin or sulphonylureas e.g. gliclazide (for If you forget to take Indometacin capsules the following side effects: diabetes) • Eyes: • phenytoin (for epilepsy) If you forget to take your capsules, take the missed dose as soon as you remember, unless it is nearly - blurred and double vision • diazepam (for anxiety, difficulty sleeping, - inflammation of the optic nerve (which may withdrawal, seizures and muscle spasm) time for your next dose. Do not take a double dose to make up for one you have missed. cause eye pain and loss of vision) • medicines used to treat high blood pressure such - eye pain as beta blockers (e.g. atenolol), alpha blockers (e.g. - changes in your sight. prazosin), ACE inhibitors (e.g. lisinopril), angiotensin • Ear: II antagonists (e.g. valsartan), hydralazine - ringing or buzzing in the ears (vasodilator) or - hearing disturbances including deafness.

page 2 296x210 reel fed bi-fold leaflet profile UK BST (DR/RW/MC 10.02.11) page 3

Indomentacin Capsules 25mg & 50mg 28 Capsules PIL - UK colours/plates: 1. Black

item no: AAAF5110 50740411 dimensions: 296x210 Reel fed 2. 3. print proof no: 2 pharmacode: 3691 4. origination date: 18.06.13 min pt size: 5. R.Wrey (BST Technical) originated by: SA 6. approved for print/date Non Printing Colours revision date: 31.07.13 Technical Approval 1. revised by: SA date sent: 05/06/13 2. supplier: Actavis UK technically app. date: 05/06/13 3.