ARTHREXIN indometacin Consumer Medicine Information What is in this leaflet • swelling of the face, lips, tongue or other Tell your doctor if you currently have an parts of the body infection. This leaflet answers some common questions • rash, itching or hives on the skin ARTHREXIN may hide some of the signs of about ARTHREXIN. It does not contain all If you are allergic to aspirin or NSAID an infection. This may make you think, the available information. It does not take the mistakenly, that you are better or that it is place of talking to your doctor or pharmacist. medicines and use ARTHREXIN, the above symptoms may be severe. less serious than it might be. All medicines have risks and benefits. Your Do not take this medicine if you are Signs of an infection include fever, pain, doctor has weighed the risks of you taking swelling or redness. ARTHREXIN against the benefits they pregnant or intend to become pregnant. If you have not told your doctor about any expect it will have for you. Women considering pregnancy should not use ARTHREXIN unless advised to by their of the above, tell them before you start If you have any concerns about taking this doctor. ARTHREXIN may have a reversible taking ARTHREXIN. medicine, ask your doctor or pharmacist. inhibitory effect on fertility. Taking other medicines Keep this leaflet with the medicine. The safety of this medicine during pregnancy You may need to read it again. Tell your doctor or pharmacist if you are has not been established. taking any other medicines, including any that you get without a prescription from What ARTHREXIN is used for Do not breastfeed if you are taking this medicine. your pharmacy, supermarket or health ARTHREXIN contains the active ingredient, The active ingredient in ARTHREXIN food shop. indometacin. It belongs to a group of passes into breast milk and there is a Some medicines and ARTHREXIN may medicines called Non-Steroidal Anti- possibility that your baby may be affected. interfere with each other. These include: Inflammatory Drugs (NSAIDs). Do not take ARTHREXIN if: • aspirin, salicylates or other NSAID ARTHREXIN is used to relieve pain and • you have an active peptic ulcer (i.e. a medicines (e.g. ibuprofen) reduce inflammation (swelling, redness and stomach or duodenal ulcer) or have had • anticoagulants such as warfarin, a soreness) that may occur in the following peptic ulcers more than once before medicine used to prevent blood clots conditions: • you have severe heart failure • digoxin, a medicine used to treat heart • different types of arthritis including • you have recently had heart bypass failure or irregular heart beats rheumatoid arthritis, osteoarthritis, gouty surgery arthritis, ankylosing spondylitis and • lithium, a medicine used to treat mood degenerative joint disease of the hip • you have severe liver failure swings and some types of depression • gout • you experience asthma attacks, hives or • probenecid, a medicine used to treat gout rash or itching of the nose, throat or eyes • muscle and bone injuries such as sprains, • diuretics, also known as fluid or water with aspirin or other NSAIDs strains, low back pain (lumbago) and tablets tendonitis, such as tennis elbow • you are vomiting blood or material that • some medicines used to treat high blood looks like coffee grounds • pain and swelling after setting broken or pressure or heart conditions, including dislocated bones • you are bleeding from the back passage, ACE inhibitors or betablockers or have black sticky bowel motions or medicines used in combination with a • menstrual cramps (period pain) bloody diarrhoea thiazide diuretic Although ARTHREXIN can relieve the Do not take this medicine after the expiry • decongestants symptoms of pain and inflammation, it will date printed on the pack has passed or if not cure your condition. • ciclosporin, a medicine used to prevent the packaging is torn or shows signs of organ transplant rejection or suppress the Ask your doctor if you have any questions tampering. immune system about why this medicine has been If it has expired or is damaged, return it to • methotrexate, a medicine used to treat prescribed for you. your pharmacist for disposal. Your doctor may have prescribed it for arthritis and certain types of cancers If you are not sure whether you should another reason. These medicines may be affected by start taking this medicine, talk to your This medicine is not addictive. ARTHREXIN or may affect how well it doctor. works. You may need different amounts of It is available only with a doctor's Before you start to take it your medicines or you may need to take prescription. Tell your doctor if you have allergies to different medicines. There is not enough information to any other medicines, including aspirin and Your doctor and pharmacist have more recommend the use of this medicine for other NSAID medicines, foods, dyes or information on medicines to be careful with children under the age of 2 years preservatives. or avoid while taking ARTHREXIN. Before you take ARTHREXIN Tell your doctor if you have, or have had, Use in the elderly any of the following medical conditions: Elderly patients may be more sensitive to the When you must not take it • stomach ulcers or other stomach effects or side effects of this medicine. Do not take ARTHREXIN if you have an problems allergy to: • heartburn or indigestion How to take ARTHREXIN • any medicine containing indometacin • bowel or intestinal problems such as Follow all directions given to you by your • aspirin or any other NSAID medicines ulcerative colitis doctor and pharmacist carefully. • any of the ingredients listed at the end of • kidney or liver disease They may differ from the information contained in this leaflet. this leaflet • diabetes If you do not understand the instructions Many medicines used to treat headache, • high blood pressure or heart disease period pain and other aches and pains contain on the box/bottle, ask your doctor or • history of chest pain (angina), heart pharmacist for help. aspirin or other NSAID medicines. problems or stroke How much to take If you are not sure if you are taking any of • history of swelling in the feet or ankles these medicines, ask your doctor or Your doctor will tell you how many capsules pharmacist. • a tendency to bleed or other blood you need to take each day. The dose will problems Some of the symptoms of an allergic reaction depend on the condition being treated and may include: • psychiatric problems your response to the treatment. Your initial • shortness of breath • seizures or fits (epilepsy) dose will be maintained or adjusted until a satisfactory response is noted. • wheezing or difficulty breathing • Parkinson's disease • asthma • eye disease

ARTHREXIN Published by MIMS July 2021 1 The dose varies from patient to patient. The While you are taking ARTHREXIN Do not be alarmed by the following list of usual dose is between 50 mg and 200 mg per side effects. day, given in divided doses. Things you must do You may not experience any of them. Elderly patients may need smaller doses. If you are about to be started on any new Ask your doctor or pharmacist to answer Tell your doctor of any changes in your medicine, remind your doctor and any questions you may have. condition, as you may require a change in pharmacist that you are taking Tell your doctor or pharmacist if you the dose of ARTHREXIN. ARTHREXIN. notice any of the following and they worry The dose for menstrual cramps (period pain) Tell any other doctors, dentists and you: is usually one 25 mg capsule every eight pharmacists who treat you that you are • stomach upset or pain including nausea hours, starting with the onset of bleeding or taking this medicine. (feeling sick), vomiting, cramps, loss of cramps. If you are going to have surgery, tell the appetite How to take it surgeon or anaesthetist that you are • heartburn or indigestion (possible taking this medicine. symptoms of an ulcer in the tube that Swallow the capsules whole with a full ARTHREXIN may cause prolonged bleeding glass of water. carries food from the throat to the and may need to be stopped before surgery. stomach) ARTHREXIN may also be taken with food, If you become pregnant while taking this Some of the stomach upset, such as nausea milk or an antacid, if advised by your doctor medicine, tell your doctor immediately. or pharmacist. and heartburn, may be reduced by taking the Tell your doctor if you get an infection capsules with food or an antacid, if advised This may help reduce the possibility of while taking ARTHREXIN. by your doctor or pharmacist. stomach and bowel problems. ARTHREXIN may hide some of the signs of • constipation, diarrhoea When to take it an infection and may make you think, mistakenly, that you are better or that it is • hearing disturbances such as buzzing or Take ARTHREXIN with or immediately ringing in the ears after food. less serious than it might be. • headache, dizziness, light-headedness How long to take it Signs of an infection include fever, pain, swelling or redness. may occur in the first few days of Continue taking your medicine for as long treatment. If this worries you or as your doctor tells you to. If you are about to have any blood tests, continues, contact your doctor tell your doctor that you are taking this Depending on your condition, you may need medicine. • tiredness this medicine for a few days, a few weeks or • change in mood such as depression, for longer periods. Keep all of your doctor's appointments so that your progress can be checked. anxiety or irritability As with other NSAID medicines, if you are ARTHREXIN can increase blood pressure in These are the more common side effects of using ARTHREXIN for arthritis, it will not some people, so your doctor will want to ARTHREXIN. cure your condition but it should help to check your blood pressure from time to time. Tell your doctor immediately if you notice control pain, swelling and stiffness. If you any of the following: have arthritis, ARTHREXIN should be taken As blurred vision is a possible side effect of every day for as long as your doctor long term therapy with ARTHREXIN, • severe pain or tenderness in the stomach prescribes. patients should visit their optometrist for • eye problems such as blurred vision or regular eye checks. For sprains and strains, ARTHREXIN is difficulty seeing usually only needed for a few days. Things you must not do • fast or irregular heartbeats, also called For gout, ARTHREXIN can be stopped Do not take ARTHREXIN to treat any palpitations when all symptoms subside. other complaints unless your doctor tells • signs of frequent or worrying infections you to. For menstrual cramps, ARTHREXIN should such as fever, severe chills, sore throat be taken at the start of bleeding or cramps Do not give your medicine to anyone else, or mouth ulcers and continued for as long as the cramps last. even if they have the same condition as • bleeding or bruising more easily than you. If you forget to take it normal Do not stop taking your medicine or lower • signs of anaemia, such as tiredness, If it is almost time for your next dose, skip the dosage without checking with your being short of breath, looking pale the dose you missed and take your next doctor. dose when you are meant to. • yellowing of the skin and eyes, also Things to be careful of called jaundice Otherwise, take it as soon as you remember, and then go back to taking Be careful driving or operating machinery • unusual weight gain or swelling of your medicine as you would normally. until you know how ARTHREXIN affects ankles or legs you. Do not take a double dose to make up for • dark coloured or cloudy urine or pain in As with other NSAID medicines, this the dose you missed. the kidney region medicine may cause dizziness or light- This may increase the chance of you getting • difficulty in passing water (urinating) or headedness in some people. If this occurs, do an unwanted side effect. a sudden decrease in the amount of urine not drive, operate machinery or do anything passed If you are not sure what to do, ask your else that could be dangerous. doctor or pharmacist. • drowsiness, disorientation, forgetfulness If you drink alcohol, the dizziness or light- If you have trouble remembering to take headedness may be worse. • shakiness, sleeplessness, nightmares your medicine, ask your pharmacist for • tingling or numbness of the hands or feet some hints. Side effects If any of the following happen, tell your If you take too much (overdose) doctor immediately or go to Accident and Tell your doctor or pharmacist as soon as Emergency at your nearest hospital: Immediately telephone your doctor or the possible if you do not feel well while you Poisons Information Centre (telephone 13 are taking ARTHREXIN. • vomiting blood or material that looks 11 26) for advice, or go to Accident and like coffee grounds. This may occur at This medicine helps most people with pain or Emergency at the nearest hospital, if you any time during use and without warning inflammation, but it may have unwanted side think you or anyone else may have taken effects in a few people. All medicines can • bleeding from the back passage, black too much ARTHREXIN. Do this even if have side effects. Sometimes they are sticky bowel motions (stools) or bloody there are no signs of discomfort or serious, most of the time they are not. You diarrhoea. This may occur at any time poisoning. may need medical attention if you get some during use and without warning You may need urgent medical attention. of the side effects. • swelling of the face, lips or tongue Symptoms of an overdose may include If you are over 65 years of age, have liver or which may cause difficulty in nausea, vomiting, headache, dizziness, kidney problems or are diabetic, you may swallowing or breathing confusion, fatigue, numbness or fits. have an increased chance of getting side • sudden or severe itching, skin rash or effects. hives on the skin

ARTHREXIN Published by MIMS July 2021 2 • asthma, wheezing, shortness of breath • severe dizziness, light-headedness or fainting • seizures or fits • pain or tightness in the chest The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare. Tell your doctor if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

After taking ARTHREXIN Storage Keep your capsules in the pack until it is time to take them. If you take the capsules out of the pack they may not keep well. Keep your tablets in a cool dry place where the temperature stays below 30°C. Do not store ARTHREXIN or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines. Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines. Disposal If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine left over.

Product description What it looks like ARTHREXIN capsules are white and are marked with "IN-25". Each bottle contains 50 capsules. Ingredients ARTHREXIN contains 25 mg of indometacin as the active ingredient. The capsules also contain: • lactose monohydrate • sodium starch glycollate • sodium lauryl sulfate • magnesium stearate • Empty hard gelatin capsules bovine size 3 white-opaque/white-opaque G3ICSRA0399 1 U (proprietary ingredient: 140186) • Opacode Black A-10259 (proprietary ingredient: 1659) The capsules are gluten free. Manufacturer Alphapharm Pty Limited (ABN 93 002 359 739) Level 1, 30 The Bond 30-34 Hickson Road Millers Point NSW 2000 Phone: (02) 9298 3999 www.mylan.com.au ARTHREXIN 25 mg capsules: AUST R 353403 This leaflet was prepared in May 2021. arthrexin_cmi\May21/00

ARTHREXIN Published by MIMS July 2021 3