APO-Meloxicam Tablets Contains the active ingredient, meloxicam Consumer Medicine Information For a copy of a large print leaflet, Ph: • You have a disease of the heart with • high cholesterol or other risk factors for heart 1800 195 055 shortness of breath, and swelling of the disease feet or lips due to fluid build-up • heartburn, indigestion, ulcers or other What is in this leaflet • You experience bleeding from the stomach problems such as bleeding from the stomach, gut or any other bleeding digestive tract Read this leaflet carefully before taking your • • medicine. You have had a stroke resulting from a kidney or liver disease bleed in the brain or have a bleeding • asthma or any other breathing problems This leaflet answers some common questions disorder about meloxicam. It does not contain all the 3. You are using an IUD (Intra-Uterine Device) • available information. It does not take the place You currently have a peptic (stomach) for birth control. of talking to your doctor or pharmacist. ulcer 4. You are pregnant or planning to become • The information in this leaflet was last updated You have Crohn's Disease or Ulcerative pregnant. Do not take this medicine whilst on the date listed on the last page. More recent Colitis pregnant until you and your doctor have information on this medicine may be available. • You have severe liver or kidney problems discussed the risks and benefits involved. Ask your doctor or pharmacist: • You are currently taking other medicines 5. You are planning to have surgery. • if there is anything you do not understand in known as: sulfinpyrazone (used to treat 6. You are currently receiving or are planning this leaflet, gout), fluconazole (used to treat fungal to receive dental treatment. infections) or certain sulfur antibiotics (eg. 7. You are taking or are planning to take any • if you are worried about taking your sulfaphenazole or sulfamethoxazole) other medicines. This includes vitamins and medicine, or • You are breastfeeding or intend to supplements that are available from your • to obtain the most up-to-date information. breastfeed pharmacy, supermarket or health food shop. All medicines have risks and benefits. Your Meloxicam may pass into breast milk and Some medicines may interact with meloxicam. doctor has weighed the risks of you using this affect your baby. These include: medicine against the benefits they expect it will • You have had any of the following • any other medicines used to treat high blood have for you. symptoms after taking aspirin or other pressure and some other heart problems- Pharmaceutical companies cannot give you NSAIDS: asthma, nasal polyps, swollen such as ACE inhibitors, angiotensin receptor medical advice or an individual diagnosis. face or urticaria antagonists and diuretics (also called fluid or Keep this leaflet with your medicine. You may • You are hypersensitive to, or have had an water tablets). When taken together these want to read it again. allergic reaction to, meloxicam, aspirin or medicines can cause kidney problems. any other NSAID, or any of the • aspirin, salicylates or other NSAID What this medicine is used for ingredients listed at the end of this leaflet. medicines This includes rare inherited conditions of • medicines used to thin your blood (such as The name of your medicine is APO- Meloxicam. galactose intolerance. These tablets warfarin, heparin and ticlopidine) It contains the active ingredient meloxicam. contain lactose • lithium, a medicine used to treat some types It is used to treat the symptoms of: Symptoms of an allergic reaction may include shortness of breath, wheezing or of mood disorders • osteoarthritis difficulty breathing; swelling of the face, • antidepressants called selective serotonin • rheumatoid arthritis. lips, tongue, throat or other parts of the body, reuptake inhibitors (SSRIs) Both diseases mainly affect the joints, causing itching or hives on the skin. • methotrexate, a medicine used to treat pain and swelling. If you think you are having an allergic rheumatoid arthritis, psoriasis and some reaction, contact your doctor immediately Although meloxicam can relieve symptoms such types of cancer or go to the Accident and Emergency as pain and inflammation, it will not cure your • department at the nearest hospital. cyclosporin, a medicine used to treat condition. Other serious allergic reactions include rheumatoid arthritis and certain problems Ask your doctor if you have any questions about Erythema Multiforme (red patches on the with the immune system why this medicine has been prescribed for you. arms, legs and face with blisters on the lips • pemetrexed, used to treat lung cancer Your doctor may have prescribed this medicine and lining of the mouth), Stevens-Johnson • diuretics, also called fluid or water tablets for another reason. syndrome (rash with blisters) and Toxic (e.g. frusemide) Epidermal Necrolysis (blisters covering large Ask your doctor if you have any questions about • medicines used to treat high blood pressure areas of the body, with peeling or burning of why this medicine has been prescribed for you. • Your doctor may have prescribed this medicine large amounts of skin). medicines used to treat heart problems (such for another reason. Make especially sure that you tell your as amiodarone or quinidine) doctor if you have had these or any type of • medicines used to treat diabetes This medicine is available only with a doctor's skin reaction before. prescription. • cholestyramine, a medicine used to treat high • It has passed the expiry date (EXP) cholesterol levels in the blood How it works printed on the pack. • corticosteroids (drugs usually used to treat Meloxicam belongs to a family of medicines • The packaging is torn, shows signs of inflammatory conditions, such as skin rash called Non-Steroidal Anti-inflammatory Drugs tampering or it does not look quite right. and asthma) (NSAIDs). These medicines work by relieving • pain and inflammation. Before you start to take it some medicines used to treat fungal infections (such as fluconazole, This medicine is available only with a doctor's Before you start taking this medicine, tell your doctor if: ketoconazole, itraconazole) prescription. • 1. You have allergies to: some sulfur antibiotics (such as Use in children sulfaphenazole and sulfamethoxazole) • any other medicines including aspirin or • Do not give meloxicam to children and other NSAID medicines some antihistamines (medicines used for adolescents under 18 years of age. • allergy, hay fever or insect stings), e.g. lactose - this medicine contains lactose terfenadine. • any other substances, such as foods, Before you take this medicine If you are taking any of these you may need a preservatives or dyes. different dose or you may need to take different When you must not take it 2. You have or have had any medical medicines. conditions, especially the following: Do not take this medicine if: Other medicines not listed above may also • • You are about to undergo coronary artery high blood pressure or fluid retention interact with meloxicam. bypass graft surgery • diabetes

APO-Meloxicam Tablets Published by MIMS September 2015 1 How to take this medicine • blurred vision • constipation or diarrhoea • dizziness • dizziness or light-headedness Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may • fits or seizures • skin rashes which may be caused by be different to the information in this leaflet. • low blood pressure exposure to sunlight, can blister and may take on the appearance of a severe burn How much to take • difficulty in breathing • increase in blood pressure Your doctor or pharmacist will tell you how • impaired consciousness, or coma • tinnitus (ringing in the ear). much of this medicine you should take. This will • kidney failure depend on your condition and whether you are Tell your doctor as soon as possible if you taking any other medicines. notice any of the following. While you are taking this medicine For the treatment of osteoarthritis: These may be serious side effects and you may The usual dose is 7.5 mg, taken as a single dose Things you must do need medical attention. each day. Your doctor may increase this to 15 mg Tell your doctor that you are taking this medicine • blurred vision once each day if necessary. if: • any change in the amount or colour of your For the treatment of rheumatoid arthritis: • you are about to be started on any new urine (red or brown) or any pain or difficulty The usual dose of meloxicam is 15 mg taken as a medicine experienced when urinating single dose each day. • you get an infection. • collapse or fainting, shortness of breath or Depending on your response, your doctor may Meloxicam may hide some of the signs of an tiredness, fast or irregular heartbeat (also reduce this dose to 7.5 mg taken as a single dose infection (e.g. pain, fever, redness and called palpitations), chest pain, swollen or each day. swelling). You may think, mistakenly, that sore leg veins The maximum recommended daily dose of you are better or that the infection is not • severe pain or tenderness in the stomach serious. meloxicam is 15 mg. • yellowing of the skin and eyes (known as • For patients with kidney problems undergoing you are about to have any blood tests jaundice) • dialysis, the maximum recommended daily dose you are going to have surgery (including • severe dizziness is 7.5 mg. dental surgery). Meloxicam can affect blood • clotting. swelling of your ankles, legs or other parts of Do not stop taking your medicine or change your your body dosage without first checking with your doctor. Your doctor may occasionally do tests to make • signs of anaemia (such as tiredness, being sure the medicine is working and to prevent side How to take it short of breath and looking pale). effects. Go to your doctor regularly for a check- Swallow the tablets with some fluid. up. If you experience any of the following, stop taking your medicine and contact your doctor When to take it Tell any other doctors, dentists and pharmacists immediately or go to the Accident and who are treating you that you take this medicine. Take this medicine immediately after food to Emergency department at your nearest avoid the chance of an upset stomach. Things you must not do hospital. Take this medicine at the same time each day, Do not: These are very serious side effects. You may either morning or evening. Taking it at the same • Give this medicine to anyone else, even if need urgent medical attention or hospitalisation. time each day will have the best effect and will their symptoms seem similar to yours. • also help you remember when to take it. vomiting of blood or material that looks like • Take your medicine to treat any other coffee grounds How long to take it for condition unless your doctor or pharmacist • bleeding from your back passage (rectum), Continue taking your medicine for as long as tells you to. black sticky motions (stools) or bloody your doctor tells you. • Stop taking your medicine, or change the diarrhoea Make sure you have enough to last over dosage, without first checking with your • weakness in one part or side of your body, weekends and holidays. doctor. slurred speech or visual disturbances If you forget to take it Things to be careful of • unable to pass urine If it is almost time for your next dose, skip the Be careful when driving or operating • collapse or fainting, shortness of breath or missed dose and take your next dose at the usual machinery until you know how this medicine tiredness and/or chest pain time. affects you. • These are very serious side effects. You may Otherwise, take it as soon as you remember and As with other NSAID medicines, meloxicam may need urgent medical attention or then go back to taking your medicine as you cause dizziness, drowsiness or blurred vision in hospitalisation. some people. would normally. Other side effects not listed above may occur in Do not take a double dose to make up for Make sure you know how you react to some patients. meloxicam before you drive a car, operate missed doses. Allergic reactions This may increase the chance of unwanted side machinery, or do anything else that could be effects. dangerous if you are not alert. If you think you are having an allergic reaction to meloxicam, stop taking this If you have trouble remembering to take your Possible side effects medicine and tell your doctor immediately or medicine, ask your pharmacist for some hints. go to the Accident and Emergency department If you take too much (overdose) Tell your doctor or pharmacist as soon as possible at your nearest hospital. if you do not feel well while you are taking If you think that you or anyone else may have Symptoms of an allergic reaction may include meloxicam or if you have any questions or taken too much of this medicine, immediately some or all of the following: concerns. telephone your doctor or the Poisons • cough, shortness of breath, wheezing or Information Centre (Tel: 13 11 26 in Do not be alarmed by the following lists of side difficulty breathing and/or stuffy nose and/or Australia) for advice. Alternatively go to the effects. You may not experience any of them. All nasal polyps Accident and Emergency Department at your medicines can have side effects. Sometimes they • are serious but most of the time they are not. swelling of the face, lips, tongue, throat or nearest hospital. other parts of the body Tell your doctor or pharmacist if you notice Do this even if there are no signs of discomfort • sudden or severe rash, itching or hives on the any of the following: or poisoning. You may need urgent medical skin attention. • stomach upset including nausea, vomiting, • fainting heartburn, indigestion, burping. wind, cramps If you take too much meloxicam, you may • experience any or all of the following: or pain hay fever-like symptoms • nausea and/or vomiting • headache • headache • sore throat or discomfort when swallowing • drowsiness • 'flu'-like symptoms, including • coughing and/or fever or chills

APO-Meloxicam Tablets Published by MIMS September 2015 2 Storage and disposal Storage Keep your medicine in its original packaging until it is time to take it. If you take your medicine out of its original packaging it may not keep well. Keep your medicine in a cool dry place where the temperature will stay below 25°C. Do not store your medicine, 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 it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description What APO-Meloxicam looks like • APO-Meloxicam 7.5 mg tablets Pastel yellow, round, biconvex tablets. Engraved "APO" on one side and "7.5" on the other side. Blister packs of 30 tablets. • APO-Meloxicam 15 mg tablets Pastel yellow, round, flat-faced, bevelled- edge tablets. Scored and engraved "MEL" over "15" on one side, "APO" on the other side. Blister packs of 30 tablets. Ingredients Each tablet contains 7.5 or 15 mg of meloxicam as the active ingredient. It also contains the following inactive ingredients: • lactose • microcrystalline cellulose • sodium bicarbonate • croscarmellose sodium • magnesium stearate • colloidal anhydrous silica. Australian Registration Numbers • APO-Meloxicam 7.5 mg tablets Blister packs AUST R 127503. • APO-Meloxicam 15 mg tablets Blister packs AUST R 127510. Sponsor Apotex Pty Ltd 16 Giffnock Avenue Macquarie Park NSW 2113 APO and APOTEX are registered trade marks of Apotex Inc. This leaflet was last updated in April 2015.

APO-Meloxicam Tablets Published by MIMS September 2015 3