Meloxicam AN tablets meloxicam

Consumer Medicine Information

What is in this leaflet Ask your doctor if you have any • you have a disease of the heart questions about why with shortness of breath, and This leaflet answers some common MELOXICAM AN has been swelling of the feet or lips due to prescribed for you. questions about MELOXICAM AN. fluid build-up Your doctor may have prescribed It does not contain all available • you experience bleeding from the MELOXICAM AN for another information, nor does it take the stomach, gut or any other reason. place of talking to your doctor or bleeding pharmacist. • you have had a stroke resulting All medicines have risks and from a bleed in the brain or have benefits. Your doctor has weighed a bleeding disorder Before you take • the risks of you taking MELOXICAM AN you are breastfeeding, or intend MELOXICAM AN against the to breastfeed benefits they expect it will have for The active ingredient in you. When you must not take it MELOXICAM AN may pass into breast milk and may affect your Keep this information. Do not take MELOXICAM AN if baby. You may need to read it again later. you have an allergy to: • you currently have a peptic If you have any concerns about • the active ingredient, meloxicam, (stomach) ulcer taking this medicine, ask your or any of the other ingredients in • you have Crohn's Disease or doctor or pharmacist. MELOXICAM AN (all of these Ulcerative Colitis ingredients are listed at the end of • you have severe liver or kidney this leaflet). This includes rare problems inherited conditions of galactose • you are currently taking other What MELOXICAM AN intolerance is used for medicines known as: • aspirin or any other NSAID sulfinpyrazone (used to treat medicine. gout), fluconazole (used to treat MELOXICAM AN is used to treat Some of the symptoms of an allergic fungal infections) or certain the symptoms of: reaction may include: sulfur antibiotics (e.g. • osteoarthritis • rash, itching or hives on the skin sulfaphenazole or • rheumatoid arthritis sulfamethoxazole). • swelling of the face, lips, tongue Both diseases mainly affect the joints or other parts of the body Do not give MELOXICAM AN to causing pain and swelling. children and adolescents under 18 • shortness of breath, wheezing or years of age. Although MELOXICAM AN can troubled breathing. relieve symptoms such as pain and Ask your doctor if you are unsure Do not take MELOXICAM AN if inflammation, it will not cure your if you are allergic to these the packaging is torn or shows condition. ingredients. signs of tampering. MELOXICAM AN belongs to a Do not take MELOXICAM AN if: Do not take MELOXICAM AN if family of medicines called Non- the EXPIRY DATE printed on the • Steroidal Anti-inflammatory Drugs you are about to undergo pack has passed. (NSAIDs). These medicines work by coronary artery bypass graft surgery relieving pain and inflammation. Before you start to take it

You must tell your doctor or pharmacist if:

Meloxicam AN tablets Published by MIMS October 2015 1 • you have any allergies to any • lithium, a medicine used to treat How much to take other medicines, including aspirin some types of depression For the treatment of osteoarthritis or other NSAID medicines • antidepressants called selective The usual dose of MELOXICAM • you have or have had any medical serotonin reuptake inhibitors AN is 7.5 mg, taken as a single dose conditions, especially the (SSRIs) each day. following: • methotrexate, a medicine used to - high blood pressure or fluid treat rheumatoid arthritis (a However, your doctor will prescribe retention painful joint disease) and some a dose suitable for your condition. - diabetes types of cancer For the treatment of rheumatoid - high cholesterol • cyclosporin, a medicine used to arthritis - heartburn, indigestion, ulcers or treat rheumatoid arthritis and The usual dose of MELOXICAM other stomach problems certain problems with the AN is 15 mg taken as a single dose - kidney or liver disease immune system each day. - asthma or any other breathing • diuretics, also called fluid or problems Depending on your response, your water tablets doctor may reduce this dose to 7.5 • you are using an IUD for birth • medicines used to treat high mg taken as a single dose each day. control blood pressure • you are pregnant or intend to The maximum recommended daily • medicines used to treat heart become pregnant dose of MELOXICAM AN is 15 mg. problems If it is necessary for you to take For patients with kidney problems • medicines to treat diabetes MELOXICAM AN, your doctor undergoing dialysis, the maximum • will discuss the risks and benefits cholestyramine, a medicine used recommended daily dose is 7.5 mg. of taking it during pregnancy. to treat high cholesterol levels in Ask your doctor for more • the blood you are taking MELOXICAM information if you have been • corticosteroids (drugs usually AN together with any medicines advised to take a different dose. used to treat high blood pressure used to treat inflammatory and some other heart problems conditions, such as skin rash and How to take it such as ACE inhibitors, asthma) • angiotensin receptor antagonists some medicines used to treat Swallow the tablets with fluid. and diuretics (also called fluid or fungal infections It is best to take MELOXICAM AN water tablets). • some sulfur antibiotics immediately after food to avoid the • When taken together these medicines some medicines used to treat chance of an upset stomach. can cause kidney problems. irregular heart beats • some antihistamines (medicines Try to take MELOXICAM AN at If you have not told your doctor or the same time each day, either used to prevent or relieve the pharmacist about any of the above, morning or evening. tell them before you start taking symptoms of allergy, such as hay MELOXICAM AN. fever or insect stings). How long to take it These medicines may be affected by Taking other medicines MELOXICAM AN or may affect Keep taking MELOXICAM AN how well MELOXICAM AN works. every day until your doctor tells Before taking MELOXICAM AN, Your doctor or pharmacist has more you to stop. tell your doctor or pharmacist if information on medicines to be MELOXICAM AN will not cure you are taking any other careful with or avoid while taking your condition but it should help medicines, including medicines MELOXICAM AN. control pain, swelling and stiffness. that you buy without a prescription from a pharmacy, supermarket or health food shop. If you forget to take it There may be interference between How to take If it is almost time for your next MELOXICAM AN and some dose (e.g. within 2-3 hours), skip medicines. These include: MELOXICAM AN the dose you missed and take the • next dose when you are meant to. aspirin, salicylates or other Follow all directions given to you NSAID medicines by your doctor or pharmacist Otherwise, take it as soon as you • medicines used to thin your blood carefully. remember, then go back to taking (such as warfarin, heparin and They may differ from the it as you would normally. ticlopidine) information contained in this leaflet.

Meloxicam AN tablets Published by MIMS October 2015 2 Do not try to make up for missed If you get an infection while using • skin rashes, which may be caused doses by taking more than one dose MELOXICAM AN, tell your by exposure to sunlight, can at a time. doctor. blister and may take on the MELOXICAM AN may hide some If you are not sure what to do, appearance of a severe burn check with your doctor or of the signs of an infection (e.g. pain, • increase in blood pressure fever, redness and swelling). You pharmacist. • tinnitus (ringing in the ear). may think, mistakenly, that you are better or that the infection is not These side effects are usually mild. If you have taken too much serious. (overdose) Tell your doctor immediately if you notice any of the following: Immediately telephone your doctor Things to be careful of • blurred vision or Poisons Information Centre • any change in the amount or (telephone 13 11 26) for advice, or Be careful driving or operating colour of your urine (red or go to Accident and Emergency at machinery until you know how brown) your nearest hospital if you think MELOXICAM AN affects you. that you or anyone else may have As with other NSAID medicines, • any pain or difficulty experienced taken too much MELOXICAM MELOXICAM AN may cause when urinating AN. Do this even if there are no dizziness, drowsiness or blurred • collapse or fainting, shortness of signs of discomfort or poisoning. vision in some people. breath or tiredness, fast or Signs of an overdose with Make sure you know how you irregular heartbeat (also called MELOXICAM AN may include: react to MELOXICAM AN before palpitations), chest pain, swollen or sore leg veins • nausea and/or vomiting you drive a car, operate machinery, or do anything else that • severe pain or tenderness in the • headache could be dangerous if you are not stomach • drowsiness alert. • severe dizziness • blurred vision • yellowing of the skin and eyes • dizziness (known as jaundice) • fits or seizures • swelling of your ankles, legs or • low blood pressure Side Effects other parts of your body • difficulty in breathing • You should be aware that all signs of anaemia (such as • impaired consciousness medicines carry some risks and that tiredness, being short of breath • kidney failure. all possible risks may not be known and looking pale) at this stage despite thorough testing. • irritation of your mucous membranes (e.g. lips, mouth, eyes Check with your doctor as soon as or genitals). While taking possible if you have any problems while taking MELOXICAM AN, These are rare but serious side MELOXICAM AN even if you do not think the effects. You may need urgent problems are connected with the medical attention. medicine or are not listed in this If any of the following happen, Things you must do leaflet. STOP taking MELOXICAM AN If you become pregnant while Tell your doctor if you notice any and tell your doctor immediately taking MELOXICAM AN, tell of the following and they worry or go to Emergency at your nearest your doctor immediately. you: hospital: If you are about to start any new • stomach upset including nausea, • vomiting of blood or material that medicines, tell your doctor and vomiting, heartburn, indigestion, looks like coffee grounds pharmacist that you are taking belching, cramps or pain • bleeding from your back passage MELOXICAM AN. • headache (rectum), black sticky motions If you are going to have surgery, • sore mouth or throat, discomfort (stools) or bloody diarrhoea including dental surgery, tell your when swallowing • swelling of the face, lips or doctor or dentist that you are • constipation, diarrhoea or wind tongue which may make taking MELOXICAM AN. swallowing or breathing difficult • dizziness or light-headedness MELOXICAM AN can slow down • asthma, wheezing or shortness of • skin rash or itching blood clotting. breath • sudden or severe itching, skin rash or hives

Meloxicam AN tablets Published by MIMS October 2015 3 • weakness in one part or side of Product Description your body, slurred speech, blurred vision or visual disturbances. What MELOXICAM AN looks These are rare but very serious side like effects. You may need urgent MELOXICAM AN (7.5 & 15 mg medical attention or hospitalisation. meloxicam) is presented in pack Not all of these side effects have sizes of 30's & 60's in blister packs. been reported with MELOXICAM • MELOXICAM AN 7.5 mg AN but have been seen with similar (AUST R 188880) medicines. Light yellow, round, uncoated Other side effects not listed above tablet with score line between 'F' may occur in some people. and '1' debossed on one side and plain on the other side. Tell your doctor if you notice • anything else that is making you MELOXICAM AN 15 mg feel unwell. (AUST R 188879) Light yellow, round, uncoated Do not be alarmed by this list of tablet with score line between 'F' possible side effects. You may not and '2' debossed on one side and experience any of them. plain on the other side.

Ingredients After taking Active Ingredient: MELOXICAM AN Meloxicam. Each tablet may contain either 7.5 mg or 15 mg of Meloxicam. Storage Other Ingredients: Keep your tablets in their pack • sodium citrate until it is time to take them. • lactose If you take them out of their • microcrystalline cellulose packaging, they will not keep well. • povidone Keep MELOXICAM AN in a cool • crospovidone dry place where the temperature • colloidal anhydrous silica stays below 25°C and protected from light. • magnesium stearate. MELOXICAM AN should not be Name and Address of the stored in direct sunlight or heat. Sponsor Keep your tablets where children cannot reach them. Amneal Pharma Australia Pty Ltd A locked cupboard at least one-and 12 River Street one-half metres above the ground is a South Yarra 3141 good place to store medicines. Australia Date of Preparation Disposal October 2014

Your pharmacist or doctor should be able to safely dispose of any unused MELOXICAM AN.

Meloxicam AN tablets Published by MIMS October 2015 4