APO-Glimepiride Contains the active ingredient glimepiride Consumer Medicine Information For a copy of a large print leaflet, Ph: 1800 Ask your doctor if you have any questions Talk to your doctor or pharmacist if you are 195 055 about why this medicine has been prescribed not sure whether you should start taking this for you. medicine. What is in this leaflet This medicine is available only with a doctor's Before you start to take it prescription. Tell your doctor if: This leaflet answers some common questions There is no evidence that this medicine is about APO-Glimepiride. It does not contain all of addictive. 1. You have allergies to: the available information. - any other medicines - lactose It does not take the place of talking to your doctor Before you take this medicine or pharmacist. - any other substances such as food, preservatives, or dyes All medicines have risks and benefits. Your When you must not take it 2. You have or have had any medical doctor has weighed the risks of you taking this Do not take this medicine if you have had an conditions, especially the following: medicine against the benefits this medicine is allergic reaction to: expected to have for you. - liver problems • glimepiride or other sulfonylureas - kidney problems Ask your doctor or pharmacist if you have any • antibiotics called sulphonamides - a deficiency in the enzyme in your body concerns about taking this medicine. • thiazide diuretics (a type of fluid or water called glucose-6-phosphate dehydrogenase Keep this leaflet with the medicine. tablets) (G6PD) You may need to read it again. • - a history of diabetic coma lactose (these tablets contain lactose) - adrenal, pituitary or thyroid problems • What this medicine is used for any of the ingredients listed at the end of this - heart failure leaflet 3. You drink alcohol in any amount The name of your medicine is APO-Glimepiride. Symptoms of an allergic reaction may include: 4. You do not eat regular meals It contains the active ingredient glimepiride. • shortness of breath 5. You do a lot of exercise or you do heavy This type of diabetes is also known as non- • wheezing or difficulty breathing exercise or work insulin-dependent diabetes mellitus (NIDDM) or maturity onset diabetes. • swelling of the face, lips, tongue, throat or 6. You are ill or feeling unwell other parts of the body 7. You plan to become pregnant of breast-feed Glimepiride is used when diet and exercise are not enough to control your blood glucose. • muscle pain or tenderness or joint pain or 8. You are taking any other anti-diabetic rash treatments Glimepiride can be used alone, or together with • insulin or other medicines for treating diabetes. itching or hives on the skin. Alcohol, diet, exercise, and your general health all strongly affect the control of your diabetes. How it works Check with your doctor if you are not sure if you have any of the above. If you have not told you doctor, pharmacist, of Glimepiride belongs to a group of medicines diabetes educator about any of the above, tell called sulphonylureas. Do not take this medicine if you have, or have had any of the following conditions: them before you start taking this medicine. Glimepiride lowers high blood glucose by • type 1 diabetes mellitus (insulin dependent Taking other medicines increasing the amount of insulin produced by diabetes mellitus, also known as IDDM, or your pancreas. Tell your doctor if you are taking any other juvenile or growth onset diabetes) medicines, including medicines that you buy If your blood glucose is not properly controlled, • a history of ketoacidosis without a prescription from a pharmacy, you may experience hypoglycaemia (low blood supermarket or health food shop. glucose) or hyperglycaemia (high blood glucose). • unstable diabetes • diabetic ketoacidosis Some medicines may interfere with glimepiride. Hypoglycaemia (low blood glucose) can occur These include: suddenly. Signs may include: • diabetic coma or pre-coma • other medicines used to treat diabetes (tablets • • Weakness, trembling or shaking severe kidney disease or undergoing dialysis and insulin) • • Sweating severe liver disease • some medicines used to treat high blood • Lightheadedness, dizziness, headache or lack • Glucose-6-phosphate dehydrogenase (G6PD) pressure or heart conditions, eg. beta of concentration deficiency blockers, ACE inhibitors, calcium channel • Tearfulness or crying Do not take this medicine if you are pregnant blockers, amiodarone, disopyramide, reserpine or guanethidine • Irritability or plan to become pregnant. Glimepiride may affect your developing baby if • some hormones used in hormone • Hunger you take it during pregnancy. Insulin is more replacement therapy and oral contraceptives • Numbness around the lips and tongue suitable for controlling blood glucose during (oestrogen and progestogens) If not treated promptly, these may progress to: pregnancy. Your doctor will usually replace • monoamine oxidase inhibitors (MAOIs), • Loss of co-ordination glimepiride with insulin while you are pregnant. used for treating depression, Parkinson's • Slurred speech Do not take this medicine of you are breast- Disease or infections feeding or planning to breast-feed. • • Confusion some medicines used for mental illness (eg. Glimepiride can pass into the breast milk and phenothiazines) • Loss of consciousness or seizures harm your baby. • barbiturates, used for epilepsy and sedation Hyperglycaemia (high blood glucose) usually Do not give this medicine to children. during anaesthetics occurs more slowly than low blood glucose. There is not enough experience with the use of • phenytoin, used for epilepsy Signs of high blood glucose may include: glimepiride in children. • medicines for treating high cholesterol / • Lethargy or tiredness Do not take this medicine past the expiry date blood fats • Headache (EXP) printed on the pack. • some medicines used to treat arthritis, pain • Thirst If you take this medicine after the expiry it may not work as well. and inflammation (diclofenac, naproxen, • Passing large amounts of urine ibuprofen, azapropazone, fenyramidol, Do not take this medicine if the packaging is • Blurred vision oxyphenbutazone, phenylbutazone, torn, shows signs of tampering or if it does not salicylates) High blood glucose can lead to serious problems look quite right. • with your heart, eyes, circulation or kidneys. If it has expired or is damaged, return it to your antibiotics called sulfonamides, quinolones, pharmacist for disposal. sulfinpyrazone, tetracyclines, rifampicin, isoniazid, clarithromycin or chloramphenicol

APO-Glimepiride Published by MIMS September 2014 1 • miconazole, or fluconazole, used to treat How to take it While you are taking this medicine fungal infections Swallow the tablets whole with a glass of Things you must do • some medicines used to prevent or treat water. Do not chew tablets. blood clots (warfarin and similar medicines) Take your tablets exactly as your doctor has When to take it • cimetidine, famotidine, nizatidine and prescribed. ranitidine, used to treat acid reflux and Take glimepiride immediately before or with a Tell all doctors, dentists and pharmacists who stomach ulcers meal. are treating you that you are taking Glimepiride tablets are usually taken once a day, • glimepiride. medicines called corticosteroids (e.g. immediately before breakfast. If you only eat a prednisolone, cortisone) light breakfast, you should delay taking the tablet If you plan to have surgery that needs a • anabolic steroids, male sex hormones until the first main meal of the day (e.g. lunch). general anaesthetic, tell your doctor or dentist that you are taking glimepiride. • thyroid hormones, used to treat thyroid Do not skip meals while taking glimepiride problems tablets. Tell your doctor immediately if you become pregnant. • oxpentifylline used to prevent or treat blood Take it at about the same time each day. vessel problems It will also help you remember when to take Tell your doctor if you feel APO-Glimepiride is not helping your condition. • clonidine, used for high blood pressure or them. migraine It is important that you eat regular meals. Tell your doctor that you are taking this medicine if you are about to have any blood • diuretics, also known as fluid tablets (e.g. How long to take it for chlorothiazide) tests. • Continue taking your medicine for as long as Tell your doctor and pharmacist that you are diazoxide, used mainly for treating very high your doctor tells you. blood pressure taking glimepiride if you are about to start Glimepiride will help control your Type 2 taking any new medicines. • acetazolamide, used to treat glaucoma, diabetes but will not cure it. Most people will epilepsy and oedema (swelling due to fluid) need to take glimepiride for long periods of time. Tell all doctors, dentists, pharmacists and • diabetes educators who are involved with your some antidepressants Make sure you have enough to last over treatment that you are taking this medicine. • weight reduction medicines weekends and holidays. Make sure you, your friends, family and work • tritoqualine, an antihistamine Do not skip meals while taking glimepiride colleagues can recognise the symptoms of • trofosfamide, cyclophosphamide, ifosfamide, tablets. hypoglycaemia (low blood glucose) and used for treating certain cancers Take it at about the same time each day. hyperglycaemia (high blood glucose) and know • laxatives (long-term use) It will also help you remember when to take what to do. Provide them with the telephone them. number for your doctor, the Poisons • probenecid, used for treating gout It is important that you eat regular meals. Information Centre (13 11 26 in Australia). • glucagon, used to help balance blood sugar If you forget to take it Always carry some sugary food or drink with levels you. • If it is almost time for your next dose, skip the medicines used in asthma medicines and cold Tell your doctor immediately if you notice the dose you missed and take your next dose when remedies. return of any symptoms of hyperglycaemia you are meant to. These medicines may be affected by glimepiride that you had before starting glimepiride, or if or may affect how well it works. This may result Otherwise, take it as soon as you remember your blood sugar levels are high. (immediately before food), and then go back to in levels of blood sugar which are too high or too These may be signs that glimepiride is no longer taking it as you would normally. low. working, even though you may have been taking In addition, alcohol, certain heart medications Skipping a dose may result in hyperglycaemia. If it successfully for some time. you experience any symptoms of such as beta- blockers, clonidine, guanethidine or If you are elderly or are taking other hyperglycaemia, contact your doctor reserpine, may hide the symptoms of low blood medicines for diabetes (e.g. insulin or immediately. glucose (hypoglycaemia). metformin), the risk of hypoglycaemia (low You may need different amounts of your If you are not sure whether to skip the dose, blood sugar) is increased. talk to your doctor or pharmacist. medicines, or you may need to take different The risk of hypoglycaemia is also increased in medicines. Do not take a double dose to make up for the the following situations: Your doctor and pharmacist can tell you if you dose that you missed. • too much glimepiride are taking any of these medicines. They may also If you double dose this may cause low blood • have more information on medicines to be careful glucose (hypoglycaemia). too much unexpected exercise • with or avoid while taking glimepiride. Ask you pharmacist for some hints if you have delayed meal or snack Drinking alcohol can also affect your blood sugar trouble remembering to take your medicine. • too little food levels and how well glimepiride works. If you take too much (overdose) If you experience any of the signs of hyperglycaemia (high blood glucose), contact Other interactions not listed above may also If you think that you or anyone else may have your doctor immediately. occur. taken too much of this medicine, immediately Ask your doctor or pharmacist if you are not telephone your doctor or the Poisons The risk of hyperglycaemia is increased in the sure if you are taking any of these medicines. Information Centre (Tel: 13 11 26 in following situations: Australia) for advice. Alternatively, go to the • undiagnosed or uncontrolled diabetes How to take this medicine Accident and Emergency department at your • illness, infection or stress nearest hospital. Also report any other • Follow all directions given to you by your doctor, medicine or alcohol which has been taken. too little glimepiride pharmacist or diabetes educator carefully. • Do this even if there are no signs of discomfort taking certain medicines They may differ from the information contained or poisoning. You may need urgent medical • too little exercise in this leaflet. attention. • eating more carbohydrates than normal If you do not understand the instructions on the If you take too much glimepiride, you may • sudden immobilisation, e.g. after an accident box, ask your doctor or pharmacist for help. experience symptoms of hypoglycaemia (low Tell your doctor if you: blood glucose). How much to take • become ill If not treated quickly, these symptoms may Your doctor or pharmacist will tell you how • become dehydrated many tablets you will need to take. This depends progress to loss of co-ordination, slurred speech, • on your condition and whether or not you are confusion, loss of consciousness and fitting. are excessively stressed taking any other medicines. Your doctor may At the first signs of hypoglycaemia, raise your • are injured increase or decrease the dose, depending on your blood glucose quickly by eating jelly beans, • have a fever blood glucose levels. sugar or honey, drinking non-diet soft drink or • have serious infection taking glucose tablets. • are having surgery.

APO-Glimepiride Published by MIMS September 2014 2 Your blood glucose may become difficult to Ask your doctor or pharmacist to answer any Disposal control at these times. Your doctor may decide to questions you may have. If your doctor tells you to stop taking this replace glimepiride with insulin. Tell your doctor if you notice any of the medicine or it has passed its expiry date, your Visit your doctor for regular blood tests and following and they worry you: pharmacist can dispose of the remaining medicine checks of your eyes, feet, kidneys, heart, • signs of hypoglycaemia, which may include safely. circulation, blood, and blood pressure. weakness, trembling or shaking, sweating, Make sure you check your blood glucose levels light-headedness, headache, dizziness, lack Product description regularly. of concentration, tearfulness or crying, This is the best way to tell if your diabetes is irritability, hunger and numbness around the What APO-Glimepiride looks like being controlled properly. You doctor of diabetes lips and fingers APO-Glimepiride 1 mg Tablets: educator will show you how and when to do this. • nausea Pink, round tablet, G1 on one side and plain on Carefully follow your doctor's and dietician's • vomiting the other. advice on diet, drinking alcohol and exercise. • abdominal pain of discomfort APO-Glimepiride 2 mg Tablets: Things you must not do • Green, capsule-shaped tablet, G2, scoreline, G2 diarrhoea or feeling of fullness in the on one side and scoreline, on the other. Do not skip meals while taking glimepiride. stomach APO-Glimepiride 3 mg Tablets: • blurred or double vision Do not give this medicine to anyone else, even Pale yellow, capsule-shaped tablet, G3, scoreline, if their symptoms seem similar to yours. Tell your doctor as soon as possible if you G3 on one side and scoreline, on the other. notice any of the following. Do not stop taking your medicine, or change APO-Glimepiride 4 mg Tablets: the dosage, without checking with your doctor. These may be serious side effects and you may Blue, capsule-shaped tablet, G4, scoreline, G4 on Do not take your medicine to treat any other need medical attention: one side and scoreline on the other. complaints unless your doctor or pharmacist • hypoglycaemia or hyperglycaemia, Blister packs of 30 tablets. tells you to. symptoms of sunburn such as redness, Ingredients Things to be careful of itching, swelling or blistering which may occur more quickly than normal after being Each tablet contains 1, 2, 3 or 4 mg of Protect your skin when you are outdoors or in in the sun glimepiride as the active ingredient. the sun, especially between 10 am and 3 pm, • wear protective clothing and use a 15+ bleeding or bruising more easily than normal, It also contains the following inactive ingredients: sunscreen. If your skin appears to be burning, or reddish or purplish blotches under the skin • lactose • tell your doctor immediately. signs of frequent or worrying infections, such • microcrystalline cellulose Glimepiride may cause your skin to be more as fever, severe chills, sore throat or mouth • povidone sensitive to sunlight than it is normally. Exposure ulcers • sodium starch glycollate to sunlight may cause skin rash, itching, redness • signs of anaemia, such as tiredness, being or severe sunburn. short of breath and looking pale. • magnesium stearate Be careful while driving or operating If you experience any of the following, stop • iron oxide red CI77491 (1 mg tablets) machinery until you know how glimepiride taking your medicine and contact your doctor • iron oxide yellow CI77492 (2 mg, 3 mg affects you. immediately or go to the Accident and tablets) If you have to be alert, e.g. when driving, be Emergency department at your nearest • indigo carmine CI73015 (2 mg, 4 mg tablets) especially careful not to let your blood glucose hospital. Australian Registration Numbers levels fall too low. These are very serious side effects and you may Low blood glucose levels may slow your reaction need urgent medical attention or hospitalisation: APO-Glimepiride 1 mg tablets time and affect your ability to drive or operate Blister pack • rash, sores, redness or itching of the skin, machinery. Drinking alcohol can make this AUST R 151570 worse. Your vision may also be temporarily itchy hives-like rash of spots (this could APO-Glimepiride 2 mg tablets affected. mean that you are allergic to glimepiride) • yellowing of the skin or eyes, also called Blister pack If you are travelling it is a good idea to: jaundice AUST R 151571 1. Wear some form of identification showing Tell your doctor or pharmacist if you notice APO-Glimepiride 3 mg tablets you have diabetes Blister pack anything that is making you fell unwell. AUST R 151572 2. Carry some form of sugar to treat Other side effects not listed above may occur in hypoglycaemia (low blood glucose) if it some people. APO-Glimepiride 4 mg tablets occurs, for example, sugar sachets or jelly Blister pack Do not be alarmed by this list of possible side beans AUST R 151573 effects. 3. Carry emergency food rations in case of a You may not experience any of them. APO-Glimepiride does not contain gluten, delay, for example, dried fruit, biscuits or sucrose, tartrazine or any other azo dyes. muesli bars 4. Keep glimepiride tablets readily available. Storage and disposal Sponsor If you become sick with a cold, fever or flu, it is Storage Aspen Pharma Pty Ltd 34-36 Chandos Street, very important to continue taking glimepiride, Keep your tablets in their blister pack until it even if you feel unable to eat your normal meal. St. Leonards NSW 2065 is time to take them. Australia If you have trouble eating solid food, use sugar- If you take the tablets out of the box or the blister sweetened drinks as a carbohydrate substitute or pack they may not keep well. Distributor eat small amounts of bland food. Keep your medicine in a cool dry place where Apotex Pty Ltd Your diabetes educator or dietician can give the temperature will stay below 25°C. 16 Giffnock Avenue you a list of foods to use for sick days. Macquarie Park NSW 2113 Do not store your medicine, or any other Australia medicine, in the bathroom or near a sink. Do Possible side effects not leave it on a window sill or in the car. APO and APOTEX are registered trade marks of Heat and dampness can destroy some medicines. Apotex Inc. Tell your doctor or pharmacist as soon as possible This leaflet was last updated in: if you do not feel well while you are using Keep this medicine where children cannot June 2014 Glimepiride, or if you have any questions or reach it. concerns. A locked cupboard at least one-and-a-half metres above the ground is a good place to store All medicines may have side effects. Sometimes medicines. they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

APO-Glimepiride Published by MIMS September 2014 3