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APO-Gliclazide uncoated Tablets Gliclazide Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet How it works Ask your doctor if you have any questions about why this medicine Glucose is used by the body as fuel, has been prescribed for you. This leaflet answers some common and all people have glucose questions about gliclazide. It does not circulating in their blood. In , Your doctor may have prescribed this contain all the available information. levels of blood glucose are higher medicine for another reason. It does not take the place of talking to than is needed. This is called This medicine is available only with your doctor, pharmacist or diabetes hyperglycaemia. a doctor©s prescription. educator. Gliclazide lowers high blood glucose This medicine is not addictive. There All medicines have risks and by increasing the amount of is not enough information to benefits. Your doctor has weighed produced by your pancreas. recommend the use of this medicine the risks of you using this medicine If your blood glucose is not properly in children. against the benefits they expect it controlled, you may experience will have for you. hypoglycaemia (low blood glucose) If you have any concerns about or hyperglycaemia (high blood taking this medicine, ask your glucose). High blood glucose can Before you take this doctor or pharmacist. lead to serious problems with our medicine Keep this leaflet with the medicine. heart, circulation and/or kidneys. There are some people who should You may want to read it again. not take gliclazide. Please read the It is very important to control high lists below. blood glucose whether or not you feel unwell. This really helps to If you think any of these situations What this medicine is avoid serious long-term health apply to you, or you have any used for problems, which can involve the questions, please consult your heart, eyes, circulation, and/or doctor, pharmacist, or diabetes Gliclazide belongs to a group of kidneys. educator. medicines called . A section at the end of this leaflet When you must not take it It is used to control blood glucose contains advice about recognising (sugar) in patients with Type II and treating hyperglycaemia. Do not take this medicine if you are allergic to: diabetes mellitus. This type of As with many medicines used for the diabetes is also known as non- treatment of diabetes, there is a · gliclazide insulin-dependent diabetes mellitus possibility that blood glucose levels · other sulfonylureas (NIDDM) or maturity onset diabetes. may become very low during · sulphonamides, such as sulfa Gliclazide is used when diet and treatment with gliclazide. This is antibiotics or diuretics exercise are not enough to control called hypoglycaemia. your blood glucose. · any of the ingredients listed at the A section at the end of this leaflet end of this leaflet. Gliclazide can be used alone or contains advice about recognising together with other medicines for and treating hypoglycaemia. Some of the symptoms of an allergic treating diabetes. reaction may include: · shortness of breath

APO-GLICLAZIDE TABLETS 1 · wheezing or difficulty breathing · kidney disease Taking this medicine may mask the · swelling of the face, lips, tongue, · liver disease symptoms of diabetes. throat or other parts of the body · a growth in your pancreas, called Tell your doctor if you suffer from · rash, itching or hives on the skin an insulinoma lactose intolerance or malabsorption. Do not take this medicine if you · a history of diabetic coma These tablets contain lactose have or have had any of the · adrenal, pituitary or thyroid following medical conditions: problems Taking other medicines · Type I diabetes mellitus (insulin · heart failure dependent diabetes mellitus, also Tell your doctor, pharmacist or known as IDDM, or juvenile or · a condition called Glucose-6- diabetes educator if you are taking growth onset diabetes) Phosphate Dehydrogenase any other medicines, including any Deficiency (G6PD), lowering of that you get without a prescription · unstable or brittle diabetes haemoglobin level and from your pharmacy, supermarket · diabetic acidosis or breakdown of red blood cells or health food shop. (haemolytic anaemia) can occur. · diabetic coma or pre-coma Some medicines and gliclazide may · a history of repeated ketoacidosis · you are pregnant or plan to interfere with each other. These or coma become pregnant or are include: breastfeeding. · severe kidney disease · miconazole or , used · Your doctor can discuss with you · severe liver disease. to treat fungal infections the risks and benefits involved. · other medicines used to treat Do not take this medicine if you Tell your doctor if you have any diabetes (e.g. and are pregnant or plan to become medical condition, or do anything, insulin) pregnant or are breastfeeding. that may increase the risk of · some medicines used to treat high Gliclazide may affect your hyperglycaemia (high blood blood pressure and other heart developing baby if you take it glucose). This may include: conditions (e.g. beta-blockers, during . Your doctor · illness or feeling unwell ACE inhibitors) will usually replace gliclazide with (especially with fever or · monoamine oxidase inhibitors insulin while you are pregnant. It infection) is not known whether gliclazide (MAOIs), used for treating passes into human breast milk. · injury depression, Parkinson's Disease or infections Do not take this medicine if you · surgery are using miconazole, a medicine · taking less gliclazide than · clofibrate, a medicine for used to treat fungal infections. prescribed lowering Do not take this medicine if you · doing less exercise than normal · medicines used to treat arthritis, pain and inflammation (e.g. are taking medicines called · eating more carbohydrates than oxyphenbutazone, or . normal phenylbutazone, high dose Do not take this medicine after the Tell your doctor if you have any salicylates) expiry date printed on the pack or medical condition, or do anything, · some antibiotics (e.g. if the packaging is torn or shows that may increase the risk of sulphonamides, tetracyclines, signs of tampering. hypoglycaemia (low blood glucose). chloramphenicol If it is expired or damaged, return it This may include: · cimetidine and similar medicines to your pharmacist for disposal. · drinking alcoholic drinks used to treat acid reflux and If you are not sure whether you · not eating regular meals, stomach ulcers should start taking gliclazide, talk including breakfast to your doctor. · diuretics, also known as fluid · doing more exercise than usual tablets (e.g. chlorothiazide) Before you start to take it · eating less carbohydrate than · normal. Tell your doctor if you have Some medicines may lead to high allergies to any other medicines, Alcohol, diet, exercise, and your blood glucose levels foods, preservatives or dyes. general health all strongly affect (hyperglycaemia) by weakening the the control of your diabetes. Tell your doctor if you have or blood glucose-lowering effect of have had any of the following Tell your doctor if you are taking a gliclazide. These include: conditions: medicine called a beta-blocker. · alcohol

APO-GLICLAZIDE TABLETS 2 · some medicines for epilepsy (e.g. How to take this Make sure you have enough of this phenobarbitone) medicine medicine to last over weekends and · some medicines for hormonal holidays. disturbances (e.g. danazol) Follow all directions given to you If you forget to take it · some medicines used for mental by your doctor carefully. illness (e.g. ) They may differ to the information If it is almost time for your next dose, skip the dose you missed and · some hormones used in hormone contained in this leaflet. take your next dose when you are replacement therapy and oral If you do not understand the meant to. contraceptives (oestrogens and instructions on the box, ask your ) doctor or pharmacist for help. Otherwise, take it as soon as you remember (with food), then go · St John's wort, (hypericum back to taking your tablets as you perforatum), used to treat How much to take would normally. depression Your doctor will tell you how much Missed doses can cause · salbutamol and terbutaline, of this medicine you should take. hyperglycaemia (high blood medicines for asthma This will depend on your condition glucose). · , medicines used for and whether you are taking any other Do not take a double dose to make sedation medicines. up for the dose that you missed. · steroid medicines called The starting dose is usually 40 mg If you double a dose, this may cause (e.g. (half a tablet) per day. This will be hypoglycaemia (low blood glucose). prednisolone, cortisone) adjusted slowly over several weeks, depending on how well your body If you are not sure what to do, ask Some medicines may lead to unstable responds to the dose. your doctor or pharmacist. blood glucose (low blood sugar and If you have trouble remembering high blood sugar) when taken at the How to take it same time as gliclazide, especially in to take your medicine, ask your elderly patients. These include: Swallow the tablets whole with a pharmacist for some hints to help glass of water. Tablets can be broken you remember. · fluoroquinolone antibiotics (e.g. in half, however they should not be ciprofloxacin, norfloxacin or crushed or chewed. If you take too much moxifloxacin) Crushing or chewing the tablets may (overdose) Gliclazide may change the effects of change the effectiveness of the tablet. some other medicines: Immediately telephone your doctor Taking these tablets with food can or the Poisons Information Centre · some medicines used to prevent help to minimise the risk of (telephone 13 11 26) for advice, or blood clots (warfarin and similar hypoglycaemia. go to Accident and Emergency at medicines) Do not skip meals while taking your nearest hospital, if you think If you are taking any of these, you these tablets. that you or anyone else may have may need a different dose or you taken too much of this medicine. may need to take different medicines. When to take it Do this even if there are no signs of Remember to keep checking your discomfort or poisoning. Take your medicine at about the blood glucose levels. You may need urgent medical same time each day, usually with attention. Drinking alcohol can also affect your breakfast. blood glucose levels and how well If you take too much gliclazide you Taking it at the same time each day gliclazide works. may experience symptoms of will have the best effect. It will also hypoglycaemia (low blood glucose). Other medicines not listed above help you remember when to take may also interact with gliclazide. them. If not treated quickly, these Ask your doctor or pharmacist if symptoms may progress to loss of you are not sure if you are taking How long to take it for co-ordination, slurred speech, any of these medicines. confusion, loss of consciousness and Continue taking your medicine for fitting. as long as your doctor tells you. At the first signs of hypoglycaemia Gliclazide can help control your (low blood glucose), raise your diabetes but cannot cure it. Therefore blood glucose quickly by following you may have to take it for a long the instructions at the end of this time. leaflet.

APO-GLICLAZIDE TABLETS 3 If you experience any of these Tell your doctor immediately if Gliclazide may cause your skin to be symptoms, immediately get you notice the return of any more sensitive to sunlight than it is medical help. symptoms of hyperglycaemia that normally. Exposure to sunlight may you had before starting gliclazide. cause a skin rash, itching, redness, or These may include lethargy or severe sunburn. tiredness, headache, thirst, passing If outdoors, wear protective While you are taking large amounts of urine and blurred clothing and use a 30+ sunscreen. this medicine vision. If your skin does appear to be These may be signs that gliclazide is burning, tell your doctor Things you must do no longer working, even though you immediately. If you are about to be started on may have been taking it successfully If you are travelling, it is a good any new medicine, remind your for some time. idea to: doctor and pharmacist that you · wear some form of identification are taking gliclazide. Things you must not do showing you have diabetes Tell any other doctors, dentists and Do not give this medicine to anyone · carry some form of sugar to treat pharmacists who are treating you else, even if they have the same hypoglycaemia if it occurs, for that you take this medicine. condition as you. example, sugar sachets or jelly If you become pregnant while Do not take your medicine to treat beans taking this medicine, tell your any other complaints unless your · carry emergency food rations in doctor immediately. doctor or pharmacist tells you to. case of a delay, for example, Tell your doctor if you are about to Do not stop taking your medicine dried fruit, biscuits or muesli bars have any blood tests. or change the dosage without first · keep gliclazide readily available checking with your doctor. Tell your doctor if you are going to If you become sick with a cold, have surgery or are going into Do not skip meals while taking fever or flu, it is very important to hospital. gliclazide. continue taking gliclazide, even if Take your tablets exactly as your you feel unable to eat your normal Things to be careful of doctor has prescribed. Otherwise meal. you may not get the full benefits Be careful when driving or If you have trouble eating solid food, from treatment. operating machinery until you use sugar-sweetened drinks as a Make sure you check your blood know how this medicine affects carbohydrate substitute or eat small glucose levels regularly. you. Also, be careful not to let your amounts of bland food. Your diabetes blood glucose levels fall too low. educator or dietician can give you a This is the best way to tell if your list of foods to use for sick days. diabetes is being controlled properly. Gliclazide may cause dizziness and Your doctor or diabetes educator will drowsiness in some people. show you how and when to do this. Hypoglycaemia may slow your reaction time and affect your ability Make sure that you, your friends, to drive or operate machinery. A Side effects family and work colleagues can section at the end of this leaflet recognise the symptoms of contains advice about recognising Tell your doctor or pharmacist as hypoglycaemia (low blood glucose) and treating hypoglycaemia. soon as possible if you do not feel and hyperglycaemia (high blood well while you are taking Drinking alcohol can make this glucose) and know how to treat gliclazide. them. worse. If either of these occurs, do not drive, operate machinery or do Gliclazide helps most people with Instructions at the end of this leaflet anything else that could be diabetes, however it may have can help you with this. dangerous. unwanted side effects. All medicines can have side effects. Sometimes Visit your doctor for regular blood If you drink alcohol while taking they are serious but most of the time tests and checks of your eyes, feet, gliclazide, you may get flushing, they are not. You may need medical kidneys, heart, circulation, blood, headache, breathing difficulties, attention if you get some of the side and blood pressure. rapid heartbeat, stomach pains or feel effects. Follow carefully your doctor©s advice sick and vomit. on diet, drinking alcohol and Do not be alarmed by the following Protect your skin when you are in exercise. list of side effects. You may not the sun, especially between 10am experience any of them. and 3pm.

APO-GLICLAZIDE TABLETS 4 Ask your doctor or pharmacist if The above list includes serious side Storage and disposal you have any concerns. effects that may require medical attention. Tell your doctor if you notice any Storage of the following: If any of the following happen, stop Keep the tablets in the pack until it · hypoglycaemia and taking this medicine and tell your is time to take them. hyperglycaemia. doctor immediately or go to the Accident and Emergency If you take your medicine out of the A section at the end of this department at your nearest pack it may not keep well. leaflet contains advice about hospital: recognising and treating Keep your medicine in a cool dry hypoglycaemia and · shortness of breath, wheezing or place where the temperature stays hyperglycaemia difficulty breathing; swelling of below 25°C. the face, lips, tongue, throat or Do not store your medicine, or any · stomach upset with symptoms other parts of the body; rash, other medicine, in the bathroom or like feeling sick, heartburn, itching or hives on the skin near a sink. Do not leave it on a diarrhoea or constipation (symptoms of a severe allergic window sill or in the car. · headache, unusual weakness reaction) Heat and dampness can destroy some · runny or blocked nose, sneezing, · decrease in the number of cells in medicines. facial pressure or pain, bronchitis, the blood (e.g. platelets, red and sore throat and discomfort when white blood cells) which may Keep this medicine where children swallowing, coughing cause paleness, prolonged cannot reach it. · arthralgia, back pain, arthrosis bleeding, bruising, sore throat and A locked cupboard at least one-and- fever have been reported. These a-half metres above the ground is a · dizziness symptoms usually vanish when good place to store medicines. · stomach upset with symptoms the treatment is discontinued like feeling sick, stomach pain, · increase of some hepatic enzymes Disposal , diarrhoea or levels, and exceptionally a liver constipation. If your doctor tells you to stop disease taking this medicine or the expiry · your vision may be affected for a · widespread blistering rash or date has passed, ask your short time especially at the start peeling of the skin - may be the pharmacist what to do with any of treatment. This effect is due to first sign of rare life-threatening medicine that is left over. changes in blood sugar levels conditions (e.g. Stevens-Johnson · tiredness, weariness. syndrome (SJS), toxic epidermal · decrease in the number of cells in necrolysis (TEN) and severe the blood (e.g. platelets, red and hypersensitivity reactions Product description white blood cells) which may (DRESS). cause paleness, prolonged As for other sulphonylureas, the What it looks like bleeding, bruising, sore throat and following adverse events have been White, round, flat-sided tablets with fever have been reported. These observed: cases of severe changes in bevelled edges, engraved "APO" symptoms usually vanish when the number of blood cells and over "80" on one side, cross-scored the treatment is discontinued. allergic inflammation of the wall of on the other side. · Increase of some hepatic enzymes blood vessels, reduction in blood Blister packs of 100 tablets. AUST R levels, and exceptionally a liver sodium (hyponatraemia), symptoms 80084 disease of liver impairment (e.g. jaundice) which in most cases disappeared The above list includes the more after withdrawal of the Ingredients common side effects of your but may lead to life-threatening liver medicine. Each tablet contains 80 mg of failure in isolated cases. gliclazide as the active ingredient. Tell your doctor as soon as possible If you notice anything else that is if you notice any of the following: It also contains the following: making you feel unwell - you · croscarmellose sodium · high blood pressure, chest pain should consult your doctor or · urinary tract infection, viral pharmacist. · stearate infection Other side effects not listed above · colloidal anhydrous silica · sinus, throat or upper lung may also occur in some people. · lactose monohydrate infection · microcrystalline cellulose

APO-GLICLAZIDE TABLETS 5 This medicine does not contain Note that taking artificial It is very important to control high gluten, sucrose, tartrazine or other sweeteners will NOT help raise blood glucose whether or not you azo dyes. your blood sugar levels. feel unwell. This really helps to This medicine contains lactose as Then take some extra avoid serious long-term health sugar. carbohydrates such as plain problems, which can involve the biscuits, fruit or milk - unless you heart, eyes, circulation, and/or Sponsor are within 10-15 minutes of your kidneys. next meal. If you experience any of the signs Apotex Pty Ltd Taking this extra carbohydrate will of hyperglycaemia (high blood 16 Giffnock Avenue help to prevent a second drop in your glucose) contact your doctor or Macquarie Park NSW 2113 blood glucose level. diabetes educator for advice immediately. If not treated quickly, hypoglycaemia symptoms may This leaflet was prepared in progress to loss of co-ordination, September 2020. Recognising and slurred speech, confusion, fits or treating loss of consciousness. hypoglycaemia (low If hypoglycaemia symptoms do not blood glucose) get better straight away after taking sugar, or the symptoms are Hypoglycaemia may occur during severe or prolonged, then go to gliclazide treatment. Accident and Emergency at your The first signs of hypoglycaemia nearest hospital - if necessary by may include weakness, trembling or calling an ambulance. shaking, sweating, anxiety, changes Contact your doctor or diabetes in heart rate or breathing, problems educator for advice if you are with sight, depression, aggression, concerned about hypoglycaemia. nausea, vomiting, cheat pain, light- headedness, dizziness, headache or lack of concentration, irritability, tearfulness, hunger, and/ or numbness around the lips and tongue. Recognising and treating These symptoms can occur suddenly. hyperglycaemia (high blood glucose) If not treated promptly, these may progress to: Some people may feel fine when · loss of co -ordination their glucose levels are high. · slurred speech High blood glucose usually occurs more slowly than low blood glucose. · confusion Signs of high blood glucose may · drowsiness include: · loss of consciousness or fitting. · tiredness or lethargy At the first signs of hypoglycaemia · lack of energy take some sugar to raise your · thirst blood sugar level quickly. · passing large amounts of urine Do this by taking one of the following: · headache · 5-7 jelly beans · blurred vision. · 3 teaspoons of sugar or honey If you notice symptoms of hyperglycaemia, or your blood sugar · half a can of ordinary (non-diet) levels are high, tell your doctor soft drink immediately. You may need · 2-3 concentrated glucose tablets adjustments of the dose or type of · a tube of glucose gel medicines you are taking.

APO-GLICLAZIDE TABLETS 6