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What you need to know before you take Gliclazide tablets

Do not take Gliclazide tablets • If you are allergic to gliclazide or any of the other ingredients of Gliclazide tablets (listed in section 6), to other medicines of the same group (sulfonylureas), to other related medicines (hypoglycaemic sulfonamides) • If you have insulin-dependent diabetes (type 1) • If you have ketone bodies and sugar in your urine (this may mean you have keto-acidosis), a diabetic pre-coma and coma • If you have severe kidney or liver disease • If you are taking miconazole (a treatment for fungal infections) (see section Other medicines and Gliclazide tablets) • If you are breast-feeding (see section Pregnancy and breastfeeding) Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Gliclazide tablets. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, you observe the dietary regimen, have physical exercise and, where necessary, reduce weight. During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary. Low blood sugar (hypoglycaemia) may occur: • If you take meals irregularly or skip meals altogether • If you are fasting • If you are malnourished • If you change your diet • If you increase your physical activity and carbohydrate intake does not match this increase • If you drink alcohol, especially in combination with skipped meals • If you take other medicines or natural remedies at the same time • If you take too high doses of gliclazide • If you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, of the pituitary gland or adrenal cortex) • If your kidney function or liver function is severely decreased If you have low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness, and helplessness. The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris). If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious. In most cases the symptoms of low blood sugar vanish very quickly when you consume some form of sugar, e.g. glucose tablets, sugar cubes, sweet juice, sweetened tea. You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur. Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (e.g. those acting on the central nervous system and beta blockers). If you are in stress-situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy. Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar, when you have not complied with the treatment plan prescribed by your doctor, if you take St John’s Wort (Hypercium perforatum) preparations (see section Other medicine and Gliclazide tablets) or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance. If these symptoms occur, you must contact your doctor, pharmacist or nurse. While taking Gliclazide tablets you should: • Follow a regular diet: it is important to eat regular meals, including breakfast and never to miss or delay a meal • Take your medicine regularly (see How to take Gliclazide tablets) • Check your blood glucose regularly as recommended by your doctor Blood glucose disturbance (low blood sugar and high blood sugar) can occur when gliclazide is prescribed at the same time as medicines belonging to a class of antibiotics called fluroquinolones, especially in elderly patients. In this case, your doctor will remind you the importance of monitoring your blood glucose. Children and Adolescents Gliclazide tablets are not recommended for use in children. Other medicines and Gliclazide tablets Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the following medicines is taken: • Other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor inhibitors or insulin) • Antibiotics (e.g. sulfonamides, clarithromycin) • Medicines to treat high blood pressure or heart failure (beta blockers, ACE-inhibitors such as captopril or enalapril) • Medicines to treat fungal infections (miconazole, fluconazole) • Medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists) • Medicines to treat depression (monoamine oxidase inhibitors) • Painkiller or antirheumatics (phenylbutazone, ibuprofen) • Medicines containing alcohol The blood glucose lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken: • Medicines to treat disorders of the central nervous system (chlorpromazine) • Medicines reducing inflammation (corticosteroids) • Medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline) • Medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol) • St John’s Wort – Hypericum perforatum – preparations Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluroquinolones is taken at the same time as Gliclazide tablets, especially in elderly patients. Gliclazide tablets may increase the effects of medicines which reduce blood clotting (e.g. warfarin). Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking Gliclazide tablets. Gliclazide tablets with food, drink and alcohol Gliclazide tablets can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes. Pregnancy and breast-feeding Gliclazide tablets are not recommended for use during pregnancy. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor for advice before taking this medicine. You must not take Gliclazide tablets while you are breastfeeding. Driving and using machines Provided your blood glucose levels are satisfactorily controlled on Gliclazide tablets, your ability to drive or use machines should not be affected. However, if your blood glucose levels become too low, this could adversely affect your concentration, and therefore your ability to perform these tasks. Ask your doctor whether you can drive a car if you: • Have frequent episodes of low blood sugar (hypoglycaemia) • Have few or no warning signals of low blood sugar (hypoglycaemia) Gliclazide tablets contain lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.