Product Details

What you need to know before you take Glimepiride Tablets

. Do not take Glimepiride: • if you are allergic to glimepiride or other sulfonylureas (medicines used to lower your blood sugar such as glibenclamide) or sulfonamides (medicines for bacterial infections such as sulfamethoxazole) or any of the other ingredients of this medicine (listed in section 6) • if you have insulin dependent diabetes (Type I diabetes mellitus) • if you have diabetic ketoacidosis (a complication of diabetes when your acid level is raised in your body and you may have some of the following signs: fatigue, feeling sick (nausea), frequent urination and muscular stiffness) • if you are in a diabetic coma • if you have severe kidney disease • if you have a severe liver disease Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Glimepiride. Warnings and precautions: Talk to your doctor or pharmacist before taking Glimepiride if: • You are recovering from an injury, operation, infections with fever, or from other forms of stress, inform your doctor as temporary change of treatment may be necessary. • You have a severe liver or kidney disorder . If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Glimepiride. Lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anemia) can occur in patients missing the enzyme glucose-6-phosphate dehydrogenase. The information available on the use of Glimepiride in people under 18 years of age is limited. Therefore, its use in these patients is not recommended. Important information about hypoglycaemia (low blood sugar) When you take Glimepiride, you may get hypoglycaemia (low blood sugar). Please see below for additional information about hypoglycaemia, its signs and treatment. Following factors could increase the risk of you getting hypoglycaemia: • Undernourishment, irregular meal time, missed or delayed meal or period of fasting • Changes to your diet • Taking more Glimepiride than needed • Having kidneys that do not work properly • Having severe liver disease • If you suffer from particular hormone-induced disorders (disorders of the thyroid glands, of the pituitary gland or adrenal cortex) • Drinking alcohol (especially when you skip a meal) • Taking certain other medicines (see below “Other medicines and Glimepiride”) • If you increase the amount of exercise you do and you don’t eat enough food or eat food containing less carbohydrate than usual. Signs of hypoglycaemia include: • Hunger pangs, headache, nausea, vomiting, sluggishness, sleepiness, problems sleeping, restlessness, aggression, problems with concentration, reduced alertness and reaction time, depression, confusion, problems with your speech and sight, slurred speech, shakiness, partial paralysis, sensory disturbances, dizziness, helplessness • The following signs may also occur: sweating, clammy skin, anxiety, fast or increased heart beat, high blood pressure, awareness of your heart beat (palpitations), sudden strong pain in the breast that may radiate into neighbouring areas (angina pectoris and cardiac arrhythmias) If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop fits (convulsions), lose self control, breathing may be shallow and your heart beat slowed down, you may fall into unconsciousness. The clinical picture of a severe reduced blood sugar level may resemble that of a stroke. Treating hypoglycaemia: In most cases the signs of reduced blood sugar vanish very quickly when you consume some form of sugar, e.g. sugar cubes, sweet juice, sweetened tea. You should therefore always take some form of sugar with you (e.g. sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or go to the hospital if taking sugar does not help or if the symptoms recur. Laboratory tests The level of sugar in your blood or urine should be checked regularly. Your doctor may also take blood tests to monitor your blood cell levels and liver function. Children and adolescents Glimepiride is not recommended for use in children under 18 years of age. Other medicines and Glimepiride Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may wish to change your dose of Glimepiride if you are taking other medicines, which may weaken or strengthen the effect of Glimepiride on the level of sugar in your blood. The following medicines can increase the blood sugar lowering effect of Glimepiride. This can lead to a risk of hypoglycaemia (low blood sugar): • Other medicines to treat diabetes mellitus (such as insulin or metformin) • Medicines to treat pain and inflammation (phenylbutazone, azopropazone, oxyphenbutazone, aspirin-like medicines) • Medicines to treat urinary infections (such as some long acting sulfonamides) • Medicines to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin) • Medicines to inhibit blood clotting (coumarin derivatives such as warfarin) • Medicines supporting muscle build up (anabolics) • Medicines used for male sex hormone replacement therapy • Medicines to treat depression (fluoxetine, MAO inhibitors) • Medicines lowering high cholesterol level (fibrates) • Medicines lowering high blood pressure (ACE inhibitors) • Medicines called anti-arrhythmic agents used to control abnormal heart beat (disopyramide) • Medicines to treat gout (allopurinol, probenecid, sulfinpyrazone) • Medicines to treat cancer (cyclophosphamide, ifosfamide, trofosfamide) • Medicines used to reduce weight (fenfluramine) • Medicines to increase circulation when given in a high dose intravenous infusion (pentoxifylline) • Medicines to treat nasal allergies such as hay fever (tritoqualine) • Medicines called sympatholytics to treat high blood pressure, heart failure, or prostate symptoms The following medicines may decrease the blood sugar lowering effect of Glimepiride. This can lead to a risk of hyperglycaemia (high blood sugar level): • Medicines containing female sex hormones (oestrogens, progestogens) • Medicines to treat high blood pressure called thiazide diuretics (water tablets) • Medicines used to stimulate the thyroid gland (such as levothyroxine) • Medicines to treat allergies and inflammation (glucocorticoids) • Medicines to treat severe mental disorders (chlorpromazine and other phenothiazine derivatives) • Medicines used to raise heart beat, to treat asthma or nasal congestion, coughs and colds, used to reduce weight, or used in life-threatening emergencies (adrenaline and sympathomimetics) • Medicines to treat high cholesterol level (nicotinic acid) • Medicines to treat constipation when they are used long term (laxatives) • Medicines to treat fits (phenytoin) • Medicines to treat nervousness and sleep problems (barbiturates) • Medicines to treat increased pressure in the eye (azetazolamide) • Medicines to treat high blood pressure or low blood sugar (diazoxide) • Medicines to treat infections, tuberculosis (rifampicine) • Medicines to treat severe low blood sugar levels (glucagon) The following medicines can increase or decrease the blood sugar lowering effect of Glimepiride: • Medicines to treat stomach ulcers (called H2 antagonists) • Medicines to treat high blood pressure or heart failure such as beta-blockers, clonidine, guanethidine and reserpine. These can also hide the signs of hypoglycaemia, so special care is needed when taking these medicines Glimepiride may either increase or weaken the effects of the following medicines: • Medicines inhibiting blood clotting (coumarin derivatives such as warfarin). • Colesevelam, a medicine used to reduce cholesterol, has an effect on the absorption of Glimepiride. To avoid this effect, you should be advised to take Glimepiride at least 4 hours before colesevelam Glimepiride with food, drink and alcohol Alcohol intake may increase or decrease the blood sugar lowering action of Glimepiride in an unpredictable way. Pregnancy and breast-feeding Pregnancy Glimepiride should not be taken during pregnancy. Tell your doctor if you are, you think you might be or are planning to become pregnant. Breast-feeding Glimepiride may pass into breast milk. Glimepiride should not be taken during breast feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Your ability to concentrate or react may be impaired if your blood sugar is lowered (hypoglycaemia), or raised (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (e.g. when driving a car or using machines). Please ask your doctor whether you can drive a car if you: • have frequent episodes of hypoglycaemia, • have fewer or no warning signals of hypoglycaemia. Glimepiride tablets contains 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.