PACKAGE LEAFLET Package leaflet: Information for the patient Glimepiride Mylan 1 mg, tabletten Glimepiride Mylan2 mg, tabletten Glimepiride Mylan3 mg, tabletten Glimepiride Mylan4 mg, tabletten (glimepiride) Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Glimepiride Mylan is and what it is used for 2. What you need to know before you take Glimepiride Mylan 3. How to take Glimepiride Mylan 4. Possible side effects 5. How to store Glimepiride Mylan 6. Contents of the pack and other information 1. What Glimepiride Mylan is and what it is used for Glimepiride Mylan contains the active substance glimepiride. Glimepiride Mylan belongs to a group of medicines called oral hypoglycaemics. These medicines help to lower your blood sugar (glucose) if you suffer from Type 2 diabetes (diabetes mellitus). Your doctor will prescribe Glimepiride Mylan for you if your diabetes cannot be controlled just by good diet, regular exercise or weight loss. 2. What you need to know before you take Glimepiride Mylan Do not take Glimepiride Mylan: • 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 to any of the other ingredients of this medicine listed in section 6 • if you suffer from insulin dependent diabetes (also called Type 1 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 have severe kidney or liver problems. Glimepiride should not be given to patients in a diabetic coma. Warnings and precautions Talk to your doctor or pharmacist before taking Glimepiride Mylan: • if you are recovering from an injury, operation, infection with fever, or from other forms of stress, as temporary change of treatment may be necessary • if you have a liver or kidney disorder. Lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur in patients missing the enzyme glucose-6-phosphate dehydrogenase. In the above cases, your doctor may change the number of tablets you should take or he/she may revise your entire treatment plan. Children and adolescents The information available on the use of Glimepiride Mylan in children and adolescents under 18 years of age is limited. Therefore its use in these patients is not recommended. Control of your blood sugar levels During Glimepiride Mylan treatment, regular checking of your blood (or urine) sugar levels is necessary. Your doctor may also perform certain blood tests to monitor your blood cell levels and liver function. You should follow the treatment plan prescribed by your doctor in order to control your blood sugar levels. This means that you should continue with your diabetic diet, take regular exercise and if necessary, lose weight. In the first few weeks of treatment, there is a greater risk of having low blood sugar levels (hypoglycaemia). Your doctor will therefore monitor your progress closely. The following factors could increase the risk of you getting low blood sugar levels if: • you are unwilling or unable to co-operate • you are undernourished, have an irregular meal time, miss or delay meals or are undergoing a period of fasting • you change your diet • you increase your physical activity and you do not eat enough or eat food containing less carbohydrate than normal • you are elderly or in poor health • you drink alcohol (especially if you also skip meals) • you have liver or kidney problems • you suffer from particular hormone-induced disorders (disorders of the thyroid glands, of the pituitary gland or adrenal cortex) • you take more Glimepiride Mylan than needed • you take certain other medicines at the same time (see “Other medicines and Glimepiride Mylan”). If you suffer from low blood sugar levels, you may have the following signs: • headache • difficulty concentrating • sweating • hunger pangs • feeling less alert • clammy skin • exhaustion • reduced reaction time • anxiety • nausea • depression • faster heart beat • vomiting • confusion • high blood pressure • weariness • slurred speech • feeling of an • sleepiness • eyesight problems abnormally strong or • problems • dizziness irregular heartbeat sleeping • helplessness • sudden strong pain in • restlessness • shaking or tremors the breast that may • aggression • sensory disturbances radiate into neighbouring areas (angina pectoris and cardiac arrhythmias) • loss of self control If your blood sugar levels continue to drop, you may suffer from considerable confusion (delirium), you may develop “fits” (convulsions), suffer from paralysis (loss or impaired body movement), have breathing difficulties, your heartbeat may slow down and you may fall into unconsciousness. Treating low blood sugar levels: In most cases, the signs of reduced blood sugar vanish very quickly when you eat or drink something sugary e.g. sugar cubes, sweet juice, sweetened tea. You should therefore always carry some form of sugar with you. Remember that sweeteners are not effective. Please contact your doctor or go to the hospital if taking sugar does not help or if any of these symptoms return. Other medicines and Glimepiride Mylan Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The following medicines, if taken with Glimepiride Mylan, may lower your blood sugar (glucose) levels too much. This can lead to a risk of hypoglycaemia (low blood sugar): • insulin or other medicines for diabetes (e.g. metformin) • medicines to treat pain and inflammation (e.g. phenylbutazone, azapropazone, oxyphenbutazone, salicylates) • medicines to treat gout (e.g. allopurinol, sulfinpyrazone, probenecid) • medicines to treat bacterial infections such as tetracyclines (e.g. doxycycline), chloramphenicol, sulfonamides (e.g. trimethoprim, co-trimoxazole, sulfadiazine), quinolones (e.g. ciprofloxacin), clarithromycin • medicines to treat fungal infections (e.g. fluconazole, miconazole) • medicines to inhibit blood clotting (coumarin anticoagulants such as warfarin) • medicines that lower high cholesterol levels (fibrates) • medicines that lower high blood pressure (ACE inhibitors) • disopyramide, an anti-arrhythmic agent used to control abnormal heart beat • medicines to treat depression (fluoxetine, MAO-inhibitors) • medicines that support muscle build up(anabolics) • medicines used for male sex hormone replacement therapy • medicines used to reduce weight (fenfluramine) • medicines to treat nasal allergies such as hay fever (tritoqualine) • medicines to treat cancer (cyclophosphamide, trophosphamide and iphosphamide) • medicines to increase circulation when given in a high dose intravenous infusion (pentoxyfylline) • medicines called sympatholytics to treat high blood pressure, heart failure, or prostate symptoms. The following medicines, if taken with Glimepiride Mylan, may keep the blood sugar (glucose) levels too high. This can lead to a risk of hyperglycaemia (high blood sugar level): • medicines containing female sex hormones (oestrogens or progestogens), such as hormone replacement therapy (HRT) or oral contraceptives • medicines for mental illness (e.g. chlorpromazine and other phenothiazine derivative) • medicines that support urine production (thiazide diuretics - water tablets) • medicines used to stimulate the thyroid gland (such as levothyroxine) • medicines used to treat allergies and inflammation (e.g. glucocorticoids) • medicines used to raise heart beat, to treat asthma or nasal congestion, coughs and colds, to reduce weight, or used in life-threatening emergencies (e.g. 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 epilepsy (e.g. phenytoin) • medicines to treat nervousness and sleep problems (e.g. barbiturates) • medicines to treat increased pressure in the eye (acetazolamide) • medicines used to treat high blood pressure or lowering blood sugar (e.g. diazoxide) • medicines to treat tuberculosis (rifampicin) • medicines used to treat severe low blood sugar levels (e.g. glucagon). Other medicines, if taken with Glimepiride Mylan, may affect the control of blood glucose levels (causing either high or low levels): • medicines to treat stomach ulcers (called H2 antagonists like cimetidine, ranitidine) • 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 Mylan 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