Product Details

Product Information of Glanil 5mg Tablets

Do not take Glibenclamide Tablets if:
 You are allergic (hypersensitive) to glibenclamide, sulphonamides (medicines for bacterial infection) or any of the other ingredients of Glibenclamide.
 You have insulin dependent diabetes (type 1 diabetes mellitus)
 You have diabetic ketoacidosis (a complication of diabetes with some of the following signs: fatigue, nausea
(feeling sick), frequent urination and muscular stiffness)
 You are in a diabetic coma
 You are pregnant
 You are breast-feeding
 You have severe problems with your kidneys
 You have a severe liver disease

• You are receiving a medicine called bosentan, used to treat high blood pressure 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 glibenclamide. Warning and Precautions Take special care with Glibenclamide Tablets Check with your doctor or pharmacist before taking your medicine 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 glibenclamide. Lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anemia) can occur in patients missing the enzyme glucose-6-phosphate dehydrogenase. Epidemiological studies suggest an increased of cardiovascular mortality with administration of glibenclamide, when compared to metformin or gliclazide. The risk was especially observed in patients with diagnosed coronary (heart) diseases. Children The information available on the use of glibenclamide in people under 18 years of age is limited. Therefore glibenclamide is not recommended for use in children. Important information about hypoglycaemia (low blood sugar) When you take glibenclamide, 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 glibenclamide than needed · Having kidneys that do not work properly · Having severe liver disease · If you suffer from particular hormoneinduced 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 Taking other medicines below) · If you increase the amount of exercise you do and you don’t eat enough food or eat food containing less carbohydrate than usual. · If you are elderly or have adrenal or pituitary insufficiency Patients aged 65 years and older are particularly sensitive to hypoglycemic action of glibenclamide and are therefore more at risk of hypoglycaemia. In the elderly, low blood sugar may be somewhat difficult to recognise. The initial dose and the maintenance dose of glibenclamide, must be set by your doctor carefully in order to avoid hypoglycemic reactions. 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, dizziness, helplessness ID: PL 43 IE Version: 07 Effective Date: · The following signs may also occur: sweating, clammy skin, anxiety, fast or increased heart beat, high blood pressure, awareness of your heart beat, 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, 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. Other medicines and Glibenclamide 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 glibenclamide if you are taking other medicines, which may weaken or strengthen the effect of glibenclamide on the level of sugar in your blood. The following medicines can increase the blood sugar lowering effect of glibenclamide. This can lead to a risk of hypoglycaemia (low blood sugar): · Other medicines to treat diabetes mellitus (such as insulin) · Medicines to treat pain and inflammation (phenylbutazone, azopropazone, oxyphenbutazone) · 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 to treat gout (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 glibenclamide. 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 · Medicines to treat allergies and inflammation (glucocorticoids) · Medicines to treat severe mental disorders (phenothiazine derivatives) · Medicines used to raise heart beat, to treat asthma or nasal congestion, coughs and colds, used to reduce weight, or used in lifethreatening emergencies (adrenaline and sympathomimetics) ID: PL 43 IE Version: 07 Effective Date: · 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 · Medicines to treat high blood pressure or lowering blood sugar (diazoxide) · Medicines to treat infections, tuberculosis (rifampicin) · Medicines to treat severe low blood sugar levels (glucagon) The following medicines can increase or decrease the blood sugar lowering effect of glibenclamide: · 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 Glibenclamide may either increase or weaken the effects of the following medicines: · Medicines inhibiting blood clotting (coumarin derivatives such as warfarin) Taking Glibenclamide Tablets with food and drink Alcohol intake may increase or decrease the blood sugar lowering action of Glibenclamide in an unpredictable way. Pregnancy,breast-feeding and fertility Glibenclamide should not be taken during pregnancy. Tell your doctor if you are, you think you might be or are planning to be pregnant. Glibenclamide may pass into breast milk. Gibenclamide should not be taken during breast-feeding. Ask you doctor or pharmacist for advice before taking any medicine. Driving and using machines Your ability to concentrate or react may be reduced 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 Important information about some of the ingredients of Glibenclamide Tablets Glibenclamide contains lactose. If you have been told by your doctor that you cannot tolerate some sugars, contact your doctor before taking this medicinal product.