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 Mylan. To avoid this effect, you should be advised to take Glimepiride Mylan at least 4 hours before colesevelam.
Glimepiride Mylan with alcohol You should not drink alcohol while being treated with this medicine. Alcohol intake may increase or decrease the blood sugar lowering action of glimepiride in an unpredictable way.
Pregnancy and 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.
Glimepiride Mylan should not be taken during pregnancy.
Glimepiride Mylan may pass into breast milk. If you are breast-feeding, you should not take Glimepiride Mylan.
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 Mylan contains lactose and sodium. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodum (23 mg) per tablet, that is to say essentially “sodium free”.
3. How to take Glimepiride Mylan
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults The recommended starting dose is 1 mg of Glimepiride Mylan each day. Depending on how your blood glucose level responds, your doctor may increase this dose by 1 mg every 1-2 weeks. The maximum dose is 6 mg a day.
If the lowest dose of 1 mg of Glimepiride Mylan a day reduces your blood glucose concentration too far (hypoglycaemia) then your doctor may decide that your blood sugar can be controlled by diet management alone and will discuss this option with you.
During the course of treatment, the dose of Glimepiride Mylan may need to be adjusted by your doctor, especially if your weight or lifestyle changes.
Combination therapy You may already be taking the maximum dose of metformin for diabetes and may, in addition, need to take Glimepiride Mylan. Your doctor will start you on a low dose of Glimepiride Mylan. Your blood glucose level will need to be monitored closely.
If the maximum daily dose of Glimepiride Mylan does not control your blood sugar well enough your doctor may want you to start using insulin. In such cases, your blood glucose level will need to be closely monitored. This is to make sure you do not suffer from hypoglycaemia (low blood sugar).
Switching medication If your doctor feels it is necessary to change from another antidiabetic medicine to Glimepiride Mylan, this must be done under close medical supervision. In some cases, there may need to be a break between the medication so the previous medication does not have an additive effect, leading to hypoglycaemia.
Use in children Glimepiride Mylan is not recommended for use in children.
Method of administration Swallow your tablets whole with a small glass of water . Take your tablets shortly before or with your first main meal of the day. . Do not stop taking this medicine unless your doctor tells you to.
Regular exercise and a good diet are important to help control your diabetes. You must check your blood and urine glucose levels regularly. Your doctor will tell you how to do this. If you are unsure check with your doctor.
If you take more Glimepiride Mylan than you should
If you have taken too many tablets, this will cause your blood sugar level to drop too low (hypoglycaemia - for symptoms of hypoglycaemia see section 2). You should eat or drink something sugary as soon as you can (e.g. sugar cubes, sweet juice, sweetened tea) and tell your doctor immediately. When treating hypoglycaemia due to accidental intake in children, the quantity of sugar given must be carefully controlled to avoid the possibility of producing dangerous hyperglycaemia. Persons in a state of unconsciousness must not be given food or drink.
Since the state of hypoglycaemia may last for some time it is very important that the patient is carefully monitored until there is no more danger. Admission into hospital may be necessary, also as a measure of precaution. Show the doctor the package or remaining tablets, so the doctor knows what has been taken.
Severe cases of hypoglycaemia accompanied by loss of consciousness and severe neurological failure are cases of medical emergency requiring immediate medical treatment and admission into hospital. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Glimepiride Mylan
If you forget to take Glimepiride Mylan, take the next dose as soon as you remember or feel faint, otherwise your blood sugar level will become too high and you may go into a coma (unconscious). Do not take a double dose to make up for a forgotten dose.
If you stop taking Glimepiride Mylan
If you interrupt or stop the treatment you should be aware that the desired blood sugar lowering effect will not be achieved or that the disease will deteriorate again. Keep taking Glimepiride Mylan until your doctor tells you to stop.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can sometimes cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following:
Rare (may affect up to 1 in 1,000 people) • changes in your blood, which can be severe, and may make you feel unusually tired and look pale, bruise or bleed more easily or you may suffer from infections with sore throats or mouth ulcers. These effects usually go away if treatment is stopped • severe hypoglycaemia including loss of consciousness, seizures or coma.
Very rare (may affect up to 1 in 10,000 people) • abnormal liver function including yellowing of the skin and eyes (jaundice), problems with the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure • allergic reactions (including inflammation of blood vessels, often with skin rash) which may develop into serious reactions with difficulty in breathing, fall in blood pressure and sometimes progressing to shock.
Not known (frequency cannot be estimated from the available data) • allergy (hypersensitivity) of the skin such as a rash or itchy red swollen skin and increased sensitivity to sun. Some mild allergic reactions may develop into serious reactions. • Severe decrease in the number of blood platelets (thrombocytopenia) and bleeding into the skin (thrombocytopenic purpura).
Other possible side effects:
Rare (may affect up to 1 in 1,000 people): • lower blood sugar than normal (hypoglycaemia) (See section 2 - Warnings and precautions). • weight gain. • hair loss. • changes in your sense of taste.
Very rare (may affect up to 1 in 10,000 people): • feeling and being sick, diarrhoea, feeling bloated, abdominal discomfort or pain • decrease in blood sodium levels.
Not known (frequency cannot be estimated from the available data): • patients allergic to glimepiride may also be allergic to similar antidiabetic medicines or antibiotics called sulfonamides • change in eyesight at the start of the treatment due to changes in blood sugar levels but this should improve as treatment continues • raised liver enzymes in the blood.
Your doctor will take blood samples and check your liver is working properly from time to time to make sure that your tablets are not causing side effects.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
5. How to store Glimepiride Mylan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store your tablets above 25 °C. Store in the original package
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Glimepiride Mylan contains The active substance is glimepiride. Each tablet contains either 1 mg, 2 mg, 3 mg or 4 mg of glimepiride. The other ingredients are lactose monohydrate; povidone K25; cellulose, microcrystalline; magnesium stearate; sodium starch glycolate (Type A); iron oxide red E172 (1 mg tablets); iron oxide yellow E172 (2 mg and 3 mg tablets) and indigo carmineE132 (2 mg and 4 mg tablets).
What Glimepiride Mylan looks like and contents of the pack The Glimepiride Mylan 1 mg tablet is an oblong shaped pink tablet with ‘GM’ breakline ‘1’on one side and ‘G’ breakline ‘G’ on the other side. The 2 mg tablet is an oblong shaped green tablet with ‘GM’ breakline ‘2’ on one side and ‘G’ breakline ‘G’ on the other side. The 3 mg tablet is an oblong shaped yellow tablet with ‘GM’ breakline ‘3’on one side and ‘G’ breakline ‘G’ on the other. The 4 mg tablet is an oblong shaped blue tablet with ‘GM’ breakline ‘4’ on one side and ‘G’ breakline ‘G’ on the other side.
Glimepiride Mylan is available in blister packs of 30, 50, 60, 90, 100, 120 or 250 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road,Dublin 13, Ireland Mylan Hungary Kft, Mylan Utca 1, Komárom, 2900, Hungary
This medicinal product is authorised in the Member States of the EEA under the following names:
Czech Republic: Glimepirid Mylan 2, 3, 4 mg Italy: Glimepiride Mylan Generics 2 mg Compresse The Netherlands: Glimepiride Mylan 1, 2, 3, 4 mg Tabletten Spain: Glimepirida MYLAN 2, 4 mg comprimidos EFG
This leaflet was last revised in