Artwork No. - Colours Used Customer Accord Pantone Black Description Glimepiride Market UK-IE Language English Size 170 x 550 mm (PIL) Min. Font Size 9 Version No. 10 (Page 1 of 2) (IB026) Date 25/07/14 (Glimepiride (ACC-UK-IE)NEW-IB026-VAR-PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance

You should therefore always take some form of • have frequent episodes of hypoglycaemia • Feeling or being sick, diarrhoea, feeling full or sugar with you (e.g. sugar cubes). Remember • have fewer or no warning signals of bloated, and abdominal pain that artificial sweeteners are not effective. Please hypoglycaemia • Decrease in the amount of sodium level in your Package leaflet: Information for the user contact your doctor or go to the hospital if taking blood (shown by blood tests) sugar does not help or if the symptoms recur. Glimepiride Tablets contains lactose Glimepiride 1 mg Tablets If you have been told by your doctor that you Not known (frequency cannot be estimated Glimepiride 2 mg Tablets Laboratory Tests cannot tolerate some sugars, contact your doctor from the available data) The level of sugar in your blood or urine should before taking this medicinal product. • Allergy (hypersensitivity) of the skin may occur Glimepiride 3 mg Tablets be checked regularly. Your doctor may also take such as itching, rash, hives and increased blood tests to monitor your blood cell levels and sensitivity to sun. Some mild allergic reactions Glimepiride 4 mg Tablets liver function. 3. How to take Glimepiride Tablets may develop into serious reactions with Glimepiride swallowing or breathing problems, swelling of Always take this medicine exactly as described in your lips, throat or tongue. Therefore in the Children and adolescents this leaflet or as your doctor or pharmacist has Read all of this leaflet carefully before you start event of one of these side effects, tell your Glimepiride Tablets is not recommended for use told you. Check with your doctor or pharmacist if taking this medicine because it contains in children under 18 years of age. doctor immediately. important information for you. you are not sure • Allergic reactions with sulfonylureas, • Keep this leaflet. You may need to read it again. Other medicines and Glimepiride tablets: sulfonamides, or related drugs may occur • If you have any further questions, ask your Taking this medicine • Problems with your sight may occur when Tell your doctor or pharmacist if you are taking, • Take this medicine by mouth just before or with doctor or pharmacist. have recently taken or might take any other beginning treatment with Glimepiride Tablets. • This medicine has been prescribed for you only. the first main meal of the day (usually breakfast). This is due to changes in blood sugar levels medicines, including medicines obtained without If you do not have breakfast you should take the Do not pass it on to others. It may harm them, a prescription. and should soon improve even if their signs of illness are the same as yours. product on schedule as prescribed by your • Increased liver enzymes • If you get any side effects, talk to your doctor or doctor. It is important not to leave out any meal • Severe unusual bleeding or bruising under the skin Your doctor may wish to change your dose of when you are on Glimepiride Tablets pharmacist. This includes any possible side Glimepiride tablets if you are taking other effects not listed in this leaflet. See section 4. • Swallow the tablets whole with at least half Reporting of side effects medicines, which may weaken or strengthen the glass of water. Do not crush or chew the tablets effect of Glimepiride tablets on the level of sugar If you get any side effects, talk to your doctor or What is in this leaflet in your blood. pharmacist. This includes any possible side 1. What Glimepiride Tablets is and what it is used for How much to take effects not listed in this leaflet. By reporting side The dose of Glimepiride Tablets depends on your 2. What you need to know before you take The following medicines can increase the effects you can help provide more information on Glimepiride Tablets needs, condition and results of blood and urine the safety of this medicine. blood sugar lowering effect of Glimepiride sugar tests and is determined by your doctor. Do not 3. How to take Glimepiride Tablets tablets. This can lead to a risk of 4. Possible side effects take more tablets than your doctor has prescribed. For UK - You can also report side effects directly hypoglycaemia (low blood sugar): • The usual starting dose is one Glimepiride 1 mg via the Yellow Card Scheme at: 5. How to store Glimepiride Tablets • Medicines to treat pain and inflammation 6. Contents of the pack and other information tablet once a day. www.mhra.gov.uk/yellowcard (phenylbutazone, azopropazone, • If necessary, your doctor may increase the dose oxyphenbutazone, aspirin-like medicines) after each 1 - 2 weeks of treatment. For Ireland - You can also report side effects • 1. What Glimepiride Tablets is Other medicines to treat diabetes mellitus (such • The maximum recommended dose is 6 mg directly via HPRA Pharmacovigilance as insulin or metformin) Glimepiride tablet per day. Earlsfort Terrace and what it is used for • Medicines supporting muscle build up (anabolics) • A combination therapy of glimepiride plus IRL - Dublin 2 • Medicines to inhibit blood clotting (coumarin Glimepiride is an orally active blood sugar metformin or of glimepiride plus insulin may be Tel: +353 1 6764971, Fax: +353 1 6762517 derivatives such as warfarin) lowering drug. This drug belongs to a blood sugar started . In such a case your doctor will Website: www.hpra.ie • Medicines used to reduce weight (fenfluramine) lowering group of medicines called sulfonylureas. determine the proper doses of glimepiride, e-mail: [email protected] • Medicines called anti-arrhythmic agents used to Glimepiride works by increasing the amount of metformin or insulin individually for you control abnormal heart beat (disopyramide) insulin released from your pancreas. The insulin • Your dose of Glimepiride tablets may need to be • Medicines lowering high cholesterol level (fibrates) 5. How to store Glimepiride then lowers your blood sugar levels. adjusted if you change weight, change your • Medicines lowering high blood pressure (ACE lifestyle, or if you are under a lot of stress. Tablets inhibitors) What Glimepiride Tablets is used for: Please speak to your doctor if any of these • Medicines to treat depression (fluoxetine, MAO • Glimepiride Tablets is used to treat a certain form situations apply to you. Keep this medicine out of the sight and reach of inhibitors) of diabetes (type 2 diabetes mellitus) when diet, • If you feel the effect of your medicine is too children • Medicines to treat gout (allopurinol, • physical exercise and weight reduction alone have weak or too strong do not change the dose This medicinal product does not require any probenecid, sulfinpyrazone) not been able to control your blood sugar levels. yourself, but ask your doctor special temperature storage condition. Store in • Medicines to treat cancer (cyclophosphamide , the original package in order to protect from ifosfamide, trofosfamide) If you take more Glimepiride Tablets than you moisture. Keep the blister in the outer carton. 2. What you need to know before • Medicines to treat bacterial and fungal infections • should Do not use this medicine after the expiry date (tetracyclines, chloramphenicol, fluconazole, you take Glimepiride Tablets If you happen to have taken too much which is stated on the carton (EXP). The expiry miconazole, quinolones, clarithromycin) Glimepiride Tablets or an additional dose there is date refers to the last day of that month. • Do not take Glimepiride Tablets and tell your Medicines to treat nasal allergies such as hay a danger of hypoglycaemia and therefore you • Do not use this medicine if you notice visible doctor if: fever (tritoqualine) should instantly consume enough sugar (e.g. a signs of deterioration. • • You are allergic (hypersensitive) to Glimepiride Medicines to increase circulation when given in small bar of sugar cubes, sweet juice, sweetened • Do not throw away any medicines via wastewater or other sulfonylureas (medicines used to lower a high dose intravenous infusion (pentoxifylline) tea) and inform a doctor immediately. When or household waste. Ask your pharmacist how to • your blood sugar such as glibenclamide) or Medicines to treat urinary infections (such as treating hypoglycaemia due to accidental intake throw away medicines you no longer use. These sulfonamides (medicines for bacterial infections some long acting sulfonamides) in children, the quantity of sugar given must be measures will help protect the environment. • such as sulfamethoxazole) or any of the other Medicines used for male sex hormone carefully controlled to avoid the possibility of ingredients of this medicine (listed in section 6 replacement therapy producing dangerous hyperglycaemia. Persons in • 6. Contents of the pack and what Glimepiride tablets contains). Medicines called sympatholytics to treat high blood a state of unconsciousness must not be given • You have insulin dependent diabetes pressure, heart failure, or prostate symptoms food or drink. other information (type 1 diabetes mellitus) • You have diabetic ketoacidosis ( a complication The following medicines may decrease the What Glimepiride Tablets contains: Since the state of hypoglycaemia may last for The active substance is Glimepiride. of diabetes when your acid level is raised in blood sugar lowering effect of Glimepiride some time it is very important that the patient is your body and you may have some of the Tablets. This can lead to a risk of For 1 mg: Each tablet contains 1 mg of glimepiride. carefully monitored until there is no more danger. For 2 mg: Each tablet contains 2 mg of glimepiride. following signs: fatigue, feeling sick (nausea), hyperglycaemia (high blood sugar level): Admission into hospital may be necessary, also frequent urination and muscular stiffness) • Medicines containing female sex hormones For 3 mg: Each tablet contains 3 mg of glimepiride. as a measure of precaution. Show the doctor the For 4 mg: Each tablet contains 4 mg of glimepiride. • You are in a diabetic coma. (oestrogens, progestogens) package or remaining tablets, so the doctor • Medicines to treat high blood pressure called • You have severe kidney disease. knows what has been taken. The other ingredients are: • You have a severe liver disease thiazide diuretics (water tablets) • Medicines used to stimulate the thyroid gland Core tablet: lactose monohydrate, sodium starch Severe cases of hypoglycaemia accompanied by glycolate (type A), povidone (K-30), magnesium Do not take this medicine if any of the above apply (such as levothyroxine) loss of consciousness and coma are cases of • stearate to you. If you are not sure, talk to your doctor or Medicines to treat allergies and inflammation medical emergency requiring immediate medical (glucocorticoids) pharmacist before taking Glimepiride tablets. treatment and admission into hospital. It may be Coloring agent: • Medicines to treat severe mental disorders helpful to tell your family & friends to call a doctor Glimepiride Tablets 1 mg: Iron oxide red (E172) (chlorpromazine and other phenothiazine Warnings and precautions immediately if this happens to you. Glimepiride Tablets 2 mg: Iron oxide red (E172) derivatives Talk to your doctor or pharmacist before Glimepiride Tablets 3 mg: Iron oxide yellow (E172) • Medicines used to raise heart beat, to treat taking Glimepiride Tablets If you forget to take Glimepiride Tablets • If you are recovering from an injury, operation, asthma or nasal congestion, coughs and colds, If you forget to take a dose, do not take a double What Glimepiride Tablets looks like and infections with fever, or from other forms of used to reduce weight, or used in dose to make up for forgotten doses. contents of the pack stress, inform your doctor as temporary change life-threatening emergencies (adrenaline and sympathomimetics) of treatment may be necessary If you stop taking Glimepiride Tablets Glimepiride Tablets 1 mg: Pink coloured round, • • If you have severe liver or kidney disorder Medicines to treat high cholesterol level If you interrupt or stop the treatment you should flat uncoated tablets with beveled edges and If you are not sure if any of these apply to you, (nicotinic acid) be aware that the desired blood sugar lowering score line on one side and plain on other side. • talk to your doctor or pharmacist before taking Medicines to treat constipation when they are effect is not achieved or that the disease will get Glimepiride Tablets 2 mg: Light pink coloured Glimepiride Tablets used long term (laxatives) worse again. Keep taking Glimepiride Tablets oval shaped, uncoated tablets with score line on • Lowering of the haemoglobin level and Medicines to treat fits (phenytoin) until your doctor tells you to stop. one side and plain on other side. breakdown of red blood cells (haemolytic • Medicines to treat high blood pressure or Glimepiride Tablets 3 mg: Pale yellow, oval anemia) can occur in patients missing the lowering blood sugar (diazoxide) If you have any further questions on the use of this shaped uncoated tablets with score line on one • enzyme glucose-6-phoshate dehydrogenase. Medicines to treat severe low blood sugar levels medicine, ask your doctor or pharmacist or nurse. side and plain on other side. (glucagon) Glimepiride Tablets 4 mg: White oval shaped Important information about hypoglycaemia • Medicines to treat nervousness and sleep uncoated tablets with score line on one side and (low blood sugar) problems (barbiturates) 4. Possible side effects plain on other side. When you take Glimepiride tablets, you may get • Medicines to treat infections, tuberculosis Like all medicines, this medicine can cause side hypoglycaemia (low blood sugar). Please see (rifampicine) The score line is only to facilitate breaking for ease effects, although not everybody gets them. below for additional information about • Medicines to treat increased pressure in the eye of swallowing and not to divide into equal doses Tell your doctor immediately if you experience hypoglycaemia, its signs and treatment. (acetazolamide) any of the following symptoms : Glimepiride Tablets are available in blister packs • Allergic reactions (including inflammation of of 10, 30, 60, 90,120 and 180 tablets. Following factors could increase the risk of The following medicinal products can blood vessels, often with skin rash) which may you getting hypoglycaemia: increase or decrease the blood sugar develop into serious reactions with difficulty in Not all packs sizes may be marketed. • Undernourishment, irregular meal time, missed lowering effect of Glimepiride Tablets: breathing, fall in blood pressure and sometimes or delayed meal or period of fasting • Medicines to treat high blood pressure or heart Marketing Authorisation Holder and manufacturer progressing to shock • Changes to your diet failure such as beta-blockers, clonidine, United Kingdom. Accord Healthcare Limited • Abnormal liver function including yellowing of • Taking more Glimepiride tablets than needed guanethidine and reserpine. These can also Sage House, 319 Pinner Road, North Harrow, the skin and eyes (jaundice), problems with the • Having kidneys that do not work properly hide the signs of hypoglycaemia, so special Middlesex, HA1 4HF, United Kingdom bile flow (cholestasis), inflammation of the liver • Having severe liver disease care is needed when taking these medicines. (hepatitis) or liver failure • If you suffer from particular hormone-induced • Medicines to treat stomach ulcers (called H2 Ireland. Accord Healthcare Ireland Limited • Allergy (hypersensitivity) of the skin such as disorders (disorders of the thyroid glands, of the antagonists) Euro House, Euro Business Park itching, rash, hives and increased sensitivity to pituitary gland or adrenal cortex) Little Island, Cork T45 K857, Ireland sun. Some mild allergic reactions may develop • Drinking alcohol (especially when you skip a meal) Glimepiride tablets may either increase or into serious reactions • Taking certain other medicines (See Taking weaken the effects of the following medicines: Manufacturer. Accord Healthcare Limited • Severe hypoglycaemia including loss of other medicines below) • Medicines inhibiting blood clotting (coumarin Sage House, 319 Pinner Road, North Harrow, consciousness, seizures or coma • If you increase the amount of exercise you do derivatives such as warfarin) Middlesex, HA1 4HF, United Kingdom and you don’t eat enough food or eat food • Colesevelam, a medicine used to reduce Other possible side effects with Glimepiride Accord Healthcare Polska Sp.z o.o., containing less carbohydrate than usual. cholesterol, has an effect on the absorption of Glimepiride Tablets. To avoid this effect, you Tablets: ul. Lutomierska 50,95-200 Pabianice, Poland should be advised to take Glimepiride Tablets at Rare side effects (may affect up to 1 in 1000 Signs of hypoglycaemia include: This medicinal product is authorised in the Hunger pangs, headache, nausea, vomiting, least 4 hours before colesevelam. people) • Lower blood sugar than normal Member States of the EEA under the following sluggishness, sleepiness, problems sleeping, (hypoglycaemia) (See Section 2) names: restlessness, aggression, problems with Glimepiride Tablets with food and drink: • Decrease in the number of blood cells: Name of the Name of the medicinal product concentration, reduced alertness and reaction Alcohol intake may increase or decrease the Blood platelets (which increases risk of bleeding member state time, depression, confusion, problems with your blood sugar lowering action of Glimepiride or bruising) Estonia Glimepiride Accord 1mg/ 2mg/ speech and sight, slurred speech, shakiness, Tablets in an unpredictable way White blood cells (which makes infections more 3mg/ 4mg tabletid partial paralysis, dizziness, helplessness. likely) France Glimepiride Accord Healthcare The following signs may also occur: Pregnancy, breast-feeding and fertility: Red blood cells (which can make the skin pale 1 mg/ 2 mg/ 3 mg/ 4 mg sweating, clammy skin, anxiety, fast or increased Pregnancy Comprimes Glimepiride Tablets should not be taken during and cause weakness or breathlessness) heart beat, high blood pressure, awareness of Germany Glimepiride Accord 1 mg/ 2 mg/ pregnancy. Tell your doctor if you are, you think These problems generally get better after you your heart beat, sudden strong pain in the breast 3 mg/ 4 mg Tabletten you might be or are planning to become pregnant. stop taking Glimepiride tablets that may radiate into neighbouring areas (angina Ireland Glimepiride 1 mg/ 2 mg/ 3 mg/ pectoris and cardiac arrhythmias) 4 mg Tablets Breast feeding Very rare side effects (may affect up to 1 in Italy Glimepiride Accord Healthcare If blood sugar levels continue to drop you may Glimepiride may pass into breast milk. Glimepiride 10,000 people): • Allergic reactions (including inflammation of 2 mg/ 3 mg/ 4 mg Compresse suffer from considerable confusion (delirium), should not be taken during breast feeding. blood vessels, often with skin rash) which may Latvia Glimepiride Accord 1 mg/ 2 mg/ develop fits, lose self control, breathing may be Ask your doctor or pharmacist for advice before develop into serious reactions with difficulty in 3 mg/ 4 mg Tabletes shallow and your heart beat slowed down, you taking this medicine. breathing, fall in blood pressure and sometimes Lithuania Glimepiride Accord 1 mg/ 2 mg/ may fall into unconsciousness. The clinical 3 mg/ 4 mg tablets Driving and using machines: progressing to shock. If you experience any of picture of a severe reduced blood sugar level The Netherlands Glimepiride Accord 1 mg/ 2 mg/ Your ability to concentrate or react may be these symptoms, tell your doctor may resemble that of a stroke. 3 mg/ 4 mg Tabletten reduced if your blood sugar is lowered immediately. • Abnormal liver function including yellowing of Poland Glimepiride Accord Treating hypoglycaemia: (hypoglycaemia), or raised (hyperglycaemia) or if the skin and eyes (jaundice), impairment of the Portugal Glimepirida Accord 1 mg/ 2 mg/ In most cases the signs of reduced blood sugar you develop visual problems as a result of such bile flow (cholestasis), inflammation of the liver 3 mg/ 4 mg Comprimidos vanish very quickly when you consume some conditions. Bear in mind that you could endanger (hepatitis) or liver failure. If you experience any United Kingdom Glimepiride 1 mg/ 2 mg/ 3 mg/ form of sugar, e.g. sugar cubes, sweet juice, yourself or others (e.g. when driving a car or of these symptoms , 4 mg Tablets sweetened tea. using machines). Please ask your doctor whether tell your doctor immediately. you can drive a car if you: The leaflet was last revised in 03/2019.

(694715) Date: 01_05_19 Artwork No. - Colours Used Customer Accord Pantone Black Description Glimepiride Market UK-IE Language English Size 170 x 550 mm (PIL) Min. Font Size 9 Version No. 10 (Page 2 of 2) (IB026) Date 25/07/14 (Glimepiride (ACC-UK-IE)NEW-IB026-VAR-PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance

You should therefore always take some form of • have frequent episodes of hypoglycaemia • Feeling or being sick, diarrhoea, feeling full or sugar with you (e.g. sugar cubes). Remember • have fewer or no warning signals of bloated, and abdominal pain that artificial sweeteners are not effective. Please hypoglycaemia • Decrease in the amount of sodium level in your Package leaflet: Information for the user contact your doctor or go to the hospital if taking blood (shown by blood tests) sugar does not help or if the symptoms recur. Glimepiride Tablets contains lactose Glimepiride 1 mg Tablets If you have been told by your doctor that you Not known (frequency cannot be estimated Glimepiride 2 mg Tablets Laboratory Tests cannot tolerate some sugars, contact your doctor from the available data) The level of sugar in your blood or urine should before taking this medicinal product. • Allergy (hypersensitivity) of the skin may occur Glimepiride 3 mg Tablets be checked regularly. Your doctor may also take such as itching, rash, hives and increased blood tests to monitor your blood cell levels and sensitivity to sun. Some mild allergic reactions Glimepiride 4 mg Tablets liver function. 3. How to take Glimepiride Tablets may develop into serious reactions with Glimepiride swallowing or breathing problems, swelling of Always take this medicine exactly as described in your lips, throat or tongue. Therefore in the Children and adolescents this leaflet or as your doctor or pharmacist has Read all of this leaflet carefully before you start event of one of these side effects, tell your Glimepiride Tablets is not recommended for use told you. Check with your doctor or pharmacist if taking this medicine because it contains in children under 18 years of age. doctor immediately. important information for you. you are not sure • Allergic reactions with sulfonylureas, • Keep this leaflet. You may need to read it again. Other medicines and Glimepiride tablets: sulfonamides, or related drugs may occur • If you have any further questions, ask your Taking this medicine • Problems with your sight may occur when Tell your doctor or pharmacist if you are taking, • Take this medicine by mouth just before or with doctor or pharmacist. have recently taken or might take any other beginning treatment with Glimepiride Tablets. • This medicine has been prescribed for you only. the first main meal of the day (usually breakfast). This is due to changes in blood sugar levels medicines, including medicines obtained without If you do not have breakfast you should take the Do not pass it on to others. It may harm them, a prescription. and should soon improve even if their signs of illness are the same as yours. product on schedule as prescribed by your • Increased liver enzymes • If you get any side effects, talk to your doctor or doctor. It is important not to leave out any meal • Severe unusual bleeding or bruising under the skin Your doctor may wish to change your dose of when you are on Glimepiride Tablets pharmacist. This includes any possible side Glimepiride tablets if you are taking other effects not listed in this leaflet. See section 4. • Swallow the tablets whole with at least half Reporting of side effects medicines, which may weaken or strengthen the glass of water. Do not crush or chew the tablets effect of Glimepiride tablets on the level of sugar If you get any side effects, talk to your doctor or What is in this leaflet in your blood. pharmacist. This includes any possible side 1. What Glimepiride Tablets is and what it is used for How much to take effects not listed in this leaflet. By reporting side The dose of Glimepiride Tablets depends on your 2. What you need to know before you take The following medicines can increase the effects you can help provide more information on Glimepiride Tablets needs, condition and results of blood and urine the safety of this medicine. blood sugar lowering effect of Glimepiride sugar tests and is determined by your doctor. Do not 3. How to take Glimepiride Tablets tablets. This can lead to a risk of 4. Possible side effects take more tablets than your doctor has prescribed. For UK - You can also report side effects directly hypoglycaemia (low blood sugar): • The usual starting dose is one Glimepiride 1 mg via the Yellow Card Scheme at: 5. How to store Glimepiride Tablets • Medicines to treat pain and inflammation 6. Contents of the pack and other information tablet once a day. www.mhra.gov.uk/yellowcard (phenylbutazone, azopropazone, • If necessary, your doctor may increase the dose oxyphenbutazone, aspirin-like medicines) after each 1 - 2 weeks of treatment. For Ireland - You can also report side effects • 1. What Glimepiride Tablets is Other medicines to treat diabetes mellitus (such • The maximum recommended dose is 6 mg directly via HPRA Pharmacovigilance as insulin or metformin) Glimepiride tablet per day. Earlsfort Terrace and what it is used for • Medicines supporting muscle build up (anabolics) • A combination therapy of glimepiride plus IRL - Dublin 2 • Medicines to inhibit blood clotting (coumarin Glimepiride is an orally active blood sugar metformin or of glimepiride plus insulin may be Tel: +353 1 6764971, Fax: +353 1 6762517 derivatives such as warfarin) lowering drug. This drug belongs to a blood sugar started . In such a case your doctor will Website: www.hpra.ie • Medicines used to reduce weight (fenfluramine) lowering group of medicines called sulfonylureas. determine the proper doses of glimepiride, e-mail: [email protected] • Medicines called anti-arrhythmic agents used to Glimepiride works by increasing the amount of metformin or insulin individually for you control abnormal heart beat (disopyramide) insulin released from your pancreas. The insulin • Your dose of Glimepiride tablets may need to be • Medicines lowering high cholesterol level (fibrates) 5. How to store Glimepiride then lowers your blood sugar levels. adjusted if you change weight, change your • Medicines lowering high blood pressure (ACE lifestyle, or if you are under a lot of stress. Tablets inhibitors) What Glimepiride Tablets is used for: Please speak to your doctor if any of these • Medicines to treat depression (fluoxetine, MAO • Glimepiride Tablets is used to treat a certain form situations apply to you. Keep this medicine out of the sight and reach of inhibitors) of diabetes (type 2 diabetes mellitus) when diet, • If you feel the effect of your medicine is too children • Medicines to treat gout (allopurinol, • physical exercise and weight reduction alone have weak or too strong do not change the dose This medicinal product does not require any probenecid, sulfinpyrazone) not been able to control your blood sugar levels. yourself, but ask your doctor special temperature storage condition. Store in • Medicines to treat cancer (cyclophosphamide , the original package in order to protect from ifosfamide, trofosfamide) If you take more Glimepiride Tablets than you moisture. Keep the blister in the outer carton. 2. What you need to know before • Medicines to treat bacterial and fungal infections • should Do not use this medicine after the expiry date (tetracyclines, chloramphenicol, fluconazole, you take Glimepiride Tablets If you happen to have taken too much which is stated on the carton (EXP). The expiry miconazole, quinolones, clarithromycin) Glimepiride Tablets or an additional dose there is date refers to the last day of that month. • Do not take Glimepiride Tablets and tell your Medicines to treat nasal allergies such as hay a danger of hypoglycaemia and therefore you • Do not use this medicine if you notice visible doctor if: fever (tritoqualine) should instantly consume enough sugar (e.g. a signs of deterioration. • • You are allergic (hypersensitive) to Glimepiride Medicines to increase circulation when given in small bar of sugar cubes, sweet juice, sweetened • Do not throw away any medicines via wastewater or other sulfonylureas (medicines used to lower a high dose intravenous infusion (pentoxifylline) tea) and inform a doctor immediately. When or household waste. Ask your pharmacist how to • your blood sugar such as glibenclamide) or Medicines to treat urinary infections (such as treating hypoglycaemia due to accidental intake throw away medicines you no longer use. These sulfonamides (medicines for bacterial infections some long acting sulfonamides) in children, the quantity of sugar given must be measures will help protect the environment. • such as sulfamethoxazole) or any of the other Medicines used for male sex hormone carefully controlled to avoid the possibility of ingredients of this medicine (listed in section 6 replacement therapy producing dangerous hyperglycaemia. Persons in • 6. Contents of the pack and what Glimepiride tablets contains). Medicines called sympatholytics to treat high blood a state of unconsciousness must not be given • You have insulin dependent diabetes pressure, heart failure, or prostate symptoms food or drink. other information (type 1 diabetes mellitus) • You have diabetic ketoacidosis ( a complication The following medicines may decrease the What Glimepiride Tablets contains: Since the state of hypoglycaemia may last for The active substance is Glimepiride. of diabetes when your acid level is raised in blood sugar lowering effect of Glimepiride some time it is very important that the patient is your body and you may have some of the Tablets. This can lead to a risk of For 1 mg: Each tablet contains 1 mg of glimepiride. carefully monitored until there is no more danger. For 2 mg: Each tablet contains 2 mg of glimepiride. following signs: fatigue, feeling sick (nausea), hyperglycaemia (high blood sugar level): Admission into hospital may be necessary, also frequent urination and muscular stiffness) • Medicines containing female sex hormones For 3 mg: Each tablet contains 3 mg of glimepiride. as a measure of precaution. Show the doctor the For 4 mg: Each tablet contains 4 mg of glimepiride. • You are in a diabetic coma. (oestrogens, progestogens) package or remaining tablets, so the doctor • Medicines to treat high blood pressure called • You have severe kidney disease. knows what has been taken. The other ingredients are: • You have a severe liver disease thiazide diuretics (water tablets) • Medicines used to stimulate the thyroid gland Core tablet: lactose monohydrate, sodium starch Severe cases of hypoglycaemia accompanied by glycolate (type A), povidone (K-30), magnesium Do not take this medicine if any of the above apply (such as levothyroxine) loss of consciousness and coma are cases of • stearate to you. If you are not sure, talk to your doctor or Medicines to treat allergies and inflammation medical emergency requiring immediate medical (glucocorticoids) pharmacist before taking Glimepiride tablets. treatment and admission into hospital. It may be Coloring agent: • Medicines to treat severe mental disorders helpful to tell your family & friends to call a doctor Glimepiride Tablets 1 mg: Iron oxide red (E172) (chlorpromazine and other phenothiazine Warnings and precautions immediately if this happens to you. Glimepiride Tablets 2 mg: Iron oxide red (E172) derivatives Talk to your doctor or pharmacist before Glimepiride Tablets 3 mg: Iron oxide yellow (E172) • Medicines used to raise heart beat, to treat taking Glimepiride Tablets If you forget to take Glimepiride Tablets • If you are recovering from an injury, operation, asthma or nasal congestion, coughs and colds, If you forget to take a dose, do not take a double What Glimepiride Tablets looks like and infections with fever, or from other forms of used to reduce weight, or used in dose to make up for forgotten doses. contents of the pack stress, inform your doctor as temporary change life-threatening emergencies (adrenaline and sympathomimetics) of treatment may be necessary If you stop taking Glimepiride Tablets Glimepiride Tablets 1 mg: Pink coloured round, • • If you have severe liver or kidney disorder Medicines to treat high cholesterol level If you interrupt or stop the treatment you should flat uncoated tablets with beveled edges and If you are not sure if any of these apply to you, (nicotinic acid) be aware that the desired blood sugar lowering score line on one side and plain on other side. • talk to your doctor or pharmacist before taking Medicines to treat constipation when they are effect is not achieved or that the disease will get Glimepiride Tablets 2 mg: Light pink coloured Glimepiride Tablets used long term (laxatives) worse again. Keep taking Glimepiride Tablets oval shaped, uncoated tablets with score line on • Lowering of the haemoglobin level and Medicines to treat fits (phenytoin) until your doctor tells you to stop. one side and plain on other side. breakdown of red blood cells (haemolytic • Medicines to treat high blood pressure or Glimepiride Tablets 3 mg: Pale yellow, oval anemia) can occur in patients missing the lowering blood sugar (diazoxide) If you have any further questions on the use of this shaped uncoated tablets with score line on one • enzyme glucose-6-phoshate dehydrogenase. Medicines to treat severe low blood sugar levels medicine, ask your doctor or pharmacist or nurse. side and plain on other side. (glucagon) Glimepiride Tablets 4 mg: White oval shaped Important information about hypoglycaemia • Medicines to treat nervousness and sleep uncoated tablets with score line on one side and (low blood sugar) problems (barbiturates) 4. Possible side effects plain on other side. When you take Glimepiride tablets, you may get • Medicines to treat infections, tuberculosis Like all medicines, this medicine can cause side hypoglycaemia (low blood sugar). Please see (rifampicine) The score line is only to facilitate breaking for ease effects, although not everybody gets them. below for additional information about • Medicines to treat increased pressure in the eye of swallowing and not to divide into equal doses Tell your doctor immediately if you experience hypoglycaemia, its signs and treatment. (acetazolamide) any of the following symptoms : Glimepiride Tablets are available in blister packs • Allergic reactions (including inflammation of of 10, 30, 60, 90,120 and 180 tablets. Following factors could increase the risk of The following medicinal products can blood vessels, often with skin rash) which may you getting hypoglycaemia: increase or decrease the blood sugar develop into serious reactions with difficulty in Not all packs sizes may be marketed. • Undernourishment, irregular meal time, missed lowering effect of Glimepiride Tablets: breathing, fall in blood pressure and sometimes or delayed meal or period of fasting • Medicines to treat high blood pressure or heart Marketing Authorisation Holder and manufacturer progressing to shock • Changes to your diet failure such as beta-blockers, clonidine, United Kingdom. Accord Healthcare Limited • Abnormal liver function including yellowing of • Taking more Glimepiride tablets than needed guanethidine and reserpine. These can also Sage House, 319 Pinner Road, North Harrow, the skin and eyes (jaundice), problems with the • Having kidneys that do not work properly hide the signs of hypoglycaemia, so special Middlesex, HA1 4HF, United Kingdom bile flow (cholestasis), inflammation of the liver • Having severe liver disease care is needed when taking these medicines. (hepatitis) or liver failure • If you suffer from particular hormone-induced • Medicines to treat stomach ulcers (called H2 Ireland. Accord Healthcare Ireland Limited • Allergy (hypersensitivity) of the skin such as disorders (disorders of the thyroid glands, of the antagonists) Euro House, Euro Business Park itching, rash, hives and increased sensitivity to pituitary gland or adrenal cortex) Little Island, Cork T45 K857, Ireland sun. Some mild allergic reactions may develop • Drinking alcohol (especially when you skip a meal) Glimepiride tablets may either increase or into serious reactions • Taking certain other medicines (See Taking weaken the effects of the following medicines: Manufacturer. Accord Healthcare Limited • Severe hypoglycaemia including loss of other medicines below) • Medicines inhibiting blood clotting (coumarin Sage House, 319 Pinner Road, North Harrow, consciousness, seizures or coma • If you increase the amount of exercise you do derivatives such as warfarin) Middlesex, HA1 4HF, United Kingdom and you don’t eat enough food or eat food • Colesevelam, a medicine used to reduce Other possible side effects with Glimepiride Accord Healthcare Polska Sp.z o.o., containing less carbohydrate than usual. cholesterol, has an effect on the absorption of Glimepiride Tablets. To avoid this effect, you Tablets: ul. Lutomierska 50,95-200 Pabianice, Poland should be advised to take Glimepiride Tablets at Rare side effects (may affect up to 1 in 1000 Signs of hypoglycaemia include: This medicinal product is authorised in the Hunger pangs, headache, nausea, vomiting, least 4 hours before colesevelam. people) • Lower blood sugar than normal Member States of the EEA under the following sluggishness, sleepiness, problems sleeping, (hypoglycaemia) (See Section 2) names: restlessness, aggression, problems with Glimepiride Tablets with food and drink: • Decrease in the number of blood cells: Name of the Name of the medicinal product concentration, reduced alertness and reaction Alcohol intake may increase or decrease the Blood platelets (which increases risk of bleeding member state time, depression, confusion, problems with your blood sugar lowering action of Glimepiride or bruising) Estonia Glimepiride Accord 1mg/ 2mg/ speech and sight, slurred speech, shakiness, Tablets in an unpredictable way White blood cells (which makes infections more 3mg/ 4mg tabletid partial paralysis, dizziness, helplessness. likely) France Glimepiride Accord Healthcare The following signs may also occur: Pregnancy, breast-feeding and fertility: Red blood cells (which can make the skin pale 1 mg/ 2 mg/ 3 mg/ 4 mg sweating, clammy skin, anxiety, fast or increased Pregnancy Comprimes Glimepiride Tablets should not be taken during and cause weakness or breathlessness) heart beat, high blood pressure, awareness of Germany Glimepiride Accord 1 mg/ 2 mg/ pregnancy. Tell your doctor if you are, you think These problems generally get better after you your heart beat, sudden strong pain in the breast 3 mg/ 4 mg Tabletten you might be or are planning to become pregnant. stop taking Glimepiride tablets that may radiate into neighbouring areas (angina Ireland Glimepiride 1 mg/ 2 mg/ 3 mg/ pectoris and cardiac arrhythmias) 4 mg Tablets Breast feeding Very rare side effects (may affect up to 1 in Italy Glimepiride Accord Healthcare If blood sugar levels continue to drop you may Glimepiride may pass into breast milk. Glimepiride 10,000 people): • Allergic reactions (including inflammation of 2 mg/ 3 mg/ 4 mg Compresse suffer from considerable confusion (delirium), should not be taken during breast feeding. blood vessels, often with skin rash) which may Latvia Glimepiride Accord 1 mg/ 2 mg/ develop fits, lose self control, breathing may be Ask your doctor or pharmacist for advice before develop into serious reactions with difficulty in 3 mg/ 4 mg Tabletes shallow and your heart beat slowed down, you taking this medicine. breathing, fall in blood pressure and sometimes Lithuania Glimepiride Accord 1 mg/ 2 mg/ may fall into unconsciousness. The clinical 3 mg/ 4 mg tablets Driving and using machines: progressing to shock. If you experience any of picture of a severe reduced blood sugar level The Netherlands Glimepiride Accord 1 mg/ 2 mg/ Your ability to concentrate or react may be these symptoms, tell your doctor may resemble that of a stroke. 3 mg/ 4 mg Tabletten reduced if your blood sugar is lowered immediately. • Abnormal liver function including yellowing of Poland Glimepiride Accord Treating hypoglycaemia: (hypoglycaemia), or raised (hyperglycaemia) or if the skin and eyes (jaundice), impairment of the Portugal Glimepirida Accord 1 mg/ 2 mg/ In most cases the signs of reduced blood sugar you develop visual problems as a result of such bile flow (cholestasis), inflammation of the liver 3 mg/ 4 mg Comprimidos vanish very quickly when you consume some conditions. Bear in mind that you could endanger (hepatitis) or liver failure. If you experience any United Kingdom Glimepiride 1 mg/ 2 mg/ 3 mg/ form of sugar, e.g. sugar cubes, sweet juice, yourself or others (e.g. when driving a car or of these symptoms , 4 mg Tablets sweetened tea. using machines). Please ask your doctor whether tell your doctor you can drive a car if you: immediately.

The leaflet was last revised in 03/2019. 10 3515 0 694715 INP001

(694715) Date: 01_05_19