AMARYL 1MG TABLETS

S1072 LEAFLET Amaryl 20121108

PACKAGE LEAFLET: INFORMATION FOR THE USER

AMARYL 1mg TABLETS (glimepiride)
Your medicine is known as Amaryl 1mg Tablets but will be referred to as Amaryl throughout the following patient information leaflet. Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

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. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor may wish to change your dose of Amaryl if you are taking other medicines, which may weaken or strengthen the effect of Amaryl on the level of sugar in your blood. The following medicines can increase the blood sugar lowering effect of Amaryl. 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



In this leaflet: 1. What Amaryl is and what it is used for 2. Before you take Amaryl 3. How to take Amaryl 4. Possible side effects 5. How to store Amaryl 6. Further information 1. WHAT AMARYL IS AND WHAT IT IS USED FOR Amaryl is a medicine taken by mouth to help lower blood sugar. It belongs to a group of medicines called sulfonylureas. Amaryl works by increasing the amount of insulin released from your pancreas. The insulin then lowers your blood sugar levels. What Amaryl is used for: Amaryl is used to treat a certain form of diabetes (type 2 diabetes mellitus) when diet, physical exercise and weight reduction alone have not been able to control your blood sugar levels

2. BEFORE YOU TAKE AMARYL Do not take Amaryl and tell your doctor if: You are allergic (hypersensitive) 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 Amaryl (listed in Section 6 What Amaryl contains) You have insulin dependent diabetes (type 1 diabetes mellitus) 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) You are in a diabetic coma You have severe kidney disease 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 Amaryl. Take special care with Amaryl 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 Amaryl. 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 Amaryl 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 Amaryl, 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 Amaryl 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 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.

The following medicines may decrease the blood sugar lowering effect of Amaryl. 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 lowering 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 Amaryl: 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

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 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)

Amaryl may either increase or weaken the effects of the following medicines: Medicines inhibiting blood clotting (coumarin derivatives such as warfarin)



Taking Amaryl with food and drink Alcohol intake may increase or decrease the blood sugar lowering action of Amaryl in an unpredictable way. Pregnancy and breast-feeding Pregnancy Amaryl 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 Amaryl may pass into breast milk. Amaryl should not be taken during breast feeeding. Ask your 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

4. POSSIBLE SIDE EFFECTS Like all medicines, Amaryl can cause side effects, although not everybody gets them. Tell your doctor immediately if you experience any of the following symptoms: 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 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 Allergy (hypersensitivity) of the skin such as itching, rash, hives and increased sensitivity to sun. Some mild allergic reactions may develop into serious reactions Severe hypoglycaemia including loss of consciousness, seizures or coma







Some patients experienced the following side effects whilst taking Amaryl: Rare side effects (affects 1 to 10 patients in 10,000) Lower blood sugar than normal (hypoglycaemia) (See Section 2 - Take special care with Amaryl) Decrease in the number of blood cells: Blood platelets (which increases risk of bleeding or bruising) White blood cells (which makes infections more likely) Red blood cells (which can make the skin pale and cause weakness or breathlessness)

Important information about some of the ingredients of Amaryl Amaryl contains lactose. If you have been told by your doctor that you cannot tolerate some sugars, contact your doctor before taking this medicinal product. 3. HOW TO TAKE AMARYL Always take Amaryl exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Taking this medicine Take this medicine by mouth, just before or with the first main meal of the day (usually breakfast). If you do not have breakfast you should take the product on schedule as prescribed by your doctor. It is important not to leave out any meal when you are on Amaryl Swallow the tablets whole with at least half glass of water. Do not crush or chew the tablets

These problems generally get better after you stop taking Amaryl Very rare side effects (affects less than 1 patient in 10,000) 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. If you experience any of these symptoms, tell your doctor immediately Abnormal liver function including yellowing of the skin and eyes (jaundice), impairment of the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure. If you experience any of these symptoms, tell your doctor immediately Feeling or being sick, diarrhoea, feeling full or bloated, and abdominal pain Decrease in the amount of sodium level in your blood (shown by blood tests)







How much to take The dose of Amaryl depends on your needs, condition and results of blood and urine sugar tests and is determined by your doctor. Do not take more tablets than your doctor has prescribed. The usual starting dose is one Amaryl 1 mg tablet once a day If necessary, your doctor may increase the dose after each 1 - 2 weeks of treatment The maximum recommended dose is 6 mg Amaryl per day A combination therapy of glimepiride plus metformin or of glimepiride plus insulin may be started. In such a case your doctor will determine the proper doses of glimepiride, metformin or insulin individually for you Your dose of Amaryl may need to be adjusted if you change weight, change your lifestyle, or if you are under a lot of stress. Please speak to your doctor if any of these situations apply to you. If you feel the effect of your medicine is too weak or too strong do not change the dose yourself, but ask your doctor

Other side effects include: Allergy (hypersensitivity) of the skin may occur such as itching, rash, hives and increased sensitivity to sun. Some mild allergic reactions may develop into serious reactions with swallowing or breathing problems, swelling of your lips, throat or tongue. Therefore in the event of one of these side effects, tell your doctor immediately Allergic reactions with sulfonylureas, sulfonamides, or related drugs may occur Problems with your sight may occur when beginning treatment with Amaryl. This is due to changes in blood sugar levels and should soon improve Increased liver enzymes









If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE AMARYL KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 25C. Store in the original package. Do not use after the expiry date printed on the carton label or blister strip. If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to. If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

If you take more Amaryl than you should If you happen to have taken too much Amaryl or an additional dose there is a danger of hypoglycaemia (signs of hypoglycaemia see Section 2 - Take special care with Amaryl) and therefore you should instantly consume enough sugar (e.g. a small bar of sugar cubes, sweet juice, sweetened tea) and inform a 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 coma are cases of medical emergency requiring immediate medical treatment and admission into hospital. It may be helpful to tell your family and friends to call a doctor immediately if this happens to you. If you forget to take Amaryl If you forget to take a dose, do not take a double dose to make up for forgotten doses. If you stop taking Amaryl If you interrupt or stop the treatment you should be aware that the desired blood sugar lowering effect is not achieved or that the disease will get worse again. Keep taking Amaryl until your doctor tells you to stop. If you have any further questions on the use of this product, ask your doctor or pharmacist.



6. FURTHER INFORMATION What Amaryl contains Amaryl 1mg Tablet contains 1mg of the active ingredient, glimepiride. Amaryl also contains the following inactive ingredients: lactose monohydrate, sodium starch glycollate, povidone, microcrystalline cellulose, magnesium stearate and red iron oxide (E172).

What Amaryl looks like and contents of the pack Amaryl 1mg Tablet is a pink, oblong tablet scored on both sides and marked on both sides NMK and a logo on either side of the score line. Amaryl is available as blister packs of 30 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, Middlesex, HA0 1DX. Manufacturer This product is manufactured by Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt, Germany. Sanofi-Aventis SpA, S.S. 17 Km 22, 67019 Scoppito (AQ), Italy. POM PL 19488/1072 Amaryl 1mg Tablets

Leaflet revision date: 08 November 2012 Amaryl is a registered trade mark of Aventis Pharma Deutschland GmbH, Germany.
S1072 LEAFLET Amaryl 20121108

S1072 LEAFLET Glimepiride 20121108



PACKAGE LEAFLET: INFORMATION FOR THE USER

GLIMEPIRIDE 1mg TABLETS
Your medicine is known as Glimepiride 1mg Tablets but will be referred to as Glimepiride Tablets throughout the following patient information leaflet. Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours

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. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor may wish to change your dose of Glimepiride Tablets if you are taking other medicines, which may weaken or strengthen the effect of Glimepiride Tablets on the level of sugar in your blood. The following medicines can increase the blood sugar lowering effect of Glimepiride Tablets. 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



If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist In this leaflet: 1. What Glimepiride Tablets are and what they are used for 2. Before you take Glimepiride Tablets 3. How to take Glimepiride Tablets 4. Possible side effects 5. How to store Glimepiride Tablets 6. Further information 1. WHAT GLIMEPIRIDE TABLETS ARE AND WHAT THEY ARE USED FOR Glimepiride Tablets are medicines taken by mouth to help lower blood sugar. It belongs to a group of medicines called sulfonylureas. Glimepiride Tablets work by increasing the amount of insulin released from your pancreas. The insulin then lowers your blood sugar levels. What Glimepiride Tablets are used for: Glimepiride Tablets are used to treat a certain form of diabetes (type 2 diabetes mellitus) when diet, physical exercise and weight reduction alone have not been able to control your blood sugar levels

2. BEFORE YOU TAKE GLIMEPIRIDE TABLETS Do not take Glimepiride Tablets and tell your doctor if: You are allergic (hypersensitive) 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 Glimepiride Tablets (listed in Section 6 What Glimepiride Tablets contain) You have insulin dependent diabetes (type 1 diabetes mellitus) 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) You are in a diabetic coma You have severe kidney disease 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 Tablets. Take special care with Glimepiride 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 Glimepiride Tablets. 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 Tablets 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 Tablets, 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 Tablets 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 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.

The following medicines may decrease the blood sugar lowering effect of Glimepiride Tablets. 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 lowering blood sugar (diazoxide) Medicines to treat infections, tuberculosis (rifampicine) Medicines to treat severe low blood sugar levels (glucagon)





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

The following medicines can increase or decrease the blood sugar lowering effect of Glimepiride Tablets: 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 Tablets may either increase or weaken the effects of the following medicines: Medicines inhibiting blood clotting (coumarin derivatives such as warfarin)

Taking Glimepiride Tablets with food and drink Alcohol intake may increase or decrease the blood sugar lowering action of Glimepiride Tablets in an unpredictable way. Pregnancy and breast-feeding Pregnancy Glimepiride Tablets 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 Tablets may pass into breast milk. Glimepiride Tablets should not be taken during breast feeeding. Ask your 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

4. POSSIBLE SIDE EFFECTS Like all medicines, Glimepiride Tablets can cause side effects, although not everybody gets them. Tell your doctor immediately if you experience any of the following symptoms: 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 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 Allergy (hypersensitivity) of the skin such as itching, rash, hives and increased sensitivity to sun. Some mild allergic reactions may develop into serious reactions Severe hypoglycaemia including loss of consciousness, seizures or coma







Some patients experienced the following side effects whilst taking Glimepiride Tablets: Rare side effects (affects 1 to 10 patients in 10,000) Lower blood sugar than normal (hypoglycaemia) (See Section 2 - Take special care with Glimepiride Tablets) Decrease in the number of blood cells: Blood platelets (which increases risk of bleeding or bruising) White blood cells (which makes infections more likely) Red blood cells (which can make the skin pale and cause weakness or breathlessness)

Important information about some of the ingredients of Glimepiride Tablets Glimepiride Tablets contain lactose. If you have been told by your doctor that you cannot tolerate some sugars, contact your doctor before taking this medicinal product. 3. HOW TO TAKE GLIMEPIRIDE TABLETS Always take Glimepiride Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Taking this medicine Take this medicine by mouth, just before or with the first main meal of the day (usually breakfast). If you do not have breakfast you should take the product on schedule as prescribed by your doctor. It is important not to leave out any meal when you are on Glimepiride Tablets Swallow the tablets whole with at least half glass of water. Do not crush or chew the tablets

These problems generally get better after you stop taking Glimepiride Tablets Very rare side effects (affects less than 1 patient in 10,000) 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. If you experience any of these symptoms, tell your doctor immediately Abnormal liver function including yellowing of the skin and eyes (jaundice), impairment of the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure. If you experience any of these symptoms, tell your doctor immediately Feeling or being sick, diarrhoea, feeling full or bloated, and abdominal pain Decrease in the amount of sodium level in your blood (shown by blood tests)







How much to take The dose of Glimepiride Tablets depends on your needs, condition and results of blood and urine sugar tests and is determined by your doctor. Do not take more tablets than your doctor has prescribed. The usual starting dose is one Glimepiride 1 mg tablet once a day If necessary, your doctor may increase the dose after each 1 - 2 weeks of treatment The maximum recommended dose is 6 mg Glimepiride Tablets per day A combination therapy of glimepiride plus metformin or of glimepiride plus insulin may be started. In such a case your doctor will determine the proper doses of glimepiride, metformin or insulin individually for you Your dose of Glimepiride Tablets may need to be adjusted if you change weight, change your lifestyle, or if you are under a lot of stress. Please speak to your doctor if any of these situations apply to you. If you feel the effect of your medicine is too weak or too strong do not change the dose yourself, but ask your doctor

Other side effects include: Allergy (hypersensitivity) of the skin may occur such as itching, rash, hives and increased sensitivity to sun. Some mild allergic reactions may develop into serious reactions with swallowing or breathing problems, swelling of your lips, throat or tongue. Therefore in the event of one of these side effects, tell your doctor immediately Allergic reactions with sulfonylureas, sulfonamides, or related drugs may occur Problems with your sight may occur when beginning treatment with Glimepiride Tablets. This is due to changes in blood sugar levels and should soon improve Increased liver enzymes





If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE GLIMEPIRIDE KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 25C. Store in the original package. Do not use after the expiry date printed on the carton label or blister strip. If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to. If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.



If you take more Glimepiride Tablets than you should If you happen to have taken too much Glimepiride Tablets or an additional dose there is a danger of hypoglycaemia (signs of hypoglycaemia see Section 2 - Take special care with Glimepiride Tablets) and therefore you should instantly consume enough sugar (e.g. a small bar of sugar cubes, sweet juice, sweetened tea) and inform a 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 coma are cases of medical emergency requiring immediate medical treatment and admission into hospital. It may be helpful to tell your family and friends to call a doctor immediately if this happens to you. If you forget to take Glimepiride Tablets If you forget to take a dose, do not take a double dose to make up for forgotten doses. If you stop taking Glimepiride Tablets If you interrupt or stop the treatment you should be aware that the desired blood sugar lowering effect is not achieved or that the disease will get worse again. Keep taking Glimepiride Tablets until your doctor tells you to stop. If you have any further questions on the use of this product, ask your doctor or pharmacist.



6. FURTHER INFORMATION What Glimepiride contains Glimepiride 1mg Tablet contains 1mg of the active ingredient, glimepiride. Glimepiride also contains the following inactive ingredients: lactose monohydrate, sodium starch glycollate, povidone, microcrystalline cellulose, magnesium stearate and red iron oxide (E172).

What Glimepiride looks like and contents of the pack Glimepiride 1mg Tablet is a pink, oblong tablet scored on both sides and marked on both sides NMK and a logo on either side of the score line. Glimepiride is available as blister packs of 30 tablets. Product Licence holder Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, Middlesex, HA0 1DX. Manufacturer This product is manufactured by Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt, Germany. Sanofi-Aventis SpA, S.S. 17 Km 22, 67019 Scoppito (AQ), Italy.

POM

PL 19488/1072

Glimepiride 1mg Tablets

Leaflet revision date: 08 November 2012
S1072 LEAFLET Glimepiride 20121108