What it is and what it is used for

for

Glimepiride is one of a group of medicines called oral hypoglycaemics, which are used for treatment of diabetes (a disease where the body does not produce enough insulin to control the level of blood sugar). Oral hypoglycaemics help control blood sugar level. The active ingredient in your Glimepiride tablets is Glimepiride. What Glimepiride is used for: Glimepiride is used in the treatment of non-insulin dependent (Type II) diabetes mellitus. You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Type II diabetes can sometimes be controlled by good diet, physical exercise and weight reduction alone, but where this is not possible, Glimepiride is used in addition.

2.

What you need to know before you take it

e Glimepiride.

Do not take Glimepiride: • • •

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 any of the other ingredients of this medicine (listed in section 6) if you have insulin dependent diabetes (Type I 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 are in a diabetic coma if you have severe kidney disease if 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. Warnings and precautions: Talk to your doctor or pharmacist before taking Glimepiride 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. 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 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, 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 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 below "Other medicines and Glimepiride") If you increase the amount of exercise you do and you don't eat enough food or eat food containing less carbohydrate than usual.

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, sensory disturbances, 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 (palpitations), 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 (convulsions), 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. Children and adolescents Glimepiride is not recommended for use in children under 18 years of age. Other medicines and Glimepiride Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may wish to change your dose of Glimepiride if you are taking other medicines, which may weaken or strengthen the effect of Glimepiride on the level of sugar in your blood. The following medicines can increase the blood sugar lowering effect of Glimepiride. 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

The following medicines may decrease the blood sugar lowering effect of Glimepiride. 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 low 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 Glimepiride: • 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 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. To avoid this effect, you should be advised to take Glimepiride at least 4 hours before colesevelam Glimepiride with food, drink and alcohol Alcohol intake may increase or decrease the blood sugar lowering action of Glimepiride in an unpredictable way. Pregnancy and breast-feeding Pregnancy Glimepiride 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 may pass into breast milk. Glimepiride should not be taken during 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. 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 tablets contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.

How to take it

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 medicine on schedule as prescribed by your doctor. It is important not to leave out any meal when you are on Glimepiride • The tablet can be divided into equal doses. Swallow the tablets with at least half glass of water. Do not crush or chew the tablets. How much to take The dose of glimepiride 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 6mg per day • A combination therapy of glimepiride plus metformin or of glimepiride plus insulin may be initiated. In such a case your doctor will determine the proper doses of glimepiride, metformin or insulin individually for you • If your weight changes or if you change your lifestyle, or you are in a stress situation this may require changed glimepiride doses, therefore inform your doctor. • If you feel the effect of your medicine is too weak or too strong do not change the dose yourself, but ask your doctor If you take more Glimepiride than you should If you happen to have taken too much Glimepiride or an additional dose there is a danger of hypoglycaemia ( for signs of hypoglycaemia see section 2) 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 (severe neurological failure) 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 If you forget to take a tablet, do not take a double dose to make up for forgotten doses. If you stop taking Glimepiride 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 until your doctor tells you to stop. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Glimepiride 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: Rare side effects (may affect up to 1 in 1,000 people) • Lower blood sugar than normal (hypoglycaemia) (see section 2) • 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) These problems generally get better after you stop taking Glimepiride
• Changes in your sense of taste.
• Loss of hair.
• Weight gain. Very rare side effects (may affect up to 1 in 10,000 people) • 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

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Decrease in the amount of sodium level in your blood (shown by blood tests)

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Not known side effects (frequency cannot be estimated from the available data)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 medicines may occur Problems with your sight may occur when beginning treatment with Glimepiride. This is due to changes in blood sugar levels and should soon improve Increased liver enzymes Severe unusual bleeding or bruising under the skin

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Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store it

glimepiride tablets

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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 label after EXP. The expiry date refers to the last day of that month. Do not store the tablets above 25° C

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Store in the original package in order to protect from moisture. Do not use this medicine if you notice visible signs of deterioration. 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 protect the environment.

6.

Contents of the pack and other information

What Glimepiride tablet contains The active substance is Glimepiride. The other ingredients are lactose, sodium starch glycolate, povidone, sodium lauryl sulphate, magnesium stearate, microcrystalline cellulose, red iron oxide E172 (1mg tablets), yellow iron oxide E172 (2mg and 3mg tablets) and indigo carmine aluminium lake E132 (2mg and 4mg tablets). What Glimepiride tablets looks like and contents of the pack Glimepiride 1mg tablets are Pink coloured capsule shaped tablet with debossing "GM" & "1" with score line on one side and score line on the other side. Glimepiride 2mg tablets are Pale green coloured capsule shaped tablet with debossing "GM" & "2" with score line on one side and score line on the other side. Glimepiride 3mg tablets are Pale yellow coloured capsule shaped tablet with debossing "GM" & "3" with score line on one side and score line on the other side.

Glimepiride 4mg tablets are Light blue coloured capsule shaped tablet with debossing "GM" & "4" with score line on one side and score line on the other side. Pack size: Cartons containing 30 tablets in two blisters, each of 15 tablets. Marketing Authorisation Holder and Manufacturer Brown & Burk UK Limited 5 Marryat Close, Hounslow West Middlesex, TW4 5DQ United Kingdom

This leaflet was last updated in December 2020