Glimepiride Aurobindo

Package leaflet: Information for the user

Glimepiride Aurobindo 2 mg tablets, 3 mg tablets, 4 mg tablets

Equivalent medicinal product
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Glimepiride Aurobindo is and what it is used for
2. What you need to know before taking Glimepiride Aurobindo
3. How to take Glimepiride Aurobindo
4. Possible side effects
5. How to store Glimepiride Aurobindo
6. Contents of the pack and other information

1. What Glimepiride Aurobindo is and what it is used for

Glimepiride Aurobindo is an orally active medicine that lowers blood sugar levels. This
medicine belongs to a group of medicines that reduce blood sugar levels, known as
sulfonylureas. Glimepiride Aurobindo works by increasing the amount of insulin released by the pancreas.
Insulin in turn reduces blood sugar levels.
What Glimepiride Aurobindo is used for:

• Glimepiride Aurobindo is used to treat a type of diabetes (type 2 diabetes mellitus) when diet, physical exercise, and weight reduction alone are not sufficient to control blood sugar levels.

2. What you need to know before taking Glimepiride Aurobindo

Do not take Glimepiride Aurobindo and inform your doctor if:

• you are allergic to glimepiride or to other sulfonylureas (medicines used to lower blood sugar levels such as glibenclamide) or to sulfonamides (medicines for bacterial infections such as sulfamethoxazole) or to any of the other ingredients of this medicine (listed in section 6);
• you have insulin-dependent diabetes (type 1 diabetes mellitus);
• you have diabetic ketoacidosis (a complication of diabetes in which the level of acid in the body is increased and you may experience some of the following symptoms: fatigue, feeling unwell (nausea), frequent need to urinate, and muscle stiffness);
• you are in a diabetic coma;
• you suffer from severe kidney disease;
• you suffer from severe liver disease.

Do not take this medicine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Glimepiride Aurobindo.
Warnings and precautions
Talk to your doctor or pharmacist before taking Glimepiride Aurobindo if:

• you are recovering from any trauma, surgery, infection with fever, or other forms of stress; inform your doctor, as your treatment may need to be temporarily adjusted;
• you suffer from severe liver or kidney disease.

If you are unsure whether any of these situations apply to you, consult your doctor or pharmacist before taking Glimepiride Aurobindo.
In patients lacking the enzyme glucose-6-phosphate dehydrogenase, a decrease in hemoglobin levels and breakdown of red blood cells (hemolytic anemia) may occur.
Available information on the use of Glimepiride Aurobindo in individuals under 18 years of age is limited. Therefore, use in these patients is not recommended.
Important information about hypoglycemia (low blood sugar levels)
When taking Glimepiride Aurobindo, you may experience hypoglycemia (low blood sugar levels). Read below for further information on hypoglycemia, its symptoms, and treatment.
The following factors may increase the risk of hypoglycemia:

• you are not eating enough, eating at irregular times, skipping or delaying meals, or fasting;
• you have changed your diet;
• you have taken more Glimepiride Aurobindo than required;
• you have reduced kidney function;
• you suffer from severe liver disease;
• you have certain hormone-related disorders (thyroid, pituitary, or adrenal cortex disorders);
• you consume alcohol (especially if skipping a meal);
• you are taking certain other medicines (see “Other medicines and Glimepiride Aurobindo”);
• you are doing more physical exercise than usual and not eating enough or consuming foods with fewer carbohydrates than normal.

Signs of hypoglycemia include:

• hunger pangs, headache, nausea, vomiting, lethargy, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision disturbances, slurred speech, tremor, partial paralysis, sensory disturbances, dizziness, weakness;
• the following may also occur: sweating, moist skin, anxiety, rapid heartbeat, hypertension, palpitations, sudden chest pain radiating to surrounding areas (angina pectoris and cardiac arrhythmias).

If blood sugar levels continue to fall, you may experience severe confusion (delirium), seizures, loss of consciousness, shallow breathing, and slowed heartbeat, and you may lose consciousness. The clinical course of very low blood sugar levels may resemble that of a stroke.
Treatment of hypoglycemia
In many cases, symptoms of low blood sugar disappear rapidly after consuming sugar, such as sugar lumps, fruit juice, or sweetened tea.
Always carry a source of sugar (e.g., sugar lumps) with you. Remember that artificial sweeteners are not effective. Contact your doctor or go to hospital if taking sugar does not help or if symptoms recur.
Laboratory tests
You should regularly monitor your blood or urine sugar levels. Your doctor may also prescribe blood tests to monitor blood cell counts and liver function.
Children and adolescents
The use of Glimepiride Aurobindo in children under 18 years of age is not recommended.
Other medicines and Glimepiride Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust your dose of Glimepiride Aurobindo if you are taking other medicines that may decrease or increase its blood sugar-lowering effects.
The following medicines may enhance the blood sugar-lowering effect of Glimepiride Aurobindo. This may lead to an increased risk of hypoglycemia (low blood sugar):

• other medicines used to treat diabetes mellitus (such as insulin or metformin);
• medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, aspirin-like drugs);
• medicines used to treat urinary tract infections (such as long-acting sulfonamides);
• medicines used to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin);
• medicines used to inhibit blood clotting (coumarin derivatives such as warfarin);
• medicines used to promote muscle growth (anabolic agents);
• medicines used for male hormone replacement therapy;
• medicines used to treat depression (fluoxetine, MAO inhibitors);
• medicines that reduce high cholesterol levels (fibrates);
• medicines that reduce high blood pressure (ACE inhibitors);
• medicines called antiarrhythmics used to control abnormal heart rhythms (disopyramide);
• medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone);
• medicines used to treat cancer (cyclophosphamide, ifosfamide, trofosfamide);
• medicines used for weight reduction (fenfluramine);
• medicines used to improve circulation when administered intravenously at high doses (pentoxifylline);
• medicines used to treat nasal allergies, such as hay fever (tritoqualine);
• medicines called sympatholytics used to treat high blood pressure, heart failure, or prostate symptoms.

The following medicines may reduce the blood sugar-lowering effect of Glimepiride Aurobindo. This may lead to a risk of hyperglycemia (high blood sugar levels):

• medicines containing female sex hormones (estrogens, progestogens);
• medicines used to promote urine production (thiazide diuretics);
• medicines used to stimulate the thyroid (such as levothyroxine);
• medicines used to treat allergies and inflammation (glucocorticoids);
• medicines used to treat severe mental disorders (chlorpromazine and other phenothiazine derivatives);
• medicines used to increase heart rate, treat asthma or nasal congestion, cough and cold, used for weight reduction, or used in life-threatening emergencies (adrenaline and sympathomimetics);
• medicines used to treat high cholesterol (nicotinic acid);
• medicines used to treat constipation when used long-term (laxatives);
• medicines used to treat seizures (phenytoin);
• medicines used to treat nervousness and sleep disorders (barbiturates);
• medicines used to treat increased eye pressure (acetazolamide);
• medicines used to treat high blood pressure or low blood sugar (diazoxide);
• medicines used to treat infections and tuberculosis (rifampicin);
• medicines used to treat very low blood sugar (glucagon).

The following medicines may increase or decrease the blood sugar-lowering effect of Glimepiride Aurobindo:

• medicines used to treat stomach ulcers (H2 antagonists);
• medicines used to treat high blood pressure or heart failure such as beta-blockers, clonidine, guanethidine, and reserpine. These may also mask the symptoms of hypoglycemia; therefore, special caution is required when taking these medicines.

Glimepiride Aurobindo may increase or decrease the effects of the following medicines:

• medicines used to inhibit blood clotting (coumarin derivatives such as warfarin).

Colesevelam, a medicine used to lower cholesterol, affects the absorption of Glimepiride Aurobindo. To avoid this interaction, it is recommended to take Glimepiride Aurobindo at least 4 hours before colesevelam.
Glimepiride Aurobindo with food, drinks, and alcohol
Consumption of alcohol may unpredictably increase or decrease the blood sugar-lowering effect of Glimepiride Aurobindo.
Pregnancy, breastfeeding, and fertility
Pregnancy
Glimepiride Aurobindo must not be taken during pregnancy. If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Breastfeeding
Glimepiride Aurobindo may pass into breast milk. Glimepiride Aurobindo must not be taken if you are breastfeeding.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar levels are low (hypoglycemia) or high (hyperglycemia), or if you develop vision problems as a consequence of these conditions. Be aware that this may pose a risk to yourself and others (e.g., when driving vehicles or operating machinery). Ask your doctor whether you may drive if:

• you experience frequent episodes of hypoglycemia,
• you have few or no warning symptoms of hypoglycemia.

Glimepiride Aurobindo contains lactose. If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Glimepiride Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
How to take this medicine

• Take this medicine by mouth, immediately before or during your first main meal of the day (usually breakfast). If you do not eat breakfast, you should take the medicine at the time prescribed by your doctor. It is important not to skip any meals while taking Glimepiride Aurobindo.
• Swallow the tablets with at least half a glass of water. Do not crush or chew the tablets.

Each tablet may be divided into equal doses.
How much medicine to take
The dose of Glimepiride Aurobindo depends on your individual needs, condition, and results of blood and urine sugar tests, and is determined by your doctor. Do not take more tablets than prescribed by your doctor.

• The recommended starting dose of Glimepiride Aurobindo is one 1 mg tablet once daily.
• If necessary, your doctor may increase the dose every 1–2 weeks of treatment.
• The maximum recommended dose is 6 mg of Glimepiride Aurobindo per day.
• Combination therapy with glimepiride and metformin or glimepiride and insulin may be initiated. In such cases, your doctor will determine the appropriate doses of glimepiride, metformin, or insulin specific to you.
• If your weight changes, your lifestyle changes, or you are under stress, your Glimepiride Aurobindo dose may need adjustment; therefore, inform your doctor.
• If you think the effect of the medicine is too weak or too strong, do not change the dose on your own, but consult your doctor.

If you take more Glimepiride Aurobindo than you should
If you accidentally take too much Glimepiride Aurobindo or take an extra dose, there is a risk of hypoglycaemia (for signs of hypoglycaemia, see section 2 – Warnings and precautions). You should immediately consume an adequate amount of sugar (e.g. a small bar of sugar cubes, fruit juice, or sweetened tea) and contact your doctor immediately. If treating hypoglycaemia caused by accidental ingestion in children, the amount of sugar administered must be carefully monitored to avoid causing dangerous hyperglycaemia. Food or drinks must not be given to unconscious individuals.
Since hypoglycaemic states can last for some time, it is very important that the patient is closely monitored until there is no longer any danger. Hospitalisation may be necessary, even as a precautionary measure. Show your doctor the medicine pack or any remaining tablets so that the doctor can see what has been taken.
Severe cases of hypoglycaemia with loss of consciousness and severe neurological impairment are medical emergencies requiring immediate medical treatment and hospitalisation. Ensure that there is always an informed person available who can call the doctor in an emergency.
If you forget to take Glimepiride Aurobindo
If you forget to take a dose, do not take a double dose to make up for the missed dose.
If you stop taking Glimepiride Aurobindo
If you interrupt or stop treatment, you should know that you will no longer achieve the desired blood sugar-lowering effect and your condition may worsen again. Continue taking Glimepiride Aurobindo until your doctor tells you to stop.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Immediately inform your doctor if any of the following symptoms occur:

• allergic reactions (including inflammation of blood vessels, often with skin rash), which may become a severe reaction with difficulty breathing, drop in blood pressure, and sometimes progress to shock;
• abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), inflammation of the liver (hepatitis), or liver failure;
• skin allergy (hypersensitivity) such as itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions may progress to severe reactions;
• severe hypoglycaemia with loss of consciousness, seizures, or coma.

The following adverse events have been reported in some patients taking Glimepiride Aurobindo:
Rare side effects (may affect up to 1 in 1,000 patients)

• blood sugar level lower than normal (hypoglycaemia) (see section 2 - Warnings and precautions);
• decrease in blood cell counts:
• platelets (which increases the risk of bleeding or bruising),
• white blood cells (which increases the risk of infections),
• red blood cells (which may cause pale skin, weakness, and shortness of breath). These problems usually improve after stopping Glimepiride Aurobindo;
• weight gain;
• hair loss;
• altered sense of taste.

Very rare side effects (may affect up to 1 in 10,000 patients)

• allergic reactions (including inflammation of blood vessels, often with skin rash), which may become a severe reaction with difficulty breathing, drop in blood pressure, and sometimes progress to shock. If any of these symptoms occur, immediately inform your doctor;
• abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), inflammation of the liver (hepatitis), or liver failure. If any of these symptoms occur, immediately inform your doctor;
• nausea or vomiting, diarrhoea, feeling of fullness or bloating, and abdominal pain;
• decrease in sodium levels in the blood (detected by blood tests).

Side effects not known (frequency cannot be estimated from the available data):

• skin allergy (hypersensitivity) such as itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions may progress to severe reactions with difficulty swallowing or breathing, swelling of the lips, throat, or tongue. Therefore, if any of these side effects occur, immediately inform your doctor;
• allergic reactions may occur with sulphonamides, sulphonylureas, or related medicines;
• at the beginning of treatment with Glimepiride Aurobindo, vision problems may occur. This is due to changes in blood sugar levels and should improve quickly;
• increased liver enzymes;
• unusual severe bleeding or bruising under the skin.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Glimepiride Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, the packaging and the bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Glimepiride Aurobindo if you notice any visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Glimepiride Aurobindo Contains
The active substance is glimepiride. Each tablet contains 2 mg/3 mg/4 mg of glimepiride.

• Other components are: microcrystalline cellulose, lactose monohydrate, povidone (K 25), sodium starch glycolate, magnesium stearate.
• Additionally, the tablets contain colouring agents:
• tablets of 3 mg strength contain yellow iron oxide (E172)
• tablets of 4 mg strength contain indigo carmine aluminium lake (E132)

Description of the Appearance of Glimepiride Aurobindo and Contents of the Pack
Tablet.
Glimepiride Aurobindo 2 mg tablets:
White to almost white, flat, oblong, uncoated tablets with bevelled edges and double-scored, imprinted with “Y” and “32” on either side of the score line on one side, and smooth on the other side.
The tablet can be divided into two equal doses.
Glimepiride Aurobindo 3 mg tablets:
Light yellow, flat, oblong, uncoated tablets with bevelled edges and double-scored, imprinted with “Y” and “33” on either side of the score line on one side, and smooth on the other side.
The tablet can be divided into two equal doses.
Glimepiride Aurobindo 4 mg tablets:
Sky blue to blue, flat, oblong, uncoated tablets with bevelled edges and double-scored, imprinted with “Y” and “34” on either side of the score line on one side, and smooth on the other side.
The tablet can be divided into two equal doses.
Glimepiride Aurobindo tablets are available in blister packs and in HDPE bottles with polypropylene caps.
Pack sizes:
Blister packs: 15, 30, 50, 60, 90 and 120 tablets.
HDPE bottle: 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l.
via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia
BBG 3000
Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road, Ruislip
HA4 6QD
United Kingdom

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Glimepirid Aurovitas
Italy: Glimepiride Aurobindo
Netherlands: Glimepiride Aurobindo 1 mg/2 mg /3 mg /4 mg, tabletten
Poland: Glimepiride Aurovitas
Portugal: Glimepirida Aurovitas
Spain: GLIMEPIRIDA AUROVITAS 2 mg/ 4 mg comprimidos EFG