GLIMEPIRIDE AUROVITAS 2 mg TABLETS

2. What you need to know before you take Glimepiride Aurovitas

Do not take Glimepiride Aurovitas and talk to your doctor if:

• You are allergic to glimepiride or other sulfonylureas (medicines used to lower your blood sugar levels, 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).
• You have type 1 diabetes mellitus.
• You have diabetic ketoacidosis (a complication of diabetes when your acid levels rise in your body and you may have some of the following symptoms: fatigue, dizziness, frequent urination, and muscle stiffness).
• You are in a diabetic coma.
• You have severe kidney disease.
• You have severe liver disease.

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking glimepiride.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Glimepiride Aurovitas if:

• You are recovering from any injury, surgery, infection with fever, or other forms of stress. Inform your doctor, as it may be necessary to make some change in your treatment.
• You have any severe liver or kidney disorder.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking glimepiride.

It may happen that your hemoglobin levels decrease and you may experience a breakdown of red blood cells (hemolytic anemia) if you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase.

Information on the use of glimepiride in children under 18 years of age is limited. Therefore, its use is not recommended in these patients.

Important information about hypoglycemia (low blood sugar levels)

If you are taking glimepiride, you may experience hypoglycemia (low blood sugar levels). See below for more information about hypoglycemia, its signs, and treatment.

The following factors can increase the risk of you experiencing hypoglycemia:

• Malnutrition, irregular meal schedule, skipping meals, or periods of fasting.
• Changes in your diet.
• Taking more glimepiride than you need.
• Having reduced kidney function.
• Having severe liver disease.
• Having other hormonal disorders (such as thyroid, pituitary, or adrenal gland problems).
• Consuming alcohol (especially if you skip a meal).
• Taking certain medicines (see below "Other medicines and Glimepiride Aurovitas").
• Increasing your physical exercise and not eating enough or taking foods with less carbohydrates than usual.

Signs of hypoglycemia include:

• Feeling of empty stomach, headache, nausea, vomiting, drowsiness, sleepiness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision disturbances, tremors, slurred speech, partial paralysis, sensory disturbances, dizziness, and feeling of helplessness.

• The following signs may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, palpitations, sudden chest pain that may radiate to adjacent areas (angina pectoris and cardiac arrhythmias).

If your blood sugar levels continue to drop, you may experience severe confusion (delirium), have convulsions, lose self-control, have shallow breathing and a slow heart rate, and may become unconscious. The clinical picture of severe hypoglycemia is similar to a stroke.

Treatment of hypoglycemia:

In most cases, the symptoms of low blood sugar disappear quickly when you take some sugar, such as sugar cubes, sweet juices, sugary tea.

Therefore, you should always carry some sugar with you (e.g., sugar cubes). Note that artificial sweeteners are not effective. Please consult your doctor or go to the hospital if you do not recover after taking sugar or if the symptoms recur.

Blood tests

Your blood sugar or urine levels should be regularly checked. Your doctor may also ask for blood tests to check your blood cell count and to see how your liver is working.

Children and adolescents

The use of glimepiride is not recommended in children under 18 years of age.

Other medicines and Glimepiride Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Your doctor may want to change your dose of glimepiride if you are taking other medicines that may lower or increase the effect of glimepiride on your blood sugar levels.

The following medicines may increase the hypoglycemic effect of glimepiride. This may lead to a risk of hypoglycemia (low blood sugar levels):

• Other medicines for treating diabetes mellitus (such as insulin or metformin).
• Medicines for treating pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, and aspirin derivatives).
• Medicines for treating urinary tract infections (such as some long-acting sulfonamides).
• Medicines for treating bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin).
• Medicines that inhibit blood coagulation (coumarin derivatives such as warfarin).
• Medicines for increasing muscle mass (anabolic agents).
• Medicines used in hormone replacement therapy in men.
• Medicines for treating depression (fluoxetine, MAO inhibitors).
• Medicines for lowering high cholesterol levels (fibrates).
• Medicines for lowering high blood pressure (ACE inhibitors).
• Medicines called antiarrhythmics used for controlling abnormal heart rhythm (disopyramide).
• Medicines for treating gout (allopurinol, probenecid, sulfinpyrazone).
• Medicines for treating cancer (cyclophosphamide, ifosfamide, trofosfamide).
• Medicines used for weight loss (fenfluramine).
• Medicines that improve circulation when administered at high doses in intravenous infusion (pentoxifylline).
• Medicines for treating nasal allergies such as hay fever (tritoqualine).
• Medicines called sympatholytics used for treating high blood pressure, heart failure, or prostate symptoms.

The following medicines may decrease the hypoglycemic effect of glimepiride. This may lead to a risk of hyperglycemia (high blood sugar levels):

• Medicines containing female sex hormones (estrogens, progestogens).
• Medicines for increasing urine production (thiazide diuretics).
• Medicines used to stimulate the thyroid gland (such as levothyroxine).
• Medicines for treating allergies and inflammation (glucocorticoids).
• Medicines for treating severe mental disorders (chlorpromazine and other phenothiazine derivatives).
• Medicines used to increase heart rate, for treating asthma or nasal congestion, cough and colds, used for weight loss, or in life-threatening emergency situations (adrenaline and sympathomimetics).
• Medicines for lowering high cholesterol levels (nicotinic acid).
• Medicines used to treat constipation when used for long periods (laxatives).
• Medicines for treating seizures (phenytoin).
• Medicines for treating nervousness and sleep problems (barbiturates).
• Medicines for treating eye pressure (acetazolamide).
• Medicines for treating high blood pressure or low blood sugar levels (diazoxide).
• Medicines for treating infections, tuberculosis (rifampicin).
• Medicines used to treat very low blood sugar levels (glucagon).

The following medicines may increase or decrease the hypoglycemic effect of glimepiride:

• Medicines for treating stomach ulcers (called H2 antagonists).
• Medicines for treating high blood pressure or heart failure, such as beta-blockers, clonidine, guanethidine, and reserpine. These may also mask the signs of hypoglycemia, so special care is needed when taking these medicines.

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

• Medicines that inhibit blood coagulation (coumarin derivatives such as warfarin).

Colesevelam, a medicine used to lower cholesterol, affects the absorption of glimepiride. To avoid this effect, it is recommended to take glimepiride at least 4 hours before colesevelam.

Taking Glimepiride Aurovitas with food, drinks, and alcohol

Consuming alcohol may increase or decrease the hypoglycemic effect of glimepiride in an unpredictable way.

Pregnancy and breastfeeding

Pregnancy

Glimepiride should not be taken during pregnancy. Consult your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.

Breastfeeding

Glimepiride may pass into breast milk. It should not be used during breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Your ability to concentrate and react may be impaired due to the symptoms caused by hypoglycemia or hyperglycemia, such as vision disturbances. This can be dangerous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor if it is advisable to drive or use machines.

Please consult your doctor if you can drive if:

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

Glimepiride Aurovitas contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Glimepiride Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Glimepiride Aurovitas

Follow exactly the instructions for administration of this medicine given by your doctor. If you are not sure, consult your doctor or pharmacist again.

Taking this medicine

• Take this medicine by mouth, just before or with the first meal of the day (usually breakfast). If you do not have breakfast, take the medicine as your doctor has told you. It is important not to skip any meals when taking glimepiride.
• Swallow the tablets whole with at least half a glass of water. Do not break or chew the tablets.

The tablet can be divided into equal doses.

How much to take

The dose depends on your needs, condition, and results of your blood sugar and urine tests, and will be determined by your doctor. Do not take more tablets than your doctor has told you.

• The initial dose is usually 1 mg of glimepiride once a day.
• If necessary, your doctor may increase your dose after each 1-2 weeks of treatment.
• The maximum recommended dose is 6 mg of glimepiride per day.
• You may start with a combination treatment of glimepiride and metformin or glimepiride and insulin. In these cases, your doctor will tell you the individual doses of glimepiride, metformin, and insulin.
• If your weight changes or you change your lifestyle, or you are under stress, you may need to change your glimepiride dose, so inform your doctor.
• If you feel that the effect of this medicine is too strong or too weak, do not change the dose yourself and inform your doctor.

If you take more Glimepiride Aurovitas than you should

If you take too much glimepiride or an extra dose, there is a risk that you may experience hypoglycemia (for signs of hypoglycemia, see section 2), and you should immediately consume some sugar (e.g., sugar cubes, sweet juices, sugary tea) and inform your doctor immediately. When treating hypoglycemia due to accidental ingestion in children, the amount of sugar to be administered should be carefully controlled to avoid the possibility of producing a dangerous hyperglycemia. Unconscious patients should not be given food or drink.

As hypoglycemia may last for a while, it is very important that the patient is carefully monitored until there is no more danger. It may be necessary to be hospitalized as a precautionary measure. Show the package or remaining tablets to the doctor so they can see what you have taken.

Severe cases of hypoglycemia with loss of consciousness and severe neurological impairment are medical emergencies that require immediate medical treatment and hospitalization. Make sure there is always someone informed who can call a doctor in case of an emergency.

If you forget to take Glimepiride Aurovitas

If you forget a dose, do not take a double dose to make up for the forgotten doses.

If you stop taking Glimepiride Aurovitas

If you stop or interrupt treatment, keep in mind that the desired effect of lowering blood sugar levels will not be achieved, or the disease may worsen again. Continue taking glimepiride until your doctor tells you to stop.

If you have any other questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Consult your doctor immediately if you suffer from any of the following symptoms:

• Allergic reactions (including inflammation of blood vessels, frequently with skin rash) that can trigger severe reactions with difficulty breathing, low blood pressure, and sometimes ending in shock.
• Abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), liver inflammation (hepatitis), or liver failure.
• Skin allergy (hypersensitivity) such as itching, skin rash, hives, and hypersensitivity to light. Some mild allergic reactions can become severe.
• Severe hypoglycemia, including loss of consciousness, convulsions, or coma.

Some patients have suffered the following adverse effects while taking glimepiride:

• Weight gain.
• Hair loss.
• Change in taste.

Rare Adverse Effects(may affect up to 1 in 1,000 people)

• Low blood sugar levels (hypoglycemia) (see section 2).
• Reduction in the number of blood cells:

• Platelets (which increases the risk of bleeding or bruising).
• White blood cells (which makes infections more frequent).
• Red blood cells (which can cause pale skin and produce weakness or difficulty breathing).

In general, these alterations disappear when treatment with glimepiride is discontinued.

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

• Allergic reactions (including inflammation of blood vessels, frequently with skin rash) that can trigger severe reactions with difficulty breathing, low blood pressure, and sometimes ending in shock. If you experience any of these symptoms, inform your doctor immediately.
• Abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), liver inflammation, or liver failure. If you experience any of these symptoms, inform your doctor immediately.
• Feeling of nausea, vomiting, diarrhea, feeling of heaviness in the stomach or bloating, and stomach pain.
• Decrease in sodium levels in the blood (visible in blood tests).

Frequency Not Known (cannot be estimated from available data):

• Skin allergy (hypersensitivity) such as itching, skin rash, hives, and hypersensitivity to light. Some mild allergic reactions can become severe reactions with swallowing or breathing problems, swelling of the lips, throat, or tongue. Therefore, if you experience any of these adverse effects, inform your doctor immediately.
• Allergic reactions to sulfonylureas, sulfonamides, or related medications.
• You may experience vision difficulties when starting treatment with glimepiride. This is due to changes in blood sugar levels and should improve soon.
• Increased liver enzymes.
• Unusual intense bleeding or bruising under the skin.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Glimepirida Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions. Do not use Glimepirida Aurovitas if you observe visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Glimepirida Aurovitas

• The active ingredient is glimepiride. Each tablet contains 2 mg of glimepiride.
• The other components are: microcrystalline cellulose, lactose monohydrate, povidone (K 25), sodium carboxymethyl starch (type A) of potato, magnesium stearate.

Appearance of the Product and Package Contents

Uncoated white to off-white tablets, oblong, with flat faces, scored on both faces, with "Y" and "32" engraved on either side of the score on one face and without engraving on the other.

The tablet can be divided into equal doses.

Glimepirida Aurovitas tablets are available in blister packs and high-density polyethylene (HDPE) bottles with polypropylene closures.

Package Sizes

Blister pack: 15, 30, 50, 60, 90, and 120 tablets.

High-density polyethylene (HDPE) bottle: 500 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Half Far Industrial Estate, Hal Far,

Birzebbuggia, BBG 3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Glimepirida Aurovitas 2 mg tablets EFG

Italy: GLIMEPIRIDE AUROBINDO

Netherlands: Glimepiride Aurobindo 2 mg tablets

Portugal: Glimepirida Aurovitas

Date of the Last Revision of this Leaflet:June 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)