Glimepiride Aurovitas 2 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glimepiride Aurovitas 2 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Glimepirida Aurovitas is and what it is used for

Glimepirida Aurovitas is a medicine that lowers blood sugar levels and is active when taken orally. This medicine belongs to a group of blood sugar-lowering medicines called sulfonylureas. Glimepiride increases the amount of insulin released by your pancreas. Insulin reduces the levels of sugar in your blood.

What Glimepirida Aurovitas is used for:

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

2. What you need to know before taking Glimepirida Aurovitas

Do not take Glimepirida Aurovitas and speak with your doctor if:

• You are allergic to glimepiride or other sulfonylureas (medications used to lower your blood sugar levels such as glibenclamide) or sulfonamides (medications for bacterial infections such as sulfamethoxazole), or to 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 in which acid levels rise in your body and you may experience symptoms such as fatigue, dizziness (nausea), frequent urination, and muscle stiffness).
• You are suffering from diabetic coma.
• You have severe kidney disease.
• You have severe liver disease.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Glimepirida Aurovitas if:

• You are recovering from an injury, surgery, infection with fever, or other forms of stress. Inform your doctor, as your treatment may need to be adjusted.
• You have severe liver or kidney impairment.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking glimepiride.

A decrease in hemoglobin levels and breakdown of red blood cells (hemolytic anemia) may occur in patients who lack an enzyme called glucose-6-phosphate dehydrogenase.

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

Important information about hypoglycemia (low blood sugar)

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

The following factors may increase your risk of hypoglycemia:

• Malnutrition, irregular meal times, skipping or delaying meals, or fasting periods.
• Changes in your diet.
• Taking more glimepiride than you need.
• Impaired kidney function.
• Severe liver disease.
• Other hormonal disorders (such as thyroid, pituitary, or adrenal cortex gland problems).
• Consuming alcohol (especially if you skip a meal).
• Taking certain medications (see "Other medicines and Glimepirida Aurovitas" below).
• Increasing physical activity without eating enough or consuming fewer carbohydrates than usual.

Signs of hypoglycemia include:

• Feeling hungry, headache, nausea, vomiting, lethargy, drowsiness, 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 a sense 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 nearby areas (angina pectoris and cardiac arrhythmias).

If your blood sugar continues to drop, you may experience severe confusion (delirium), seizures, loss of consciousness, shallow breathing, and a slowed heart rate. The clinical picture of severe hypoglycemia may resemble a stroke.

Treatment of hypoglycemia:

In most cases, symptoms of low blood sugar resolve quickly after consuming sugar, such as sugar lumps, sweet fruit juices, or sugared tea.

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

Blood tests

Your blood or urine sugar levels should be monitored regularly. Your doctor may also request blood tests to monitor your blood cell counts and liver function.

Children and adolescents

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

Other medicines and Glimepirida Aurovitas

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

Your doctor may need to adjust your dose of glimepiride if you are taking other medicines that may decrease or increase glimepiride's effect on your blood sugar levels.

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

• Other medications for treating diabetes mellitus (such as insulin or metformin).
• Medicines for pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, and aspirin derivatives).
• Medicines for urinary tract infections (such as certain long-acting sulfonamides).
• Medicines for bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin).
• Medicines that inhibit blood clotting (coumarin derivatives such as warfarin).
• Medicines to increase muscle mass (anabolic agents).
• Medicines used in male hormone replacement therapy.
• Medicines for depression (fluoxetine, MAO inhibitors).
• Medicines to lower high cholesterol levels (fibrates).
• Medicines to lower high blood pressure (ACE inhibitors).
• Medicines called antiarrhythmics used to control abnormal heart rhythms (disopyramide).
• Medicines for gout (allopurinol, probenecid, sulfinpyrazone).
• Medicines for cancer (cyclophosphamide, ifosfamide, trofosfamide).
• Medicines used for weight loss (fenfluramine).
• Medicines that improve circulation when administered at high doses intravenously (pentoxifylline).
• Medicines for 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 decrease the hypoglycemic effect of glimepiride. This may lead to a risk of hyperglycemia (high blood sugar):

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

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

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

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

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

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

Taking Glimepirida Aurovitas with food, drinks, and alcohol

Alcohol consumption may unpredictably increase or decrease the hypoglycemic action of glimepiride.

Pregnancy and breastfeeding

Pregnancy

Glimepiride must 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 symptoms caused by hypoglycemia or hyperglycemia, such as vision problems. This could be dangerous in situations where these skills are important (e.g., driving or operating machinery). Therefore, consult your doctor to determine whether it is safe for you to drive or operate machinery.

Please consult your doctor if you can drive if:

• You experience frequent episodes of hypoglycemia,
• You have absent or few warning symptoms of hypoglycemia.

Glimepirida Aurovitas contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

Glimepirida Aurovitas contains sodium

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

3. How to take Glimepiride Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Taking this medicine

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

The tablet may be divided into equal doses.

How much to take

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

• The usual starting dose is one 1 mg glimepiride tablet once daily.
• If necessary, your doctor may increase your dose after every 1–2 weeks of treatment.
• The maximum recommended dose is 6 mg of glimepiride per day.
• You may start combination therapy with glimepiride plus metformin or glimepiride plus insulin. In such cases, your doctor will individually determine the appropriate doses of glimepiride, metformin, and insulin for you.
• If your weight changes, or if your lifestyle changes, or you are under stress, you may need to adjust your glimepiride dose; therefore, inform your doctor.
• If you feel that the effect of this medicine is too strong or too weak, do not change the dose yourself; inform your doctor.

If you take more Glimepiride Aurovitas than you should

If you have accidentally taken too much glimepiride or an extra dose, there is a risk of hypoglycemia (for signs of hypoglycemia, see section 2). You should immediately consume sufficient sugar (e.g. sugar lumps, sweet fruit juice, sugared tea) and contact your doctor immediately. When treating hypoglycemia due to accidental ingestion in children, the amount of sugar administered must be carefully controlled to avoid causing dangerous hyperglycemia. Unconscious individuals must not be given food or drink.

Since hypoglycemia may persist for some time, it is very important that the patient is carefully monitored until there is no further danger. As a precaution, hospital admission may be necessary. Show the packaging or any remaining tablets to the doctor so they can determine what you have taken.

Severe cases of hypoglycemia associated with loss of consciousness and serious neurological impairment are medical emergencies requiring immediate medical treatment and hospitalization. Ensure that there is always a person informed and ready to call a doctor in case of emergency.

If you forget to take Glimepiride Aurovitas

If you miss a dose, do not take a double dose to make up for the missed dose.

If you stop taking Glimepiride Aurovitas

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

If you have any further 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 everyone will experience them.

Contact your doctor immediately if you experience any of the following symptoms:

• Allergic reactions (including inflammation of blood vessels, frequently with skin rash), which may lead to severe reactions with breathing difficulties, low blood pressure, and sometimes resulting in 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, skin rash, urticaria, and light sensitivity. Some mild allergic reactions may progress to severe reactions.
• Severe hypoglycaemia, including loss of consciousness, seizures, or coma.

Some patients taking glimepiride have experienced the following adverse effects:

• Weight gain.
• Hair loss.
• Changes in taste sensation.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Blood sugar levels lower than normal (hypoglycaemia) (see section 2).

• Reduction in blood cell counts:

• Platelets (increasing the risk of bleeding or bruising).

• White blood cells (making infections more likely).

• Red blood cells (which may cause paleness of the skin and lead to weakness or difficulty breathing).

In general, these abnormalities resolve 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), which may lead to severe reactions with breathing difficulties, low blood pressure, and sometimes resulting 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), inflammation of the liver, or liver failure. If you experience any of these symptoms, inform your doctor immediately.
• Nausea, vomiting, diarrhoea, a feeling of fullness or bloating, and stomach pain.
• Decreased levels of sodium in the blood (detectable in blood tests).

Frequency not known (cannot be estimated from available data):

• Skin allergy (hypersensitivity), such as itching, skin rash, urticaria, and light sensitivity. Some mild allergic reactions may progress to severe reactions with difficulty swallowing or breathing, or 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 medicines.
• You may experience visual disturbances when starting treatment with glimepiride. These are due to changes in blood sugar levels and should improve quickly.
• Increased liver enzymes.
• Unusual severe bleeding or bruising under the skin.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glimepiride Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions. Do not use Glimepiride Aurovitas if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be handed over to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Glimepiride Aurovitas

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

Appearance of the product and contents of the container

Uncoated tablets, white to off-white, oblong, flat-faced, scored on both sides, engraved with "Y" and "32" on either side of the score on one side, and unmarked on the other.

The tablet can be divided into equal doses.

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

Package sizes

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

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

Only some 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 medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Spain: Glimepirida Aurovitas 2 mg comprimidos EFG

Italy: GLIMEPIRIDE AUROBINDO

Netherlands: Glimepiride Aurobindo 2 mg tabletten

Portugal: Glimepirida Aurovitas

Date of the latest revision of this leaflet: June 2025

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