Glimepiride Aurovitas 4 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glimepiride Aurovitas 4 mg tablets EFG

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 harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 adverse 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 medication that lowers blood sugar levels and is active when taken orally. This medicine belongs to a group of blood sugar-lowering medications 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 when 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 starting 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 impairment of liver or kidney function.

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

Low 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.
• 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 below “Other medicines and Glimepirida Aurovitas”).
• 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 feelings 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 and cardiac arrhythmias).

If your blood sugar continues to drop, you may experience severe confusion (delirium), seizures, loss of consciousness, shallow breathing, and 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 when you consume sugar, such as sugar lumps, sweet fruit juice, or sugary tea.

Therefore, you should always carry some sugar with you (e.g., sugar lumps). Please remember that artificial sweeteners are not effective. Consult your doctor or go to the hospital if your symptoms do not improve 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 blood cell counts and assess 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 glimepiride dose 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 a risk of hypoglycemia (low blood sugar):

• Other medicines 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 via intravenous infusion (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 used over 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 extra 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, glimepiride should be taken 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 might 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 may 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 use machines.

Please consult your doctor if you can drive if:

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

Glimepirida Aurovitas contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult 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 using this medicine as given by your doctor. If 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 instructed 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 prescribed by your doctor.

• 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 you change your lifestyle, or 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 accidentally take 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 should be carefully controlled to avoid causing dangerous hyperglycemia. Unconscious individuals should 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 risk. As a precaution, hospitalization may be necessary. Show the packaging or any remaining tablets to your 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 someone informed is always available 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, keep in mind that the desired effect of lowering blood sugar will not be achieved, or 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, often accompanied by 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 photosensitivity. Some mild allergic reactions may progress into 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 below normal (hypoglycaemia) (see section 2).

• Reduction in blood cell counts:

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

• White blood cells (increasing susceptibility to infections).

• 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, often accompanied by skin rash), which may trigger 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 heaviness or bloating in the stomach, and stomach pain.
• Decreased sodium levels 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 photosensitivity. Some mild allergic reactions may progress into 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 vision disturbances when starting treatment with glimepiride. 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 adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers 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 4 mg of glimepiride.

• The other components are: microcrystalline cellulose, lactose monohydrate, povidone (K 25), sodium carboxymethyl starch (type A) from potato, magnesium stearate.

• In addition, the tablets contain colouring agents:

The 4 mg tablets contain indigo carmine aluminium lake (E132).

Nature of the product and contents of the pack

Uncoated tablets, light blue to blue in colour, oblong-shaped, flat-faced, scored on both sides, with "Y" and "34" engraved on each side of the score on one face, and unmarked on the other.

The tablet can be divided into equal doses.

Glimepirida 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 certain 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 member states under the following names:

Spain: Glimepirida Aurovitas 4 mg comprimidos EFG

Italy: GLIMEPIRIDE AUROBINDO

Netherlands: Glimepiride Aurobindo 4 mg tabletten

Portugal: Glimepirida Aurovitas

Date of the most recent review of this leaflet: June 2025

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