Package Leaflet: Information for the User

Glimepiride Aurovitas 4 mg Tablets EFG

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Glimepiride Aurovitas

3.How to take Glimepiride Aurovitas

4.Possible side effects

5.Storage of Glimepiride Aurovitas

6.Contents of the pack and additional information

Glimepirida Aurovitas is a medication that lowers blood sugar levels, taken orally. This medication belongs to a group of medications that lower blood sugar levels called sulfonylureas. Glimepirida Aurovitas increases the amount of insulin released by your pancreas. Insulin lowers your blood sugar levels.

What is Glimepirida Aurovitas used for:

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

Do not take Glimepirida 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 to any of the other components of this medicine (listed in section 6).
• You have insulin-dependent diabetes (type 1 diabetes).
• You have diabetic ketoacidosis (a complication of diabetes when your body's acid levels rise 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 circumstances affect you. If you are unsure, consult your doctor or pharmacist before taking Glimepirida Aurovitas.

Warnings and precautions

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

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

If you are unsure whether anything mentioned above affects you, consult your doctor or pharmacist before taking Glimepirida Aurovitas.

It may occur that your red blood cell count decreases and you develop a rupture of red blood cells (hemolytic anemia) in patients who lack an enzyme called glucose-6-phosphate dehydrogenase.

The available information on the use of glimepiride in people under 18 years 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 have hypoglycemia (low blood sugar). See below for additional information about hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of you suffering hypoglycemia:

• Malnutrition, irregular meal times, omission or delay of meals, or periods of fasting.
• Changes in your diet.
• Taking more glimepiride than you need.
• Having reduced renal function.
• Having severe liver disease.
• Having any other hormonal disorder (such as thyroid gland problems, pituitary gland problems, or adrenal cortex problems).
• Consuming alcohol (especially if you skip a meal).
• Taking certain medications (see below “Taking Glimepirida Aurovitas with other medicines”).
• Increasing physical exercise and not eating enough or taking foods with fewer carbohydrates than usual.

The symptoms of hypoglycemia include:

• Feeling of empty stomach, headache, nausea, vomiting, lethargy, sleepiness, sleep disturbances, restlessness, irritability, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision disturbances, tremors, slurred speech, partial paralysis, sensory disturbances, dizziness, and feelings of abandonment.

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

If your blood sugar levels continue to drop, you may experience severe confusion (delirium), seizures, loss of self-control, shallow breathing, and a decrease in heart rate, and you may become unconscious. The clinical procedure for a severe drop in blood sugar is similar to a stroke.

Treatment of hypoglycemia:

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

Therefore, you should always carry something sweet (such as sugar cubes) with you. Please note that artificial sweeteners are not effective. Please consult your doctor or go to the hospital if, after taking sugar, you do not recover or if the symptoms recur.

Blood tests

Your blood sugar levels or urine should be regularly monitored. Your doctor may also ask you to have blood tests to check your red blood cell count and see how your liver is functioning.

Children and adolescents

Glimepirida Aurovitas is not recommended for use in children under 18 years.

Other medicines and Glimepirida Aurovitas

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

Your doctor may want to change your Glimepirida Aurovitas dose if you are taking other medicines that can decrease 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):

• Other medicines for treating diabetes mellitus (such as insulin or metformin).
• Medicines for treating pain and inflammation (phenylbutazone, azapropazone, oxifenbutazone, 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 clotting (cumarinic derivatives such as warfarin).
• Medicines used in anabolic therapy.
• 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, trophosphamide).
• Medicines used for weight loss (fenfluramine).
• Medicines that improve circulation when administered at high doses in intravenous perfusion (pentoxifylline).
• Medicines for treating allergic rhinitis 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):

• 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 congestion, cough, and cold, used for weight loss, or in emergency situations that put life at risk (adrenaline and sympathomimetics).
• Medicines for lowering high cholesterol levels (nicotinic acid).
• Medicines used for treating 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 (diazoxide).
• Medicines for treating infections, tuberculosis (rifampicin).
• Medicines used to treat very low blood sugar (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 symptoms 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 clotting (cumarinic 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 Glimepirida Aurovitas with food, drinks, and alcohol

The consumption of alcohol may increase or decrease the hypoglycemic effect of glimepiride in an unpredictable manner.

Pregnancy, breastfeeding, and fertility

Pregnancy

Glimepirida Aurovitas should not be taken during pregnancy. If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding

Glimepirida Aurovitas may pass into breast milk. It should not be used during lactation.

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 may be hazardous in situations where these skills are important (such as driving or using machines). Therefore, consult your doctor if it is recommended 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 symptoms of hypoglycemia.

Glimepirida Aurovitas contains lactose.If your doctor has told you that you have 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; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How to take this medication

• Take this medication orally, just before or with the first meal of the day (usually breakfast). If you do not take breakfast, take the medication as your doctor has told you. It is essential not to skip any meals while 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 analysis, and will be established by your doctor. Do not take more tablets than your doctor has told you.

• The recommended initial dose is 1 mg of Glimepiride Aurovitas once a day.
• If necessary, your doctor may increase the dose after each 1-2 weeks of treatment.
• The maximum recommended dose is 6 mg of glimepiride per day.
• You may start with a combined treatment of glimepiride and metformin or glimepiride and insulin. In these cases, your doctor will indicate the appropriate doses of glimepiride, metformin, and insulin for you individually.
• If your weight changes or you change your lifestyle, or you are under stress, you may need to change the doses of glimepiride, so inform your doctor.
• If you feel that the effect of this medication 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 have taken too much glimepiride or an additional dose, there is a risk of hypoglycemia (for signs of hypoglycemia see section 2 - "Warnings and precautions"), and therefore you must consume sufficient sugar immediately (e.g. sugar cubes, sweet juices, sweet tea) and inform your doctor immediately. When treating hypoglycemia due to accidental ingestion in children, the amount of sugar to be administered must be carefully controlled to avoid the possibility of producing a dangerous hyperglycemia. People in a coma should not take food or drinks.

Since hypoglycemia can last for a while, it is very important that the patient be closely monitored until there is no longer a risk. It may be necessary as a safety measure to be admitted to the hospital. Show the packaging or tablets that are left for your doctor to know what you have taken.

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

If you forgot to take Glimepiride Aurovitas

If you forget a dose, do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Glimepiride Aurovitas

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• Allergic reactions (including blood vessel inflammation, frequently with skin rash) that can trigger severe reactions with difficulty breathing, low blood pressure, and sometimes leading to shock.
• Abnormal liver function, including yellow discoloration of skin and eyes (jaundice), bile flow problems (cholestasis), liver inflammation (hepatitis), or liver insufficiency.
• Skin allergy (hypersensitivity) such as itching, skin rash, urticaria, and light sensitivity. Some mild allergic reactions can become severe.
• Severe hypoglycemia, including loss of consciousness, seizures, or coma.

Some patients have experienced the following side effects while taking Glimepiride Aurovitas:

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

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

• Low blood sugar levels (hypoglycemia) (see section 2 "Warnings and precautions").
• 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 tone and difficulty breathing).

These changes usually disappear when treatment with Glimepiride Aurovitas is stopped.

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

• Allergic reactions (including blood vessel inflammation, frequently with skin rash) that can trigger severe reactions with difficulty breathing, low blood pressure, and sometimes leading to shock. If you experience any of these symptoms,inform your doctor immediately.
• Abnormal liver function, including yellow discoloration of skin and eyes (jaundice), bile flow problems (cholestasis), liver inflammation, or liver insufficiency. If you experience any of these symptoms,inform your doctor immediately.
• Nausea, vomiting, diarrhea, feeling of fullness in the stomach or bloating, and stomach pain.
• Decreased 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, urticaria, and light sensitivity. Some mild allergic reactions can become severe reactions with difficulty swallowing or breathing, swelling of lips, throat, or tongue. Therefore, if you experience any of these side effects,inform your doctor immediately.
• Allergic reactions with sulfonilureas, 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 of side effects:

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Glimepiride Aurovitas

• The active ingredient is glimepiride.Each tablet contains 4 mg of glimepiride..
• The other components are:microcrystalline cellulose, lactose monohydrate, povidone (K 25), carboxymethylstarch sodium (type A) from potato, magnesium stearate.

-Additionally, the tablets contain coloring agents:

The 4mg tablets contain aluminum lake of indigotin (E132).

Appearance of the product and contents of the package

Uncoated tablets of light blue to blue color, oblong, flat faces, scored on both faces, with “Y” and “34” engraved on one side of the score of one face and not engraved on the other.

The tablet can be divided into equal doses.

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

Packaging sizes

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

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

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Tel: 91 630 86 45

Fax: 91 630 26 64

Responsible 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 with the following names:

Spain:Glimepiride Aurovitas 4mg tablets EFG

Italy:GLIMEPIRIDEAUROBINDO

Netherlands:Glimepiride Aurobindo 4mgtabletten

Poland:Glimepiride Aurovitas

Portugal:Glimepiride Aurovitas

Czech Republic:Glimepirid Aurovitas

Last review date of this leaflet:May 2021

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