Leaflet: Information for the user

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

1.What is Glimepiride MABO 4 mg tablets and what it is used for

2.What you need to know before you start taking Glimepiride MABO 4 mg tablets

3.How to take Glimepiride MABO 4 mg tablets

4.Possible side effects

5.Storage of Glimepiride MABO 4 mg tablets

6.Contents of the pack and additional information

Glimepirida MABO 4 mg tablets is a medication taken orally that reduces blood sugar levels.

It belongs to a group of medications known as sulfonylureas.

Glimepirida acts by increasing the amount of insulin released by the pancreas. Subsequently, insulin decreases blood sugar levels.

Glimepirida MABO 4 mg tablets is used to treat a specific type of diabetes (type 2 diabetes mellitus) when diet, exercise, and weight loss alone are insufficient to control blood sugar levels.

Do not take Glimepiride MABO 4 mg tablets

• If you are allergic to glimepiride or any of the other ingredients of this medicine (listed in Section 6).
• If you are allergic to other sulfonylureas (medicines used to lower blood sugar, such as glibenclamide) or sulfonamides (medicines used to combat bacterial infections, such as sulfamethoxazole).
• If you have insulin-dependent diabetes (Type 1 diabetes);
• If you have diabetic ketoacidosis (a complication of diabetes that consists of an increase in the body's acidity, with symptoms such as fatigue, nausea, frequent urination, and muscle stiffness).
• If you are in a diabetic coma.
• If you have severe kidney disease.
• If you have severe liver disease.
• If you are pregnant
• If you are breastfeeding

Do not take this medicine if you are in any of the above situations. If you are unsure, speak with your doctor or pharmacist before taking Glimepiride MABO 4 mg tablets.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeGlimepiride MABO 2 mg tablets:

• If you are recovering from an injury, operation, infection with fever, or other form of stress, you should speak with your doctor, as it may be necessary to temporarily modify the treatment.
• If you have severe liver or kidney disease.

If you are unsure whether you are in any of these circumstances, speak with your doctor or pharmacist before taking Glimepiride MABO 4 mg tablets.

In patients with a deficiency of the glucose-6-phosphate dehydrogenase enzyme, there may be a decrease in hemoglobin levels and red blood cell rupture in the blood (hemolytic anemia).

Children and adolescents

The available information on the use of Glimepiride MABO 4 mg tablets in people under 18 years of age is limited. Therefore, its use is not recommended in these patients.

Important information about hypoglycemia (low blood sugar)

When you take Glimepiride MABO 4 mg tablets, you may experience hypoglycemia (low blood sugar). See below for more complete information on hypoglycemia, its symptoms, and its treatment.

Factors that increase the risk of hypoglycemia:

• Poor nutrition, irregular meal times, skipping meals, or delaying them, or fasting.
• Changes in diet.
• Taking more Glimepiride MABO 4 mg tablets than necessary.
• Renal insufficiency.
• Severe liver disease.
• Suffering from certain hormone-related disorders (thyroid, pituitary, or adrenal gland disorders).
• Consuming alcohol (especially after skipping a meal).
• Taking certain medications (see Use of other medicines, below).
• Engaging in more physical exercise and not eating enough or consuming foods with less carbohydrates than normal.

Symptoms of hypoglycemia:

• Episodes of hunger, headache, nausea, vomiting, lethargy, drowsiness, sleep disturbances, restlessness, irritability, decreased concentration, decreased vigilance, and reaction time, depression, confusion, speech disorders, and visual disturbances, inarticulate speech, tremors, partial paralysis, sensory disorders, dizziness, and feelings of impotence.
• The following symptoms may also appear: sweating, skin moisture, anxiety, increased heart rate, elevated blood pressure, palpitations, severe and sudden chest pain that may radiate to adjacent areas (angina pectoris), and cardiac arrhythmias.

If blood glucose levels continue to drop, you may experience significant confusion (delirium), convulsions, loss of control, shallow breathing, and decreased heart rate, and you may become unconscious. The clinical picture of a severe hypoglycemic crisis may resemble that of a stroke.

Treatment of hypoglycemia:

In most cases, hypoglycemia symptoms disappear immediately after consuming any form of sugar, such as sugar cubes, sweet juices, or tea with sugar.

Therefore, you should always carry some form of sugar (sugar cubes, for example) with you. Remember that artificial sweeteners are not effective. Contact your doctor or go to a hospital if taking sugar does not help or if symptoms reappear.

Laboratory tests

You should have your blood sugar levels and urine checked regularly. Your doctor may also take blood samples to measure your blood cells and liver function.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medicine, including those purchased without a prescription.

Your doctor may advise you to modify the dose of Glimepiride MABO 4 mg tablets if you are taking other medicines that weaken or intensify the effect of Glimepiride MABO 4 mg tablets on blood sugar.

The following medicines may intensify the blood sugar-lowering effect of Glimepiride MABO 4 mg tablets, increasing the risk of hypoglycemia:

• Other medicines used to treat diabetes mellitus (such as insulin or metformin).
• Medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxifenbutazone, and similar aspirin-like medicines).
• Medicines used to treat urinary tract infections (such as some sulfonamides with prolonged action).
• Medicines used to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin).
• Medicines used to prevent blood clots (cumarin derivatives, such as warfarin).
• Medicines used to stimulate muscle tissue (anabolic steroids).
• Medicines used to treat male hormone replacement therapy.
• Medicines used to treat depression (fluoxetine, MAO inhibitors).
• Medicines used to lower cholesterol (fibrates).
• Medicines used to treat high blood pressure (ACE inhibitors).
• Medicines used to control abnormal heart rhythms (disopyramide).
• Medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone).
• Medicines used to treat cancer (cyclophosphamide, ifosfamide, trophosphamide).
• Medicines used to aid weight loss (fenfluramine).
• Medicines used to stimulate circulation when high doses are administered intravenously (pentoxifylline).
• Medicines used to treat allergic rhinitis, such as hay fever (tritoclonine).
• Medicines called sympatholytics used to treat high blood pressure, heart failure, or prostatic symptoms.

The following medicines may weaken the blood sugar-lowering effect of Glimepiride MABO 4 mg tablets, increasing the risk of hyperglycemia:

• Medicines containing female sex hormones (estrogens, progestogens).
• Medicines that increase urine production (thiazide diuretics).
• Medicines that stimulate the thyroid gland (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 congestion, cough, and cold, aid weight loss, or in emergency situations with vital risk (adrenaline and sympathomimetics).
• Medicines used to treat high cholesterol (nicotinic acid).
• Medicines used to treat constipation when used for a long time (laxatives).
• Medicines used to treat seizures (phenytoin).
• Medicines used to treat nervousness and sleep disorders (barbiturates).
• Medicines used to treat increased intraocular pressure (acetazolamide).
• Medicines used to treat high blood pressure or to lower blood sugar (diazoxide).
• Medicines used to treat infections and tuberculosis (rifampicin).
• Medicines used to treat severe hypoglycemia (glucagon).

The following medicines may intensify or weaken the blood sugar-lowering effect of Glimepiride MABO 4 mg tablets:

• Medicines used to treat stomach ulcers (called H2 antagonists).
• Medicines used to treat high blood pressure or heart failure, such as beta-blockers, clonidine, guanethidine, or reserpine. These medicines may also mask the symptoms of hypoglycemia, requiring special caution when taken.

Glimepiride MABO 4 mg tablets may intensify or weaken the effect of the following medicines:

• Medicines used to prevent blood clots (cumarin derivatives, such as warfarin).

Taking Glimepiride MABO 4 mg tablets with food, drinks, and alcohol

Alcoholic beverages may intensify or weaken the blood sugar-lowering effect of Glimepiride MABO 4 mg tablets in an unpredictable manner.

Pregnancy and lactation

Pregnancy

Glimepiride should not be used during pregnancy. If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medicine.

Lactation

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

Driving and operating machines

Your ability to concentrate or react may be impaired if your blood sugar levels decrease (hypoglycemia) or increase (hyperglycemia), or if you experience visual disturbances as a result of these circumstances. Be aware that you may put yourself or others at risk (e.g., by driving a car or operating machines). Ask your doctor if you can drive if:

• You have experienced frequent episodes of hypoglycemia;
• You have fewer warning signs of hypoglycemia, or none.

Glimepiride MABO 4 mg tablets contain lactose.If your doctor has told you that you have an intolerance to some sugars, speak with him before taking this medicine.

Glimepiride MABO 4 mg tablets contain sodium.This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free."

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

Take this medication orally, just before the first meal of the day (usually breakfast) or with it. If you do not have breakfast, take the medication at the same time every day as indicated by your doctor. It is essential not to skip any meals while receiving treatment with Glimepiride MABO 4 mg tablets.

Swallow the tablet whole, with at least half a glass of water. Do not crush or chew the tablets.

The dose of Glimepiride MABO 4 mg tablets depends on your needs, condition, and the results of blood sugar and urine analysis, and is determined by your doctor. Do not take more tablets than prescribed by your doctor.

• The usual initial dose is 1 mg of glimepiride once a day.
• If necessary, your doctor may increase the dose at the end of 1 or 2 weeks of treatment.
• The maximum recommended dose is 6 mg of glimepiride per day.
• A combined treatment with glimepiride and metformin or glimepiride and insulin may be initiated. In this case, your doctor will determine the doses of glimepiride, metformin, or insulin that are suitable for you.
• If you change your weight or lifestyle or are in a stressful situation, it may be necessary to modify the dose of Glimepiride MABO; therefore, in these cases, inform your doctor.
• If you notice that the effect of the medication is too weak or too strong, talk to your doctor, but do not change the dose on your own initiative.

If you take more Glimepiride MABO 4 mg tablets than you should

If you have taken more Glimepiride MABO 4 mg tablets than you should, consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, contact the Toxicological Information Service, phone 91 562 04 20

If you take too much glimepiride or an extra dose, you are at risk of hypoglycemia (see hypoglycemia signs in section 2, Warnings and Precautions), so you should consume enough sugar immediately (e.g., a few sugar cubes, a sweet juice, sweet tea) and inform your doctor immediately. When treating accidental hypoglycemia in children, it is essential to carefully control the amount of sugar administered to avoid the risk of causing a potentially dangerous hyperglycemia. People who have lost consciousness should not receive food or drinks.

Since hypoglycemia can last for some time, it is very important to closely monitor the patient until the danger passes. It may be necessary to admit them to the hospital as a precautionary measure. Show the packaging or remaining tablets to the doctor so they know what you have taken.

Severe hypoglycemia with loss of consciousness and severe neurological insufficiency are medical emergencies that require immediate treatment and hospital admission. Ensure that there is always someone previously informed who can call a doctor in case of an emergency.

If you forget to take Glimepiride MABO 4 mg tablets

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Glimepiride MABO 4 mg tablets

If you interrupt or discontinue treatment, be aware that you will not achieve the effect of reducing blood sugar concentration, or that the disease will worsen again. Continue taking Glimepiride MABO 4 mg tablets until your doctor tells you to stop treatment.

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

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

Seek medical attention immediately if you experience any of the following symptoms:

• Allergic reactions (including inflammation of blood vessels, often with skin rash), which may progress to a severe reaction with difficulty breathing, low blood pressure, and sometimes shock.
• Liver function abnormalities, such as yellowing of the skin and eyes (jaundice), bile flow alterations (cholestasis), liver inflammation (hepatitis), or liver failure.
• Cutaneous allergy (hypersensitivity), such as itching, rash, hives, or increased sensitivity to sunlight. Some mild allergic reactions may become severe with difficulty swallowing or breathing, swelling of the lips, throat, or tongue.
• Severe hypoglycemia, such as loss of consciousness, seizures, or coma.

The following side effects have also been reported:

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

• Low blood sugar (hypoglycemia) (see section 2, Warnings and precautions
• Decreased number of blood cells:
• • platelets (increasing the risk of bleeding and bruising)
  • white blood cells (increasing the risk of infection)
  • red blood cells (pale skin and weakness or breathing difficulties)

These disorders usually improve when Glimepiride MABO 4 mg tablets are discontinued.

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

• Allergic reactions (including inflammation of blood vessels, often with skin rash), which may progress to a severe reaction with difficulty breathing, low blood pressure, and sometimes shock. If you experience any of these symptoms,seek medical attention immediately.
• Liver function abnormalities, such as yellowing of the skin and eyes (jaundice), bile flow alterations (cholestasis), liver inflammation (hepatitis), or liver failure. If you experience any of these symptoms,seek medical attention immediately.
• Discomfort, diarrhea, feeling of fullness or bloating, abdominal pain.
• Decreased sodium concentration in the blood (detected in blood tests).

Unknown frequency(cannot be determined from available data):

• Cutaneous allergy (hypersensitivity), which may present as itching, rash, hives, or increased sensitivity to sunlight. Some mild allergic reactions may become severe, with difficulty swallowing or breathing and swelling of the lips, throat, or tongue. Therefore, if you experience any of these side effects,seek medical attention immediately.
• Allergic reactions to sulfonilureas, sulfonamides, and other related medications may occur.
• You may notice visual disturbances when starting treatment with Glimepiride MABO 4 mg tablets. These are due to changes in blood sugar concentration and should improve soon.
• Increased liver enzymes.
• Unusual intense bleeding or purpura under the skin.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use, website:www.notificaram.es.By reporting adverse reactions, 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 Glimepiride MABO 4 mg tablets after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe visible changes in the appearance of the medication.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medication that you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medication. By doing so, you will help protect the environment.

Composition of Glimepiride MABO 4 mg tablets

• The active ingredient is glimepiride. Each tablet contains 4mg of glimepiride.
• The other components (excipients) are: lactose monohydrate, sodium glycolate type A starch, microcrystalline cellulose, povidone K30, magnesium stearate and indigotin (E-132)

Appearance of the product and contents of the packaging

The tablets are light blue, oblong, and have a notch on both sides. They are presented in transparent PVC/aluminum blisters. Each package contains 30 or 120 tablets.

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada, Madrid

Responsible manufacturer

PharmaPath S.A.

28is Oktovriou 1,

Agia Varvara, 12351

Greece

This leaflet was approved in March 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es