GLIMEPIRIDE MABO 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

GLIMEPIRIDE MABO 2 mg tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What Glimepiride MABO 2 mg tablets are and what they are used for
2. What you need to know before you start taking Glimepiride MABO 2 mg tablets
3. How to take Glimepiride MABO 2 mg tablets
4. Possible side effects
5. Storage of Glimepiride MABO 2 mg tablets
6. Contents of the pack and further information

1. What Glimepiride MABO 2 mg tablets are and what they are used for

Glimepiride MABO 2 mg tablets are a medicine that is taken orally and lowers blood sugar levels.

They belong to a group of medicines called sulfonylureas.

Glimepiride works by increasing the amount of insulin released by the pancreas. Then, insulin lowers the blood sugar levels.

Glimepiride MABO 2 mg tablets are used to treat a specific type of diabetes (type 2 diabetes mellitus) when diet, exercise, and weight loss alone are not enough to control blood sugar levels.

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

Do not take Glimepiride MABO 2 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 treat bacterial infections, such as sulfamethoxazole).
• If you have insulin-dependent diabetes (type 1 diabetes mellitus).
• If you have diabetic ketoacidosis (a complication of diabetes that consists of increased acidity of the body, with signs 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 not sure, talk to your doctor or pharmacist before taking Glimepiride MABO 2 mg tablets.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Glimepiride MABO 2 mg tablets:

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

If you are not sure if you are in any of these situations, talk to your doctor or pharmacist before taking Glimepiride MABO 2 mg tablets.

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

Children and adolescents

There is limited information available on the use of Glimepiride MABO 2 mg tablets in people under 18 years of age. Therefore, it is not recommended for use in these patients.

Important information about hypoglycemia (low blood sugar levels)

When taking Glimepiride MABO 2 mg tablets, you may experience hypoglycemia (low blood sugar levels). See below for more information on hypoglycemia, its signs, and treatment.

The following factors increase the risk of hypoglycemia:

• Malnutrition, irregular meal schedule, skipping meals, or delaying them or fasting.
• Diet changes.
• Taking more Glimepiride MABO 2 mg tablets than necessary.
• Kidney failure.
• Severe liver disease.
• Hormonal disorders (thyroid, pituitary, or adrenal disorders).
• Drinking alcohol (especially after skipping a meal).
• Taking certain medications (see Use of other medications, below).
• Engaging in more physical exercise and not eating enough or taking foods with less carbohydrates than usual.

Signs of hypoglycemia:

• Hunger attacks, headache, nausea, vomiting, lethargy, drowsiness, sleep disorders, restlessness, aggression, decreased concentration, decreased alertness and reaction time, depression, confusion, speech and vision disorders, slurred speech, tremors, partial paralysis, sensory disorders, dizziness, and feelings of impotence.
• Other signs may also appear, such as 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 sugar levels continue to drop, you may experience significant confusion (delirium), seizures, loss of control, shallow breathing, and decreased heart rate, and you may become unconscious. The clinical picture of a severe hypoglycemic episode may resemble that of a stroke.

Treatment of hypoglycemia:

In most cases, the signs of hypoglycemia disappear quickly after consuming any form of sugar, such as sugar cubes, sweet juices, or sugary tea.

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

Laboratory tests

Regularly check your blood and urine sugar levels. Your doctor may also take blood samples to measure your blood cells and liver function.

Use of other medications

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medications, including those purchased without a prescription.

Your doctor may advise you to modify the dose of Glimepiride MABO 2 mg tablets if you are taking other medications that may weaken or enhance the effect of Glimepiride MABO 2 mg tablets on blood sugar levels.

The following medications may enhance the blood sugar-lowering effect of Glimepiride MABO 2 mg tablets. This may increase the risk of hypoglycemia (low blood sugar levels):

• Other medications used to treat diabetes mellitus (such as insulin or metformin).
• Medications used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, medications similar to aspirin).
• Medications used to treat urinary tract infections (such as some long-acting sulfonamides).
• Medications used to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin).
• Medications used to prevent blood clots (coumarin derivatives, such as warfarin).
• Medications that stimulate muscle growth (anabolic agents).
• Medications used in male hormone replacement therapy.
• Medications used to treat depression (fluoxetine, MAO inhibitors).
• Medications that lower cholesterol levels (fibrates).
• Medications that lower blood pressure (ACE inhibitors).
• Anti-arrhythmic medications used to control abnormal heart rhythms (disopyramide).
• Medications used to treat gout (allopurinol, probenecid, sulfinpyrazone).
• Medications used to treat cancer (cyclophosphamide, ifosfamide, trofosfamide).
• Medications used for weight loss (fenfluramine).
• Medications used to stimulate circulation when administered intravenously at high doses (pentoxifylline).
• Medications used to treat nasal allergies, such as hay fever (tritoqualine).
• Medications called sympatholytics used to treat high blood pressure, heart failure, or prostate symptoms.

The following medications may weaken the blood sugar-lowering effect of Glimepiride MABO 2 mg tablets. This may increase the risk of hyperglycemia (high blood sugar levels):

• Medications that contain female sex hormones (estrogens, progestogens).
• Medications that increase urine production (thiazide diuretics).
• Medications that stimulate the thyroid gland (levothyroxine).
• Medications used to treat allergies and inflammation (glucocorticoids).
• Medications used to treat severe mental disorders (chlorpromazine and other phenothiazine derivatives).
• Medications used to increase heart rate, treat asthma or nasal congestion, cough, and cold, for weight loss, or in life-threatening emergencies (adrenaline and sympathomimetics).
• Medications used to lower cholesterol levels (nicotinic acid).
• Medications used to treat constipation when used for a long time (laxatives).
• Medications used to treat seizures (phenytoin).
• Medications used to treat nervousness and sleep disorders (barbiturates).
• Medications used to treat increased intraocular pressure (acetazolamide).
• Medications used to treat high blood pressure or lower blood sugar levels (diazoxide).
• Medications used to treat infections and tuberculosis (rifampicin).
• Medications used to treat severe hypoglycemia (glucagon).

The following medications may enhance or weaken the blood sugar-lowering effect of Glimepiride MABO 2 mg tablets.

• Medications used to treat stomach ulcers (called H2 antagonists).
• Medications used to treat high blood pressure or heart failure, such as beta-blockers, clonidine, guanethidine, or reserpine. These medications may also mask the signs of hypoglycemia, which requires extra caution when taking such medications.

Glimepiride MABO 2 mg tablets may enhance or weaken the effect of the following medications:

• Medications used to prevent blood clots (coumarin derivatives, such as warfarin).

Taking Glimepiride MABO 2 mg tablets with food, drinks, and alcohol

Alcoholic beverages may enhance or weaken the blood sugar-lowering effect of Glimepiride MABO 2 mg tablets in an unpredictable manner.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

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

Driving and using machines

Your ability to concentrate or react may be impaired if your blood sugar levels drop (hypoglycemia) or rise (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., when driving a car or using 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 at all.

Glimepiride MABO 2 mg tablets contain lactose.If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

Glimepiride MABO 2 mg tablets contain sodium.This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Glimepiride MABO 2 mg tablets

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Take this medicine orally, just before the first meal of the day (usually breakfast) or with it. If you do not have breakfast, take the medicine at the same time every day, as indicated by your doctor. It is important that you do not skip any meals while receiving treatment with Glimepiride MABO 2 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 2 mg tablets depends on your needs, your condition, and the results of your blood and urine sugar tests, and is determined by your doctor. Do not take more tablets than your doctor has prescribed.

• The usual initial dose is 1 mg of glimepiride once a day.
• If necessary, your doctor may increase the dose after 1 or 2 weeks of treatment.
• The maximum recommended dose is 6 mg of glimepiride per day.
• Combination therapy with glimepiride and metformin or glimepiride and insulin may be initiated. In such cases, your doctor will determine the doses of glimepiride, metformin, or insulin that are suitable for you.
• If you change your weight or lifestyle or if you are in a stressful situation, it may be necessary to modify the dose of Glimepiride MABO; therefore, in these cases, you should inform your doctor.
• If you notice that the effect of the medicine 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 2 mg tablets than you should

If you have taken more Glimepiride MABO 2 mg tablets than you should, contact your doctor or pharmacist immediately. In case of overdose or accidental ingestion, contact the Toxicology Information Service, phone 91 562 04 20.

If you take too much glimepiride or an extra dose, you are at risk of hypoglycemia (see the signs of hypoglycemia in section 2, Warnings and precautions), so you should consume sugar in sufficient quantity (e.g., sugar cubes, sweet juice, sugary tea) and inform your doctor immediately. When treating hypoglycemia in children due to accidental ingestion, carefully control the amount of sugar administered to avoid the risk of causing dangerous hyperglycemia. People who have lost consciousness should not be given food or drink.

As the hypoglycemic situation may last for some time, it is very important to closely monitor the patient until the danger has passed. It may be necessary to hospitalize the patient as a precaution. Show your doctor the package or remaining tablets so they know what you have taken.

Severe cases of hypoglycemia with loss of consciousness and severe neurological impairment are medical emergencies that require immediate treatment and hospitalization. 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 2 mg tablets

Do not take a double dose to make up for the forgotten dose.

If you stop taking Glimepiride MABO 2 mg tablets

If you stop or suspend treatment, you should be aware that the effect of reducing blood sugar levels will not be achieved, or that the disease will worsen again. Continue taking Glimepiride MABO 2 mg tablets until your doctor tells you to stop the treatment.

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

4. Possible Adverse Effects

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

Go to the doctor immediately if you experience any of the following symptoms:

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

The following adverse effects have also been reported:

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

• Low blood sugar (hypoglycemia) (see section 2, Warnings and Precautions)
• Decrease in blood cell count:
• • platelets (which increases the risk of bleeding and bruising)
  • white blood cells (which increases the risk of infection)
  • red blood cells (pale skin and weakness or breathing difficulties)

These disorders usually improve when stopping Glimepirida MABO 2 mg tablets.

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

• Allergic reactions (including inflammation of the blood vessels, often with skin rash), which can evolve into a severe reaction with difficulty breathing, low blood pressure, and sometimes shock. If you experience any of these symptoms, go to the doctor immediately.
• Liver function abnormalities, such as yellowish skin and eyes (jaundice), bile flow disorders (cholestasis), liver inflammation (hepatitis), or liver failure. If you experience any of these symptoms, go to the doctor immediately.
• Discomfort, diarrhea, feeling of fullness or bloating, abdominal pain.
• Decrease in sodium levels in the blood (detected in blood tests).

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

• Skin allergy (hypersensitivity), which can manifest as itching, rash, hives, or increased sensitivity to sunlight. Some mild allergic reactions can become severe, with difficulty swallowing or breathing, and swelling of the lips, throat, or tongue. Therefore, if you experience any of these side effects, go to the doctor immediately.

• Allergic reactions to sulfonylureas, sulfonamides, and other related medicines may occur.
• When starting treatment with Glimepirida MABO 2 mg tablets, you may notice changes in vision. These are due to changes in blood sugar levels and should improve soon.
• Increased liver enzymes.
• Unusual or severe bleeding or bruising under the skin.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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, website: www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Glimepirida MABO 2 mg Tablets

Keep this medicine out of sight and reach of children.

Do not use Glimepirida MABO 2 mg tablets after the expiration date shown on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Do not use this medicine if you notice visible changes in the appearance of the medicine.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. If in 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 MABO 2 mg Tablets

• The active ingredient is glimepiride. Each tablet contains 2 mg of glimepiride.
• The other components (excipients) are: lactose monohydrate, sodium glycolate starch type A, microcrystalline cellulose, povidone K30, magnesium stearate, yellow iron oxide (E-172), and indigotine (E-132)

Appearance of the Product and Package Contents

The tablets are green, oblong, and scored on both sides. They are presented in transparent PVC/aluminum blisters. Each package contains 30 or 120 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada, Madrid

Manufacturer

PharmaPath S.A.

28is Oktovriou 1,

Agia Varvara, 12351

Greece

This leaflet was approved in March 2021

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