Label: information for the user

Glimepiride Viatris 4 mg tablets EFG

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given 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 label. See section 4.

Glimepirida Viatris contains the active ingredient glimepiride.

Glimepirida Viatris belongs to a group of medicines called oral antidiabetics. These medicines help to reduce blood sugar (glucose) levels if you have type 2 diabetes (diabetes mellitus). Your doctor will prescribe Glimepirida Viatris if your diabetes cannot be controlled with diet, physical exercise, or weight reduction.

Do not take Glimepirida Viatris:

• If you are allergic to glimepiride or other sulfonylureas (medicines used to lower blood sugar 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).
• If you have insulin-dependent diabetes (also known as type 1 diabetes).
• If you have diabetes “ketoacidosis” (a complication of diabetes when your body's acid level increases and you may experience some of the following symptoms: fatigue, dizziness, frequent urination, and muscle stiffness).
• If you have severe kidney or liver damage.

Glimepiride should not be administered to patients with diabetic coma.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Glimepirida Viatris:

• If you are recovering from an injury, operation, infection with fever or other type of stress, as you may need a temporary change in treatment.
• If you have severe liver or kidney damage.

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

If any of the above cases occur, your doctor may change the number of tablets you should take or review your complete treatment plan.

Children and adolescents

The available information on the use of Glimepirida Viatris in children and adolescents under 18 years is limited. Therefore, its use is not recommended in these patients.

Blood sugar control

Regular blood sugar (and urine) checks are necessary during treatment with Glimepirida Viatris.Your doctor may also perform certain blood tests to monitor your red blood cell levels and liver function. You should follow the treatment prescribed by your doctor to control your blood sugar levels. This means you should continue with your diabetic diet, exercise regularly, and, if necessary, lose weight.

There is a higher risk of having low blood sugar (hypoglycemia) during the first weeks of treatment. For this reason, your doctor will closely monitor your progress.

The following factors may increase the risk of you having low blood sugar:

• You are not willing or unable to cooperate.
• You are malnourished, have irregular meals, skip or eliminate meals, or have periods of fasting.
• You change your diet.
• You increase your physical activity and do not eat enough or consume foods with less carbohydrates than normal.
• You drink alcohol (especially if you also skip meals).
• Your kidneys do not function correctly.
• You have severe liver disease.
• You have a hormonal disease (such as thyroid gland problems, pituitary gland problems, or adrenal cortex problems).
• You take more Glimepirida Viatris than you need.
• You take certain medications at the same time (see “Glimepirida Viatris use with other medications”).

The symptoms of hypoglycemia include:

- Hunger, headache, nausea, vomiting, lethargy, drowsiness, difficulty falling asleep, restlessness, irritability, concentration problems, decreased alertness and reaction time, depression, confusion, speech problems, and vision problems.

- The following symptoms may also occur: sweating, moist skin, anxiety, increased or accelerated heart rate, hypertension, consciousness of heartbeats (palpitations), sudden and severe chest pain that may radiate to adjacent areas (angina pectoris and cardiac arrhythmias).If your blood sugar levels continue to drop, you may experience severe confusion (delirium), develop “attacks” (convulsions), paralysis (loss or impairment of body movement), breathing difficulties, decreased heart rate, and unconsciousness.

Treatment of hypoglycemia:

In most cases, hypoglycemia symptoms disappear quickly after eating or drinking something sweet, such as sugar cubes, a sweet juice, or sweet tea. Therefore, always carry something sweet with you. Remember that artificial sweeteners are not effective. If taking sugar does not help or if any of these symptoms reappear, contact your doctor or go to the hospital.

Other medications and Glimepirida Viatris

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

Your doctor may want to change your glimepiride dose if you are taking other medications that may weaken or strengthen the effect of glimepiride on your blood sugar level.

Glimepirida Viatris use with other medications

Your blood sugar level (glucose) may decrease too much if you take Glimepirida Viatris with the following medications, increasing the risk of hypoglycemia:

• Insulin or other diabetes medications (e.g. metformin).
• Pain and inflammation medications (e.g. phenylbutazone, azapropazone, oxifenbutazone, salicylates).
• Gout medications (e.g. allopurinol, sulfinpyrazone, and probenecid).
• Bacterial infection medications such as tetracyclines (e.g. doxycycline), chloramphenicol, sulfonamides (e.g. trimethoprim, cotrimoxazole, sulfadiazine), quinolones (e.g. ciprofloxacin), clarithromycin.
• Fungal infection medications (e.g. fluconazole, miconazole).
• Blood clotting inhibitors (cumarinic derivatives such as warfarin).
• Cholesterol-lowering medications (fibrates).
• Antihypertensive medications (ACE inhibitors).
• Antiarrhythmic medications such as disopyramide.
• Depression medications (fluoxetine, MAO inhibitors).
• Bodybuilding medications (anabolic steroids).
• Hormone replacement therapy in men.
• Weight loss medications (fenfluramine).
• Allergies medications such as hay fever (tritoqualine).
• Cancer medications (cyclophosphamide, thiofosfamide, and ifosfamide).
• Circulation medications administered at high doses in intravenous infusion (pentoxifylline).
• Sympatholytic medications for high blood pressure, heart failure, or prostatic symptoms.

Glimepirida Viatris use with other medications

Your blood sugar level (glucose) may increase too much if you take Glimepirida Viatris with the following medications, increasing the risk of hyperglycemia:

• Medications containing female sex hormones (estrogens or progestogens) such as Hormone Replacement Therapy (HRT) or oral contraceptives.
• Medications for severe mental disorders (e.g. chlorpromazine and other phenothiazine derivatives).
• Diuretics (thiazide diuretics).
• Thyroid-stimulating medications (e.g. levothyroxine).
• Medications for allergies and inflammation (e.g. glucocorticoids).
• Medications for increasing heart rate, for treating asthma or congestion, coughs, and colds, for reducing weight, or used in life-threatening emergencies (adrenaline and sympathomimetics).
• Medications for high cholesterol (nicotinic acid).
• Medications for constipation when used for a prolonged period (laxatives).
• Medications for epilepsy (e.g. phenytoin).
• Medications for anxiety and sleep disorders (e.g. barbiturates).
• Medications for increasing eye pressure (acetazolamide).
• Medications for high blood pressure or reducing blood sugar levels (e.g. diazoxide).
• Tuberculosis medications (rifampicin).
• Medications for severe hypoglycemia (e.g. glucagon).

Glimepirida Viatris use with other compounds

Your blood sugar level (glucose) may increase or decrease too much if you take Glimepirida Viatris with the following compounds:

• Medications for stomach ulcers (H2 antagonists such as cimetidine, ranitidine).
• Medications for high blood pressure or heart failure such as beta-blockers, clonidine, guanethidine, and reserpine. These may even mask the symptoms of hypoglycemia, so special care is needed when taking these medications.

Glimepirida Viatris may also increase or decrease the effects of the following medications:

• Blood clotting inhibitors (cumarinic derivatives such as warfarin).

Colesevelam, a medication used to reduce cholesterol, affects the absorption of Glimepirida Viatris. To avoid this effect, take Glimepirida Viatris at least 4 hours before colesevelam.

Glimepirida Viatris and alcohol

Do not drink alcoholic beverages while taking this medication. Alcohol consumption may unpredictably increase or decrease the hypoglycemic effect of glimepiride.

Pregnancy and breastfeeding

Pregnancy

Glimepiride should not be taken during pregnancy. Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.

Lactation

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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

Your ability to concentrate or react may be reduced if your blood sugar levels drop (hypoglycemia) or rise (hyperglycemia) or if you experience vision problems due to these conditions. Be aware that this puts you and others at risk (e.g., when driving or operating machinery).

Please consult your doctor if you can drive if:

• You have frequent episodes of hypoglycemia.

• You have a fever or no warning symptoms of hypoglycemia.

Glimepirida Viatris contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Adults

The dose of glimepiride depends on your needs, your 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 recommended initial dose is 1 mg of Glimepiride Viatris per day. Depending on the response of blood sugar levels, your doctor may increase this dose by 1 mg every 1-2 weeks. The maximum dose is 6 mg of Glimepiride Viatris per day.

If the minimum dose of 1 mg of Glimepiride Viatris per day reduces your blood sugar levels to very low levels (hypoglycemia), your doctor may decide that your blood sugar levels can be controlled solely by diet and will discuss this opinion with you.

If your weight changes or if you change your lifestyle, or if you are under stress, you may need to change the dose of glimepiride, so inform your doctor.

If you think the effect of your medication is too weak or too strong, do not change the dose yourself, consult your doctor.

Combined therapy

You may already be taking the maximum dose of metformin for diabetes and may also need to take Glimepiride Viatris. Your doctor will prescribe an initial low dose of Glimepiride Viatris. Your blood sugar levels will need to be closely monitored.

If the maximum daily dose of Glimepiride Viatris does not control your blood sugar levels well enough, your doctor will decide if you need to start using insulin. In this case, your blood sugar levels will need to be closely monitored. This measure is taken to ensure that you do not suffer from hypoglycemia (low blood sugar).

Change of medication

If your doctor considers it necessary to change from another antidiabetic medication to Glimepiride Viatris, this should be done under strict medical supervision. In some cases, it may be necessary to take a break in treatment to prevent the previous medication from having an additive effect, which may lead to hypoglycemia.

Use in children

The use of Glimepiride Viatris in children is not recommended.

Method of administration

Swallow the tablets whole with a small glass of water. Do not crush or chew the tablets.

• Take the tablets a little before or during your first meal of the day (usually breakfast). If you do not have breakfast, you should take the medication at the prescribed time by your doctor. It is essential not to miss any meals while taking glimepiride.
• Do not stop treatment unless your doctor tells you to.

If you take more Glimepiride Viatris than you should

If you have taken too many tablets, this will cause your blood sugar levels to drop too low (hypoglycemia - for hypoglycemia symptoms see section 2). You should eat or drink something sweet as soon as possible (e.g., sugar cubes, sweet juice, sweet tea) and inform your doctorimmediately.In the case of 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 state of unconsciousness should not take or drink anything.

Since hypoglycemia can last for a long time, it is very important that the patient be closely monitored until there is no longer a risk. It may be necessary as a precautionary measure to be admitted to the hospital. Show the packaging or remaining tablets to your doctor so that he or she can know what you have taken.

Severe cases of hypoglycemia accompanied by loss of consciousness and coma are medical emergencies that require immediate medical treatment and hospital admission. It may be helpful to inform your family and friends to call the doctor immediately if this happens to you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Glimepiride Viatris

If you forget to take Glimepiride Viatris, take the next dose as soon as you remember or feel weak, otherwise your blood sugar levels will be too high and you may fall into a coma (unconsciousness).Do not takea double dose to compensate for the missed doses.

If you interrupt treatment with Glimepiride Viatris

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

If you have any other doubts about the use of this medication, ask 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:

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

• Changes in your blood, which can be serious and make you feel unusually tired and pale, bruise or bleed more easily, or suffer from sore throat or mouth ulcers. These effects usually disappear when treatment is stopped.
• Severe hypoglycemia, including loss of consciousness, seizures, or coma.

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

• Abnormal liver function, including yellowing of the skin and eyes (jaundice), bile flow problems (cholestasis), liver inflammation (hepatitis), or liver failure.
• Allergic reactions (including inflammation of blood vessels, often with skin rash) that can trigger severe reactions with difficulty breathing, low blood pressure, and sometimes leading to shock.

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

• Allergic skin reactions such as skin rash or itching and inflamed skin, and sun sensitivity. Some moderate allergic reactions may lead to severe reactions with difficulty swallowing or breathing, swelling of lips, throat, or tongue.
• Severe decrease in the number of platelets in the blood (thrombocytopenia) and skin bleeding (purpura thrombocytopenica).

Other possible side effects:

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

• Low blood sugar (hypoglycemia) (see section 2 – Warnings and precautions).
• Weight gain.
• Weight loss.
• Changes in taste.

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

• Feeling and being sick, diarrhea, feeling bloated, abdominal discomfort, or pain.
• Decreased sodium levels in the blood.

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

• May cause allergic reactions with sulfonylureas, sulfonamides, or related medications.
• Changes in vision at the start of treatment due to changes in blood sugar levels, but this should improve with continued treatment.
• Increased liver enzymes in the blood.

Your doctor will take blood samples and check that your liver is functioning correctly from time to time to ensure that the tablets are not causing side effects.

Reporting 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 Medicinal Products 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.

Do not store above25°C.Store in the original packaging.

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

Composition of Glimepiride Viatris

• The active ingredient is glimepiride. Each tablet contains 4 mg of glimepiride.
• The other components are: lactose monohydrate, povidone K25, microcrystalline cellulose (E-460), magnesium stearate (E-470b), sodium carboxymethylstarch potato type A (potato starch) and indigo carmine (E-132).

Appearance of the product and contents of the packaging

Glimepiride Viatris 4 mg is presented in the form of blue oval-shaped tablets, marked with the inscription "GM" groove "4" on one face and "G" groove "G" on the other.

Glimepiride Viatris is available in blisters of 30, 50, 60, 90, 100, 120 or 250 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

SpainGlimepiride Viatris 4 mg tablets EFG

Czech RepublicGlimepirid Mylan 4 mg

Last review date of this leaflet:May 2024.

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