Label: information for the user

Glimepiride Viatris 2 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 (medications used to lower blood sugar such as glibenclamide) or sulfonamides (medications for bacterial infections such as sulfamethoxazole) or to any of the other components of this medication (listed in section 6).
• If you have insulin-dependent diabetes (also known as type 1 diabetes).
• If you have diabetic ketoacidosis (a complication of diabetes when your body's acid level increases and you may experience any 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 medication 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, surgery, 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 level (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 levels (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 levels:

• 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 usual.
• You drink alcohol (especially if you also skip meals).
• Your kidneys do not function correctly.
• You have severe liver disease.
• You have a hormonal disorder (such as thyroid gland, pituitary gland, 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 signs of hypoglycemia include:

- Hunger, headache, nausea, vomiting, fatigue, drowsiness, difficulty falling asleep, restlessness, irritability, concentration problems, decreased alertness and reaction time, depression, confusion, speech and vision problems, difficulty speaking, tremors, partial paralysis, sensory alterations, dizziness, impotence.

- The following symptoms may also occur: sweating, moist skin, anxiety, increased or accelerated heart rate, hypertension, heart palpitations, sudden 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" (seizures), paralysis (loss or impairment of body movement), respiratory difficulties, decreased heart rate, and unconsciousness.

Hypoglycemia treatment:

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 taken recently, 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 medications for treating diabetes (e.g. metformin).
• Medications for pain and inflammation (e.g. phenylbutazone, azapropazone, oxifenbutazone, salicylates).
• Medications for treating gout (e.g. allopurinol, sulfinpyrazone, and probenecid).
• Medications for treating bacterial infections such as tetracyclines (e.g. doxycycline), chloramphenicol, sulfonamides (e.g. trimethoprim, cotrimoxazole, sulfadiazine), quinolones (e.g. ciprofloxacin), clarithromycin.
• Medications for treating fungal infections (e.g. fluconazole, miconazole).
• Medications for inhibiting blood coagulation (cumarinic derivatives such as warfarin).
• Medications for lowering high cholesterol levels (fibrates).
• Medications for lowering high blood pressure (ACE inhibitors).
• Disopyramide, an antiarrhythmic agent used to control abnormal heart rhythm.
• Medications for treating depression (fluoxetine, MAO inhibitors).
• Medications for increasing muscle mass (anabolic steroids).
• Medications used in hormone replacement therapy in men.
• Medications used for weight loss (fenfluramine).
• Medications used for treating allergic rhinitis such as hay fever (tritoqualine).
• Medications for treating cancer (cyclophosphamide, thiofosfamide, and ifosfamide).
• Medications for increasing circulation when administered at high doses in intravenous infusion (pentoxifylline).
• Medications called sympatholytics for treating high blood pressure, heart failure, or prostatic symptoms.

Glimepirida Viatris use with other medications may increase your blood sugar level (glucose) too much, increasing the risk of hyperglycemia:

• Medications containing female sex hormones (estrogens or progestogens) such as Hormone Replacement Therapy (HRT) or oral contraceptives.
• Medications for treating severe mental disorders (e.g. chlorpromazine and other phenothiazine derivatives).
• Medications for helping to produce urine (thiazide diuretics).
• Medications used to stimulate the thyroid gland (e.g. levothyroxine).
• Medications used to treat allergies and inflammation (e.g. glucocorticoids).
• Medications used to increase heart rate, treat asthma or congestion, cough, and colds, to reduce weight, or used in life-threatening emergencies (adrenaline and sympathomimetics).
• Medications for treating high cholesterol levels (nicotinic acid).
• Medications for treating constipation when used for a prolonged period (laxatives).
• Medications for treating epilepsy (e.g. phenytoin).
• Medications for treating nervousness and sleep problems (e.g. barbiturates).
• Medications for increasing eye pressure (acetazolamide).
• Medications for treating high blood pressure or lowering blood sugar levels (e.g. diazoxide).
• Medications for treating tuberculosis (rifampicin).
• Medications for treating severe low blood sugar levels (e.g. glucagon).

Glimepirida Viatris use with other medications may cause both an increase and a decrease in blood sugar level (glucose):

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

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

• Medications that inhibit blood coagulation (cumarinic derivatives such as warfarin).

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

Glimepirida Viatris and alcohol

You should 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 (for example, 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 do not have warning signs 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 your doctor has prescribed.

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, therefore, 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 can lead to hypoglycemia.

Use in children

Glimepiride Viatris is not recommended for use in children.

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 your 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 make your blood sugar levels 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.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 state of unconsciousness should not take or drink anything.

Since hypoglycemia can last for a long time, it is very important that the patient is closely monitored until there is no longer a risk. It may be necessary to admit the patient to the hospital as a precautionary measure. Show the packaging or remaining tablets to your doctor so that he 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 your doctor immediately if this happens.

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 the 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 may 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 may 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, frequently with skin rash) that can trigger severe reactions with respiratory difficulty, 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 skin and sun sensitivity. Some moderate allergic reactions may lead to severe reactions with swallowing or breathing difficulties, 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 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 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 above25ºC.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 of 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 GlimepirideViatris

• The active ingredient is glimepiride. Each tablet contains 2 mg of glimepiride.
• The other components are: lactose monohydrate,povidoneK25, microcrystalline cellulose (E-460), magnesium stearate (E-470b), sodium carboxymethylcellulose potato type A (potato starch), yellow iron oxide (E-172) and indigo carmine (E-132).

Appearance of the product and contents of the packaging

Glimepiride Viatris is presented in the form of green-colored oval-shaped tablets,marked with the inscription "GM" groove "2" on one face and "G" groove “G” on the other.

GlimepirideViatrisis 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 2 mg tablets EFG

Czech RepublicGlimepirid Mylan 2 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/)