GLIMEPIRIDE VIATRIS 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

Glimepiride Viatris 4 mg Tablets EFG

Read the package leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this package leaflet, 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. 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. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Glimepiride Viatris and what is it used for
2. What you need to know before taking Glimepiride Viatris
3. How to take Glimepiride Viatris
4. Possible side effects
5. Storage of Glimepiride Viatris
6. Contents of the pack and further information

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

Glimepiride Viatris contains the active substance glimepiride.

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

2. What you need to know before taking Glimepiride Viatris

Do not take Glimepiride 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 ingredients of this medicine (listed in section 6).
• If you have insulin-dependent diabetes (also called type 1 diabetes mellitus).
• If you have diabetic ketoacidosis (a complication of diabetes when your acid levels increase in your body and you may suffer from some of the following signs: fatigue, dizziness (nausea), 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 applies to you. If you are not sure, consult your doctor or pharmacist before taking glimepiride.

Warnings and Precautions

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

• If you are recovering from an injury, operation, infection with fever, or other type of stress, as it may be necessary to temporarily change your treatment.
• If you have severe liver or kidney damage.

In patients with a deficiency of the enzyme glucose-6-phosphate dehydrogenase, it may occur that the level of hemoglobin decreases and red blood cells are destroyed (hemolytic anemia).

If any of the above happens to you, your doctor may change the number of tablets you should take or may review your entire treatment plan.

Children and Adolescents

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

Blood Sugar Control

It is necessary to perform periodic checks of your blood sugar levels (and urine) during treatment with Glimepiride 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 greater risk of having low blood sugar levels (hypoglycemia) during the first few weeks of treatment. For this reason, your doctor will closely monitor your progress.

The following factors can increase the risk of you suffering from low blood sugar levels if:

• You are not willing or able 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 take foods that contain less carbohydrates than usual.
• You drink alcohol (especially if you also skip meals).
• Your kidneys do not function properly.
• You have severe liver disease.
• You suffer from any hormonal disease (such as thyroid, pituitary, or adrenal gland problems).
• You take more Glimepiride Viatris than you need.
• You take certain medicines at the same time (see "Using Glimepiride Viatris with other medicines").

The signs of hypoglycemia include:

• Feeling of hunger, headache, nausea, vomiting, laziness, drowsiness, sleep problems, restlessness, aggression, concentration problems, decreased alertness and reaction time, depression, confusion, speech and vision problems, difficulty speaking, tremors, partial paralysis, sensory disturbances, dizziness, impotence.
• The following signs may also appear: sweating, moist skin, anxiety, increased or accelerated heartbeats, hypertension, awareness of heartbeats (palpitations), severe sudden chest pain that may radiate to neighboring areas (angina pectoris and cardiac arrhythmias). If your blood sugar levels continue to drop, you may suffer from great 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, the signs of low blood sugar disappear quickly when you eat or drink something sweet, such as sugar cubes, sweet juice, or sugary tea. Therefore, you should always carry something sweet with you. Remember that sweeteners are not effective. If taking sugar does not help or if any of these symptoms recur, contact your doctor or go to the hospital.

Other Medicines and Glimepiride Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

If you take Glimepiride Viatris with the following medicines, your blood sugar level (glucose) may drop too low. This can lead to a risk of hypoglycemia (low blood sugar):

• Insulin or other medicines to treat diabetes (e.g., metformin).
• Medicines to treat pain and inflammation (e.g., phenylbutazone, azapropazone, oxyphenbutazone, salicylates).
• Medicines to treat gout (e.g., allopurinol, sulfinpyrazone, and probenecid).
• Medicines to treat bacterial infections such as tetracyclines (e.g., doxycycline), chloramphenicol, sulfonamides (e.g., trimethoprim, cotrimoxazole, sulfadiazine), quinolones (e.g., ciprofloxacin), clarithromycin.
• Medicines to treat fungal infections (e.g., fluconazole, miconazole).
• Medicines to prevent blood clotting (coumarin derivatives such as warfarin).
• Medicines to lower high cholesterol levels (fibrates).
• Medicines to lower high blood pressure (ACE inhibitors).
• Disopyramide, an antiarrhythmic agent used to control abnormal heart rhythm.
• Medicines to treat depression (fluoxetine, MAO inhibitors).
• Medicines to increase muscle mass (anabolic agents).
• Medicines used in hormone replacement therapy in men.
• Medicines used to lose weight (fenfluramine).
• Medicines used to treat nasal allergies such as hay fever (tritoqualine).
• Medicines used to treat cancer (cyclophosphamide, trofosfamide, and ifosfamide).
• Medicines used to increase circulation when administered in high doses by intravenous infusion (pentoxifylline).
• Medicines called sympatholytics to treat high blood pressure, heart failure, or prostate symptoms.

If you take Glimepiride Viatris with the following medicines, your blood sugar level (glucose) may rise too high. This can lead to a risk of hyperglycemia (high blood sugar):

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

If you take Glimepiride Viatris with the following compounds, it may cause both an increase and a decrease in blood sugar levels:

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

Glimepiride Viatris may also increase or decrease the effects of the following medicines:

• Medicines that prevent blood clotting (coumarin derivatives such as warfarin).

Colesevelam, a medicine used to lower cholesterol, has an effect on the absorption of Glimepiride Viatris. To avoid this effect, it is recommended to take Glimepiride Viatris at least 4 hours before colesevelam.

Taking Glimepiride Viatris with Alcohol

You should not drink alcoholic beverages while being treated with this medicine. Alcohol intake can increase or decrease the hypoglycemic effect of glimepiride in an unpredictable way.

Pregnancy and Breast-feeding

Pregnancy

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

Breast-feeding

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

If you are pregnant or breast-feeding, think you might be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and Using Machines

Your ability to concentrate or react may be reduced if your blood sugar levels drop (hypoglycemia) or rise (hyperglycemia) or if you suffer from vision problems as a result of these conditions. Be aware that this may put 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 fever or do not have warning signs of hypoglycemia.

Glimepiride Viatris contains Lactose and Sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to Take Glimepiride Viatris

Follow the instructions for administration of this medicine exactly as prescribed 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 your blood sugar and urine tests, 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 your 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.

In the case that 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 only 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, it may be necessary to change the dose of glimepiride; therefore, inform your doctor.

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

Combination Therapy

It is possible that you are already taking the maximum dose of metformin for diabetes and may also need to take Glimepiride Viatris. Your doctor will initially prescribe a 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 is done 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 medicine to Glimepiride Viatris, this should be done under strict medical supervision. In some cases, it may be necessary to have a break in treatment so that the previous medication does not have an additive effect, leading to hypoglycemia.

Use in Children

The use of Glimepiride Viatris is not recommended 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 shortly before or during your first meal of the day (usually breakfast). If you do not have breakfast, you should take the medicine according to the schedule prescribed by your doctor. It is important that you do not skip any meals when 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 cause your blood sugar levels to drop too low (hypoglycemia - for symptoms of hypoglycemia, see section 2). You should eat or drink something sweet as soon as possible (e.g., sugar cubes, sweet juice, sugary tea) and inform your doctor immediately. When treating hypoglycemia due to accidental ingestion in children, the amount of sugar to be administered should be carefully controlled to avoid the possibility of producing a dangerous hyperglycemia. Unconscious persons should not be given food or drink.

As hypoglycemia can last for a while, it is very important that the patient is carefully monitored until there is no more danger. It may be necessary, as a precautionary measure, to be hospitalized, even if it is just a precaution. Show the package or the remaining tablets to the doctor so that they can see 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 useful 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 medicine and the amount taken.

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 enter a coma (unconsciousness). Do not takea double dose to make up for forgotten doses.

If you stop taking Glimepiride Viatris

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

If you have any further questions about the use of this medicine, 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.

Consult your doctor immediately if you suffer from any of the following:

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

• Changes in your blood, which can be severe and may make you feel unusually tired and pale, bruise or bleed more easily, or you may suffer from infections with sore throat or mouth ulcers. These effects usually disappear when treatment is discontinued.
• 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), problems with bile flow (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 ending in shock.

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

• Skin allergy (hypersensitivity) such as skin rash or itching in inflamed and reddened skin, and hypersensitivity to the sun. Some moderate allergic reactions may lead to severe reactions with swallowing or breathing difficulties, lip, throat, or tongue swelling.
• Severe decrease in the number of platelets in the blood (thrombocytopenia) and bleeding in the skin (thrombocytopenic purpura).

Other possible adverse 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, discomfort, or abdominal pain.
• Decrease in sodium levels in the blood.

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

• Allergic reactions to sulfonylureas, sulfonamides, or related medications may occur.
• Change 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 working properly from time to time to ensure that the tablets are not causing side effects.

Reporting of adverse effects:

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

5. Storage of Glimepirida Viatris

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

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C. Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Glimepirida Viatris

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

Appearance of the Product and Package Contents

Glimepirida Viatris 4 mg is presented in the form of blue, oval-shaped tablets, marked with the inscription "GM" and a score line "4" on one side and "G" and a score line "G" on the other.

Glimepirida Viatris is available in blister packs of 30, 50, 60, 90, 100, 120, or 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain Glimepirida Viatris 4 mg tablets EFG

Czech Republic Glimepirid Mylan 4 mg

Date of the last revision of this leaflet:May 2024.

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