Glimepiride Viatris 4 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glimepiride Viatris 4 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Glimepirida Viatris contains the active substance glimepiride.

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

2. What you need to know before starting to take Glimepiride Viatris

Do not take Glimepiride Viatris:

• If you are allergic to glimepiride or other sulfonylureas (medicines used to lower blood sugar such as glyburide) 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 known as type 1 diabetes mellitus).
• If you have diabetic "ketoacidosis" (a complication of diabetes in which acid levels in your body rise and you may experience any of the following symptoms: fatigue, dizziness (nausea), frequent urination, and muscle stiffness).
• If you have severe kidney or liver problems.

Glimepiride must not be administered to patients with diabetic coma.

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Glimepiride Viatris:

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

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

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

Children and adolescents

Available information 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.

Monitoring of blood sugar levels

Regular monitoring of blood (and urine) sugar levels is necessary during treatment with Glimepiride Viatris. Your doctor may also perform certain blood tests to monitor your red blood cell levels and liver function. You must follow the treatment prescribed by your doctor to control your blood sugar levels. This means continuing your diabetic diet, exercising regularly, and, if necessary, losing weight.

There is an increased risk of 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 your risk of experiencing low blood sugar levels if you:

• Are unwilling or unable to cooperate.
• Are malnourished, eat irregularly, skip or omit meals, or fast.
• Change your diet.
• Increase your physical activity without eating enough or consuming foods with fewer carbohydrates than usual.
• Drink alcohol (especially if you also skip meals).
• Have impaired kidney function.
• Suffer from severe liver disease.
• Have a hormonal disorder (such as disorders of the thyroid gland, pituitary gland, or adrenal cortex).
• Take more Glimepiride Viatris than needed.
• Take certain medications simultaneously (see “Use of Glimepiride Viatris with other medicines”).

Signs of hypoglycemia include:

• Feeling hungry, headache, nausea, vomiting, lethargy, drowsiness, difficulty sleeping, restlessness, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision problems, difficulty speaking, trembling, partial paralysis, sensory disturbances, dizziness, impotence.
• Other signs may also occur: sweating, moist skin, anxiety, increased or rapid heartbeat, hypertension, awareness of heartbeat (palpitations), sudden severe chest pain radiating 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), breathing difficulties, slowed heart rate, and unconsciousness.

Treatment of hypoglycemia:

In most cases, symptoms of low blood sugar disappear rapidly after eating or drinking something sugary, such as sugar lumps, sweet juice, or sugared tea. Therefore, you should always carry a source of sugar. 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

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

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

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

• Insulin or other medicines for treating diabetes (e.g., metformin).
• Medicines for treating pain and inflammation (e.g., phenylbutazone, azapropazone, oxyphenbutazone, salicylates).
• Medicines for treating gout (e.g., allopurinol, sulfinpyrazone, probenecid).
• Medicines for treating bacterial infections such as tetracyclines (e.g., doxycycline), chloramphenicol, sulfonamides (e.g., trimethoprim, cotrimoxazole, sulfadiazine), quinolones (e.g., ciprofloxacin), clarithromycin.
• Medicines for treating fungal infections (e.g., fluconazole, miconazole).
• Medicines used to inhibit 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 for treating depression (fluoxetine, MAO inhibitors).
• Medicines to increase muscle mass (anabolic agents).
• Medicines used in male hormone replacement therapy.
• Medicines used for weight loss (fenfluramine).
• Medicines used to treat nasal allergies such as hay fever (tritoqualine).
• Medicines for treating cancer (cyclophosphamide, trophosphamide, ifosfamide).
• Medicines used to improve circulation when administered at high doses by intravenous infusion (pentoxifylline).
• Medicines called sympatholytics used to treat high blood pressure, heart failure, or prostate symptoms.

If you take Glimepiride Viatris together with the following medicines, your blood sugar (glucose) level may increase too much. This may 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 for treating severe mental disorders (e.g., chlorpromazine and other phenothiazine derivatives).
• Medicines used to promote urine production (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, treat asthma or nasal congestion, cough and colds, reduce weight, or used in life-threatening emergencies (adrenaline and sympathomimetics).
• Medicines for treating high cholesterol levels (nicotinic acid).
• Medicines for treating constipation when used long-term (laxatives).
• Medicines for treating epilepsy (e.g., phenytoin).
• Medicines for treating nervousness and sleep problems (e.g., barbiturates).
• Medicines to increase pressure in the eye (acetazolamide).
• Medicines for treating high blood pressure or lowering blood sugar levels (e.g., diazoxide).
• Medicines for treating tuberculosis (rifampicin).
• Medicines for treating severe low blood sugar (e.g., glucagon).

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

• Medicines for treating stomach ulcers (called H2 antagonists such as cimetidine, ranitidine).
• Medicines 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 medicines.

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

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

Colesevelam, a medicine used to lower cholesterol, affects 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 consume alcoholic beverages while being treated with this medicine. Alcohol intake 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.

Breastfeeding

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 baby, 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 experience 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 lack warning symptoms of hypoglycemia.

Glimepiride Viatris contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Glimepiride Viatris

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Adults

The dose of glimepiride depends on your individual needs, your condition, and the results of blood and urine sugar tests, and is determined by your doctor. Do not take more tablets than prescribed by your doctor.

The recommended starting dose is 1 mg of Glimepiride Viatris once daily. Depending on your blood glucose response, 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 glucose levels too much (hypoglycaemia), your doctor may decide that your blood sugar can be controlled by diet alone and will discuss this with you.

If your weight changes, if you change your lifestyle, or if you are under stress, your glimepiride dose may need to be adjusted; therefore, inform your doctor.

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

Combination therapy

You may already be taking the maximum dose of metformin for diabetes and may additionally require Glimepiride Viatris. Your doctor will initially prescribe a low dose of Glimepiride Viatris. Your blood glucose level will need to be closely monitored.

If the maximum daily dose of Glimepiride Viatris does not adequately control your blood sugar, your doctor will decide whether you need to start insulin therapy. In this case, your blood glucose level will need to be closely monitored. This is done to ensure that you do not experience hypoglycaemia (low blood sugar).

Switching medication

If your doctor considers it necessary to switch from another antidiabetic medicine to Glimepiride Viatris, this should be done under strict medical supervision. In some cases, a treatment-free interval may be required to prevent an additive effect from the previous medicine, which could lead to hypoglycaemia.

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 just before or during your first meal of the day (usually breakfast). If you do not eat breakfast, you should take the medicine according to the schedule prescribed by your doctor. It is important that you do not skip any meals while taking glimepiride.
• Do not stop your treatment unless specifically instructed by your doctor.

If you take more Glimepiride Viatris than you should

If you have taken too many tablets, your blood sugar level may drop too much (hypoglycaemia—for symptoms of hypoglycaemia, see section 2). You should eat or drink something sugary as soon as possible (for example, sugar lumps, sweet fruit juice, sugared tea) and inform your doctor immediately. When treating hypoglycaemia due to accidental ingestion in children, the amount of sugar administered should be carefully controlled to avoid causing dangerous hyperglycaemia. People who are unconscious must not be given food or drink.

Since hypoglycaemia can last for some time, it is very important that the patient is carefully monitored until there is no further risk. As a precaution, hospital admission may be necessary, even preventively. Show the packaging or remaining tablets to the doctor so they can determine what you have taken.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine 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 if you feel weak; otherwise, your blood sugar level may become too high and you could go into a coma (unconsciousness). Do not take a double dose to make up for a missed dose.

If you stop taking Glimepiride Viatris

If you interrupt or stop treatment, bear in mind that the desired effect of lowering blood sugar will not be achieved, or your condition 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 everyone will experience them.

Contact 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 may be serious and cause you to feel unusually tired and pale, bruise or bleed more easily, or suffer infections with 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), problems with bile flow (cholestasis), inflammation of the liver (hepatitis), or liver failure.
• Allergic reactions (including inflammation of blood vessels, often with skin rash), which may trigger severe reactions with breathing difficulties, low blood pressure, and sometimes leading to shock.

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

• Skin allergy (hypersensitivity), such as skin rash or itching of inflamed and reddened skin, and photosensitivity. Some moderate allergic reactions may progress 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 bleeding into the skin (thrombocytopenic purpura).

Other possible adverse effects:

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

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

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

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

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

• Allergic reactions may occur with sulfonylureas, sulfonamides, or related medicines.
• 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 periodically check that your liver is functioning properly to ensure that the tablets are not causing side effects.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glimepiride Viatris

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

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

Do not store above 25°C. Keep in the original container.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Glimepirida Viatris

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

Appearance of the product and contents of the pack

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

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

Only certain pack sizes may be commercially available.

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

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Glimepirida Viatris 4 mg tablets EFG
Czech Republic: Glimepirid Mylan 4 mg

Date of the most recent review of this leaflet: May 2024.

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