Glimehexal 4

Warnings and precautions

Before starting GlimeHEXAL, discuss it with your doctor or pharmacist if:

you are recovering from injury, surgery, infection with fever, or other forms of stress, as your treatment may need to be changed temporarily; you have severe liver or kidney problems. If in doubt whether any of these conditions apply to you, consult your doctor or pharmacist before taking GlimeHEXAL. In patients with a deficiency of the enzyme glucose-6-phosphate dehydrogenase, a decrease in hemoglobin and red blood cell breakdown (hemolytic anemia) may occur. Information on the use of GlimeHEXAL in children under 18 years of age is limited, so it is not recommended for this age group.

Important information about hypoglycemia (low blood sugar)

Patients taking GlimeHEXAL may experience hypoglycemia (low blood sugar). You should read the following additional information about hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of hypoglycemia:

malnutrition, irregular meals, skipping or delaying meals, periodic fasting, changes in diet, taking more GlimeHEXAL than prescribed, impaired kidney function, severe liver disease, certain hormonal disorders (thyroid, pituitary, or adrenal gland disorders), alcohol consumption (especially with skipped meals), taking certain medications (see below "GlimeHEXAL and other medicines"), increased physical exertion without adequate meals or meals with less carbohydrates than usual.

Symptoms of hypoglycemia may include:

hunger attacks, headache, nausea, vomiting, drowsiness, dizziness, sleep disturbances, restlessness, aggression, decreased concentration, reduced alertness and reaction time, depression, disorientation, speech and vision disorders, slurred speech, tremors, partial paralysis, sensory disturbances, dizziness, helplessness. Additionally, the following may occur: sweating, skin moisture, anxiety, rapid heart rate, high blood pressure, palpitations, sudden, severe chest pain (angina pectoris), and heart rhythm disturbances. If blood sugar levels continue to decrease, the following may occur: severe confusion (delirium), seizures, loss of self-control, shallow breathing, and slow heart rate, loss of consciousness. The clinical picture of significantly reduced blood glucose levels may resemble a stroke.

Treatment of hypoglycemia

In most cases, symptoms of low blood sugar disappear very quickly after consuming sugar, such as sugar cubes, sweet juice, or sweetened tea. Therefore, you should always carry sugar with you in an appropriate form (e.g., sugar cubes). Remember that artificial sweeteners are ineffective. If sugar administration does not stop hypoglycemia symptoms or they return, you should contact your doctor or the nearest hospital immediately.

Laboratory tests

You should regularly check your blood or urine sugar levels. Your doctor may also order blood tests to monitor your blood cell count and liver function.

Children and adolescents

GlimeHEXAL is not recommended for children under 18 years of age.

GlimeHEXAL and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Your doctor may need to adjust your GlimeHEXAL dose if you are taking other medicines that may weaken or enhance the effect of GlimeHEXAL on your blood sugar levels. The following medicines may enhance the blood sugar-lowering effect of GlimeHEXAL, which may lead to the risk of hypoglycemia (low blood sugar): other anti-diabetic medicines(such as insulin or metformin) medicines used to treat pain and inflammation(phenylbutazone, azapropazone, oxyphenbutazone, salicylates) medicines used to treat urinary tract infections(such as long-acting sulfonamides) medicines used to treat bacterial and fungal infections(tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin) medicines that inhibit blood clotting(coumarin derivatives, such as warfarin) medicines that promote muscle growth(anabolics) medicines used in male hormone replacement therapyantidepressant medicines(fluoxetine, MAO inhibitors) anti-arrhythmic medicines used to control irregular heartbeat(disopyramide) medicines that lower elevated cholesterol levels(fibrates) medicines that lower high blood pressure(ACE inhibitors) medicines used to treat gout(allopurinol, probenecid, sulfinpyrazone) medicines used to treat cancer(cyclophosphamide, ifosfamide, trofosfamide) medicines used to reduce body weight(fenfluramine) medicines used to increase blood flow, administered intravenously in high doses (pentoxifylline) medicines used to treat allergies, such as hay fever (tritoqualine) medicines called sympatholytics, used to treat high blood pressure, heart failure, or prostate symptoms. The following medicines may weaken the blood sugar-lowering effect of GlimeHEXAL, which may lead to the risk of hyperglycemia (high blood sugar): medicines containing female sex hormones(estrogens and progestogens) medicines that increase urine production(thiazide diuretics) medicines that stimulate thyroid function(such as levothyroxine) medicines used to treat allergies and inflammatory conditions(glucocorticoids) medicines used to treat severe mental illnesses(chlorpromazine and other phenothiazine derivatives) medicines used to increase heart rate, treat asthma, or relieve nasal congestion, used to reduce body weightor in life-threatening situations (adrenaline and sympathomimetics) medicines that lower elevated cholesterol levels(nicotinic acid) medicines used to treat constipation(laxatives) antiepileptic medicines(phenytoin) medicines used to treat nervousness and sleep disorders(barbiturates) medicines used to treat increased eye pressure(acetazolamide) medicines used to treat high blood pressureor low blood sugar (diazoxide) medicines used to treat infections or tuberculosis(rifampicin) medicines used to treat low blood sugar(glucagon). The following medicines may enhance or weaken the blood sugar-lowering effect of GlimeHEXAL: medicines used to treat stomach ulcers(so-called H2 receptor antagonists) medicines used to treat high blood pressureor heart failure, such as beta-blockers, clonidine, guanethidine, and reserpine. They may also mask hypoglycemia symptoms, so caution is necessary when using them. GlimeHEXAL may enhance or weaken the effect of the following medicines: medicines that inhibit blood clotting(coumarin derivatives, such as warfarin). Colesevelam, a medicine used to lower cholesterol levels, affects the absorption of GlimeHEXAL. To avoid this effect, GlimeHEXAL should be taken at least 4 hours before taking colesevelam.

GlimeHEXAL and alcohol

Alcohol may enhance or weaken the blood sugar-lowering effect of GlimeHEXAL in an unpredictable way.

Pregnancy and breastfeeding

Pregnancy GlimeHEXAL should not be used during pregnancy. Breastfeeding GlimeHEXAL may pass into breast milk. The medicine should not be used during breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

If your blood sugar levels are low (hypoglycemia) or high (hyperglycemia), or if you experience vision disturbances, your ability to concentrate or react may be impaired. You should be aware of the risk to yourself or others, e.g., when driving or operating machines. Consult your doctor if you: often experience hypoglycemia, do not experience or experience weak warning signs of hypoglycemia.

GlimeHEXAL contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take GlimeHEXAL

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

Taking the medicine

Take the medicine orally, immediately before or during the first main meal of the day (usually breakfast). If you do not eat breakfast, take the medicine at the time specified by your doctor. It is important not to skip any meals while taking GlimeHEXAL. The tablets can be divided into equal doses. Swallow the tablets with at least half a glass of water. Do not crush or chew the tablets.

How much to take

Your doctor will determine the dose of GlimeHEXAL based on your needs, health, and blood sugar levels. Do not take more tablets than prescribed by your doctor. The usual starting dose is 1 tablet of GlimeHEXAL 1 (1 mg) per day. If necessary, your doctor may increase the dose every 1-2 weeks of treatment. The maximum recommended dose of glimepiride is 6 mg per day. It is possible to start combination therapy with glimepiride and metformin or glimepiride and insulin. In such cases, your doctor will determine the appropriate dose of glimepiride, metformin, or insulin for each patient. If your weight changes or your lifestyle changes, or if you are under stress, inform your doctor, as your GlimeHEXAL dose may need to be adjusted. If you feel that the effect of the medicine is too strong or too weak, do not change the dose yourself, but consult your doctor.

Taking a higher dose of GlimeHEXAL than prescribed

If you have taken too much GlimeHEXAL or an additional dose, there is a risk of developing hypoglycemia (hypoglycemia symptoms, see section 2), so you should immediately take sufficient sugar (e.g., several sugar cubes, sweet juice, or sweetened tea) and inform your doctor immediately. In the treatment of hypoglycemia caused by accidental ingestion of the medicine by a child, carefully monitor the amount of sugar administered to avoid developing dangerous hyperglycemia. Never give food or drink to unconscious persons. The state of hypoglycemia may persist for some time, so close observation of the patient is crucial until the danger has passed. As a precaution, hospitalization may be necessary. Show your doctor the packaging or remaining tablets to determine which medicine was taken. Severe cases of hypoglycemia with loss of consciousness, seizures, or severe neurological impairment are emergency situations that require immediate medical attention and hospitalization. Always ensure that someone informed about the situation is present, who can call a doctor in case of an emergency.

Missing a dose of GlimeHEXAL

Do not take a double dose to make up for a missed dose.

Stopping GlimeHEXAL treatment

If you stop or finish treatment, be aware that the desired blood sugar-lowering effect will not be achieved, or the disease may worsen. Take GlimeHEXAL until your doctor tells you to stop. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, GlimeHEXAL can cause side effects, although not everybody gets them.

Inform your doctor immediately if you experience any of the following symptoms:

allergic reactions (including vasculitis, often with skin rash), which may develop into severe reactions with difficulty breathing, sudden drop in blood pressure, and potentially leading to shock; abnormal liver function, including yellowing of the skin and eyes (jaundice), bile flow disorders (cholestasis), liver inflammation, or liver failure. If you experience any of these symptoms, inform your doctor immediately. Skin allergy (hypersensitivity) such as itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions may develop into severe reactions. Severe hypoglycemia with loss of consciousness, seizures, or coma. Some patients taking GlimeHEXAL may experience the following side effects: Rare side effects(may occur in less than 1 in 1000 people) Lower than normal blood sugar levels (hypoglycemia), see section 2. Decreased blood cell count, including platelets (which increases the risk of bleeding or bruising), white blood cells (which increases the risk of infection), or red blood cells (which causes pale skin and may cause weakness or shortness of breath). These disorders usually disappear after stopping GlimeHEXAL. Taste disturbances. Hair loss. Weight gain. Very rare side effects(may occur in less than 1 in 10,000 people) Allergic reactions (including vasculitis, often with skin rash), which may develop into severe reactions with difficulty breathing, sudden drop in blood pressure, and potentially leading to shock. If you experience any of these symptoms, inform your doctor immediately. Abnormal liver function, including yellowing of the skin and eyes (jaundice), bile flow disorders (cholestasis), liver inflammation, or liver failure. If you experience any of these symptoms, inform your doctor immediately. Nausea or vomiting, diarrhea, feeling of fullness or bloating, abdominal pain. Decreased sodium levels in the blood (detected by blood tests). Side effects with unknown frequency(frequency cannot be estimated from available data) Skin allergy (hypersensitivity) such as itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions may develop into severe reactions with difficulty swallowing or breathing, lip, throat, or tongue swelling. Therefore, if you experience any of these side effects, inform your doctor immediately. Allergic reactions to sulfonylurea derivatives, sulfonamides, or related medicines. Vision disturbances at the beginning of GlimeHEXAL treatment, which may be caused by changes in blood sugar levels and should disappear quickly. Increased liver enzyme activity. Significant unusual bleeding or bruising (thrombocytopenia, purpura).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301/fax: +48 22 49 21 309/website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GlimeHEXAL

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton, blister, and container after EXP. The expiry date refers to the last day of the month. Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What GlimeHEXAL contains

The active substance is glimepiride. Each tablet contains 1 mg, 2 mg, 3 mg, 4 mg, or 6 mg of glimepiride. The other ingredients are: GlimeHEXAL 1: lactose monohydrate, sodium carboxymethylcellulose (type A), povidone K 25, microcrystalline cellulose, magnesium stearate, red iron oxide (E172). GlimeHEXAL 2: lactose monohydrate, sodium carboxymethylcellulose (type A), povidone K 25, microcrystalline cellulose, magnesium stearate, yellow iron oxide (E172), indigo carmine, lake (E132). GlimeHEXAL 3: lactose monohydrate, sodium carboxymethylcellulose (type A), povidone K 25, microcrystalline cellulose, magnesium stearate, yellow iron oxide (E172). GlimeHEXAL 4: lactose monohydrate, sodium carboxymethylcellulose (type A), povidone K 25, microcrystalline cellulose, magnesium stearate, indigo carmine, lake (E132). GlimeHEXAL 6: lactose monohydrate, sodium carboxymethylcellulose (type A), povidone K 25, microcrystalline cellulose, magnesium stearate.

What GlimeHEXAL looks like and contents of the pack

GlimeHEXAL 1: light red, flat, oblong tablets with a notch, marked G | 1 on one side. GlimeHEXAL 2: light green, flat, oblong tablets with a notch, marked G | 2 on one side. GlimeHEXAL 3: light yellow, flat, oblong tablets with a notch, marked G | 3 on one side. GlimeHEXAL 4: light blue, flat, oblong tablets with a notch, marked G | 4 on one side. GlimeHEXAL 6: white or almost white, flat, oblong tablets with a notch, marked G | 6 on one side. GlimeHEXAL tablets are packaged in blisters of aluminum/PVC or HDPE containers with a safety seal. The packs contain 30 or 90 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl, Austria Manufacturer Lek S.A. ul. Domaniewska 50C 02-672 Warsaw Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben, Germany Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia

For more information about this medicine and its names in other EU countries, please contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00 Sandoz logo Date of last revision of the leaflet:07/2025