Glimehexal 3

Warnings and precautions

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

the patient is recovering from injury, surgery, infection with fever, or other types of stress, as a temporary change in treatment may be necessary; the patient has severe liver or kidney dysfunction. If in doubt whether any of these conditions apply to the patient, 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). 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 "GlimeHEXAL and other medicines"), increased physical exertion without adequate meals or meals with fewer 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, restlessness, rapid heart rate, high blood pressure, heart 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 sugar levels may resemble a stroke.

Treating 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, it is essential to always carry sugar in an appropriate form (e.g., sugar cubes). Remember that artificial sweeteners are ineffective. Immediately contact your doctor or the nearest hospital if sugar administration does not stop hypoglycemia symptoms or if they return.

Lab tests

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, have recently taken, or plan to take. Your doctor may need to adjust the dose of GlimeHEXAL 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 effect of GlimeHEXAL, reducing blood sugar levels, which may lead to the risk of hypoglycemia (low blood sugar): other anti-diabetic medicines (such as insulin or metformin), pain and anti-inflammatory medicines (phenylbutazone, azapropazone, oxyphenbutazone, medicines similar to acetylsalicylic acid), 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), blood-thinning medicines (coumarin derivatives, such as warfarin), muscle-building medicines (anabolics), male hormone replacement therapy medicines, antidepressant medicines (fluoxetine, MAO inhibitors), anti-arrhythmic medicines used to control irregular heartbeat (disopyramide), cholesterol-lowering medicines (fibrates), high blood pressure medicines (ACE inhibitors), gout medicines (allopurinol, probenecid, sulfinpyrazone), cancer medicines (cyclophosphamide, ifosfamide, trofosfamide), weight loss medicines (fenfluramine), medicines used to increase blood flow, administered intravenously in high doses (pentoxifylline), allergy medicines, such as hay fever (tritoqualine), and sympatholytic medicines used to treat high blood pressure, heart failure, or prostate symptoms. The following medicines may weaken the effect of GlimeHEXAL, reducing blood sugar levels, which may lead to the risk of hyperglycemia (high blood sugar): female sex hormones (estrogens and progestogens), diuretic medicines (thiazide diuretics), thyroid-stimulating medicines (such as levothyroxine), anti-allergic and anti-inflammatory medicines (glucocorticoids), medicines used to treat severe mental illnesses (chlorpromazine and other phenothiazine derivatives), medicines used to stimulate the heart, treat asthma, or relieve nasal congestion, used to reduce weight or in life-threatening situations (adrenaline and sympathomimetics), cholesterol-lowering medicines (niacin), long-term constipation medicines (laxatives), anti-epileptic medicines (phenytoin), sleep disorder medicines (barbiturates), glaucoma medicines (acetazolamide), high blood pressure medicines (diazoxide), and tuberculosis medicines (rifampicin), as well as medicines used to treat low blood sugar (glucagon). The following medicines may enhance or weaken the effect of GlimeHEXAL on blood sugar levels: stomach ulcer medicines (so-called H2 receptor antagonists), high blood pressure or heart failure medicines, such as beta-blockers, clonidine, guanethidine, and reserpine. These medicines may also mask hypoglycemia symptoms, so caution is necessary when using them. GlimeHEXAL may enhance or weaken the effect of the following medicines: blood-thinning medicines (coumarin derivatives, such as warfarin). Colesevelam, a medicine used to lower cholesterol, 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 effect of GlimeHEXAL on blood sugar levels 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, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

GlimeHEXAL contains lactose and sodium

If you have previously been diagnosed with intolerance to some sugars, contact 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, ask 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 essential 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 test results. 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 this case, 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 in a stressful situation, inform your doctor, as a dose adjustment of GlimeHEXAL may be necessary. 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 more GlimeHEXAL than prescribed

If you have taken too much GlimeHEXAL or taken an extra dose, there is a risk of developing hypoglycemia (hypoglycemia symptoms, see section 2), so you should immediately take enough sugar (e.g., several sugar cubes, sweet juice, sweetened tea) and contact your doctor immediately. In the event of hypoglycemia treatment caused by accidental ingestion of the medicine by a child, carefully monitor the amount of sugar administered to avoid developing dangerous hyperglycemia. Do not 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 medicine packaging or remaining tablets so that it is known what medicine was taken. Severe 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

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 advises 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.

Immediately inform your doctor if you experience the following symptoms:

allergic reactions (including vasculitis, often with skin rash), which can develop into severe reactions with breathing difficulties, sudden drop in blood pressure, and sometimes progressing 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, immediately inform your doctor. Allergy (hypersensitivity) of the skin, such as itching, rash, urticaria, 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) Low 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 can develop into severe reactions with breathing difficulties, sudden drop in blood pressure, and sometimes progressing to shock. If you experience any of these symptoms, immediately inform your doctor. 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, immediately inform your doctor. 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) Allergy (hypersensitivity) of the skin, such as itching, rash, urticaria, and increased sensitivity to sunlight. Some mild allergic reactions may develop into severe reactions with difficulties in swallowing or breathing, lip, throat, or tongue swelling. Therefore, if you experience any of these side effects, immediately inform your doctor. 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 quickly disappear. Increased liver enzyme activity. Significant unusual bleeding or bruising (thrombocytopenia, purpura).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported 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. Side effects can also be reported 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 of GlimeHEXAL is glimepiride. Each tablet contains 1 mg, 2 mg, 3 mg, 4 mg, or 6 mg of glimepiride. The other ingredients of the medicine 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 lock. 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