Glimehexal 2

Leaflet accompanying the packaging: patient information

GlimeHEXAL 1, 1 mg, tablets

GlimeHEXAL 2, 2 mg, tablets

GlimeHEXAL 3, 3 mg, tablets

GlimeHEXAL 4, 4 mg, tablets

GlimeHEXAL 6, 6 mg, tablets

Glimepiride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, so you can read it again if you need to. If you have any doubts, consult your doctor or pharmacist. This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same. If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is GlimeHEXAL and what is it used for
• 2. Important information before taking GlimeHEXAL
• 3. How to take GlimeHEXAL
• 4. Possible side effects
• 5. How to store GlimeHEXAL
• 6. Contents of the packaging and other information

1. What is GlimeHEXAL and what is it used for

GlimeHEXAL is an oral anti-diabetic medicine. It belongs to the so-called sulfonylurea derivatives. GlimeHEXAL increases the amount of insulin released from the pancreas, and insulin reduces blood sugar levels.

What is GlimeHEXAL used for

GlimeHEXAL is used to treat a certain form of diabetes (type 2 diabetes), when diet, exercise, and weight loss alone are not enough to maintain proper blood sugar levels.

When not to take GlimeHEXAL and inform your doctor

If the patient is allergic to glimepiride or other sulfonylurea derivatives (used to reduce blood sugar levels, such as glibenclamide) or sulfonamides (used to treat bacterial infections, such as sulfamethoxazole), or any of the other ingredients of this medicine (listed in section 6); if the patient has type 1 diabetes; if the patient has diabetic ketoacidosis (a complication of diabetes in which the body produces too much acid and may experience symptoms such as fatigue, nausea, frequent urination, and muscle stiffness); if the patient is in a diabetic coma; if the patient has severe kidney disease; if the patient has severe liver disease. If any of the above applies to the patient, they should not take GlimeHEXAL. In case of doubt, consult your doctor or pharmacist.

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)

Patient 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:

Undernutrition, 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 activity 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, restlessness, rapid heartbeat, high blood pressure, palpitations, sudden, severe chest pain (angina pectoris), and arrhythmias. 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.

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 recommended 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 monitor blood or urine sugar levels. Your doctor may also order blood tests to monitor 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 currently taking or have recently taken, as well as any medicines you 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, salicylates), urinary tract infection medicines (such as long-acting sulfonamides), antibacterial and antifungal medicines (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin), blood clotting inhibitors (coumarin derivatives, such as warfarin), anabolic steroids, male sex hormone replacement therapy medicines, antidepressants (fluoxetine, MAO inhibitors), anti-arrhythmic medicines (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 to increase blood flow, administered intravenously in high doses (pentoxifylline), allergy medicines (tritoqualine), 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), diuretics (thiazide diuretics), thyroid-stimulating medicines (such as levothyroxine), anti-allergic and anti-inflammatory medicines (glucocorticoids), anti-psychotic medicines (chlorpromazine and other phenothiazine derivatives), medicines to stimulate the heart, treat asthma, or relieve congestion and cough (adrenaline and sympathomimetics), cholesterol-lowering medicines (niacin), long-term constipation medicines (laxatives), antiepileptic medicines (phenytoin), sleep disorder medicines (barbiturates), glaucoma medicines (acetazolamide), high blood pressure medicines (diazoxide), tuberculosis medicines (rifampicin), low blood sugar medicines (glucagon). The following medicines may enhance or weaken the effect of GlimeHEXAL on blood sugar levels: stomach ulcer medicines (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 taking them. GlimeHEXAL may enhance or weaken the effect of the following medicines: blood clotting inhibitors (coumarin derivatives, such as warfarin). Colesevelam, a cholesterol-lowering medicine, affects the absorption of GlimeHEXAL. To avoid this effect, take GlimeHEXAL 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 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 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., 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 previously 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 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 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 take enough sugar (e.g., several sugar cubes, sweet juice, sweetened tea) immediately and inform your doctor without delay. In the event of hypoglycemia treatment due to accidental ingestion 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 monitoring 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 so that they know which medicine was taken. Severe hypoglycemia with loss of consciousness, seizures, or coma is a medical emergency that requires immediate medical attention and hospitalization. Always ensure that someone informed about the situation is present, who can call a doctor in case of emergency.

Missing a dose of GlimeHEXAL

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

Stopping GlimeHEXAL treatment

If treatment is stopped or discontinued, 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.

Inform your doctor immediately if you experience any of 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, inform your doctor immediately. Allergy (hypersensitivity) of the skin, 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) Low blood sugar (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 disorders. Hair loss. Weight gain.

• platelets (which increases the risk of bleeding or bruising),
• white blood cells (which increases the risk of infection),
• red blood cells (which causes pale skin and may cause weakness or shortness of breath).

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, 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) Allergy (hypersensitivity) of the skin, 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, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 aluminum/PVC blisters or HDPE containers with a tamper-evident closure. 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