Glimehexal 1

Leaflet attached to 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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

You should keep this leaflet, so that you can read it again if you need to.
In case of any doubts, you should consult a 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 any possible side effects not listed in this leaflet, they should tell 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 medicine that reduces blood sugar levels. 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, physical exercise, and weight loss alone are not enough to maintain proper blood sugar levels.
2.Important information before taking GlimeHEXAL

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 (drugs 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 high levels of acids called ketones, and the following symptoms may occur: feeling tired, 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 statements apply to the patient, they should not take GlimeHEXAL. In case of doubt, the patient should consult a doctor or pharmacist.

Warnings and precautions

Before starting to take GlimeHEXAL, the patient should discuss it with their 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.
In case of doubt as to whether any of these conditions apply to the patient, they should consult their doctor or pharmacist before taking GlimeHEXAL.
In patients with a deficiency of the enzyme glucose-6-phosphate dehydrogenase, a decrease in hemoglobin levels 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 patients in this age group.

Important information about hypoglycemia (low blood sugar)

Patient taking GlimeHEXAL may experience hypoglycemia (low blood sugar). The patient 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 a larger dose of GlimeHEXAL than recommended,
impaired kidney function,
severe liver disease,
a specific hormonal disorder (thyroid, pituitary, or adrenal gland disorders),
consumption of alcohol (especially with skipping meals),
concomitant use of certain medications (see below "GlimeHEXAL and other medicines"),
increased physical exertion without consuming sufficient meals or consuming meals with less carbohydrates than usual.

Symptoms of hypoglycemia may include:

attacks of hunger, 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 (e.g., sugar cubes, sweet juice, sweetened tea). Therefore, the patient should always carry sugar in an appropriate form (e.g., sugar cubes). The patient should remember that artificial sweeteners are ineffective. The patient should immediately contact their doctor or the nearest hospital if administering sugar does not stop the symptoms of hypoglycemia or if they return.

Lab tests

The patient should regularly monitor their blood or urine sugar levels. The doctor may also order blood tests to monitor the number of blood cells and liver function.

Children and adolescents

GlimeHEXAL should not be used in children under 18 years of age.

GlimeHEXAL and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The doctor may recommend changing the dose of GlimeHEXAL if the patient is also taking other medicines that may weaken or enhance the effect of GlimeHEXAL on blood sugar levels.
The following medicines may enhance the effect of GlimeHEXAL in reducing blood sugar levels, which may lead to the risk of hypoglycemia (low blood sugar):
other anti-diabeticmedicines (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 hormone replacement therapy
antidepressantmedicines (fluoxetine, MAO inhibitors)
antiarrhythmic medicines used to control irregular heartbeat(disopyramide)
medicines that lower high 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 weight(fenfluramine)
medicines used to increase blood flow, administered intravenously in large 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 effect of GlimeHEXAL in reducing blood sugar levels, 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 accelerate heart rate, treat asthma, or relieve nasal congestion, used to reduce weightor in life-threatening conditions (adrenaline and sympathomimetics)
medicines that lower high cholesterol levels(nicotinic acid)
medicines used (long-term) to treat constipation(laxatives)
antiepilepticmedicines (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 (rifampicin)
medicines used to treat low blood sugar(glucagon).
The following medicines may enhance or weaken the effect of GlimeHEXAL in reducing blood sugar levels:
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 the symptoms of hypoglycemia, 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 reduce 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 effect of GlimeHEXAL in reducing 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

In case of low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia), or if vision is impaired due to these changes, the patient's ability to concentrate or react may be impaired. The patient should be aware of the risk of endangering themselves or others, e.g., when driving or operating machines.
The patient should consult their doctor if they:
often experience hypoglycemia,
do not experience or experience weak warning signs of hypoglycemia.

GlimeHEXAL contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their 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

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.

Taking the medicine

The medicine should be taken orally, immediately before or during the first large meal of the day (usually breakfast). If the patient does not eat breakfast, the medicine should be taken at the time specified by the doctor. It is essential not to skip any meals while taking GlimeHEXAL.
The tablets can be divided into equal doses. The tablets should be swallowed, washed down with at least half a glass of water. The tablets should not be crushed or chewed.

How much medicine to take

The dose of GlimeHEXAL is determined by the doctor based on the patient's needs, health status, and blood or urine sugar levels. The patient should not take more tablets than prescribed by the doctor.
The usual initial dose is 1 tablet of GlimeHEXAL 1 (1 mg) per day.
If necessary, the 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, the doctor will determine the appropriate dose of glimepiride, metformin, or insulin for each patient.
If the patient's weight or lifestyle changes or if they are in a stressful situation, they should inform their doctor, as a change in the dose of GlimeHEXAL may be necessary.
If the patient feels that the effect of the medicine is too strong or too weak, they should not change the dose themselves but should consult their doctor.

Taking a higher dose of GlimeHEXAL than recommended

In case of taking too much GlimeHEXAL or taking an additional dose, there is a risk of developing hypoglycemia (symptoms of hypoglycemia, see section 2), so the patient should immediately take a sufficient amount of sugar (e.g., several sugar cubes, sweet juice, sweetened tea) and contact their doctor immediately. In case of treating hypoglycemia caused by accidental ingestion of the medicine by a child, the patient should carefully monitor the amount of sugar administered to avoid developing dangerous hyperglycemia. Unconscious persons should not be given food or drink.
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.
The patient should show their doctor the packaging of the medicine or the remaining tablets, so that it is known which medicine was taken.
Severe cases of hypoglycemia with loss of consciousness and severe neurological impairment are emergency situations that require immediate medical attention and hospitalization.
It is always necessary to ensure the presence of an informed person who can call a doctor in case of emergency.

Missing a dose of GlimeHEXAL

The patient should not take a double dose to make up for a missed dose.

Stopping GlimeHEXAL

In case of stopping or ending treatment, the patient should be aware that the desired effect of reducing blood sugar levels will not be achieved, or the disease may worsen again.
GlimeHEXAL should be taken until the doctor recommends stopping it.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should immediately inform their doctor if they experience the following symptoms:

allergic reactions (including vasculitis, often with skin rash), which may develop into severe reactions with difficulty breathing, sudden decrease 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 such symptoms occur, the patient should immediatelyinform their doctor.
allergic reactions (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.
In some patients taking GlimeHEXAL, the following side effects may occur:
Rare side effects(may occur in less than 1 in 1000 patients)
Lower than normal blood sugar levels (hypoglycemia), see section 2.
Decreased number of blood cells

• platelets (which increases the risk of bleeding or bruising),
• white blood cells (which increases the likelihood of infections),
• 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.

Very rare side effects(may occur in less than 1 in 10,000 patients)
Allergic reactions (including vasculitis, often with skin rash), which may develop into severe reactions with difficulty breathing, sudden decrease in blood pressure, and sometimes progressing to shock. If such symptoms occur, the patient should immediatelyinform their doctor.
Abnormal liver function, including yellowing of the skin and eyes (jaundice), bile flow disorders (cholestasis), liver inflammation, or liver failure. If such symptoms occur, the patient should immediatelyinform their 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)
Allergic reactions (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, swelling of the lips, throat, or tongue. Therefore, if such side effects occur, the patient should immediatelyinform their doctor.
Allergic reactions to sulfonylurea derivatives, sulfonamides, or related medicines.
Visual disturbances at the beginning of treatment with GlimeHEXAL. This 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 the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their 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.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store GlimeHEXAL

This medicine should be stored out of the sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging, blister, or container after EXP. The expiry date refers to the last day of the month.
The medicine should not be stored at temperatures above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What GlimeHEXAL contains

The active substance of the medicine 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 containers of HDPE with a tamper-evident closure. The packaging contains 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

To obtain more detailed information on the medicine and its names in other European Economic Area member states, the patient should 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