Glimehexal 6

Warnings and precautions

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

you are recovering from an injury, surgery, infection with fever, or other types of stress, as a temporary change in treatment may be necessary,
you have severe liver or kidney dysfunction.
In case of doubt as to 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 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)

Patients taking GlimeHEXAL may experience hypoglycemia (low blood sugar). You should familiarize yourself with 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),
alcohol consumption (especially with skipped meals),
concomitant use of certain medications (see below "GlimeHEXAL and other medications"),
increased physical exertion without adequate meals or meals containing less carbohydrates than usual.

Symptoms of hypoglycemia may include:

hunger attacks, headache, nausea, vomiting, drowsiness, dizziness, sleep disturbances, restlessness, aggression, impaired 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, 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, you should always carry sugar with you in an appropriate form (e.g., sugar cubes). Remember that artificial sweeteners are ineffective. You should contact your doctor or the nearest hospital immediately if sugar administration does not stop hypoglycemia symptoms or if they return.

Lab 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 medications

You should tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Your doctor may recommend changing the dose of GlimeHEXAL if you are taking other medications that may weaken or enhance the effect of GlimeHEXAL on your blood sugar levels.
The following medications may enhance the effect of GlimeHEXAL, reducing blood sugar levels, which may lead to the risk of hypoglycemia (low blood sugar):
other anti-diabetic medications(such as insulin or metformin)
medications used to treat pain and inflammation(phenylbutazone, azapropazone, oxyphenbutazone, medications similar to acetylsalicylic acid)
medications used to treat urinary tract infections(such as long-acting sulfonamides)
medications used to treat bacterial and fungal infections(tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin)
medications that inhibit blood clotting(coumarin derivatives, such as warfarin)
medications that promote muscle growth(anabolics)
medications used in hormone replacement therapy
medications used to treat depression(fluoxetine, MAO inhibitors)
anti-arrhythmic medications used to control irregular heartbeat(disopyramide)
medications that lower high cholesterol levels(fibrates)
medications that lower high blood pressure(ACE inhibitors)
medications used to treat gout(allopurinol, probenecid, sulfinpyrazone)
medications used to treat cancer(cyclophosphamide, ifosfamide, trofosfamide)
medications used to reduce weight(fenfluramine)
medications used to increase blood flow, administered intravenously in large doses (pentoxifylline)
medications used to treat allergies, such as hay fever (tritoqualine)
medications called sympatholytics, used to treat high blood pressure, heart failure, or prostate symptoms.
The following medications may weaken the effect of GlimeHEXAL, reducing blood sugar levels, which may lead to the risk of hyperglycemia (high blood sugar):
medications containing female sex hormones(estrogens and progestogens)
medications that promote urine production(thiazide diuretics)
medications that stimulate thyroid function(such as levothyroxine)
medications used to treat allergies and inflammatory conditions(glucocorticoids)
medications used to treat severe mental illnesses(chlorpromazine and other phenothiazine derivatives)
medications used to increase heart rate, treat asthma, or relieve nasal congestion, used to reduce weightor in life-threatening situations (adrenaline and sympathomimetics)
medications that lower high cholesterol levels(nicotinic acid)
medications used to treat constipation(laxatives)
medications used to treat epilepsy(phenytoin)
medications used to treat nervousness and sleep disorders(barbiturates)
medications used to treat increased eye pressure(acetazolamide)
medications used to treat high blood pressureor low blood sugar (diazoxide)
medications used to treat (rifampicin)
medications used to treat low blood sugar(glucagon).
The following medications may enhance or weaken the effect of GlimeHEXAL, reducing blood sugar levels:
medications used to treat stomach ulcers(so-called H2 receptor antagonists)
medications 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 advised when using them.
GlimeHEXAL may enhance or weaken the effect of the following medications:
medications that inhibit blood clotting(coumarin derivatives, such as warfarin).
Colesevelam, a medication 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 effect of GlimeHEXAL, reducing blood sugar levels, in an unpredictable manner.

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, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

In case your blood sugar levels are low (hypoglycemia) or high (hyperglycemia), or if you experience vision disturbances due to these changes, your ability to concentrate or react may be impaired. You should be aware of the risk of endangering yourself or others, e.g., while driving or operating machines.
You should 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 an intolerance to some sugars, you should 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

This medicine should always be taken as directed by your doctor. In case of doubt, consult your doctor or pharmacist.

Taking the medicine

The medicine is taken orally, immediately before or during the first large 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. 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 to take

The dose of GlimeHEXAL is determined by your doctor, depending on your needs, health status, and blood sugar level test results. Do not take more tablets than prescribed by your doctor.
The usual initial 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 find yourself in a stressful situation, you should inform your doctor, as a dose adjustment of GlimeHEXAL may be necessary.
In case 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 larger dose of GlimeHEXAL than recommended

In case you take too much GlimeHEXAL or take an additional dose, there is a risk of developing hypoglycemia (hypoglycemia symptoms, see section 2), so you should immediately take a sufficient amount of sugar (e.g., several sugar cubes, sweet juice, sweetened tea) and inform your doctor without delay. In case of hypoglycemia treatment resulting from accidental ingestion by a child, you 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.
You should show your 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.
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

In case you stop or finish treatment, you should be aware that the desired blood sugar-lowering effect will not be achieved, or the disease may worsen again.
GlimeHEXAL should be taken until your doctor recommends stopping it.
In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

You should 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;
allergic reactions (hypersensitivity) of the skin, such as itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions can 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 less frequently than in 1 in 1000 people)
Lower than normal blood sugar levels (hypoglycemia), see section 2.
Decreased blood cell count

• 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 can lead to weakness or shortness of breath). These disorders usually disappear after stopping GlimeHEXAL. Taste disorders. Hair loss. Weight gain.

Very rare side effects(may occur less frequently than in 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. In case of such symptoms, you should immediately inform your doctor.
Abnormal liver function, including yellowing of the skin and eyes (jaundice), bile flow disorders (cholestasis), liver inflammation, or liver failure. In case of such symptoms, you should 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)
Allergic reactions (hypersensitivity) of the skin, such as itching, rash, hives, and increased sensitivity to sunlight. Some mild allergic reactions can develop into severe reactions with difficulties in swallowing or breathing, lip, throat, or tongue swelling. Therefore, in case of such side effects, you should immediately inform your doctor.
Allergic reactions to sulfonylurea derivatives, sulfonamides, or related medications.
Visual disturbances at the beginning of GlimeHEXAL treatment. This 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 those not listed in this leaflet, you should 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

This medicine should be stored out of 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. You should ask your 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 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 Warszawa
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 about the medicine and its names in other European Economic Area member states, please contact:

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