Glimehexal 2

Package leaflet: Information for the patient

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
Glimepiridum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
Keep this leaflet as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others.
It may harm them, even if their symptoms are the same.
If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist.
See section 4.

Contents of the leaflet:

1. What GlimeHEXAL is and what it is 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 pack and other information

1. What GlimeHEXAL is and what it is used for

GlimeHEXAL is an oral antidiabetic medicine. It belongs to a group of medicines called sulfonylureas. GlimeHEXAL increases the amount of insulin released by the pancreas, and insulin lowers blood glucose levels.
For what purpose is GlimeHEXAL used?
GlimeHEXAL is used in the treatment of a certain type of diabetes (type 2 diabetes) when diet, physical exercise, and weight reduction alone are not sufficient to maintain proper blood glucose levels.

2. Important information before taking GlimeHEXAL

When not to take GlimeHEXAL and when to inform your doctor
Do not take GlimeHEXAL if you:

• are allergic to glimepiride or to other sulfonylureas (medicines used to lower blood glucose levels, such as glibenclamide), or to sulfonamides (medicines used to treat bacterial infections, such as sulfamethoxazole), or to any of the other ingredients of this medicine (listed in section 6);
• have type 1 diabetes;
• have ketoacidosis (a complication of diabetes in which the amount of acid in the body increases and the following symptoms may occur: feeling of fatigue, nausea, frequent urination, and muscle stiffness);
• are in diabetic coma;
• have severe kidney disease;
• have severe liver disease.

If any of the above apply to you, do not take GlimeHEXAL. If in doubt, consult your doctor or pharmacist.

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

• you are recovering from injury, surgery, infection with fever, or other types of stress, as temporary changes in treatment may be necessary;
• you have severe liver or kidney dysfunction.

If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking GlimeHEXAL.

In patients with glucose-6-phosphate dehydrogenase deficiency, a decrease in hemoglobin levels and breakdown of red blood cells (hemolytic anemia) may occur.

Information on the use of GlimeHEXAL in individuals under 18 years of age is limited; therefore, its use is not recommended in this age group.

Important information about hypoglycemia (low blood glucose levels)
Hypoglycemia (low blood glucose) may occur in patients taking GlimeHEXAL. Please read the following additional information about hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of hypoglycemia:

• malnutrition, irregular meal intake, skipping or delaying meals, periodic fasting;
• changes in diet;
• taking a higher dose of GlimeHEXAL than recommended;
• impaired kidney function;
• severe liver disease;
• a specific hormonal disorder (thyroid, pituitary, or adrenal cortex dysfunction);
• alcohol consumption (especially when combined with skipped meals);
• concomitant use of certain medicines (see below "GlimeHEXAL with other medicines");
• increased physical exertion without consuming sufficient meals or meals containing fewer carbohydrates than usual.

Symptoms of hypoglycemia may include:

• hunger pangs, headache, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, impaired concentration, reduced alertness and reaction time, depression, disorientation, speech and vision disturbances, slurred speech, tremor, partial paralysis, sensory disturbances, dizziness, helplessness;
• additionally: sweating, moist skin, anxiety, rapid heartbeat, high blood pressure, palpitations, sudden strong chest pain radiating to other areas (angina pectoris), and cardiac arrhythmias.

If blood glucose continues to decrease, the following may occur: severe confusion (delirium), seizures, loss of self-control, shallow breathing and slowed 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 glucose resolve quickly after consuming sugar in the form of, for example, sugar cubes, sweet fruit juice, or sweetened tea. Therefore, you should always carry an appropriate form of sugar (e.g., sugar cubes). Remember that artificial sweeteners are ineffective. Contact your doctor or the nearest hospital immediately if sugar intake does not stop the symptoms of hypoglycemia or if symptoms recur.

Laboratory tests
You should regularly monitor your blood or urine glucose levels. Your doctor may also order blood tests to monitor blood cell counts and liver function.

Children and adolescents
GlimeHEXAL is not recommended for use in children under 18 years of age.

GlimeHEXAL with other medicines
Inform 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 also taking other medicines that may weaken or enhance its effect on blood glucose levels.

The following medicines may enhance the blood glucose-lowering effect of GlimeHEXAL, which may lead to an increased risk of hypoglycemia (low blood glucose):

• other antidiabetic medicines (such as insulin or metformin);
• medicines used to treat pain and inflammation (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);
• medicines that inhibit blood clotting (coumarin derivatives, such as warfarin);
• medicines supporting muscle mass gain (anabolic steroids);
• medicines used in androgen replacement therapy;
• antidepressants (fluoxetine, MAO inhibitors);
• antiarrhythmic medicines used to control irregular heartbeat (disopyramide);
• medicines that reduce elevated cholesterol levels (fibrates);
• medicines that reduce high blood pressure (ACE inhibitors);
• medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone);
• medicines used in cancer treatment (cyclophosphamide, ifosfamide, trofosfamide);
• medicines used for weight reduction (fenfluramine);
• medicines used to improve blood flow, administered as high-dose intravenous infusions (pentoxifylline);
• medicines used to treat allergies, such as hay fever (tritoqualine);
• medicines known as sympatholytics, used to treat high blood pressure, heart failure, or prostate gland symptoms.

The following medicines may weaken the blood glucose-lowering effect of GlimeHEXAL, which may lead to a risk of hyperglycemia (high blood glucose):

• medicines containing female sex hormones (estrogens and progestogens);
• medicines that promote 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 disorders (chlorpromazine and other phenothiazine derivatives);
• medicines used to accelerate heart rate, treat bronchial asthma, nasal congestion, cough and colds, used for weight loss, or in life-threatening conditions (adrenaline and sympathomimetics);
• medicines that reduce elevated cholesterol levels (nicotinic acid);
• medicines used (long-term) to treat constipation (laxatives);
• anticonvulsants (phenytoin);
• medicines used to treat nervousness and sleep disorders (barbiturates);
• medicines used to treat increased intraocular pressure (acetazolamide);
• medicines used to treat high blood pressure or low blood glucose (diazoxide);
• medicines used to treat infections, tuberculosis (rifampicin);
• medicines used to treat very low blood glucose (glucagon).

The following medicines may either enhance or weaken the blood glucose-lowering effect of GlimeHEXAL:

• medicines used to treat peptic ulcer disease (so-called H₂-receptor antagonists);
• medicines used to treat high blood pressure or heart failure, such as beta-blockers, clonidine, guanethidine, and reserpine. These may also mask the symptoms of hypoglycemia; therefore, caution is required when using them.

GlimeHEXAL may either 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 interaction, GlimeHEXAL should be taken at least 4 hours before colesevelam.

GlimeHEXAL and alcohol
Alcohol may unpredictably enhance or weaken the blood glucose-lowering effect of GlimeHEXAL.

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

Driving and operating machinery
If your blood glucose level is low (hypoglycemia) or high (hyperglycemia), or if vision disturbances occur due to these changes, your ability to concentrate or react may be impaired. Be aware of the potential risk to yourself or others, for example, when driving or operating machinery. Consult your doctor if you:

• frequently experience hypoglycemia;
• have no warning symptoms or only weak warning symptoms of hypoglycemia.

GlimeHEXAL contains lactose and sodium
If you have previously been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take GlimeHexal 1

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Taking the medicine
The medicine should be taken orally, immediately before or during the first main 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 important not to skip any meals while taking GlimeHexal 1.
Tablets may be divided into equal doses. Swallow the tablets whole with at least half a glass of water. Do not crush or chew the tablets.
How much medicine to take
The dose of GlimeHexal 1 is determined by the doctor according to the individual needs of the patient, his or her health condition, and the results of blood and urine glucose tests. Do not take more tablets than prescribed by your doctor.
The usual starting dose is 1 tablet of GlimeHexal 1 (1 mg) daily.
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 may be possible to initiate combination therapy with glimepiride and metformin or glimepiride and insulin. In such cases, the doctor will determine the appropriate dose of glimepiride, metformin, or insulin for each patient.
If the patient's body weight or lifestyle changes, or if the patient experiences a stressful situation, inform the doctor, as a change in the dose of GlimeHexal 1 may be necessary.
If you feel the medicine's effect is too strong or too weak, do not adjust the dose on your own; instead, contact your doctor.
Taking more GlimeHexal 1 than recommended
Taking too much GlimeHexal 1 or an extra dose may lead to hypoglycemia (hypoglycemia symptoms, see section 2). Therefore, immediately consume an adequate amount of sugar (e.g., a few sugar cubes, sweet juice, sweetened tea) and contact your doctor without delay. In cases of hypoglycemia caused by accidental ingestion of the medicine by a child, carefully monitor the amount of sugar administered to avoid the development of dangerous hyperglycemia. Do not give food or drink to unconscious individuals.
Hypoglycemia may persist for some time; therefore, close monitoring of the patient is essential until the danger has passed. For safety reasons, hospitalization may be necessary. Show the doctor the medicine packaging or any remaining tablets so that it is clear which medicine has been taken.
Severe hypoglycemia with loss of consciousness and severe neurological impairment constitutes a medical emergency requiring immediate medical intervention and hospitalization. Always ensure that someone informed about the situation is present and able to call a doctor in case of emergency.
If you miss a dose of GlimeHexal 1
Do not take a double dose to make up for a missed dose.
Stopping GlimeHexal 1 treatment
If treatment is interrupted or discontinued, be aware that the desired blood glucose-lowering effect will not be achieved or that the disease may worsen again.
GlimeHexal 1 should be taken until your doctor advises stopping it.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should inform a doctor immediately if the patient experiences any of the following symptoms:
allergic reactions (including inflammation of blood vessels, often with skin rash), which may
develop into severe reactions with difficulty breathing, sudden drop in blood pressure
and sometimes progressing to shock;
liver dysfunction, including yellowing of the skin and eyes (jaundice), disturbances in bile flow (cholestasis), liver inflammation or liver failure;
skin allergy (hypersensitivity), e.g. itching, rash, urticaria and increased sensitivity to
sunlight. Some mild allergic reactions may progress to severe reactions.
Severe hypoglycaemia with loss of consciousness, seizures or coma.

The following adverse reactions may occur in some patients treated with GlimeHexal:

Uncommon adverse reactions (may affect fewer than 1 in 1,000 people)
Lower than normal blood glucose levels (hypoglycaemia), see section 2.
Decreased number of blood cells:

• platelets (increasing the risk of bleeding or bruising),
• white blood cells (increasing the likelihood of infections),
• red blood cells (leading to pale skin and causing weakness or shortness of breath).
  These disorders usually resolve after discontinuation of GlimeHexal.
  Taste disturbances. Hair loss. Weight gain.

Very rare adverse reactions (may affect fewer than 1 in 10,000 people)
Allergic reactions (including inflammation of blood vessels, often with skin rash), which may
develop into severe reactions with difficulty breathing, sudden drop in blood pressure
and sometimes progressing to shock. If such symptoms occur, a doctor should be informed
immediately.
Liver dysfunction, including yellowing of the skin and eyes (jaundice), disturbances in bile flow (cholestasis), liver inflammation or liver failure. If such symptoms occur, a doctor should be informed immediately.
Nausea or vomiting, diarrhoea, feeling of fullness or bloating, abdominal pain.
Decreased sodium concentration in blood (detected by blood test).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)
Skin allergy (hypersensitivity) presenting as itching, rash, urticaria and photosensitivity.
Some mild allergic reactions may progress to severe reactions with difficulty swallowing or breathing, swelling of lips, throat or tongue. Therefore, in case of such adverse reactions, a doctor should be informed immediately.
Hypersensitivity reactions to sulfonylurea derivatives, sulfonamides or related medicines.
Visual disturbances at the beginning of treatment with GlimeHexal. These may be caused by changes in blood glucose levels and should resolve quickly.
Increased liver enzyme activity.
Significant unusual bleeding or development of subcutaneous bruising (thrombocytopenia, thrombocytopenic purpura).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store GlimeHexal 1

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

6. Contents of the pack 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.
Other ingredients are:
GlimeHEXAL 1: lactose monohydrate, sodium carboxymethyl starch (type A), povidone K 25, microcrystalline cellulose, magnesium stearate, iron oxide red (E172).
GlimeHEXAL 2: lactose monohydrate, sodium carboxymethyl starch (type A), povidone K 25, microcrystalline cellulose, magnesium stearate, iron oxide yellow (E172), indigo carmine, lac (E132).
GlimeHEXAL 3: lactose monohydrate, sodium carboxymethyl starch (type A), povidone K 25, microcrystalline cellulose, magnesium stearate, iron oxide yellow (E172).
GlimeHEXAL 4: lactose monohydrate, sodium carboxymethyl starch (type A), povidone K 25, microcrystalline cellulose, magnesium stearate, indigo carmine, lac (E132).
GlimeHEXAL 6: lactose monohydrate, sodium carboxymethyl starch (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 score line, marked G | 1 on one side.
GlimeHEXAL 2: light green, flat, oblong tablets with a score line, marked G | 2 on one side.
GlimeHEXAL 3: light yellow, flat, oblong tablets with a score line, marked G | 3 on one side.
GlimeHEXAL 4: light blue, flat, oblong tablets with a score line, marked G | 4 on one side.
GlimeHEXAL 6: white or almost white, flat, oblong tablets with a score line, marked G | 6 on one side.
GlimeHEXAL tablets are packed in blisters made of Aluminium/PVC foil or in HDPE containers with a tamper-evident closure. Packs contain 30 or 90 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturers
Lek S.A.
ul. Domaniewska 50C
02-672 Warszawa, Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

For further information about this medicinal product and its names in other European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00