Glibetic 2 mg

Leaflet attached to the packaging: patient information

Glibetic 1 mg, tablets

Glibetic 2 mg, tablets

Glibetic 3 mg, tablets

Glibetic 4 mg, tablets

Glimepiride

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• -If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Glibetic and what is it used for

Glibetic contains the active substance glimepiride, which, when taken orally, lowers the blood sugar (glucose) level. The medicine belongs to the group of sulfonylurea derivatives. Glibetic is indicated for the treatment of type 2 diabetes (non-insulin-dependent) when diet, physical exercise, and weight loss are not sufficiently effective. The medicine can be used in combination with metformin or insulin.

2. Important information before taking Glibetic

When not to take Glibetic

• if the patient is allergic to glimepiride, other oral sulfonylurea derivatives, sulfonamides, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has type 1 diabetes (insulin-dependent);
• if the patient has diabetic coma;
• if the patient has ketoacidosis;
• if the patient is pregnant or breastfeeding;
• if the patient has severe kidney or liver dysfunction. In the case of severe kidney or liver dysfunction, a change to insulin is necessary.

Warnings and precautions

Before starting treatment with Glibetic, the patient should discuss it with their doctor or pharmacist. During treatment with Glibetic, regular blood sugar tests are necessary. The doctor may also recommend blood tests to monitor blood cell count and liver function. The patient should follow the treatment plan prescribed by the doctor to achieve proper blood sugar control. This means that, in addition to taking the tablets regularly, the patient should follow a diet, exercise, and, if necessary, lose weight. The patient should also take care to regularly check their blood sugar levels (and, if necessary, urine) as recommended by the doctor. During the first few weeks of treatment, the risk of low blood sugar (hypoglycemia) may be increased, so the patient should be under close medical supervision. Low blood sugar may occur if:

• the patient does not eat regular meals or skips them entirely;
• the patient is fasting;
• the patient is malnourished;
• the patient changes their diet;
• the patient increases physical activity and does not increase carbohydrate intake;
• the patient consumes alcohol, especially in combination with skipping meals;
• the patient takes other medicines or natural products at the same time;
• the patient takes high doses of Glibetic;
• the patient has certain hormone-induced diseases (functional thyroid, pituitary, or adrenal disorders);
• the patient has reduced kidney function;
• the patient has significantly reduced liver function;
• the patient does not follow the doctor's or leaflet's recommendations.

If such a risk exists, the patient should inform their doctor so that they can adjust the glimepiride dose or change the treatment plan if necessary. If the patient experiences low blood sugar (hypoglycemia), the following symptoms may occur: headache, feeling of hunger, exhaustion, nausea, vomiting, fatigue, drowsiness, sleep disturbances, anxiety, aggression, decreased concentration, attention, and reaction time, depression, disorientation, speech and vision disorders, difficulty speaking or understanding speech (aphasia), tremors, weakness, sensory organ disorders, dizziness, helplessness. The following symptoms may also occur: sweating, sticky skin, anxiety, rapid heartbeat, high blood pressure, feeling of irregular or forceful heartbeat (palpitations), sudden chest pain that may radiate (angina pectoris), and heart rhythm disturbances. If blood sugar levels continue to decrease, severe disorientation (delirium), seizures, loss of self-control, shallow breathing, and slowed heart rate may occur, and the patient may lose consciousness. The clinical picture of severe low blood sugar may be similar to a stroke. In most cases, the symptoms of low blood sugar disappear very quickly if the patient consumes sugar, e.g., sugar cubes, sweet juice, sweetened tea (artificial sweeteners are ineffective). The symptoms of low blood sugar may not occur, be less severe, or develop slowly. The patient may not be aware that their blood sugar level has decreased. This can happen in elderly patients taking certain medicines (e.g., central nervous system depressants or beta-blockers) or having certain endocrine system diseases (e.g., certain thyroid, pituitary, or adrenal disorders). In stressful situations (e.g., accidents, emergency surgeries, infections with fever), temporary replacement of treatment with insulin may be indicated. High blood sugar (hyperglycemia) symptoms may occur if Glibetic does not sufficiently lower blood sugar levels or if the patient does not follow the doctor's recommendations or experiences a particularly stressful situation. These symptoms may include: increased thirst, frequent urination, dry mouth, dry and itchy skin, fungal or skin infections, decreased patient activity. In such cases, the patient should contact their doctor immediately. The patient should inform their doctor if they have a deficiency of glucose-6-phosphate dehydrogenase (a rare hereditary disease). In this case, the doctor may decide to change the medicine. Use in patients with liver or kidney dysfunction There is no data on the use of Glibetic in patients with severe liver dysfunction or those undergoing dialysis. In patients with severe kidney or liver dysfunction, a change to insulin is recommended.

Glibetic and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Taking Glibetic with certain medicines may enhance or weaken the hypoglycemic effect of glimepiride. The effect of other medicines may also be disrupted if taken simultaneously with Glibetic. Therefore, other medicines should only be taken with the doctor's consent or prescription. The hypoglycemic effect of Glibetic may be enhanced, and low blood sugar symptoms may occur if the patient takes one of the following medicines:

• insulin, other oral antidiabetic medicines, such as metformin;
• antibiotics (e.g., chloramphenicol, quinolones, tetracyclines, sulfonamides, clarithromycin);
• analgesic and anti-rheumatic medicines (pyrazolone derivatives, e.g., phenylbutazone, azapropazone, oxyphenbutazone);
• analgesics (salicylates);
• medicines used to treat tuberculosis (para-aminosalicylic acid);
• medicines used to build muscle mass (anabolics and male hormones);
• medicines that prevent blood clotting (coumarin derivatives);
• medicines used to treat fungal infections (miconazole, fluconazole);
• medicines that lower blood pressure or heart rate (ACE inhibitors, beta-blockers, sympatholytics);
• anti-arrhythmic medicines (disopyramide);
• medicines that improve mood and are used to treat depression (fluoxetine, MAO inhibitors);
• medicines that reduce appetite (fenfluramine);
• medicines that lower high blood lipid levels (fibrates);
• certain medicines used to treat cancer (cyclo-, tro-, and ifosfamides);
• medicines used to treat allergies (tritoqualine);
• high doses of medicines that improve blood flow (pentoxifylline);
• medicines used to treat gout (probenecid, allopurinol, sulfinpyrazone).

The hypoglycemic effect of Glibetic may be weakened, and high blood sugar symptoms may occur if the patient takes one of the following medicines:

• female sex hormones (estrogens and progestogens);
• medicines that increase urine production (diuretics that increase sodium excretion, thiazide diuretics);
• thyroid hormones;
• glucocorticosteroids;
• medicines used to treat convulsions or schizophrenia (phenytoin, phenothiazine derivatives);
• medicines that lower blood pressure (diazoxide);
• medicines used to treat infections, including tuberculosis (rifampicin);
• medicines used to treat low blood sugar (glucagon);
• sedatives (containing barbiturates);
• medicines used to treat certain eye diseases (acetazolamide);
• medicines that increase heart rate (adrenaline and sympathomimetics);
• medicines that lower high blood lipid levels (nicotinic acid derivatives),
• prolonged use of laxatives.

Medicines used to treat stomach or duodenal ulcers (H receptor antagonists) or medicines that lower blood pressure (beta-blockers, clonidine, and reserpine) may enhance or weaken the hypoglycemic effect of glimepiride. Central nervous system depressants (beta-blockers, clonidine, guanethidine, or reserpine) may mask or completely eliminate the symptoms of low blood sugar. Glibetic may enhance or weaken the effect of medicines that prevent blood clotting (coumarin derivatives).

Glibetic with food, drink, and alcohol

The medicine should be taken directly before or during breakfast, or another main meal. The tablets should be swallowed whole, washed down with water. Alcohol may enhance or weaken the effect of Glibetic in an unpredictable way.

Pregnancy and 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. Pregnancy Glibetic is contraindicated during pregnancy. During pregnancy, insulin should be used. Patients planning to become pregnant should inform their doctor. Breastfeeding Glibetic is contraindicated in breastfeeding women.

Driving and using machines

Due to hypoglycemia or hyperglycemia, or as a result of vision, concentration, and reaction disturbances, the patient's ability to drive or operate machines may be impaired. It should be considered whether, in these circumstances, it is possible to drive or operate machines.

Glibetic contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Glibetic

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor should be consulted. The doses of the medicine may vary for different patients. Changes in external factors, diet, physical exercise, stress may require a change in the dosage of the medicine. Oral antidiabetic medicines or insulin are not effective if the patient does not follow the prescribed diet. The dosage is determined by the doctor based on the results of blood glucose and urine tests. Usually, a single daily dose of glimepiride is sufficient. It is recommended to take the medicine shortly before or during breakfast, or (if breakfast is skipped) shortly before or during the first main meal. The tablets should be swallowed whole, washed down with a small amount of water. Initially, glimepiride is administered at a dose of 1 mg per day. If this dose provides good glycemic control, it should be taken as a maintenance dose. If satisfactory glycemic control is not achieved, the doctor may gradually increase the dose based on the results of glycemic control, at 1-2 week intervals, to achieve a daily dose of 2 mg, 3 mg, or 4 mg of glimepiride. Only in exceptional cases does a glimepiride dose greater than 4 mg per day provide better therapeutic results. The maximum recommended daily dose is 6 mg of glimepiride. In patients who have not achieved satisfactory efficacy with the maximum daily dose of metformin, the doctor may use combination therapy with glimepiride. While maintaining the metformin dose, treatment with Glibetic should be started with small doses, which, depending on the effectiveness of glucose control, can be increased up to the maximum daily dose. Combination therapy should be started under close medical supervision. In patients who have not achieved satisfactory efficacy with the maximum daily dose of Glibetic, the doctor may, if necessary, start concurrent treatment with insulin. While maintaining the Glibetic dose, insulin treatment should be started with small doses, which can be gradually increased depending on the effectiveness of glucose control. Combination therapy should be started under close medical supervision. During treatment, if blood sugar control improves and insulin sensitivity increases, the need for glimepiride may decrease. Therefore, to avoid hypoglycemia, it may be necessary to consider reducing the dose or completely stopping the medicine. The doctor will also consider changing the dosage in case of changes in the patient's weight or lifestyle, as well as the occurrence of other factors that increase the risk of hypo- or hyperglycemia.

Replacing other oral antidiabetic medicines with Glibetic

It is possible to change the treatment by replacing other oral antidiabetic medicines with Glibetic. The recommended initial dose of Glibetic is 1 mg per day. Depending on the response to treatment, the doctor may gradually increase the dose of Glibetic, according to the above recommendations.

Replacing insulin with Glibetic

In exceptional cases, in patients with type 2 diabetes treated with insulin, a change in treatment to Glibetic may be indicated. The change in treatment should be carried out under close medical supervision.

Use in case of kidney or liver failure

See section 2. Warnings and precautions. If it is felt that the effect of the medicine is too strong or too weak, the doctor should be consulted. The patient should not change the dosage of the medicine on their own.

Taking a higher dose of Glibetic than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately contact their doctor, who will provide appropriate treatment. Taking too much of the medicine can cause hypoglycemia lasting from 12 to 72 hours (symptoms - see Warnings and precautions). Symptoms may not occur until 24 hours after taking the excessive amount of medicine. In case of significant overdose, gastric lavage can be performed, and activated charcoal can be administered. In a conscious patient with hypoglycemia symptoms, vomiting can be induced, water or lemonade with activated charcoal can be given, sodium sulfate (as a laxative) can be administered, and carbohydrates (sugar) can be taken orally.

Missing a dose of Glibetic

In case of missing a dose, it should be taken as soon as possible. A double dose should not be taken to make up for the missed dose. In case of any further doubts about taking this medicine, the doctor should be consulted.

4. Possible side effects

Like all medicines, Glibetic can cause side effects, although not everybody gets them. The following classification of the frequency of side effects has been adopted: Very common (occurring in more than 1 in 10 patients): not reported. Common (occurring in less than 1 in 10 patients): not reported. Uncommon (occurring in less than 1 in 100 patients): not reported. Rare (occurring in less than 1 in 1,000 patients): changes in blood count (usually disappearing after withdrawal of the medicine), hypoglycemia (i.e., low blood sugar, which usually occurs suddenly and can be dangerous - see also sections 2 and 3). Very rare (occurring in less than 1 in 10,000 patients): allergic vasculitis; hypersensitivity reactions (usually mild, can also be severe with respiratory, blood pressure, or shock disorders); nausea, vomiting, and diarrhea; feeling of pressure or discomfort in the abdominal cavity, abdominal pain; liver function disorders (e.g., including cholestasis or jaundice), hepatitis that can lead to liver failure, decreased sodium levels in the serum. Frequency not known (cannot be estimated from the available data): transient vision disturbances, which usually occur at the beginning of treatment; increased liver enzyme activity; cross-hypersensitivity to sulfonylurea derivatives, sulfonamides, or related substances; symptoms of skin allergy, such as itching, rash, and urticaria, hypersensitivity to light.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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, more information can be collected on the safety of the medicine.

5. How to store Glibetic

Do not store above 25°C. Store in the original packaging to protect from light and moisture. The medicine should be stored in a place that is out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT, it means the batch number. 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 Glibetic contains

Glibetic 1 mg

• The active substance of the medicine is glimepiride. Each tablet contains 1 mg of glimepiride.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose, lactose monohydrate, povidone, magnesium stearate, red iron oxide (E 172).

Glibetic 2 mg

• The active substance of the medicine is glimepiride. Each tablet contains 2 mg of glimepiride.
• The other ingredients of the medicine are: microcrystalline cellulose, sodium carboxymethylcellulose, lactose monohydrate, povidone, magnesium stearate, yellow iron oxide (E 172), indigocarmine (E 132).

Glibetic 3 mg

• The active substance of the medicine is glimepiride. Each tablet contains 3 mg of glimepiride.
• The other ingredients of the medicine are: microcrystalline cellulose, sodium carboxymethylcellulose, lactose monohydrate, povidone, magnesium stearate, yellow iron oxide (E 172).

Glibetic 4 mg

• The active substance of the medicine is glimepiride. Each tablet contains 4 mg of glimepiride.
• The other ingredients of the medicine are: microcrystalline cellulose, sodium carboxymethylcellulose, lactose monohydrate, povidone, magnesium stearate, indigocarmine (E 132).

What Glibetic looks like and what the packaging contains

Glibetic 1 mg, tablets: pink, oblong tablet with a dividing line on both sides. Glibetic 2 mg, tablets: green, oblong tablet with a dividing line on both sides. Glibetic 3 mg, tablets: cream-colored, oblong tablet with a dividing line on both sides. Glibetic 4 mg, tablets: blue, oblong tablet with a dividing line on both sides. The packaging contains 30 tablets.

Marketing authorization holder and manufacturer

Polpharma S.A. ul. Pelplińska 19, 83-200 Starogard Gdański tel. +48 22 364 61 01

Date of last revision of the leaflet