Glibetic 3 mg

Package leaflet: information for the patient

Glibetic 1 mg, tablets
Glibetic 2 mg, tablets
Glibetic 3 mg, tablets
Glibetic 4 mg, tablets
Glimepiridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Glibetic is and what it is used for

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

2. Important information before using Glibetic

When not to use 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 (insulin-dependent) diabetes;
• if the patient is in a diabetic coma;
• if the patient has ketoacidosis;
• if the patient is pregnant or breastfeeding;
• if the patient has severe renal or hepatic impairment. In case of severe renal or hepatic dysfunction, switching to insulin therapy is required.

Warnings and precautions
Before starting treatment with Glibetic, discuss this with your doctor or pharmacist.
During treatment with Glibetic, regular monitoring of blood glucose levels is necessary. Your doctor may
also recommend blood tests to monitor blood cell counts and liver function.
The patient should carefully follow the treatment plan recommended by the doctor to achieve proper
blood glucose control. This means that, in addition to taking the tablets regularly, the patient should
adhere to a diet, perform physical exercise, and, if necessary, reduce body weight. Regular monitoring
of blood glucose (and possibly urine glucose) according to the doctor's recommendations should also be maintained.
During the first few weeks of treatment, the risk of low blood sugar (hypoglycaemia) may be increased, therefore the patient should remain under close medical supervision.
Low blood sugar may occur if:

• the patient does not eat meals regularly or skips meals completely;
• the patient is fasting;
• the patient is malnourished;
• the patient changes their diet;
• the patient increases physical activity without increasing carbohydrate intake;
• the patient consumes alcohol, especially in combination with skipped meals;
• the patient is taking other medicines or natural remedies simultaneously;
• the patient takes high doses of Glibetic;
• the patient suffers from certain hormonally-induced diseases (thyroid, pituitary, or adrenal cortex dysfunction);
• the patient has impaired kidney function;
• the patient has significantly reduced liver function;
• the patient does not follow the doctor's advice or instructions in this patient leaflet.

If such risk factors are present, the patient should inform their doctor, so that the doctor may adjust the glimepiride dose or modify the entire treatment plan if necessary.
If the patient experiences low blood sugar (hypoglycaemia), the following symptoms may occur:
headache, hunger, fatigue, nausea, vomiting, exhaustion, drowsiness, sleep disturbances, restlessness,
aggression, difficulty concentrating, impaired attention and reaction time, depression, disorientation, speech
and vision disturbances, difficulty speaking or understanding speech (aphasia), tremors, muscle weakness, sensory
disturbances, dizziness, helplessness.
Additional symptoms may include: sweating, clammy skin, anxiety, rapid heartbeat, high blood pressure, sensation of unusually strong or irregular heartbeat (palpitations), sudden chest pain radiating (angina pectoris), and cardiac arrhythmias.
If blood glucose continues to drop, severe disorientation (delirium), epileptic seizures, loss of self-control, shallow breathing, slowed heart rate, or loss of consciousness may occur. The clinical picture of severe hypoglycaemia may resemble a stroke.
In most cases, symptoms of low blood sugar resolve quickly if the patient consumes sugar, e.g. sugar cubes, sweet fruit juice, sweetened tea (artificial sweeteners are ineffective).
Symptoms of low blood sugar may be absent, less pronounced, or develop slowly. The patient may not be aware that blood glucose has dropped. This may occur in elderly patients or those taking certain medications (e.g. drugs acting on the central nervous system or beta-adrenergic blocking agents). It may also occur if the patient suffers from certain endocrine disorders (e.g. certain thyroid or anterior pituitary dysfunction, or adrenal insufficiency).
In stressful situations (e.g. accidents, acute surgery, infections with fever, etc.), temporary switching to insulin therapy may be indicated.
Symptoms of high blood sugar (hyperglycaemia – may occur if Glibetic has not sufficiently lowered blood glucose, if the patient does not follow medical advice, or during particularly stressful situations) may include: increased thirst, frequent urination, dry mouth, dry and itchy skin, fungal or skin infections, and reduced patient activity.
In such cases, contact your doctor immediately.
Inform your doctor if the patient has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder). In such cases, the doctor may decide to change the medication.

Use of Glibetic in patients with liver and/or kidney impairment
There are no data on the use of Glibetic in patients with severe hepatic dysfunction or in dialysed patients. In patients with severe renal or hepatic impairment, switching to insulin therapy is recommended.

Glibetic with other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient intends to take.
Concurrent use of Glibetic with certain medicines may either enhance or reduce the hypoglycaemic effect of glimepiride. The effect of other medicines may also be altered when taken simultaneously with Glibetic. Therefore, other medicines should only be taken with the doctor's approval (or prescription).
The blood glucose-lowering effect of Glibetic may be enhanced, and symptoms of low blood sugar may occur, if any of the following medicines are taken:

• insulin, other oral antidiabetic agents such as metformin;
• antimicrobial agents (e.g. chloramphenicol, quinolones, tetracyclines, sulfonamides, clarithromycin);
• analgesics and anti-rheumatic drugs (pyrazolone derivatives, e.g. phenylbutazone, azapropazone, oxyphenbutazone);
• analgesics (salicylates);
• drugs used in tuberculosis treatment (para-aminosalicylic acid);
• anabolic agents and male hormones (anabolic steroids and androgens);
• anticoagulants (coumarin derivatives);
• antifungal drugs (miconazole, fluconazole);
• antihypertensive drugs or drugs reducing heart rate (angiotensin-converting enzyme (ACE) inhibitors, beta-adrenergic blocking agents, sympatholytics);
• antiarrhythmic drugs (disopyramide);
• mood-enhancing and antidepressant drugs (fluoxetine, MAO inhibitors);
• appetite suppressants (fenfluramine);
• lipid-lowering drugs (fibrates);
• certain anticancer drugs (cyclo-, tro-, and ifosfamide);
• antiallergic drugs (tritoqualine);
• high doses of drugs used to improve blood flow (pentoxifylline);
• drugs used in gout treatment (probenecid, allopurinol, sulfinpyrazone).

The blood glucose-lowering effect of Glibetic may be reduced, and symptoms of high blood sugar may occur, if any of the following medicines are taken:

• female sex hormones (estrogens and progestogens);
• diuretics (diuretics increasing sodium excretion, thiazide diuretics);
• thyroid hormones;
• glucocorticoids;
• drugs used in epilepsy or schizophrenia treatment (phenytoin, phenothiazine derivatives);
• antihypertensive drugs (diazoxide);
• drugs used in infections, including tuberculosis (rifampicin);
• drugs used in hypoglycaemia treatment (glucagon);
• hypnotics (containing barbiturates);
• drugs used in certain eye diseases (acetazolamide);
• drugs increasing heart rate (adrenaline and sympathomimetics);
• lipid-lowering drugs (nicotinic acid derivatives);
• long-term use of laxatives (purgatives).

Drugs used in peptic ulcer treatment (H--receptor antagonists) or antihypertensive drugs (beta-adrenergic blockers, clonidine, and reserpine) may enhance or reduce the blood glucose-lowering effect of glimepiride.
Drugs acting on the central nervous system (beta-adrenergic blockers, clonidine, guanethidine, or reserpine) may mask or completely suppress symptoms of low blood sugar.
Glibetic may enhance or reduce the effect of anticoagulant drugs (coumarin derivatives).

Glibetic with food, drink, and alcohol
The medicine should be taken immediately before or during breakfast or another main meal. Tablets should be swallowed whole with water.
Alcohol may unpredictably enhance or reduce the effect of Glibetic.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Glibetic is contraindicated during pregnancy. Insulin should be used during pregnancy. Women planning pregnancy should inform their doctor.

Breastfeeding
Glibetic is contraindicated in breastfeeding women.

Driving and operating machinery
Hypoglycaemia or hyperglycaemia, as well as visual disturbances, may impair concentration and reaction speed. This may negatively affect the ability to drive vehicles or operate machinery. Consider whether driving or operating machinery is possible under these circumstances.

Glibetic contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Glibetic

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts, consult your doctor. The dosage may vary for different patients.
External factors such as diet, physical exercise, and stress may require adjustment of the dosage.
Oral antidiabetic medicines or insulin are not effective if the patient does not follow the recommended diet.
The dosage is determined by the doctor based on blood and urine glucose test results.
Typically, a single daily dose of glimepiride is sufficient. It is recommended to take the medicine shortly before or during breakfast, or (if breakfast has been omitted) shortly before or during the first main meal.
Tablets should be swallowed whole with a small amount of water.
Initially, glimepiride is administered at a dose of 1 mg per day. If this dose ensures adequate glycemic control, it should be maintained as the maintenance dose.
If satisfactory glycemic control is not achieved, the doctor may gradually increase the dose based on glycemic monitoring, at intervals of 1-2 weeks, up to a daily dose of 2 mg, 3 mg, or 4 mg of glimepiride.
Only in exceptional cases does a glimepiride dose exceeding 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 initiate combination therapy with glimepiride. While maintaining the metformin dose, treatment with Glibetic should be started at a low dose, which is then gradually increased depending on glucose control, up to the maximum daily dose. Combination therapy should be initiated under strict medical supervision.
In patients who have not achieved satisfactory efficacy with the maximum daily dose of Glibetic, the doctor may, if necessary, initiate concomitant insulin therapy. While maintaining the Glibetic dose, insulin treatment should be started at a low dose, which is then gradually increased depending on glucose control. Combination therapy should be initiated under strict medical supervision.
During treatment, when improvement in diabetes control increases insulin sensitivity, the requirement for glimepiride may decrease. Therefore, to avoid hypoglycemia, consideration should be given to reducing or completely discontinuing the medicine. The doctor will consider adjusting the dosage also in case of changes in body weight or lifestyle, or occurrence of other factors increasing the risk of hypoglycemia or hyperglycemia.

Switching from other oral antidiabetic medicines to Glibetic
It is possible to change the treatment regimen 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.

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

Use in renal or hepatic impairment
See section 2. Warnings and precautions.

If you feel the medicine's effect is too strong or too weak, consult your doctor.
Do not change the dosage of the medicine on your own.

Taking more than the recommended dose of Glibetic
If you take more medicine than recommended, contact your doctor immediately. The doctor will initiate appropriate treatment.
Taking too high a dose may cause hypoglycemia lasting from 12 to 72 hours (symptoms see - Warnings and precautions). Symptoms may not appear until up to 24 hours after taking an excessive amount of the medicine. In case of significant overdose, gastric lavage and administration of activated charcoal may be performed. In an alert patient with symptoms of hypoglycemia, induce vomiting, administer water or lemonade with activated charcoal, sodium sulfate (as a laxative), and oral carbohydrates (sugar).

Missed dose of Glibetic
If you miss a dose, take it as soon as possible. Do not take a double dose to make up for the missed dose.
If you have any further doubts about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following classification of frequency of adverse reactions has been adopted:
Very common (affects more than 1 in 10 people): not reported.
Common (affects less than 1 in 10 people): not reported.
Uncommon (affects less than 1 in 100 people): not reported.
Rare (affects less than 1 in 1,000 people): changes in blood parameters (usually reversible after discontinuation of the medicine), hypoglycaemia (i.e. reduced blood sugar concentration, which usually occurs suddenly and may be dangerous – see also sections 2 and 3).
Very rare (affects less than 1 in 10,000 people): allergic vasculitis; hypersensitivity reactions (usually mild, but may also be severe with breathing difficulties, decreased blood pressure, and even shock); nausea, vomiting, and diarrhoea; pressure or discomfort in the abdominal cavity, abdominal pain; liver function disorders (e.g. including cholestasis or jaundice), hepatitis which may lead to liver failure, decreased serum sodium concentration.
Frequency not known (cannot be estimated from the available data): transient visual disturbances, which usually occur at the beginning of treatment; increased liver enzyme activity; cross-sensitivity to sulfonylureas, sulfonamides or related substances; skin allergy symptoms such as itching, rash and urticaria, photosensitivity.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further collection of information on the safety of the medicine.

5. How to store Glibetic 4 mg

Do not store above 25°C. Keep in the original packaging to
protect from light and moisture.
Keep the medicine out of the 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 stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Glibetic contains
Glibetic 1 mg

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

Glibetic 2 mg

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

Glibetic 3 mg

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

Glibetic 4 mg

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

What Glibetic looks like and contents of the pack
Glibetic 1 mg, tablets: elongated, pink tablets with a score line on both sides.
Glibetic 2 mg, tablets: elongated, green tablets with a score line on both sides.
Glibetic 3 mg, tablets: elongated, cream-coloured tablets with a score line on both sides.
Glibetic 4 mg, tablets: elongated, blue tablets with a score line on both sides.
Pack contains 30 tablets.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Date of the latest revision of the leaflet: