Glitoprel

PATIENT INFORMATION LEAFLET: USER INFORMATION

GLITOPREL, 1 mg, tablets

GLITOPREL, 2 mg, tablets

GLITOPREL, 3 mg, tablets

GLITOPREL, 4 mg, tablets

(Glimepiride)

Read the leaflet carefully before taking the medicine

• You should keep this leaflet, so you can read it again if you need to.
• You should consult your doctor or pharmacist if you need advice or more information.
• This medicine has been prescribed for you only. Do not give it to others, as it may harm them, even if their symptoms are the same as yours.

Table of contents of the leaflet:

• 1. What is Glitoprel and what is it used for
• 2. Important information before taking Glitoprel
• 3. How to take Glitoprel
• 4. Possible side effects
• 5. How to store Glitoprel
• 6. Other information

1. WHAT IS GLITOPREL AND WHAT IS IT USED FOR

Glitoprel contains the active substance glimepiride. It is an oral anti-diabetic medicine from the sulfonylurea group, which reduces blood sugar levels mainly by stimulating insulin release from the pancreas, as well as increasing tissue sensitivity to insulin and reducing insulin uptake by the liver.
The indication for use of Glitoprel is type 2 diabetes (non-insulin-dependent) in cases where non-pharmacological methods of treatment, such as diet, physical exercise, or weight loss, do not reduce blood sugar levels.
Glitoprel can also be used in combination with metformin or insulin.
Glimepiride is completely absorbed from the gastrointestinal tract after oral administration. The effect of Glitoprel lasts for 24 hours after its administration.

2. IMPORTANT INFORMATION BEFORE TAKING GLITOPREL

When not to take Glitoprel

• in case of known hypersensitivity to glimepiride or other sulfonylureas or sulfonamides or any other component of the preparation,
• in diabetic ketoacidosis, with or without coma (this condition requires insulin treatment),
• in type 1 diabetes (insulin-dependent),
• in severe liver or kidney dysfunction (insulin treatment is necessary).

When to exercise special caution when taking Glitoprel

Any changes in the dosage of Glitoprel or other medications taken simultaneously should be made after consulting a doctor. Patients treated with glimepiride should not start taking other medications without consulting a doctor; this also applies to over-the-counter medications.
During the use of Glitoprel (especially at the beginning of treatment), as with other oral anti-diabetic medications from the sulfonylurea group, the risk of hypoglycemia cannot be excluded. The likelihood of hypoglycemia during glimepiride treatment increases if the doctor's dosage recommendations are not followed, meals are not eaten regularly, physical activity is low, alcohol is consumed, kidney or liver function is impaired, or certain thyroid, pituitary, or adrenal gland diseases are present, or when taking medications that interact with glimepiride (see: Taking Glitoprel with other medications).
Periodic insulin use may also be indicated in stressful situations (e.g., injuries, surgical procedures, infectious diseases with fever).
Possible symptoms of hypoglycemia include: headaches, feeling of great hunger ("wolfish appetite"), nausea, vomiting, fatigue, drowsiness, sleep disorders, restlessness, aggression, concentration disorders, alertness and reaction time, depression, disorientation, speech and vision disorders, tremors, weakness, sensation disorders, dizziness, helplessness, loss of self-control, delirium, seizures of cerebral origin, loss of consciousness up to coma, shallow breathing, and slowed heart rate. After hypoglycemia has resolved, these symptoms disappear.

Taking Glitoprel with other medications

Similarly to other oral anti-diabetic medications, concomitant use of glimepiride with other medications may enhance the blood sugar-lowering effect and increase the risk of hypoglycemia. The risk of hypoglycemia due to interactions between glimepiride and other medications is particularly relevant for beta-blockers (e.g., acebutolol, atenolol, metoprolol, propranolol), anti-inflammatory and analgesic medications, as well as insulin and metformin.
Weakening or enhancement of the anti-diabetic effect of glimepiride may occur during its concomitant use with certain hormonal, diuretic, and laxative medications.
The examples given above do not exhaust all possible interactions between glimepiride and other medications, and therefore patients starting Glitoprel should always inform their doctor about all medications they are taking, and during glimepiride treatment, they should inform their doctor about any medications prescribed or discontinued by other doctors.

Pregnancy and breastfeeding

Before taking any medication, consult your doctor or pharmacist.
Glitoprel is not recommended during pregnancy.
Glitoprel is not recommended during breastfeeding.

Driving and operating machinery

Symptoms of hypo- or hyperglycemia, which may occur in diabetes and during treatment with oral anti-diabetic medications from the sulfonylurea group (including Glitoprel), especially if taken irregularly, may impair reaction speed and concentration, thereby negatively affecting the ability to drive and operate machinery.
General precautions for patients treated with anti-diabetic medications
Proper treatment of diabetes requires periodic, regular measurement of blood sugar levels and performance of other laboratory tests to determine the effectiveness and safety of the therapy.
Diabetes is treated comprehensively, which means that in addition to taking medications, dietary recommendations, physical exercise, and maintaining a healthy body weight must also be followed.
Due to the risk of hypoglycemia, diabetic patients should always carry easily absorbable sugar and an easily accessible document (identifier) informing others about their condition.
Glitoprel contains lactose monohydrate.
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking the medication.
The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. HOW TO TAKE GLITOPREL

Individual dosing of Glitoprel for each patient is determined by the doctor based on laboratory test results, which allow for the assessment of the severity of diabetes and the degree of its control.
Initially, 1 mg of Glitoprel is administered once a day. If the effect is not satisfactory, the dose should be gradually increased at 1-2 week intervals to 2, 3, or 4 mg per day. The maximum recommended daily dose is 6 mg of glimepiride; this dose is usually used in combination with insulin.
Treatment with Glitoprel is usually long-term.
Improvement in diabetes control is usually associated with increased insulin sensitivity, which may necessitate a reduction in the dosage of the preparation during treatment.
Any changes in the dosage of Glitoprel should be made after consulting a doctor.

• Taking with insulin In patients who do not show sufficient anti-diabetic effect after taking the maximum daily dose of Glitoprel, concomitant insulin treatment can be initiated. Using the established dose of glimepiride, treatment should begin with small doses of insulin, which should be gradually increased to achieve optimal diabetes control. Combination therapy with insulin should only be started under medical supervision.
• Taking with metformin In patients who do not show sufficient effect after taking the maximum daily dose of metformin, Glitoprel can be used concomitantly. During maintenance treatment with a fixed dose of metformin, glimepiride treatment should be started with small doses, which should be increased according to the desired blood sugar control. Combination therapy should only be started under close medical supervision.

Method of administration
Glitoprel should be taken directly before or during breakfast or another main meal. The tablets should be swallowed whole, washed down with a liquid (about half a glass).

Missing a dose of Glitoprel

If a dose is missed, do not double the next dose, but take it at the next scheduled time.

Taking a higher dose of Glitoprel than recommended

Taking too high a dose of Glitoprel may cause hypoglycemia, which can last from 12 to 72 hours; its symptoms may not be noticeable until 24 hours after taking the medication.
In case of glimepiride overdose, consult a doctor. After significant overdose, gastric lavage can be performed, and activated charcoal can be administered. A patient who is conscious and shows symptoms of hypoglycemia should be given carbohydrates (sugar) orally.

4. POSSIBLE SIDE EFFECTS

Like all medications, Glitoprel can cause side effects, although they do not occur in everyone.
Glitoprel is generally well-tolerated, and when properly dosed, it rarely causes side effects. Sometimes, especially at the beginning of treatment, hypoglycemia and related temporary vision disorders, dizziness, weakness, headaches (see: When to exercise special caution when taking Glitoprel) may occur. During glimepiride treatment, rare cases of nausea, vomiting, diarrhea, abdominal pain have also been reported. Allergic reactions and generalized allergic reactions, changes in blood count, and liver function disorders (e.g., with cholestasis and jaundice) may also occur, as with other sulfonylureas.
If any side effect worsens or any side effect not mentioned in the leaflet occurs, consult your doctor or pharmacist.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181 C
02-222 Warsaw
Phone: +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 will help gather more information on the safety of the medication.

5. HOW TO STORE GLITOPREL

Do not store above 25°C.
Keep out of the reach and sight of children.
Do not use Glitoprel after the expiration date stated on the packaging.
The expiration date refers to the last day of the given month.
Medications should not be disposed of in the sewage system or household waste containers. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. OTHER INFORMATION

What Glitoprel contains

The active substance of Glitoprel is glimepiride. Each tablet contains 1 mg, 2 mg, 3 mg, or 4 mg of glimepiride.
Glitoprel 1 mg, 2 mg, and 4 mg tablets:
Other ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone, magnesium stearate.
Glitoprel 3 mg tablets:
Other ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone, magnesium stearate, quinoline yellow (E 104).

What Glitoprel looks like and what the pack contains:

Glitoprel is in the form of tablets and is available in a package containing 30 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
Józefów 9
99-300 Kutno
To obtain more detailed information, please contact the representative of the marketing authorization holder.

Date of leaflet approval: