GLITOPREL 3 mg Tablets

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET: USER INFORMATION
2. GLITOPREL, 1 mg, tablets
3. GLITOPREL, 2 mg, tablets
4. GLITOPREL, 3 mg, tablets
5. GLITOPREL, 4 mg, tablets
   1. Read the leaflet carefully before taking the medicine
   2. Contents of the leaflet:
6. WHAT IS GLITOPREL AND WHAT IS IT USED FOR
7. IMPORTANT INFORMATION BEFORE TAKING GLITOPREL
   1. When not to take Glitoprel
   2. When to exercise special caution when taking Glitoprel
   3. Using Glitoprel with other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
8. HOW TO TAKE GLITOPREL
   1. Missing a dose of Glitoprel
   2. Taking a higher dose of Glitoprel than recommended
9. POSSIBLE SIDE EFFECTS
10. HOW TO STORE GLITOPREL
11. OTHER INFORMATION
    1. What Glitoprel contains
    2. What Glitoprel looks like and what the pack contains:
    3. Marketing authorization holder and manufacturer
    4. Date of leaflet approval:

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

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you need further information or advice.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.

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 belonging to the sulfonylurea group, which reduces blood glucose 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) when non-pharmacological methods such as diet, physical exercise, or weight loss do not reduce blood glucose 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 impairment (insulin treatment is necessary).

When to exercise special caution when taking Glitoprel

Any changes in Glitoprel dosing or other concomitantly used medicines should be made after consulting a doctor. Patients treated with glimepiride should not start taking other medicines without consulting a doctor; this also applies to over-the-counter medicines.
During Glitoprel treatment (especially at the beginning of treatment), as with other oral anti-diabetic medicines from the sulfonylurea group, the risk of hypoglycemia cannot be excluded.
The likelihood of hypoglycemia during glimepiride treatment increases if the doctor's dosing 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 medicines that interact with glimepiride (see: Using Glitoprel with other medicines).
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 disturbances, restlessness, aggression, concentration disorders, alertness and reaction time disorders, depression, disorientation, speech and vision disorders, tremors, paresis, sensory disturbances, 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 will subside.

Using Glitoprel with other medicines

Similarly to other oral anti-diabetic medicines, concomitant use of glimepiride with other medicines may lead to increased glucose-lowering effects and increased risk of hypoglycemia.
The risk of hypoglycemia due to interactions between glimepiride and other medicines is particularly relevant for beta-blockers (e.g., acebutolol, atenolol, metoprolol, propranolol), anti-inflammatory and analgesic medicines, as well as insulin and metformin.
Weakening or enhancement of glimepiride's anti-diabetic effect may occur when used concomitantly with certain hormonal, diuretic, or laxative medicines.
The examples listed above do not cover all possible interactions between glimepiride and other medicines, and therefore patients starting Glitoprel treatment should always inform their doctor about all medicines they are taking, and during glimepiride treatment, they should inform their doctor about any new medicines prescribed by other doctors.

Pregnancy and breastfeeding

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

Driving and using machines

Symptoms of hypo- or hyperglycemia, which may occur in diabetes and during treatment with oral anti-diabetic medicines from the sulfonylurea group (including Glitoprel), especially when taken irregularly, may impair reaction speed and concentration, thereby negatively affecting the ability to drive vehicles and operate machinery.
General precautions for patients treated with anti-diabetic medicines
Proper diabetes treatment requires periodic, regular measurement of blood glucose 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 medicines, 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 some sugars, you should consult your doctor before taking the medicine.
The medicine 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 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 dose of the preparation during treatment.
Any changes in Glitoprel dosing should be made after consulting a doctor.

• Use with insulin In patients who have not shown sufficient anti-diabetic effect after taking the maximum daily dose of Glitoprel, 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.
• Use with metformin In patients who have not shown 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 based on the desired glucose 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 for 12 to 72 hours; its symptoms may not be noticeable until 24 hours after taking the medicine.
In case of glimepiride overdose, consult a doctor. After significant overdose, gastric lavage may be performed and activated charcoal administered. A conscious patient showing symptoms of hypoglycemia should be given carbohydrates (sugar) orally.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Glitoprel can cause side effects, although not everybody gets them.
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 disturbances, dizziness, weakness, headaches (see: When to exercise special caution when taking Glitoprel) may occur. Nausea, vomiting, diarrhea, abdominal pain, and skin reactions, as well as generalized allergic reactions and changes in blood count, have also been reported. As with other sulfonylureas, glimepiride may rarely cause increased liver enzyme activity and impaired liver function (e.g., with cholestasis and jaundice).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides:
Al. Jerozolimskie 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

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 expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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, corn starch, microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone, magnesium stearate.
Glitoprel 3 mg tablets:
Other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone, magnesium stearate, quinoline yellow (E 104).

What Glitoprel looks like and what the pack contains:

Glitoprel is available in tablet form and is packaged in a container holding 30 tablets.

Marketing authorization holder and manufacturer

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

Date of leaflet approval: