Gliclazide Medreg

Package Leaflet: Information for the Patient

Gliclazide Medreg, 30 mg, prolonged-release tablets

Gliclazide Medreg, 60 mg, prolonged-release tablets

Gliclazidum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Gliclazide Medreg and what is it used for

Gliclazide Medreg is a medicine that reduces blood sugar levels (an oral antidiabetic medicine, belonging to the sulfonylurea group).
Gliclazide Medreg is used in adults with a certain type of diabetes (type 2 diabetes),
when diet, exercise, and weight loss alone have not been enough to control blood sugar levels.

2. Important information before taking Gliclazide Medreg

When not to take Gliclazide Medreg

• if you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), to other medicines of the same group (sulfonylureas) or to other similar medicines (sulfonylurea antidiabetics),
• if you have insulin-dependent diabetes (type 1),
• if you have ketone bodies and sugar in your urine (which may indicate diabetic ketoacidosis), pre-coma, or diabetic coma,
• if you have severe kidney or liver disease,
• if you are taking any medicines for fungal infections (miconazole) (see section "Gliclazide Medreg and other medicines"),
• if you are breast-feeding (see section "Pregnancy, breast-feeding, and fertility").

Warnings and precautions

Before taking Gliclazide Medreg, discuss it with your doctor or pharmacist.
Follow the treatment schedule prescribed by your doctor to achieve proper blood sugar control. This means, in addition to regular medication, following a diet,
exercising, and, if necessary, losing weight.
During gliclazide treatment, regularly monitor your blood sugar levels (and, if necessary, urine sugar levels) and hemoglobin A1c levels.
In the first few weeks of treatment, the risk of low blood sugar (hypoglycemia) may be increased. Therefore, close medical supervision is necessary.
Low blood sugar (hypoglycemia) may occur:

• if you eat irregular meals or skip meals,
• if you fast,
• if you are undernourished,
• in case of diet changes,
• in case of increased physical exertion, when the amount of carbohydrates consumed does not meet the increased demand,
• if you consume alcohol, especially if you skip meals,
• when taking other medicines, including herbal products,
• if you take too high a dose of gliclazide,
• if you have certain hormonal disorders (thyroid, pituitary, or adrenal gland disorders),
• if your kidney or liver function is significantly reduced.

If you experience low blood sugar, you may have the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, concentration disorders, decreased alertness, and prolonged reaction time, depression, confusion, speech or vision disorders, tremors, sensation disorders, dizziness, and helplessness.
Other symptoms may also occur: sweating, moist skin, restlessness, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain that may radiate to adjacent parts of the body (angina pectoris).
If your blood sugar levels continue to decrease, you may experience severe confusion (delirium), convulsions, loss of self-control, shallow breathing, and slow heartbeat, and you may lose consciousness.
Symptoms of low blood sugar disappear very quickly after consuming some form of sugar, such as glucose tablets, sugar cubes, sweet juice, or sweet tea. Therefore, you should always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Contact your doctor or the nearest hospital if taking sugar does not help or if symptoms recur.
Symptoms of low blood sugar may be absent, less noticeable, or develop very slowly, or you may not be aware that your blood sugar levels have dropped. This can happen if you are elderly and taking certain medicines (e.g., those acting on the central nervous system and beta-adrenergic blockers).
In stressful situations (accidents, surgeries, fever, etc.), your doctor may temporarily change your treatment to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) may occur if gliclazide has not yet sufficiently lowered your blood sugar levels, if you do not follow the treatment plan prescribed by your doctor, if you take products containing St. John's Wort (Hypericum perforatum) (see section "Gliclazide Medreg and other medicines"), or in special stressful situations. They may include thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and decreased performance.
If you experience these symptoms, contact your doctor or pharmacist.
Blood sugar disorders (low and high blood sugar) may occur when gliclazide is prescribed together with antibiotics of the fluoroquinolone group, especially in elderly patients. In such cases, your doctor will remind you of the importance of monitoring your blood sugar levels.
If you or your family members have or have had a deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a red blood cell disorder), you may experience a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia). Consult your doctor before taking this medicine.
In patients with porphyria (a genetic disorder characterized by the accumulation of porphyrins or their precursors in the body), cases of porphyria exacerbation have been reported after taking certain other sulfonylurea derivatives.

Children and adolescents

Gliclazide Medreg is not recommended for use in children due to a lack of data.

Gliclazide Medreg and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Taking the following medicines may enhance the blood sugar-lowering effect of gliclazide and cause low blood sugar symptoms:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists, or insulin),
• antibiotics (sulfonamides, clarithromycin),
• medicines used to treat high blood pressure or heart failure (beta-adrenergic blockers, ACE inhibitors, such as captopril or enalapril),
• medicines used to treat fungal infections (miconazole, fluconazole),
• medicines used to treat stomach or duodenal ulcers (H2 receptor antagonists),
• medicines used to treat depression (monoamine oxidase inhibitors),
• pain or anti-rheumatic medicines (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The blood sugar-lowering effect of gliclazide may be weakened, and high blood sugar may occur when taking one of the following medicines:

• medicines used to treat central nervous system disorders (chlorpromazine),
• anti-inflammatory medicines (corticosteroids),
• medicines used to treat asthma or during childbirth (salbutamol, rytodryna, and terbutaline administered intravenously),
• medicines used to treat breast diseases, heavy menstrual bleeding, and endometriosis (danazol),
• products containing St. John's Wort (Hypericum perforatum).

When taking Gliclazide Medreg at the same time as antibiotics of the fluoroquinolone group, especially in elderly patients, blood sugar disorders (low and high blood sugar) may occur.
Gliclazide Medreg may enhance the effect of concomitantly used anticoagulant medicines (e.g., warfarin).
Consult your doctor before taking any other medicine.
In case of hospitalization, inform the medical staff that you are taking Gliclazide Medreg.

Gliclazide Medreg with food, drink, and alcohol

Gliclazide Medreg can be taken with food and non-alcoholic beverages. Consuming alcohol is not recommended, as it may affect diabetes control in an unpredictable way.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Gliclazide Medreg is not recommended during pregnancy.
Gliclazide Medreg must not be used during breast-feeding.

Driving and using machines

If your blood sugar levels are too low (hypoglycemia) or too high (hyperglycemia), or if you experience vision disturbances as a result of abnormal blood sugar levels, your ability to concentrate or react may be impaired. Remember that this can be dangerous for you or others (e.g., when driving a car or operating machines).
Ask your doctor if you can drive, if:

• you experience frequent episodes of low blood sugar (hypoglycemia),
• you experience few or no warning symptoms of low blood sugar (hypoglycemia).

Gliclazide Medreg contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Gliclazide Medreg

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The dose of Gliclazide Medreg is determined by your doctor, depending on your blood sugar levels and, if necessary, urine sugar levels. Changes in external factors (weight loss, lifestyle changes, stress) or improved blood sugar control may require a change in the gliclazide dose.
The recommended daily dose is 30 to 120 mg (one to four tablets of Gliclazide Medreg, 30 mg, or half to two tablets of Gliclazide Medreg, 60 mg) once a day, at breakfast time.
The number of tablets depends on the response to treatment.
Gliclazide Medreg is intended for oral use. Take the tablet(s) with a glass of water at breakfast time (preferably at the same time every day). Swallow half a tablet or the whole tablet(s) in one piece. Do not chew or crush. After taking the tablet(s), always eat a meal.
In case of starting combination therapy with Gliclazide Medreg and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will determine the appropriate dose of each medicine individually for each patient.
Consult your doctor or pharmacist if you notice that your blood sugar levels are high, despite taking Gliclazide Medreg as prescribed.

Taking a higher dose of Gliclazide Medreg than recommended

If you have taken too many tablets, contact your doctor or go to the emergency department of the nearest hospital immediately. The symptoms of overdose are the symptoms of low blood sugar (hypoglycemia) as described in section 2. The symptoms can be alleviated by immediately consuming sugar (4 to 6 sugar cubes) or sweet drinks, followed by a substantial snack or meal. If you are unconscious, contact your doctor and call for emergency medical help immediately. Do the same if someone accidentally takes the medicine, e.g., a child. Do not give unconscious patients drinks or food.
Inform another person about your illness, who, if necessary, can call for medical help.

Missing a dose of Gliclazide Medreg

It is important to take the medicine every day, as regular treatment has a better effect.
If you forget to take a dose of Gliclazide Medreg, take the next dose at the usual time. Do not take a double dose to make up for the missed tablet.

Stopping treatment with Gliclazide Medreg

Since diabetes treatment usually lasts a lifetime, consult your doctor before stopping treatment with Gliclazide Medreg. Stopping the medicine may lead to increased blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Gliclazide Medreg can cause side effects, although not everybody gets them.
The most commonly observed side effect is low blood sugar (hypoglycemia). The symptoms and signs are listed in section 2 "Warnings and precautions".
Untreated symptoms may develop into drowsiness, loss of consciousness, or even coma. If you experience a severe or prolonged episode of low blood sugar, even if it is temporarily controlled by consuming sugar, seek medical help immediately.
Liver disorders
There have been reports of isolated cases of liver disorders causing yellowing of the skin and eyes.
Contact your doctor immediately if you experience these symptoms. These symptoms usually disappear after stopping the medicine. Your doctor will decide whether to discontinue treatment.
Skin disorders
There have been reports of skin reactions, such as rash, redness, itching, urticaria, and angioedema (sudden swelling of tissues, such as eyelids, face, lips, mouth, tongue, or throat, which can cause breathing difficulties). The rash may develop into widespread blisters or skin peeling.
If you experience these symptoms, stop taking the medicine, contact your doctor immediately, and inform them that you are taking this medicine.
Exceptionally, there have been reports of symptoms of severe hypersensitivity reactions (DRESS, Drug Rush with Eosinophilia and Systemic Symptoms): initially in the form of flu-like symptoms and rash on the face, followed by widespread rash with high fever.
Blood disorders
There have been reports of decreased numbers of certain blood cells (e.g., platelets, red and white blood cells), which may cause pallor, prolonged bleeding time, bruising, sore throat, and fever.
These symptoms usually disappear after stopping treatment.
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These effects decrease when Gliclazide Medreg is taken with meals, as recommended.
Eye disorders
Transient vision disturbances may occur, especially at the beginning of treatment. This is due to changes in blood sugar levels.
As with other sulfonylurea derivatives, the following side effects have been observed: significant changes in blood cell counts and allergic vasculitis, decreased sodium levels in the blood (hyponatremia), symptoms of liver failure (e.g., jaundice), which in most cases disappeared after stopping sulfonylurea derivatives but in isolated cases may lead to life-threatening liver failure.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring 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
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Gliclazide Medreg

Keep the medicine out of the sight and reach of children.
There are no special storage instructions for the medicine.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle after EXP. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Gliclazide Medreg contains:

Gliclazide Medreg, 30 mg:

• The active substance is gliclazide. Each prolonged-release tablet contains 30 mg of gliclazide.
• The other ingredients are: lactose monohydrate, corn starch, povidone, hypromellose, colloidal silica, and magnesium stearate.

Gliclazide Medreg, 60 mg:

• The active substance is gliclazide. Each prolonged-release tablet contains 60 mg of gliclazide.

60 mg of gliclazide.

• The other ingredients are: lactose monohydrate, corn starch, hypromellose, and magnesium stearate.

What Gliclazide Medreg looks like and contents of the pack

Gliclazide Medreg, 30 mg:
White or almost white, capsule-shaped, biconvex, approximately 10 mm long and 4 mm wide, uncoated tablets with the inscription "C12" on one side and smooth on the other.
The prolonged-release tablets are supplied in PVC/PVdC/Aluminum blisters in a cardboard box.
Pack sizes: 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 112, 120, and 180 prolonged-release tablets.
Gliclazide Medreg, 60 mg:
White or almost white, oval tablets, approximately 14 mm long and 6.5 mm wide, with the letter "C" engraved on one side and "55" on the other side of the break line and a break line on the other side.
The tablet can be divided into equal doses.
The prolonged-release tablets are supplied in Aluminum/Aluminum blisters in a cardboard box.
Pack sizes: 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 112, 120, and 180 prolonged-release tablets.
or
The prolonged-release tablets are supplied in HDPE bottles with a PP cap.
Pack sizes: 30 and 1000 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s.
Výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:

Gliclazide Medreg
Poland:
Gliclazide Medreg
Romania:
Gliclazidă Gemax Pharma 60 mg comprimate cu eliberare prelungită
Slovakia:
Gliclazide Medreg 30 mg
Gliclazide Medreg 60 mg

Date of last revision of the package leaflet: 06/2024