Gliclazide Medreg

Leaflet attached to the packaging: patient information

Gliclazide Medreg, 30 mg, prolonged-release tablets

Gliclazide Medreg, 60 mg, prolonged-release tablets

Gliclazidum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging and other information

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

Gliclazide Medreg is a medicine that lowers 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 do not have a sufficient effect on maintaining normal blood sugar levels.

2. Important information before taking Gliclazide Medreg

When not to take Gliclazide Medreg

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

Warnings and precautions

Before taking Gliclazide Medreg, the patient should discuss it with their doctor or pharmacist. The patient should follow the treatment schedule prescribed by the doctor to achieve normal blood sugar levels. This means, in addition to taking the medicine regularly, following a diet, exercising, and, if necessary, losing weight. During treatment with gliclazide, the patient should regularly monitor their blood sugar levels (and possibly urine sugar levels) and hemoglobin A1c levels. For 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 the patient eats irregularly or skips meals,
• if the patient fasts,
• if the patient is undernourished,
• in case of a change in diet,
• in case of increased physical exertion, when the amount of carbohydrates consumed does not meet the increased demand,
• if the patient consumes alcohol, especially when skipping meals,
• when taking other medicines, including herbal products,
• if the patient takes too high a dose of gliclazide,
• if the patient has certain hormonal disorders (thyroid, pituitary, or adrenal disorders),
• if the patient's kidney or liver function is significantly impaired.

If the patient experiences low blood sugar, the following symptoms may occur: 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, sensory disturbances, dizziness, and helplessness. The patient may also experience 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 blood sugar levels continue to decrease, the patient may experience severe confusion (delirium), convulsions, loss of self-control, shallow breathing, and slow heart rate, and may lose consciousness. Symptoms of low blood sugar disappear very quickly after consuming some form of sugar, e.g., glucose tablets, sugar cubes, sweet juice, or sweet tea. Therefore, the patient should always carry some form of sugar (glucose tablets, sugar cubes). The patient should remember that artificial sweeteners are not effective. The patient should contact their doctor or the nearest hospital if consuming sugar does not help or if symptoms recur. Symptoms of low blood sugar may be absent, less noticeable, or develop very slowly, or the patient may not be aware that their blood sugar levels have dropped. This may happen if the patient is 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.), the doctor may temporarily change the treatment to insulin therapy. Symptoms of high blood sugar (hyperglycemia) may occur if gliclazide has not yet sufficiently lowered blood sugar levels, if the patient does not follow the treatment plan prescribed by the doctor, if the patient takes products containing St. John's Wort (Hypericum perforatum) (see section "Gliclazide Medreg and other medicines"), or in special stressful situations. These symptoms may include thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and decreased performance. If these symptoms occur, the patient should contact their doctor or pharmacist. Blood sugar disorders (low and high blood sugar) may occur when gliclazide is prescribed together with antibiotics belonging to the fluoroquinolone group, especially in elderly patients. In such cases, the doctor will remind the patient of the importance of monitoring blood sugar levels. If the patient or their family members have or have had a deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a red blood cell disorder), a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia) may occur. The patient should contact their 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The use of the following medicines may enhance the effect of gliclazide and lower blood sugar levels, and may cause symptoms of low blood sugar:

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

• medicines used to treat central nervous system disorders (chlorpromazine),
• medicines that reduce inflammation (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 belonging to 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). Before starting to take any other medicine, the patient should consult their doctor. If hospitalization is necessary, the patient should inform the medical staff that they 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, breastfeeding, and fertility

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. Gliclazide Medreg is not recommended during pregnancy. Gliclazide Medreg should not be used during breastfeeding.

Driving and using machines

If blood sugar levels are too low (hypoglycemia) or too high (hyperglycemia), or if vision is impaired due to abnormal blood sugar levels, the patient's ability to concentrate or react may be impaired. The patient should remember that this can be dangerous for themselves or others (e.g., when driving a car or operating machines). The patient should ask their doctor if they can drive a vehicle if:

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

Gliclazide Medreg contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Gliclazide Medreg

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. The dose of the medicine is determined by the doctor based on blood sugar levels and possibly urine sugar levels. Changes in external factors (weight loss, lifestyle changes, stress) or improvement in blood sugar control may require a change in the dose of gliclazide. 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. The tablet(s) should be swallowed with a glass of water at breakfast time (preferably at the same time every day). The patient should swallow half a tablet or a whole tablet (tablets) in one piece. The patient should not chew or crush the tablet(s). After taking the tablet(s), the patient should always eat a meal. If treatment with Gliclazide Medreg is started in combination with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, the doctor will determine the appropriate dose of each of these medicines individually for each patient. The patient should consult their doctor or pharmacist if they notice that their blood sugar levels are high despite taking Gliclazide Medreg as prescribed.

Taking a higher dose of Gliclazide Medreg than recommended

If the patient has taken too many tablets, they should immediately contact their doctor or go to the emergency department of the nearest hospital. 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 the patient is unconscious, they should immediately contact their doctor and call for emergency medical help. The same applies if the medicine is accidentally ingested, e.g., by a child. An unconscious patient should not be given drinks or food. The patient should inform another person about their 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. However, if the patient forgets to take a dose of Gliclazide Medreg, they should take the next dose at the usual time. The patient should not take a double dose to make up for the missed tablet.

Stopping treatment with Gliclazide Medreg

Since diabetes treatment usually lasts a lifetime, the patient should discuss stopping treatment with their doctor. Stopping the medicine may lead to an increase in blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications. If the patient has any further doubts about taking this medicine, they should consult their 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 an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by consuming sugar, the patient should seek medical help immediately. Liver disorders have been reported, including isolated cases of liver function disorders causing yellowing of the skin and eyes. The patient should contact their doctor immediately if they experience these symptoms. These symptoms usually disappear after the medicine is discontinued. The doctor will decide whether to stop treatment. Skin disorders have been reported, including 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 such symptoms occur, the patient should stop taking the medicine, urgently contact their doctor, and inform them about taking the medicine. Exceptionally, symptoms of severe hypersensitivity reactions (DRESS, Drug Rush with Eosinophilia and Systemic Symptoms) have been reported: initially in the form of flu-like symptoms and a rash on the face, followed by a widespread rash with high fever. Blood disorders have been reported, including a decrease in the number of certain blood cells (e.g., platelets, red blood cells, and white blood cells), which may cause pallor, prolonged bleeding time, bruising, sore throat, and fever. These symptoms usually disappear after treatment is discontinued. Gastrointestinal disorders have been reported, including abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These effects decrease when Gliclazide Medreg is taken with food, as recommended. Eye disorders have been reported, including transient vision disturbances, especially at the beginning of treatment, resulting from 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 discontinuation of sulfonylurea derivatives but in individual cases may lead to life-threatening liver failure.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, more information can be collected on the safety of the medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Gliclazide Medreg

The medicine should be stored out of sight and reach of children. There are no special precautions for storing the medicine. The patient should 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging 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, cornstarch, povidone, hypromellose, colloidal silicon dioxide, anhydrous, 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, cornstarch, 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 side.
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 leaflet: 06/2024