SYMAZIDE 30 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Symazide MR 30 mg, 30 mg, Modified-Release Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Symazide MR 30 mg and what is it used for
4. Important information before taking Symazide MR 30 mg
   1. When not to take Symazide MR 30 mg:
   2. Warnings and precautions
   3. Children and adolescents
   4. Symazide MR 30 mg and other medicines
   5. Symazide MR 30 mg with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Symazide MR 30 mg contains lactose
5. How to take Symazide MR 30 mg
   1. Dose
   2. Method and route of administration
   3. Overdose of Symazide MR 30 mg
   4. Missing a dose of Symazide MR 30 mg
   5. Stopping treatment with Symazide MR 30 mg
6. Possible side effects
   1. Reporting side effects
7. How to store Symazide MR 30 mg
8. Contents of the pack and other information
   1. What Symazide MR 30 mg contains
   2. What Symazide MR 30 mg looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Symazide MR 30 mg, 30 mg, Modified-Release Tablets

Gliclazide

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

• Keep this package 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 those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Symazide MR 30 mg and what is it used for
• 2. Important information before taking Symazide MR 30 mg
• 3. How to take Symazide MR 30 mg
• 4. Possible side effects
• 5. How to store Symazide MR 30 mg
• 6. Contents of the pack and other information

1. What is Symazide MR 30 mg and what is it used for

Symazide MR 30 mg is a medicine that lowers blood sugar levels (an oral antidiabetic medicine belonging to the sulfonylurea group). Symazide MR 30 mg is used to treat a certain type of diabetes (type 2 diabetes) in adults, when diet, exercise, and weight loss alone are not sufficient to control blood sugar levels.

2. Important information before taking Symazide MR 30 mg

When not to take Symazide MR 30 mg:

• if you are 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 hypoglycemic agents);
• 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 medicines used to treat fungal infections (miconazole, see section "Symazide MR 30 mg and other medicines");
• if you are breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting to take Symazide MR 30 mg, you should discuss it with your doctor. You should follow your doctor's advice about your treatment to achieve good control of your blood sugar levels. This means that, in addition to regular tablet intake, you should follow a diet, exercise, and, if necessary, lose weight. During treatment with gliclazide, it is necessary to regularly check your blood sugar levels (and, if necessary, in your urine) as well as your hemoglobin A1c levels. During the first few weeks of treatment, the risk of low blood sugar (hypoglycemia) may be increased. Therefore, close medical monitoring is necessary. Low blood sugar (hypoglycemia) may occur if:

• you take your meals irregularly or skip meals;
• you fast;
• you are undernourished;
• you change your diet;
• you increase your physical activity and your carbohydrate intake is not sufficient;
• you consume alcohol, especially if you skip meals;
• you take other medicines or herbal remedies at the same time;
• you take too high a dose of gliclazide;
• you have certain hormonal disorders (thyroid, pituitary, or adrenal disorders);
• your kidney or liver function is severely impaired.

If you experience low blood sugar, you may have the following symptoms: headache, strong hunger, nausea, vomiting, fatigue, sleep disturbances, anxiety, aggression, decreased concentration, decreased alertness and reaction time, depression, disorientation, speech or vision disturbances, tremors, sensory disturbances, dizziness, weakness. You may also experience the following symptoms: sweating, moist skin, anxiety, 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 drop, you may experience severe confusion (delirium), convulsions, loss of self-control, shallow breathing, slow heartbeat, and you may lose consciousness. In most cases, the symptoms of low blood sugar disappear very quickly after consuming sugar, e.g., glucose tablets, sugar cubes, sweet juice, or sweet tea. Therefore, you should always carry sugar products with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. You should contact your doctor or the nearest hospital if consuming sugar does not help or if the symptoms recur. The symptoms of low blood sugar may not occur, may not be noticed by you, or may 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-blockers). In stressful situations (e.g., accident, surgery, fever, etc.), your doctor may temporarily change your treatment to insulin therapy. High blood sugar symptoms (hyperglycemia) may occur if gliclazide does not sufficiently lower your blood sugar levels, if you do not follow your doctor's treatment plan, if you take products containing St. John's Wort (Hypericum perforatum) (see section "Symazide MR 30 mg and other medicines"), or in particularly stressful situations. Symptoms may include: thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and decreased activity. If you experience these symptoms, you must contact your doctor or pharmacist. When taking Symazide MR 30 mg with medicines belonging to the group of antibiotics called fluoroquinolones, especially in elderly patients, disturbances in blood sugar levels (low and high blood sugar) may occur. Your doctor will remind you how important it is to monitor your blood sugar levels. If you or a family member have been diagnosed with a deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a red blood cell disorder), you may experience a decrease in hemoglobin levels and breakdown of red blood cells (hemolytic anemia). You should contact 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

Symazide MR 30 mg is not recommended for use in children due to the lack of sufficient data.

Symazide MR 30 mg and other medicines

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

• other medicines used to treat high blood sugar (oral antidiabetic medicines, GLP-1 receptor agonists, or insulin);
• antibiotics (sulfonamides, clarithromycin);
• medicines used to treat high blood pressure or heart failure (beta-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);
• painkillers or anti-rheumatic medicines (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The following medicines may reduce the effect of gliclazide and lead to high blood sugar:

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

When taking Symazide MR 30 mg with medicines belonging to the group of antibiotics called fluoroquinolones, especially in elderly patients, disturbances in blood sugar levels (low and high blood sugar) may occur. Symazide MR 30 mg may enhance the effect of anticoagulant medicines (e.g., warfarin). You should consult your doctor before starting to take another medicine. If you are going to the hospital, you should inform the medical staff that you are taking Symazide MR 30 mg.

Symazide MR 30 mg with food, drink, and alcohol

Symazide MR 30 mg can be taken with food and non-alcoholic drinks. You should not consume alcohol as it may unpredictably affect your diabetes control.

Pregnancy and breastfeeding

Symazide MR 30 mg should not be used during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine. You should not take Symazide MR 30 mg during breastfeeding.

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. You should remember that you may pose a risk to yourself or others (e.g., while driving a car or operating machinery). You should ask your doctor about the possibility of driving:

• if you experience low blood sugar (hypoglycemia) frequently;
• if you experience few or no symptoms of low blood sugar (hypoglycemia).

Symazide MR 30 mg contains lactose

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

3. How to take Symazide MR 30 mg

Dose

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The dose is determined by your doctor, depending on your blood sugar levels. Changes in external factors (e.g., weight loss, lifestyle changes, stress) and improvement in blood sugar control may require a change in the dose of gliclazide. The recommended daily dose is from one tablet to four tablets (maximum 120 mg), taken once during breakfast. The number of tablets depends on your response to treatment. In combination therapy with Symazide MR 30 mg and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, the appropriate dose of each medicine will be individually determined by your doctor. If you notice that your blood sugar levels are high, even though you are taking the medicine as prescribed, you should consult your doctor or pharmacist.

Method and route of administration

Oral administration. The tablets should be swallowed whole. Do not chew or crush them. The tablet(s) should be taken with a glass of water during breakfast (preferably at the same time every day). After taking the tablet(s), you should always eat a meal.

Overdose of Symazide MR 30 mg

In case of overdose, you should immediately contact your doctor or go to the nearest hospital. The symptoms of overdose are the symptoms of low blood sugar (hypoglycemia) and are described in section 2. In such situations, eating sugar (4 to 6 sugar cubes) or drinking a sweet drink, followed by a snack or meal, may help. If you are unconscious, you should immediately contact your doctor and call for emergency assistance. The same applies if you accidentally take the medicine, e.g., a child. Unconscious patients should not be given food or drink. You should inform another person about your illness, who, if necessary, can call for medical help.

Missing a dose of Symazide MR 30 mg

It is important to take the medicine every day, as regular treatment works better. However, if you miss a dose of Symazide MR 30 mg, you should take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Symazide MR 30 mg

Treatment of diabetes usually lasts for the rest of your life, so you should consult your doctor before stopping treatment with this medicine. Stopping treatment may lead to high blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications. If you have any further questions about the use of this medicine, ask your doctor or pharmacist. If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

4. Possible side effects

Like all medicines, Symazide MR 30 mg can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycemia). The objective and subjective symptoms are described in the section "Warnings and precautions". If these symptoms are not treated, they may develop into drowsiness, loss of consciousness, or coma. If the decrease in blood sugar levels is severe or prolonged, even if it is temporarily controlled by sugar administration, you should immediately consult your doctor. Liver disorders Single cases of liver disorders have been observed, which may cause yellowing of the skin and eyes. If you experience these symptoms, you should immediately contact your doctor. The symptoms usually disappear after stopping the medicine. Your doctor will decide whether to stop treatment. Skin disorders Skin reactions have been observed, such as:

• rash,
• redness,
• itching,
• hives,
• blisters,
• angioedema (rapid swelling of tissues, such as eyelids, face, lips, mouth, tongue, or throat, which may cause breathing difficulties). The rash may develop into widespread skin lesions or lead to skin peeling. If you experience these symptoms, you should stop taking Symazide MR 30 mg and immediately contact your doctor and inform them that you are taking this medicine.
• Exceptionally, symptoms of severe hypersensitivity reactions (DRESS, Drug Rash with Eosinophilia and Systemic Symptoms) have been reported: initially with flu-like symptoms and a rash on the face, which then spread, and high fever.

Blood disorders Decrease in blood cell count (e.g., platelets, red and white blood cells), which may cause:

• pale skin,
• prolonged bleeding,
• bruises,
• sore throat,
• fever. These symptoms usually disappear after stopping treatment.

Gastrointestinal disorders

• abdominal pain,
• nausea,
• vomiting,
• indigestion,
• diarrhea,
• constipation. These symptoms can be reduced by taking Symazide MR 30 mg with food as recommended.

Eyes

Temporary vision disturbances may occur, especially at the beginning of treatment. These symptoms are related to changes in blood sugar levels. As with other sulfonylurea derivatives, the following adverse events have been observed: significant changes in blood cell count and allergic vasculitis, decreased sodium levels in the blood (hyponatremia), signs of liver damage (e.g., jaundice), which in most cases disappeared after stopping treatment with sulfonylurea derivatives but may lead to life-threatening liver failure in single cases.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, you should inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety 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. You can also report side effects 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 Symazide MR 30 mg

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month. There are no special storage precautions for this medicine. 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 Symazide MR 30 mg contains

• The active substance is gliclazide. One tablet contains 30 mg of gliclazide in the form of a modified-release tablet.
• The other ingredients are: lactose monohydrate, hypromellose, magnesium stearate.

What Symazide MR 30 mg looks like and contents of the pack

Symazide MR 30 mg is a white, oval, biconvex tablet with the inscription "GLI 30" on one side and smooth on the other. The tablets are available in blisters packaged in cardboard boxes, containing 30 or 60 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Farmak International Sp. z o.o., ul. Koszykowa 65, 00-667 Warsaw, tel.: +48 22 822 93 06, e-mail: [email protected]

Manufacturer/Importer

Farmak International Sp. z o.o., ul. Chełmżyńska 249, 04-458 Warsaw

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

Poland: Symazide MR 30 mg

Date of last revision of the package leaflet:May 2025