SYMAZIDE 60 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Symazide MR 60 mg, 60 mg, modified-release tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
3. What Symazide MR 60 mg is and what it is used for
4. Before you take Symazide MR 60 mg
   1. Do not take Symazide MR 60 mg:
   2. Warnings and precautions
   3. Children and adolescents
   4. Symazide MR 60 mg with other medicines
   5. Symazide MR 60 mg with food, drink, and alcohol
   6. Pregnancy and breast-feeding
   7. Driving and using machines
   8. Symazide MR 60 mg contains lactose
5. How to take Symazide MR 60 mg
   1. Dose
   2. Method and route of administration
   3. Overdose
   4. Missed dose
   5. Stopping treatment
6. Possible side effects
7. How to store Symazide MR 60 mg
8. Contents of the pack and other information
   1. What Symazide MR 60 mg contains
   2. What Symazide MR 60 mg looks like and contents of the pack
   3. Marketing authorisation holder
   4. Manufacturer/Importer
   5. This medicine is authorised in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Symazide MR 60 mg, 60 mg, modified-release tablets

Gliclazide

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Symazide MR 60 mg is and what it is used for
• 2. Before you take Symazide MR 60 mg
• 3. How to take Symazide MR 60 mg
• 4. Possible side effects
• 5. How to store Symazide MR 60 mg
• 6. Contents of the pack and other information

1. What Symazide MR 60 mg is and what it is used for

Symazide MR 60 mg is a medicine that lowers blood sugar levels (an oral antidiabetic medicine belonging to the sulfonylurea group). Symazide MR 60 mg is used to treat a certain type of diabetes (type 2 diabetes) in adults, when diet, exercise, and weight loss alone have not been able to control blood sugar levels.

2. Before you take Symazide MR 60 mg

Do not take Symazide MR 60 mg:

• if you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), or to other sulfonylureas or to sulphonamides (a type of antibiotic);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a pre-coma or coma;
• if you have severe kidney or liver disease;
• if you are taking medicines to treat fungal infections (miconazole, see section "Symazide MR 60 mg with other medicines");
• if you are breast-feeding (see section "Pregnancy and breast-feeding").

Warnings and precautions

Before taking Symazide MR 60 mg, talk to your doctor. You should follow the diet and exercise plan agreed with your doctor. This will help you get the most from your treatment and reduce the risk of hypoglycaemia (low blood sugar levels). During treatment with gliclazide, regular monitoring of blood sugar levels and, if necessary, glycosylated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of hypoglycaemia may be increased. For this reason, close medical monitoring is necessary. Hypoglycaemia (low blood sugar) can occur if:

• you take your meals irregularly or skip meals;
• you fast;
• you are undernourished;
• you change your diet;
• you increase your physical activity without taking extra carbohydrates;
• you drink alcohol, especially if you skip meals;
• you take other medicines or herbal products at the same time;
• you take too high a dose of gliclazide;
• you have certain hormonal disorders (e.g. thyroid, pituitary or adrenal disorders);
• your kidney or liver function is severely impaired.

If you experience low blood sugar, the following symptoms may occur: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, nervousness, aggression, reduced concentration, reduced alertness and reaction time, depression, disorientation, speech and vision disturbances, tremor, sensory disturbances, dizziness, weakness. You may also experience sweating, a cold and damp skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden and severe chest pain that may radiate to adjacent areas (angina pectoris). If your blood sugar levels continue to fall, you may experience severe confusion (disorientation), convulsions, loss of consciousness, shallow breathing, slow heartbeat. In most cases, the symptoms of low blood sugar disappear quickly when you consume sugar (e.g. glucose tablets, sugar cubes, sweet juice or sweetened tea). Therefore, you should always carry sugar products with you (e.g. glucose tablets, sugar cubes). Note that artificial sweeteners are not effective. If consumption of sugar does not help or if the symptoms return, you should contact a doctor or the nearest hospital. 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 decreased. This can happen if you are elderly and are taking certain medicines (e.g. those acting on the central nervous system and beta-blockers). In stressful situations (e.g. accident, surgery, fever), your doctor may temporarily change your treatment to insulin therapy. High blood sugar levels (hyperglycaemia) can occur if gliclazide does not sufficiently lower your blood sugar levels, if you do not follow the treatment plan recommended by your doctor, if you take products containing St. John's Wort (Hypericum perforatum) (see section "Symazide MR 60 mg with other medicines"), or in stressful situations. The symptoms may be: thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and decreased activity. If you experience these symptoms, you should contact your doctor or pharmacist. When taking gliclazide with fluoroquinolone antibiotics, especially in elderly patients, disturbances in blood sugar levels (low and high blood sugar levels) may occur. Your doctor will remind you of the importance of monitoring your blood sugar levels. If in the past you or a member of your family have been diagnosed with a deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormal red blood cells), a decrease in haemoglobin and breakdown of red blood cells (haemolytic anaemia) may occur. Before taking this medicine, you should consult your doctor. In patients with porphyria (a genetic disorder characterized by the accumulation of porphyrins or their precursors in the body), cases of worsening porphyria have been reported after taking certain sulfonylurea medicines.

Children and adolescents

Symazide MR 60 mg is not recommended for use in children due to a lack of sufficient data.

Symazide MR 60 mg with 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 increase the blood sugar-lowering effect of gliclazide and cause low blood sugar levels:

• other medicines used to treat high blood sugar levels (oral antidiabetic medicines, GLP-1 receptor agonists, or insulin);
• antibiotics (sulphonamides, 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);
• analgesic or anti-rheumatic medicines (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The following medicines may reduce the blood sugar-lowering effect of gliclazide and cause high blood sugar levels:

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

When taking Symazide MR 60 mg with fluoroquinolone antibiotics, especially in elderly patients, disturbances in blood sugar levels (low and high blood sugar levels) may occur. Symazide MR 60 mg may increase the effect of anticoagulant medicines (warfarin). You should consult your doctor before taking any other medicine. If you are going to the hospital, you should inform the medical staff that you are taking Symazide MR 60 mg.

Symazide MR 60 mg with food, drink, and alcohol

Symazide MR 60 mg can be taken with food and non-alcoholic drinks. You should not drink alcohol as it may affect your ability to control your diabetes in an unpredictable way.

Pregnancy and breast-feeding

Symazide MR 60 mg should not be taken during pregnancy. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor before taking this medicine. You should not take Symazide MR 60 mg while breast-feeding.

Driving and using machines

If your blood sugar levels are too low (hypoglycaemia) or too high (hyperglycaemia), or if you experience vision disturbances as a result of abnormal blood sugar levels, your ability to concentrate and react may be impaired. You should remember that you may pose a risk to yourself and others (e.g. when driving a car or operating machinery). You should ask your doctor whether you can drive a vehicle:

• if you experience hypoglycaemia frequently;
• if you experience little or no warning signs of hypoglycaemia.

Symazide MR 60 mg contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Symazide MR 60 mg

Dose

Always take this medicine exactly as your doctor or pharmacist 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, change in lifestyle, stress) or improvement in blood sugar control may require a change in the dose of gliclazide. The recommended daily dose is from half a tablet to two tablets (maximum 120 mg), taken once daily at breakfast time. The number of tablets depends on your response to treatment. When taking Symazide MR 60 mg in combination with 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 too high, even though you are taking your medicine as prescribed, you should consult your doctor or pharmacist.

Method and route of administration

Oral use. You should swallow the tablet(s) without crushing or chewing. The tablet can be divided into equal doses. You should take the tablet(s) with a glass of water at breakfast time (preferably at the same time every day). After taking the tablet(s), you should always eat a meal.

Overdose

If you have taken too many tablets, you should immediately contact your doctor or go to the nearest hospital. The symptoms of overdose are the same as those of hypoglycaemia (low blood sugar levels) 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 a 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.

Missed dose

It is important to take your medicine every day, as regular treatment works better. However, if you miss a dose of Symazide MR 60 mg, you should take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment

Since diabetes treatment usually lasts for the rest of your life, you should consult your doctor before stopping treatment with this medicine. Stopping treatment may cause high blood sugar levels (hyperglycaemia), 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 leaflet. See section 4.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most frequently observed side effect is low blood sugar levels (hypoglycaemia). The symptoms of low blood sugar levels are described in 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 taking sugar, you should immediately consult your doctor. Liver disorders Single cases of liver disorders have been observed, which can cause yellowing of the skin and eyes. If you experience these symptoms, you should immediately contact your doctor. The symptoms usually disappear after stopping treatment with this 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 can cause difficulty breathing). The rash may develop into widespread blistering or peeling of the skin. If you experience these symptoms, you should stop taking Symazide MR 60 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 a high temperature.

Blood disorders Decrease in the number of blood cells (e.g. platelets, red and white blood cells), which can cause:

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

Gastrointestinal disorders

• abdominal pain,
• nausea,
• vomiting,
• indigestion,
• diarrhoea,
• constipation. These symptoms can be reduced by taking Symazide MR 60 mg with a meal as recommended.

Eye disorders Transient disturbances in vision may occur, especially at the beginning of treatment. These symptoms are related to changes in blood sugar levels. As with other sulfonylureas, the following adverse events have been reported: significant changes in blood cell counts and allergic vasculitis, decreased sodium levels in the blood (hyponatraemia), signs of liver damage (e.g. jaundice), which in most cases disappeared after stopping treatment with sulfonylureas, but in single cases may lead to life-threatening liver failure. Reporting of side effects If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Pharmacovigilance Department, 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 authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Symazide MR 60 mg

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. There are no special storage conditions 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Symazide MR 60 mg contains

• The active substance is gliclazide. One tablet contains 60 mg of gliclazide in the form of a modified-release tablet.
• The other ingredients are: lactose monohydrate, hypromellose, magnesium stearate.

What Symazide MR 60 mg looks like and contents of the pack

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

Marketing authorisation 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 authorised in the Member States of the European Economic Area under the following names:

Poland: Symazide MR 60 mg Date of last revision of the leaflet:May 2025