GLICLAZIDE 60 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Gliclazide Zentiva
3. 60 mg, modified-release tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Gliclazide Zentiva and what is it used for
5. Important information before taking Gliclazide Zentiva
   1. When not to take Gliclazide Zentiva:
   2. Warnings and precautions
   3. Children and adolescents
   4. Gliclazide Zentiva and other medicines
   5. Gliclazide Zentiva with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Gliclazide Zentiva contains lactose
6. How to take Gliclazide Zentiva
   1. Dosage
   2. Route and method of administration
   3. Taking a higher dose of Gliclazide Zentiva than recommended
   4. Missing a dose of Gliclazide Zentiva
   5. Stopping treatment with Gliclazide Zentiva
7. Possible side effects
8. How to store Gliclazide Zentiva
9. Contents of the packaging and other information
   1. What Gliclazide Zentiva contains
   2. What Gliclazide Zentiva looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. For further information, the patient should contact their local representative of the marketing authorization holder:

Leaflet accompanying the packaging: patient information

Gliclazide Zentiva

60 mg, modified-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 as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Gliclazide Zentiva is a medicine that reduces blood sugar levels (it is an oral antidiabetic medicine belonging to the sulfonylurea group). Gliclazide Zentiva is used to treat a certain form of diabetes (type 2 diabetes) in adults, when diet, physical exercise, and weight loss alone are not sufficient to maintain normal blood sugar levels.

2. Important information before taking Gliclazide Zentiva

When not to take Gliclazide Zentiva:

• if the patient is allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), other medicines from the same group (sulfonylureas), or other derivatives (sulfonamides with a hypoglycemic effect);
• 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 medicines used to treat fungal infections (miconazole, see section "Gliclazide Zentiva and other medicines");
• if the patient is breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting to take Gliclazide Zentiva, the patient should discuss it with their doctor. The patient should follow the doctor's recommendations for treatment to achieve proper blood sugar control. This means that, in addition to taking the tablets regularly, the patient should follow a regular diet (including carbohydrates) and exercise, and, if necessary, lose weight. During treatment with gliclazide, it is necessary to regularly check blood sugar levels (and, if necessary, urine sugar levels) and hemoglobin A1c levels. The risk of low blood sugar (hypoglycemia) may be increased during the first few weeks of treatment. Therefore, close medical monitoring is particularly important. Low blood sugar (hypoglycemia) may occur if:

• the patient takes meals irregularly or skips meals;
• the patient does not eat;
• the patient is malnourished;
• the patient changes their diet;
• the patient increases physical activity, and carbohydrate intake is not sufficient;
• the patient consumes alcohol; especially dangerous when skipping meals;
• the patient takes other medicines or herbal products at the same time;
• the patient takes too high a dose of gliclazide;
• the patient has certain hormonal disorders (thyroid, pituitary, or adrenal disorders);
• the patient's kidney or liver function is severely impaired.

If the patient has low blood sugar, the following symptoms may occur: headache, strong hunger, nausea, vomiting, fatigue, sleep disturbances, anxiety, aggression, impaired concentration, reduced alertness, and prolonged reaction time, depression, disorientation, speech or vision disorders, tremors, sensory disturbances, dizziness, weakness. The following symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain that may radiate to nearby areas of the body (angina pectoris). If blood sugar levels continue to decrease, significant confusion (delirium), convulsions, loss of self-control, shallow breathing, slow heartbeat, or loss of consciousness may occur. In most cases, the symptoms of low blood sugar disappear quickly when the patient consumes some sugar, e.g., glucose tablets, sugar cubes, or a sweet drink. Therefore, the patient should always carry sugar products with them (glucose tablets, sugar cubes). It should be remembered that artificial sweeteners are not effective. The patient should contact their doctor or go to the nearest hospital if consuming sugar does not help or if the symptoms recur. The symptoms of low blood sugar may not occur, may be mild, or may develop very slowly, or the patient may not be aware that their blood sugar levels have decreased. This can happen when the patient is elderly and taking certain medicines (e.g., those acting on the central nervous system or beta-adrenolytics). In stressful situations (e.g., accidents, surgery, fever, etc.), the doctor may temporarily change the treatment to insulin therapy. High blood sugar symptoms (hyperglycemia) may occur when gliclazide has not yet sufficiently reduced blood sugar levels, if the patient does not follow the treatment plan recommended by the doctor, if the patient takes products containing St. John's Wort (Hypericum perforatum) (see section "Gliclazide Zentiva and other medicines"), or in particularly stressful situations. The following symptoms may occur: thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and decreased activity. If these symptoms occur, the patient must contact their doctor or pharmacist. When taking gliclazide with fluoroquinolone antibiotics, especially in elderly patients, disturbances in blood sugar levels (low and high blood sugar) may occur. In this case, the doctor will remind the patient how important it is to monitor blood sugar levels. If there is a history of glucose-6-phosphate dehydrogenase deficiency (abnormal red blood cells) in the patient's family or in the patient, a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia) may occur. 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 other sulfonylurea derivatives. Before starting to take Gliclazide Zentiva, the patient should discuss it with their doctor or pharmacist.

Children and adolescents

Gliclazide Zentiva is not recommended for use in children and adolescents due to a lack of data.

Gliclazide Zentiva 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 blood sugar-lowering effect of gliclazide may be enhanced, and low blood sugar symptoms may occur when taking one of the following medicines:

• 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-adrenolytics, 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 blockers);
• medicines used to treat depression (MAO inhibitors);
• pain or anti-rheumatic medicines (phenylbutazone, ibuprofen);
• medicines containing alcohol.

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

• medicines used to treat central nervous system disorders (chlorpromazine);
• anti-inflammatory medicines (corticosteroids);
• medicines used to treat asthma or given during childbirth (intravenous 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 Gliclazide Zentiva with fluoroquinolone antibiotics, disturbances in blood sugar levels (low and high blood sugar) may occur, especially in elderly patients. Gliclazide Zentiva may increase the effect of anticoagulant medicines (e.g., warfarin). The patient should consult their doctor before starting to take another medicinal product. If the patient is going to the hospital, they should inform the medical staff that they are taking Gliclazide Zentiva.

Gliclazide Zentiva with food, drink, and alcohol

Gliclazide Zentiva can be taken with food and non-alcoholic beverages. It is not recommended to drink alcohol, as it may affect blood sugar 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 Zentiva is not recommended during pregnancy. If the patient plans to become pregnant or is pregnant, they should inform their doctor, who may recommend more suitable treatment. Gliclazide Zentiva should not be taken 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 ability to concentrate or react may be impaired. The patient should remember that they may pose a risk to themselves or others (e.g., when driving a car or operating machines). The patient should ask their doctor about the possibility of driving:

• if low blood sugar (hypoglycemia) occurs frequently;
• if the symptoms of low blood sugar (hypoglycemia) are mild or do not occur at all.

Gliclazide Zentiva contains lactose

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

3. How to take Gliclazide Zentiva

Dosage

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The dose is determined by the doctor, depending on blood sugar levels. Any changes related to external factors (e.g., weight loss, lifestyle changes, stress) or improved blood sugar control may require a change in the gliclazide dosage. The recommended daily dose is from half to two tablets (maximum 120 mg), taken once during breakfast. The dose depends on the body's response to treatment. In combination therapy with Gliclazide Zentiva 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 the doctor. If the patient notices that their blood sugar levels are high, despite taking the medicine as prescribed, they should consult their doctor or pharmacist.

Route and method of administration

Oral administration. The patient should swallow half a tablet or one (or more) tablets at once. They should 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). The patient should always eat a meal after taking the tablet(s). The tablet can be divided into equal doses.

Taking a higher dose of Gliclazide Zentiva than recommended

In case of taking too many tablets, the patient should immediately contact their 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 the patient is unconscious, they should immediately inform their doctor and call emergency services. The same applies if someone, e.g., a child, has taken the medicine by mistake. Unconscious patients should not be given food or drink. The patient should make sure that, in case of an emergency, someone will always be able to call their doctor.

Missing a dose of Gliclazide Zentiva

It is essential to take the medicine every day, as regular treatment works better. However, if the patient forgets to take a dose of Gliclazide Zentiva, they should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Gliclazide Zentiva

Since diabetes treatment usually lasts a lifetime, the patient should consult their doctor before stopping the treatment. Stopping the treatment may cause high blood sugar levels (hyperglycemia), which increases the risk of 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 Zentiva can cause side effects, although not everybody gets them. The most frequently observed symptom is low blood sugar (hypoglycemia). The objective and subjective symptoms are described in the "Warnings and precautions" section in point 2. "Important information before taking Gliclazide Zentiva". If these symptoms are left untreated, they may cause drowsiness, loss of consciousness, or coma. If the occurring decrease in blood sugar levels is significant or prolonged, even if it is temporarily controlled by sugar administration, the patient should immediately consult their doctor. Blood disorders have been reported, including a decrease in the number of blood cells (e.g., platelets, red and white blood cells), which may cause:

• pallor;
• prolonged bleeding;
• bruises;
• sore throat;
• fever. These symptoms usually disappear after stopping the treatment.

Liver disorders have been observed, including single cases of liver function disorders, which may cause yellowing of the skin and eyes. If these symptoms occur, the patient should immediately contact their doctor. The symptoms usually disappear after stopping the medicine. The doctor will decide when to stop the treatment. Skin disorders have been observed, including:

• 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 the patient experiences these symptoms, they should stop taking Gliclazide Zentiva and immediately contact their doctor and inform them about taking this medicine.
• rarely, symptoms of severe hypersensitivity reactions (Drug Rash with Eosinophilia and Systemic Symptoms, DRESS) have been reported: initially as flu-like symptoms and a rash on the face, and then a rash covering larger areas of the body with a high temperature.

Gastrointestinal disorders

• abdominal pain or discomfort;
• nausea or vomiting;
• indigestion;
• diarrhea;
• constipation. These symptoms can be reduced by taking Gliclazide Zentiva with a meal, as recommended. See section 3. "How to take Gliclazide Zentiva".

Eyes disorders

• vision disturbances, especially at the beginning of treatment. This side effect is related to changes in blood sugar levels.

As with other sulfonylurea derivatives, the following adverse events have been reported: cases of significant changes in blood cell counts and allergic vasculitis, decreased sodium levels in the blood (hyponatremia), symptoms of liver function disorders (e.g., jaundice), which in most cases disappeared after stopping the sulfonylurea derivatives, but in single 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 inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +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 or its representative in Poland. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Gliclazide Zentiva

The medicine should be stored out of 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 the month. Store in a temperature below 25°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Gliclazide Zentiva contains

• The active substance of the medicine is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
• The other ingredients are: lactose monohydrate, hypromellose 4000, hypromellose 100, magnesium stearate.

What Gliclazide Zentiva looks like and contents of the pack

White, biconvex, oval tablets with a break line and the symbols "GLI" and "60" on either side of the break line, 15.0 mm x 7.0 mm in size. The tablet can be divided into equal doses. The tablets are available in blisters packaged in cardboard boxes of 30 or 90 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s., U kabelovny 130, Dolní Mĕcholupy, 102 37 Prague 10, Czech Republic

Manufacturer/Importer

S.C. Zentiva S.A., B-dul Theodor Pallady nr. 50, sector 3, 032266 Bucharest, Romania

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

Bulgaria Гликлазид Зентива, France, Latvia, Poland, Italy Gliclazide Zentiva, Portugal Gliclazida Zentiva

For further information, the patient should contact their local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, tel: +48 22 375 92 00

Date of last revision of the leaflet:January 2022