Gliclada

Patient Information Leaflet: User Information

Gliclada, 90 mg, Prolonged-Release Tablets

Gliclazide

Read the leaflet carefully before taking the medicine, as 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Pack:

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

1. What Gliclada is and what it is used for

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

2. Important information before taking Gliclada

When not to take Gliclada

• if you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), other medicines of the same group (sulfonylureas) or other derivatives (sulfonamides with a hypoglycemic effect);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (this may indicate that you have 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 "Gliclada and other medicines");
• if you are breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting to take Gliclada, discuss it with your doctor or pharmacist. You should follow the treatment plan as prescribed by your doctor to achieve the recommended blood sugar levels. This means that you should not only take the medicine regularly but also follow a diet and exercise regularly and, if necessary, reduce your weight. During treatment with gliclazide, it is necessary to regularly check your blood sugar levels (and possibly in urine) and also check your glycosylated hemoglobin (HbA1c). The risk of low blood sugar (hypoglycemia) may be increased during the first few weeks of treatment. Therefore, close medical monitoring is particularly 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 have low blood sugar, you may experience the following symptoms: headache, strong hunger, nausea, vomiting, fatigue, sleep disturbances, anxiety, aggression, reduced concentration, reduced alertness, and reaction time, depression, disorientation, speech or vision disturbances, tremors, sensation 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 decrease, 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 when you consume some sugar (e.g., glucose tablets, sugar cubes, sweet juice, sweetened tea). Therefore, you should always carry some 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 be mild, 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 taking certain medicines (e.g., those acting on the central nervous system and beta-adrenergic blockers). In stressful situations (e.g., accidents, 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 the treatment plan prescribed by your doctor, or if you consume products containing St. John's Wort (Hypericum perforatum) (see section "Gliclada and other medicines"). This may cause thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and decreased activity. If you experience these symptoms, you should contact your doctor or pharmacist. Blood sugar disorders (low and high blood sugar levels), especially in elderly patients, may occur when Gliclada is taken with antibiotics called fluoroquinolones. In such cases, your doctor will remind you of the importance of monitoring your blood sugar levels.

If you or a family member have been diagnosed with a hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormal red blood cells), you may experience a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia). You should contact your doctor before taking this medicine. Cases of acute porphyria have been reported during the use of other sulfonylureas in patients with porphyria (hereditary genetic disorders with an accumulation of porphyrins or porphyrin precursors in the body).

Children and adolescents

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

Gliclada 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 blood sugar-lowering effect of gliclazide may be enhanced, and low blood sugar symptoms may occur when taken with one of the following medicines:

• other medicines used to treat high blood sugar (oral antidiabetic medicines, GLP-1 receptor agonists, or insulin);
• antibiotics (e.g., 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 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 during childbirth (intravenously: salbutamol, rytodryna, terbutalina);
• medicines used to treat breast disorders, heavy menstrual bleeding, and endometriosis (danazol);
• St. John's Wort (Hypericum perforatum) preparations. Blood sugar disorders (low and high blood sugar levels), especially in elderly patients, may occur when Gliclada is taken with antibiotics called fluoroquinolones. Gliclada may enhance the effect of anticoagulant medicines (e.g., 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 Gliclada.

Gliclada with food, drink, and alcohol

Gliclada, prolonged-release tablets can be taken with food and non-alcoholic drinks. It is not recommended to drink alcohol, as it may affect your diabetes control in an unpredictable way.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Gliclada is not recommended during pregnancy. You should not take Gliclada if you are 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 and 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 the symptoms of low blood sugar (hypoglycemia) are very mild or absent.

Gliclada contains lactose

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

3. How to take Gliclada

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. Any changes related to external factors (e.g., weight reduction, lifestyle changes, stress) or improvement in blood sugar control may require a change in the dose of gliclazide. The recommended dose is 30 mg to 120 mg of gliclazide taken once daily at breakfast time. The dose depends on your body's response to the treatment. The tablets can be divided into three equal parts, allowing you to take the medicine in the following doses: 30 mg (take one-third of a tablet), 60 mg (take two-thirds of a tablet), 90 mg (take one whole tablet), and 120 mg (take one whole tablet and one-third of another tablet). The tablet can also be divided into three equal parts for easier swallowing. In combination therapy, Gliclada, prolonged-release tablets 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 high, even though you are taking the medicine as prescribed, you should contact your doctor or pharmacist.

Method and route of administration

Oral use To remove a tablet from the packaging:

• 1. Hold the blister by the edges and separate the part of the blister containing one tablet by tearing it off gently along the perforation.
• 2. Pull the edge of the foil and tear it off completely.
• 3. Shake the tablet onto your hand.

To divide the Gliclada 90 mg tablet: The tablet is marked with two dividing lines that allow it to be divided into three equal parts.

• 4. Divide the tablet manually along the dividing line. Hold the tablet between your thumb and index finger, close to the dividing line of the recommended dose, as shown in figure 4. Do not divide the tablet in any other way. Swallow the tablet or part(s) of the tablet whole with a glass of water at breakfast time (preferably at the same time every day). Do not chew or crush. You should always eat a meal after taking this medicine.

Taking a higher dose of Gliclada than recommended

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 symptoms of low blood sugar (hypoglycemia) and are described in section 2. In such cases, consuming sugar (4 to 6 sugar cubes) or 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. You should do the same if someone, e.g., a child, has taken this medicine by mistake. Unconscious patients should not be given food or drink. You should ensure that someone who can call a doctor in case of an emergency is always informed.

Missing a dose of Gliclada

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

Stopping treatment with Gliclada

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 (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, Gliclada can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycemia). The subjective and objective symptoms are described in the section "Warnings and precautions". If these symptoms are left untreated, they may lead to drowsiness, loss of consciousness, or coma. If the decrease in blood sugar levels is significant or prolonged, even if it is temporarily controlled by administering sugar, you should immediately contact your doctor. Gastrointestinal disordersAbdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These symptoms can be reduced by taking Gliclada, prolonged-release tablets with a meal as recommended. Blood disordersA decrease in the number of blood cells (e.g., platelets, red and white blood cells) may cause pallor, prolonged bleeding, bruising, throat pain, and fever. These symptoms usually disappear after stopping treatment. Skin disordersSkin reactions, such as rash, redness, itching, urticaria, blisters, and angioedema (rapid swelling of tissues, such as eyelids, face, lips, mouth, tongue, or throat, which may cause difficulty breathing), have been observed. The rash may develop into widespread blistering or lead to skin peeling. If you experience any of these symptoms, you should stop taking Gliclada and immediately consult your doctor. Exceptionally, symptoms of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a rash on the face that then spreads, with high fever. Liver disordersIsolated cases of impaired liver function 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 treatment. Your doctor will decide whether to stop treatment. Eye disordersTransient vision disturbances may occur, especially at the beginning of treatment. This effect is related to changes in blood sugar levels. As with other sulfonylureas, cases of significant changes in blood cell counts and allergic vasculitis, low sodium levels in the blood (hyponatremia), signs of liver damage (e.g., jaundice), which in most cases disappeared after stopping sulfonylureas, have been reported, but in isolated cases, they may lead to life-threatening liver failure.

Reporting side effects

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

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

• The active substance is gliclazide. Each prolonged-release tablet contains 90 mg of gliclazide.
• The other ingredients are: hypromellose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate. See section 2 "Gliclada contains lactose".

What Gliclada looks like and contents of the pack

Gliclada is available in the form of white to almost white, biconvex tablets with two dividing lines. The tablet can be divided into equal doses. The dimensions of the tablet are: length 17.0-17.5 mm and thickness 4.6 mm - 5.4 mm. Gliclada is available in packs of: 10 x 1, 20 x 1, 30 x 1, 60 x 1, or 90 x 1 prolonged-release tablets in perforated unit dose blisters, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia, TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

02-235 Warsaw, Tel. 22 57 37 500, Date of last revision of the leaflet:12.02.2021