Gliclada

Leaflet attached to the packaging: patient information

Gliclada, 30 mg, prolonged-release tablets

Gliclazide

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

• Keep this leaflet, you may need to read it again.
• In case of any further doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Gliclada and what is it 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 is Gliclada and what is it 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 specific type of diabetes (type 2 diabetes) in adults, when diet, exercise, and weight loss alone are not enough 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) or other medicines from the same group (sulfonylureas), other derivatives (sulfonamides with a hypoglycemic effect),
• if you have insulin-dependent diabetes (type 1),
• in the presence of ketone bodies and glucose in the urine (diabetic ketoacidosis), pre-coma, or diabetic coma,
• if you have severe kidney or liver failure,
• when taking antifungal medicines (miconazole, see section "Gliclada and other medicines"),
• during breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before taking Gliclada, inform your doctor or pharmacist. Follow your doctor's recommendations for treatment to achieve proper blood sugar levels. This means that, in addition to taking the tablets regularly, you should follow a diet, exercise, and, if necessary, lose weight. During gliclazide treatment, regular monitoring of blood sugar levels (and possibly urine) and glycated hemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of low blood sugar (hypoglycemia) may be higher. Therefore, close medical monitoring is particularly necessary. Low blood sugar (hypoglycemia) may occur in case of:

• irregular meals or skipping meals,
• fasting,
• malnutrition,
• changes in diet,
• increased physical activity without increasing carbohydrate intake,
• consumption of alcohol, especially with skipping meals,
• concomitant use of other medicines or herbal preparations,
• high doses of gliclazide,
• hormonal disorders (thyroid, pituitary, or adrenal disorders),
• significant impairment of kidney or liver function.

Symptoms of low blood sugar may include: headache, strong hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, anxiety, aggression, impaired concentration, reduced alertness, prolonged reaction time, depression, disorientation, speech and vision disorders, tremors, sensory disturbances, dizziness, and helplessness. Additional symptoms may include: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain that may radiate (angina pectoris). If blood sugar levels continue to decrease, severe confusion (delirium), seizures, loss of self-control, shallow breathing, slow heart rate, or loss of consciousness may occur. In most cases, symptoms of low blood sugar disappear quickly when the patient consumes some sugar, e.g., glucose tablets, sugar cubes, or sweet drinks. Therefore, it is essential to always carry some sugar products (glucose tablets, sugar cubes). Note that artificial sweeteners are not effective. If sugar consumption does not help or if symptoms recur, contact a doctor or the nearest hospital. Symptoms of low blood sugar may not occur, may be mild, or may develop slowly, or the patient may not be aware that 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 and beta-adrenergic blockers). In stressful situations (e.g., accidents, surgery, fever, etc.), the doctor may temporarily change the treatment to insulin therapy. Symptoms of high blood sugar (hyperglycemia) may occur when gliclazide has not yet sufficiently lowered blood sugar levels, if the patient has not followed the treatment plan recommended by the doctor, or if the patient is taking St. John's Wort (Hypericum perforatum) (see section "Gliclada and other medicines"). This may include thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and decreased activity. If these symptoms occur, the patient should contact a doctor or pharmacist. Blood sugar disorders (low and high blood sugar levels), especially in elderly patients, may occur when gliclazide is taken with antibiotics called fluoroquinolones. In such cases, the doctor will remind the patient of the importance of monitoring blood sugar levels. If these symptoms occur, the patient should contact a doctor or pharmacist. If a patient or a family member has been diagnosed with a congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormal red blood cells), a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia) may occur. Before taking this medicine, consult a doctor.

Children and adolescents

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

Gliclada and other medicines

Tell your doctor about all 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 (symptoms of low blood sugar may occur) when taken with any 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-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 relievers or anti-rheumatic medicines (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The blood sugar-increasing effect of gliclazide may be enhanced (symptoms of hyperglycemia may occur) when taken with any of the following medicines:

• medicines used to treat central nervous system disorders (chlorpromazine);
• anti-inflammatory medicines (corticosteroids);
• medicines used to treat asthma or given during childbirth (intravenously: salbutamol, rytodryna, terbutalina);
• medicines used to treat breast diseases, 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). Before taking other medicines, consult a doctor. In case of hospitalization, inform the medical staff about taking Gliclada.

Gliclada with food, drinks, and alcohol

Gliclada can be taken with food and non-alcoholic drinks. Avoid consuming alcohol, as it may disrupt diabetes control in an unpredictable way and lead to coma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant while taking this medicine, inform your doctor, who may recommend more suitable treatment. Gliclada is not recommended during pregnancy. Do not take Gliclada while breastfeeding.

Driving and using machines

Ability to concentrate or react may be impaired in case of hypoglycemia or hyperglycemia, or due to resulting vision problems. Be aware of the risk of injuring yourself or others (e.g., while driving a car or operating a machine). Ask your doctor about the possibility of driving:

• if low blood sugar (hypoglycemia) occurs frequently;
• if symptoms of low blood sugar (hypoglycemia) are very mild or absent.

Gliclada contains lactose.

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the 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 doctor will determine the dose of Gliclada based on blood sugar and urine levels. Changes in external factors (e.g., weight loss, lifestyle changes, stress) or improvement in blood sugar control may require a change in the gliclazide dose. The recommended initial dose is one tablet per day. The dose usually ranges from one to a maximum of four tablets per day, taken in a single dose during breakfast. The dose depends on the body's response to treatment. If treatment with Gliclada 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 individually determine the dose of each medicine. If you notice that your blood sugar levels are high, even though you are taking the medicine as prescribed, consult your doctor or pharmacist.

Method of administration

Oral administration. Swallow the tablets whole. Do not chew the tablets. Take the tablet(s) with a glass of water, during breakfast, preferably at the same time every day. Always eat a meal after taking the tablet(s).

Taking a higher dose of Gliclada than recommended

In case of taking too many tablets, immediately contact a doctor or go to the nearest hospital. The symptoms of overdose are the symptoms of low blood sugar (hypoglycemia) 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, immediately inform a doctor and call emergency services. In case of accidental ingestion, e.g., by a child, follow the same procedure. Do not give food or drinks to unconscious patients. Ensure that the person who will inform the doctor in case of an emergency is aware of the diabetes treatment.

Missing a dose of Gliclada

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

Stopping Gliclada treatment

Since diabetes treatment usually lasts a lifetime, consult your doctor before stopping this medicine. Stopping treatment may lead to increased blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications. If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Gliclada can cause side effects, although not everybody gets them. The assessment of side effects is based on their frequency:

The most commonly observed side effect is low blood sugar (hypoglycemia). Objective and subjective symptoms are described in the "Warnings and precautions" section. If these symptoms are left untreated, they may lead to drowsiness, loss of consciousness, or coma. If the decrease in blood sugar is significant or prolonged, even if temporarily controlled by sugar administration, seek medical attention immediately. Gastrointestinal disordersAbdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These symptoms can be reduced by taking Gliclada with a meal, as recommended. Blood disordersDecreased blood cell count (e.g., platelets, red and white blood cells) may cause pallor, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually disappear after stopping treatment. Skin disordersSkin reactions, such as rash, redness, itching, urticaria, angioedema (rapid swelling of tissues, such as eyelids, face, lips, mouth, tongue, or throat, which may cause breathing difficulties), have been observed. The rash may develop into widespread blistering or lead to skin peeling. Exceptionally, symptoms of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a rash on the face that then spreads, accompanied by a high temperature. Liver disordersIsolated cases of impaired liver function have been observed, which may cause yellowing of the skin and eyes. If these symptoms occur, immediately contact a doctor. The symptoms usually disappear after stopping the medicine. The doctor will decide whether to discontinue treatment. Eye disordersTemporary 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 count and allergic vasculitis, decreased sodium levels in the blood (hyponatremia), liver damage symptoms (e.g., jaundice), which in most cases disappeared after discontinuing sulfonylureas, have been observed. However, 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 the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported 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 the medicine out of the sight and reach of children. Do not take Gliclada after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month. The batch number is stated on the packaging after "Lot". 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 30 mg of gliclazide.
• The other ingredients are: hypromellose, calcium carbonate, colloidal anhydrous silica, lactose monohydrate, magnesium stearate (see section 2).

What Gliclada looks like and contents of the pack

Prolonged-release tablets, white, oval, and biconvex. Packaging:30, 60, and 90 or 120 prolonged-release tablets in blisters, in a carton.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia For more detailed information on the names of medicinal products in other EU member states, contact the local representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Tel. 22 57 37 500

Date of last revision of the leaflet:

• 28.07.2017