CLAZICON 30 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Clazicon, 30 mg, modified-release tablets
3. Clazicon, 60 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
4. What is Clazicon and what is it used for
5. Important information before taking Clazicon
   1. When not to take Clazicon:
   2. Warnings and precautions
   3. Children and adolescents
   4. Clazicon and other medicines
   5. Clazicon with food, drinks, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Clazicon contains lactose
6. How to take Clazicon
   1. Dose
   2. Taking a higher dose of Clazicon than recommended
   3. Missing a dose of Clazicon
   4. Stopping treatment with Clazicon
7. Possible side effects
   1. Reporting side effects
8. How to store Clazicon
9. Contents of the pack and other information
   1. What Clazicon contains:
   2. What Clazicon looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet: March 2022

Package Leaflet: Information for the Patient

Clazicon, 30 mg, modified-release tablets

Clazicon, 60 mg, modified-release tablets

Gliclazide

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

• 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.

Table of Contents of the Package Leaflet

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

1. What is Clazicon and what is it used for

Clazicon is a medicine that reduces blood sugar levels (an oral antidiabetic medicine, belonging to the sulfonylurea group). Clazicon is used in adults with a certain type of diabetes (type 2 diabetes), in whom diet, exercise, and weight loss alone are not enough to control blood sugar levels.

2. Important information before taking Clazicon

When not to take Clazicon:

• 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 (sulfonamides that lower blood sugar levels)),
• if you have insulin-dependent diabetes (type 1),
• if you have ketone bodies and sugar in your urine (which may indicate that you have diabetic ketoacidosis), pre-coma, or diabetic coma,
• if you have severe kidney or liver disease,
• if you are taking any medicines for fungal infections (miconazole, see "Clazicon and other medicines"),
• if you are breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions

Before starting to take Clazicon, discuss it with your doctor or pharmacist. You should follow the treatment plan prescribed by your doctor to maintain proper blood sugar levels. This means, in addition to regular medication, following a diet, exercising, and, if necessary, losing weight. During treatment with gliclazide, you should regularly check your blood sugar levels (and, if necessary, your urine sugar levels) and, if necessary, your glycosylated hemoglobin (HbA1c) levels. For the first few weeks of treatment, the risk of significantly lowering blood sugar levels (hypoglycemia) may be increased. Therefore, close medical supervision is necessary. Low blood sugar levels (hypoglycemia) may occur:

• if you eat irregular meals or skip some of them;
• if you fast;
• if you are undernourished;
• in case of a change in diet;
• in case of increased physical exertion, when the amount of carbohydrates consumed does not meet the increased demand;
• if you consume alcohol, especially if you skip meals
• in case of concomitant use of other medicines, including herbal products;
• if you take too high a dose of gliclazide;
• if you have hormone-dependent diseases (such as thyroid, pituitary, or adrenal disorders);
• if your kidney or liver function is significantly reduced; If you have low blood sugar levels, you may experience the following symptoms: headache, feeling of hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, concentration disorders, decreased alertness, and prolonged reaction time to stimuli, depression, confusion, speech or vision disorders, tremors, sensation disorders, dizziness, and helplessness. You may also experience the following symptoms: sweating, moist skin, anxiety, irregular or rapid heartbeat, high blood pressure, sudden chest pain that may radiate to adjacent parts of the body (angina pectoris). If your blood sugar levels continue to decrease, you may experience confusion (delirium), seizures, loss of self-control, shallow breathing, and slow heartbeat, and you may lose consciousness. In most cases, the symptoms of low blood sugar levels disappear quickly after consuming sugar in the form of glucose tablets, sugar cubes, sweet juice, or sweet tea. Therefore, you should always carry some form of sugar with you (glucose tablets or sugar cubes). Remember that sweeteners do not have the same effect as sugar. If the symptoms do not disappear or recur after consuming sugar, you should contact your doctor or go to the emergency department of the nearest hospital. Some people may not feel the symptoms of low blood sugar levels or may not notice them, and the symptoms may develop very slowly, so you may not realize that your blood sugar levels have dropped. This can happen especially in elderly patients taking certain medications (e.g., those affecting the central nervous system and beta-blockers). If you experience a stressful situation (accident, surgery, fever), your doctor may decide to change your treatment to temporary insulin therapy. Symptoms of high blood sugar levels (hyperglycemia) may occur if gliclazide does not lower your blood sugar levels sufficiently, if you do not follow the treatment plan prescribed by your doctor, if you take preparations containing St. John's wort (Hypericum perforatum) (see "Clazicon and other medicines"), or in stressful situations. These include: thirst, increased urination, dry mouth, dry, itchy skin, skin infections, and decreased activity. If you experience these symptoms, you should consult your doctor or pharmacist.

In case of concomitant use of Clazicon with antibiotics belonging to the group of fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (low and high blood sugar levels) may occur. In this case, your doctor will remind you how important it is to monitor your blood glucose levels. If you or your family members have or have had a deficiency of glucose-6-phosphate dehydrogenase (G6PD) in the past (a disorder affecting red blood cells), a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia) may occur. Before taking gliclazide, you should consult your doctor. In patients with porphyria (a genetic disease characterized by the accumulation of porphyrins or their precursors in the body), cases of exacerbation of porphyria have been reported after taking certain other sulfonylurea derivatives.

Children and adolescents

Gliclazide is not recommended for use in children due to the lack of data.

Clazicon and other medicines

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

• other medicines used to treat high blood sugar levels (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)
• analgesic or anti-rheumatic medicines (phenylbutazone, ibuprofen)
• medicines containing alcohol. The following medicines may weaken the effect of gliclazide, leading to an increase in blood sugar levels:
• medicines used to treat central nervous system disorders (chlorpromazine)
• medicines that reduce inflammation (corticosteroids)
• medicines used to treat asthma or during childbirth (salbutamol, rytodryna, and terbutaline administered intravenously)
• medicines used to treat breast diseases, heavy menstrual bleeding, and endometriosis (danazol).
• Preparations containing St. John's wort (Hypericum perforatum). In case of concomitant use of Clazicon with antibiotics belonging to the group of fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (low and high blood sugar levels) may occur.

Clazicon may enhance the effect of concomitantly used anticoagulant medicines (e.g., warfarin). Before taking any other medicine, consult your doctor. In case of hospitalization, inform the medical staff about taking Clazicon.

Clazicon with food, drinks, and alcohol

Clazicon can be taken with food and non-alcoholic beverages. Consuming alcohol during treatment with gliclazide is not recommended, as it may unpredictably affect diabetes control.

Pregnancy and breastfeeding

Clazicon is not recommended during pregnancy. If you are pregnant, think you may be pregnant, or plan to have a baby, consult your doctor before taking this medicine. You should not take Clazicon while breastfeeding.

Driving and using machines

If your blood glucose 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. Remember that this can be dangerous for you or others (e.g., when driving a car or operating machines). Ask your doctor if you can drive, if:

• you experience frequent episodes of low blood sugar levels (hypoglycemia)
• you experience few or no warning signs of low blood sugar levels (hypoglycemia).

Clazicon contains lactose

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

3. How to take Clazicon

Dose

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The dose of Clazicon is determined by your doctor based on your blood sugar levels. Changes in external factors (e.g., weight loss, lifestyle changes, stress) or improvement in blood sugar control may require a change in the dose of gliclazide. Dose of 30 mg: the recommended dose is one to four tablets (maximum 120 mg) once a day, at breakfast time. The number of tablets depends on your response to treatment. Dose of 60 mg: the tablet can be divided into equal doses. The recommended dose is half to two tablets (maximum 120 mg) once a day, at breakfast time. The number of tablets depends on your response to treatment. Oral administration. Take the tablet(s) with a glass of water during breakfast (preferably at the same time every day). Clazicon 30 mg tablets: swallow the tablet whole. Clazicon 60 mg tablets: swallow the tablet or half of it whole. Do not chew or crush the tablets. After taking the tablet(s), you should always eat a meal. If you are taking concomitant treatment with Clazicon and metformin, alpha-glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, GLP-1 receptor agonists, or insulin, your doctor will determine the appropriate dose of each medicine individually for you. If you notice that your blood sugar levels are high despite taking Clazicon as prescribed, consult your doctor or pharmacist.

Taking a higher dose of Clazicon than recommended

If you have taken too many tablets, contact your doctor or go to the emergency department of the nearest hospital immediately. The symptoms of overdose are the symptoms of low blood sugar levels (hypoglycemia) as described in section 2. "Important information before taking Clazicon". If you do not receive proper treatment, these symptoms may worsen and lead to drowsiness, loss of consciousness, and even coma. If you experience symptoms of hypoglycemia, you should immediately consume sugar (4-6 large sugar crystals) or a sweet drink, and then eat a snack or a meal. If you are unconscious, contact your doctor and call for emergency help immediately. The same applies if you accidentally take the medicine, e.g., a child. Do not give unconscious patients drinks or food. Inform another person about your illness, who, in case of need, can call for medical help.

Missing a dose of Clazicon

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

Stopping treatment with Clazicon

Since diabetes treatment usually lasts for the rest of your life, consult your doctor before stopping treatment with Clazicon. Stopping the medicine may lead to an increase in 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.

4. Possible side effects

Like all medicines, Clazicon can cause side effects, although not everybody gets them. Low blood sugar levels (hypoglycemia) are the most common side effect. Symptoms are described in section 2. "Important information before taking Clazicon".If you do not receive proper treatment, these symptoms may worsen and lead to drowsiness, loss of consciousness, and even coma.If your symptoms of hypoglycemia worsen or persist even after consuming sugar, you should immediately consult your doctor. Blood disorders There have been reports of a decrease in the number of certain blood cells (e.g., platelets, red and white blood cells). This may cause: pale skin, prolonged bleeding time, bruising, sore throat, fever. These symptoms usually disappear after stopping treatment. Liver disorders There have been reports of single cases of liver disorders causing yellowing of the skin and eyes. You should immediately consult your doctor if you experience these symptoms. These changes usually disappear after stopping the medicine. Your doctor will decide whether to stop treatment. Skin disorders There have been reports of the following skin disorders: rash, redness, itching, hives, blisters, angioedema (sudden swelling of the eyelids, face, lips, mouth, tongue, or throat, which can cause difficulty breathing). The rash may worsen and become widespread, or blisters may appear, or the skin may peel. If you experience these symptoms, you should stop taking Clazicon and immediately consult your doctor. Rarely, symptoms of severe hypersensitivity reactions (DRESS, Drug Rash with Eosinophilia and Systemic Symptoms) have been reported: initially in the form of flu-like symptoms and a rash on the face, which then spread and were accompanied by a high temperature. Gastrointestinal disorders Discomfort or abdominal pain, nausea, vomiting, indigestion, diarrhea, constipation. The occurrence of these symptoms can be alleviated by taking Clazicon as recommended, with a meal – see section 3. "How to take Clazicon".Eye disorders Short-term vision disturbances may occur, especially at the beginning of treatment. This is due to changes in blood glucose levels. As with other sulfonylureas, the following events have been reported: significant changes in blood cell counts and allergic vasculitis, decreased sodium levels in the blood (hyponatremia), symptoms of liver damage (e.g., jaundice), which in most cases disappeared after stopping treatment with sulfonylureas but may lead to life-threatening liver failure in individual cases.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or 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 181C, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clazicon

Keep this medicine out of the sight and reach of children. There are no special precautions for storage. 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. 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 Clazicon contains:

• The active substance is gliclazide. One modified-release tablet contains 30 mg or 60 mg of the active substance – gliclazide.
• The other ingredients are: lactose monohydrate, hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

What Clazicon looks like and contents of the pack

Clazicon 30 mg modified-release tablets are white, oval, biconvex, 5 x 11 mm in size, marked with the letter "G" on one side. Clazicon 60 mg modified-release tablets are white, oval, biconvex, 7 x 15 mm in size, with a score line on both sides, marked with the letter "G" on one side of the score line and the number "60" on the other side of the score line. The tablet can be divided into equal doses. Pack sizesClazicon 30 mg: blisters of 60 modified-release tablets. Clazicon 60 mg: blisters of 30, 60 modified-release tablets.

Marketing authorization holder

Synoptis Pharma Sp. z o.o. ul. Krakowiaków 65 02-255 Warsaw

Manufacturer

Balkanpharma-Dupnitsa AD 3 Samokovsko Shosse Str. 2600 Dupnitsa Bulgaria

Date of last revision of the leaflet: March 2022