CLAZICON 60 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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
4. What is Clazicon and what is it used for
5. Before you take Clazicon
   1. Do not take Clazicon:
   2. Warnings and precautions
   3. Children and adolescents
   4. Clazicon with other medicines
   5. Clazicon with food, drinks, and alcohol
   6. Pregnancy and breast-feeding
   7. Driving and using machines
   8. Clazicon contains lactose
6. How to take Clazicon
   1. Dose
   2. If you take more Clazicon than you should
   3. If you forget to take Clazicon
   4. If you stop taking Clazicon
7. Possible side effects
   1. Reporting of 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 Authorisation 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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• You should 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 is Clazicon and what is it used for
• 2. Before you take 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 lowers blood sugar levels (oral antidiabetic medicine, belonging to the sulfonylurea group). Clazicon is used in adults with a certain type of diabetes (type 2 diabetes), where diet, exercise, and weight loss alone are not sufficient to control blood sugar levels.

2. Before you take Clazicon

Do not take Clazicon:

• 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 other similar medicines (sulfonylureas),
• if you have insulin-dependent diabetes (type 1),
• if you have ketone bodies and sugar in your urine (this may mean that you have diabetic ketoacidosis), pre-coma or coma,
• if you have severe kidney or liver disease,
• if you are taking certain medicines for fungal infections (miconazole, see "Clazicon with other medicines"),
• if you are breast-feeding (see "Pregnancy and breast-feeding").

Warnings and precautions

Before you start taking Clazicon, talk to your doctor or pharmacist. You should follow the treatment plan as advised by your doctor to maintain proper blood sugar levels. This means, in addition to regular intake of Clazicon, 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 HbA1c levels. For the first few weeks of treatment, the risk of low blood sugar (hypoglycaemia) may be increased. Therefore, close medical monitoring is necessary. Low blood sugar (hypoglycaemia) may occur:

• if you skip meals or delay taking them;
• if you fast;
• if you are undernourished;
• if you change your diet;
• if you increase your physical activity, and the amount of carbohydrates you eat does not match the increased energy expenditure;
• if you drink alcohol, especially if you skip meals;
• if you take 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 severely reduced; If you have low blood sugar, you may experience the following symptoms: headache, feeling hungry, nausea, vomiting, tiredness, sleep disturbances, restlessness, aggression, concentration disorders, reduced alertness, and prolonged reaction time, depression, confusion, speech or vision disorders, tremors, sensory disturbances, dizziness, and helplessness. You may also experience: 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), convulsions, loss of self-control, shallow breathing, and slow heartbeat, and you may lose consciousness. In most cases, the symptoms of low blood sugar disappear quickly after taking sugar (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 taking 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 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 medicines (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 (hyperglycaemia) may occur if gliclazide does not lower your blood sugar levels sufficiently, if you do not follow the treatment plan advised by your doctor, if you take products containing St. John's Wort (Hypericum perforatum) (see "Clazicon with other medicines"), or in stressful situations. These include: thirst, increased frequency of urination, dry mouth, dry, itchy skin, skin infections, and decreased activity. If you experience these symptoms, you should contact your doctor or pharmacist.

When taking Clazicon with certain antibiotics (fluoroquinolones), especially in elderly patients, disturbances in blood sugar levels (low and high blood sugar) may occur. In this case, your doctor will remind you of the importance of monitoring your blood sugar levels. If you or your family members have or have had a deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a disorder affecting red blood cells), you may experience a decrease in haemoglobin levels and breakdown of red blood cells (haemolytic anaemia). You should contact your doctor before taking gliclazide. 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 other sulfonylureas.

Children and adolescents

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

Clazicon with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. The following medicines may enhance the blood sugar lowering effect of gliclazide and increase the risk of low blood sugar:

• other medicines used to treat high blood sugar (oral antidiabetics, 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 reduce the blood sugar lowering effect of gliclazide and increase blood sugar levels:
• medicines used to treat disorders of the central nervous system (chlorpromazine),
• medicines that reduce inflammation (corticosteroids),
• medicines used to treat asthma or during childbirth (salbutamol, rytodryna, and terbutaline given by intravenous injection),
• medicines used to treat breast disorders, heavy menstrual bleeding, and endometriosis (danazol).
• Products containing St. John's Wort (Hypericum perforatum). When taking Clazicon with certain antibiotics (fluoroquinolones), especially in elderly patients, disturbances in blood sugar levels (low and high blood sugar) may occur.

Clazicon may enhance the effect of medicines that prevent blood clotting (e.g., warfarin). Before taking any other medicine, consult your doctor. If you need to be hospitalized, inform the medical staff that you are taking Clazicon.

Clazicon with food, drinks, and alcohol

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

Pregnancy and breast-feeding

Clazicon should not be used during pregnancy. If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine. You should not take Clazicon if you are 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 attention and reaction time may be impaired. Remember that this can be dangerous for you and others (e.g., when driving a car or operating machinery). Ask your doctor whether you can drive a car: if you experience frequent low blood sugar (hypoglycaemia), if you experience few or no warning symptoms of low blood sugar (hypoglycaemia).

Clazicon contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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, depending 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 (up to 120 mg) once daily, 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 (up to 120 mg) once daily, at breakfast time. The number of tablets depends on your response to treatment. Oral administration. Take the tablet(s) with a glass of water at breakfast time (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 combination therapy with Clazicon and metformin, alpha-glucosidase inhibitors, thiazolidinediones, DPP-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 advised, consult your doctor or pharmacist.

If you take more Clazicon than you should

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 (hypoglycaemia) as described in section 2. "Before you take Clazicon". If you do not take the necessary treatment, these symptoms will worsen, and you may experience drowsiness, loss of consciousness, and even coma. If you experience symptoms of hypoglycaemia, you should immediately take sugar (4-6 large sugar crystals) or a sweet drink, and then eat a substantial snack or meal. If you are unconscious, contact your doctor immediately and call for emergency help. 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, if necessary, can call for medical help.

If you forget to take Clazicon

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

If you stop taking Clazicon

Since diabetes treatment usually lasts for the rest of your life, you should talk to your doctor before stopping treatment. Stopping treatment may lead to increased blood sugar levels (hyperglycaemia), which increases the risk of developing diabetes complications. If you have any further questions on the use of this product, 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 (hypoglycaemia) is the most common side effect. The symptoms are described in section 2. "Before you take Clazicon"."Important information before you take Clazicon".If you do not take the necessary treatment, these symptoms will worsen, and you may experience drowsiness, loss of consciousness, and even coma. If your symptoms of hypoglycaemia worsen or persist even after taking sugar, you should contact your doctor immediately. Blood disorders There have been reports of reduced numbers 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 treatment is stopped. Liver disorders There have been reports of isolated cases of liver disorders causing yellowing of the skin and eyes. You should contact your doctor immediately if you experience these symptoms. These changes are usually reversible after the medicine is stopped. Your doctor will decide whether to stop treatment. Skin disorders There have been reports of the following skin disorders: rash, redness, itching, urticaria, blisters, angioedema (sudden swelling of the eyelids, face, lips, mouth, tongue, or throat, which may cause difficulty breathing). The rash may worsen and become widespread, or blisters may develop, or the skin may peel. If you experience these symptoms, you should stop taking Clazicon and contact your doctor immediately. Very rarely, there have been reports of symptoms of severe allergic reactions (DRESS, Drug Rash with Eosinophilia and Systemic Symptoms): initially flu-like symptoms and a rash on the face, which then spreads, and high fever. Gastrointestinal disorders Discomfort or stomach pain, nausea, vomiting, indigestion, diarrhoea, constipation. The occurrence of these symptoms can be alleviated by taking Clazicon as advised, with a meal – see section 3. "How to take Clazicon".Eye disorders You may experience temporary vision disturbances, especially at the beginning of treatment. This is due to changes in blood sugar 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 (hyponatraemia), signs of liver damage (e.g., jaundice), which in most cases disappeared after the sulfonylurea was stopped but in individual 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 via the national reporting system listed in the "Further information" section. 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 storage instructions for this medicine. 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. 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 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 break line on both sides, marked with the letter "G" on one side of the break line and "60" on the other side of the break line. The tablet can be divided into equal doses. Pack sizesClazicon 30 mg: blisters containing 60 modified-release tablets. Clazicon 60 mg: blisters containing 30 or 60 modified-release tablets.

Marketing Authorisation Holder

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

Manufacturer

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

Date of last revision of the leaflet: March 2022