Clazicon

Patient Information Leaflet

Clazicon, 30 mg, modified-release tablets
Clazicon, 60 mg, modified-release tablets
Gliclazidum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents

1. What Clazicon is and what it is used for
2. What you need to know 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 Clazicon is and what it is used for

Clazicon is a blood glucose-lowering agent (an oral antidiabetic drug belonging to the sulfonylurea derivatives group).
Clazicon is used in adults with a certain type of diabetes (type 2 diabetes) in whom appropriate diet, physical exercise, and weight reduction are insufficient to maintain normal blood glucose levels.

2. Important information before using Clazicon

When not to use Clazicon:

• if the patient is 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 similar drugs (antidiabetic sulfonamides),
• if the patient has insulin-dependent diabetes (type 1 diabetes),
• if the patient has ketones and glucose in the urine (this may indicate diabetic ketoacidosis), pre-coma or diabetic coma,
• if the patient has severe kidney or liver disease,
• if the patient is taking any antifungal medications (miconazole, see section "Clazicon with other medicines"),
• if the patient is breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Before starting treatment with Clazicon, discuss this with your doctor or pharmacist.
The patient should follow the treatment regimen prescribed by the attending physician to maintain proper blood glucose levels. This includes, in addition to regular intake of the medicine, adherence to diet, physical exercise, and, if necessary, weight reduction.
During treatment with gliclazide, blood glucose levels (and possibly urine glucose) should be monitored regularly, and, if needed, glycated hemoglobin (HbA1c) levels should also be checked.
During the first few weeks of treatment, the risk of significant reduction in blood glucose levels (hypoglycemia) may be increased. Therefore, close medical supervision is necessary.
Very low blood glucose levels (hypoglycemia) may occur:

• if the patient eats irregularly or skips meals;
• if the patient is fasting;
• if the patient is malnourished;
• when diet changes;
• when physical exertion increases and carbohydrate intake does not meet the increased demand;
• if the patient consumes alcohol, especially when skipping meals;
• when other medicines, including herbal products, are used concomitantly;
• if excessive doses of gliclazide are taken;
• if the patient has hormone-related disorders (such as thyroid, pituitary or adrenal cortex dysfunction);
• if kidney or liver function is significantly reduced.

If the patient has low blood glucose levels, the following symptoms may occur: headache, feeling of hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced alertness and prolonged reaction time, depression, confusion, disorientation, speech or vision disturbances, tremors, sensory disturbances, dizziness and helplessness.
Additional symptoms may include: sweating, moist skin, anxiety, irregular or rapid heartbeat, high blood pressure, sudden chest pain radiating to adjacent body parts (angina pectoris).
If blood glucose levels continue to drop, the patient may experience confusion (delirium), seizures, loss of self-control, shallow breathing and slow heartbeat, and may lose consciousness.
In most cases, symptoms of low blood glucose resolve quickly after taking sugar in the form of glucose tablets, sugar cubes, sweet juice or sweet tea. Therefore, the patient should always carry some form of sugar (glucose tablets or sugar cubes).
Please note that sweeteners do not have the same effect as sugar.
If symptoms do not improve or recur after taking sugar, the patient should contact a doctor or go to the nearest hospital emergency department.
Some people may not feel symptoms of low blood glucose, or these symptoms may go unnoticed by the patient or develop very slowly, so the patient may not realize that blood glucose has dropped. This may particularly occur in elderly patients taking certain medications (e.g., drugs affecting the central nervous system and beta-blockers).
If the patient experiences a stressful situation (accident, surgery, fever), the doctor may decide to temporarily switch treatment to insulin.
Symptoms of high blood glucose levels (hyperglycemia) may occur if gliclazide does not sufficiently lower blood glucose, if the patient does not follow the prescribed treatment regimen, if the patient takes preparations containing St. John's wort (Hypericum perforatum) (see section "Clazicon with other medicines"), or during particularly stressful situations. These symptoms include: thirst, increased frequency of urination, dry mouth, dry, itchy skin, skin infections and reduced activity.
If any of the above symptoms occur, the patient should consult a doctor or pharmacist.
When gliclazide is used concomitantly with antibiotics called fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (both low and high blood glucose) may occur. In such cases, the doctor will remind the patient how important it is to monitor blood glucose levels.
If the patient or members of their family have or have had glucose-6-phosphate dehydrogenase (G6PD) deficiency (a disorder affecting red blood cells), a decrease in hemoglobin levels and destruction of red blood cells (hemolytic anemia) may occur. Before using gliclazide, consult a doctor.
In patients with porphyria (a hereditary genetic disorder involving accumulation of porphyrins or their precursors in the body), cases of porphyria exacerbation have been reported after using certain other sulfonylurea drugs.

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

Clazicon with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
The following medicines may enhance the blood glucose-lowering effect of gliclazide and may cause symptoms of low blood glucose:

• other antidiabetic medicines (oral antidiabetic drugs, GLP-1 receptor agonists or insulin),
• antibiotics (sulfonamides, clarithromycin),
• medicines used to treat high blood pressure or heart failure (beta-blockers, angiotensin-converting enzyme (ACE) inhibitors such as captopril or enalapril),
• antifungal medicines (miconazole, fluconazole),
• medicines used to treat peptic ulcer disease of the stomach or duodenum (H₂-receptor antagonists),
• medicines used to treat depression (monoamine oxidase inhibitors),
• painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The following medicines may reduce the blood glucose-lowering effect of gliclazide and may cause increased blood glucose levels:

• medicines used to treat disorders of the central nervous system (chlorpromazine),
• anti-inflammatory medicines (corticosteroids),
• medicines used to treat asthma or to delay labor (salbutamol, ritodrine and terbutaline administered by intravenous injection),
• medicines used to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol),
• preparations containing St. John's wort (Hypericum perforatum).

When Clazicon is used concomitantly with antibiotics called fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (both low and high blood glucose) may occur.
Clazicon may enhance the effect of concomitantly used anticoagulant drugs (e.g., warfarin).
Before starting any other medicine, consult your doctor.
If hospitalization is necessary, inform the medical staff that you are taking Clazicon.

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

Pregnancy and breastfeeding
Clazicon is not recommended during pregnancy. If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Clazicon must not be used during breastfeeding.

Driving and operating machinery
If blood glucose levels are too low (hypoglycemia) or too high (hyperglycemia), or if vision disturbances occur as a result of abnormal blood glucose levels, the ability to concentrate or react may be impaired. Remember that this may be dangerous for the patient or others (e.g., when driving a car or operating machinery).
Ask your doctor whether you can drive if:

• you frequently experience low blood glucose levels (hypoglycemia),
• you have few or no warning symptoms of low blood glucose (hypoglycemia).

Clazicon contains lactose
If the patient has been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Clazicon

Dosage
This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult
your doctor or pharmacist.
The dose of the medicine is determined by the doctor depending on blood and urine glucose levels.
Changes in external factors (e.g. weight loss, lifestyle changes, stress) or improved control of blood
glucose levels may require adjustment of gliclazide dosage.
30 mg dose: The recommended dose is one to four tablets (maximum 120 mg) once daily, taken with
breakfast. The number of tablets depends on the patient's response to treatment.
60 mg dose: The tablet may be divided into equal doses. The recommended dose is half to two
tablets (maximum 120 mg) once daily, taken with breakfast. The number of tablets depends on the
patient's response to treatment.
Oral administration. The tablet(s) should be taken with a glass of water during breakfast (preferably
at the same time each day).
Clazicon tablets, 30 mg: swallow the tablet whole.
Clazicon tablets, 60 mg: swallow the tablet or half-tablet whole.
Do not chew or crush the tablets.
After taking the tablet(s), the patient must always eat a meal.
If the patient is receiving combination therapy with Clazicon and metformin, alpha-glucosidase
inhibitors, thiazolidinediones, dipeptidyl peptidase-IV inhibitors, GLP-1 receptor agonists, or insulin,
the doctor will determine the appropriate dose of each of these medicines individually for each
patient.
Consult your doctor or pharmacist if you notice that blood glucose levels remain high despite taking
Clazicon as directed.

Taking more Clazicon than prescribed
If a patient has taken too many tablets, contact a doctor immediately or go to the emergency
department of the nearest hospital. Symptoms of overdose are those of low blood glucose (hypoglycaemia), as described in section 2. Symptoms of low blood glucose may be relieved if the patient immediately consumes sugar (4–6 sugar cubes) or drinks a sweet beverage, followed by a substantial snack or meal. If the patient is unconscious, contact a doctor immediately and call emergency services. The same applies in case of accidental ingestion, for example by a child. Do not give drinks or food to an unconscious person.
Inform another person about your condition so that they can call for medical help if necessary.

Missing a dose of Clazicon
It is important to take the medicine every day, as regular treatment provides better results. However,
if the patient forgets to take a dose of Clazicon, the next dose should be taken at the usual time.
Do not take a double dose to make up for a missed tablet.

Stopping Clazicon
Since diabetes treatment usually lasts a lifetime, consult your doctor before stopping the medicine.
Discontinuing treatment may lead to increased blood glucose levels (hyperglycaemia), increasing the
risk of diabetes complications.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody experiences them.
Low blood sugar (hypoglycaemia) is the most commonly occurring adverse reaction. The symptoms are described in section 2, "Warnings and precautions", under "Important information before taking Clazicon". If appropriate treatment is not initiated, these symptoms may worsen and may lead to drowsiness, loss of consciousness and even coma. If symptoms of hypoglycaemia worsen or persist despite intake of sugar, medical attention should be sought immediately.

Blood disorders
Reduced numbers of certain blood cells (e.g. platelets, red and white blood cells) have been reported.
This may result in: pale skin, prolonged bleeding time, bruising, sore throat, fever.
These symptoms usually resolve after discontinuation of treatment.

Liver function disorders
Isolated cases of liver function disturbances causing yellowing of the skin and eyes have been reported.
Patients should contact their doctor immediately if these symptoms occur. These changes are usually reversible after discontinuation of the medicine. The doctor will decide whether treatment should be discontinued.

Skin disorders
The following skin disorders have been reported: rash, redness, itching, urticaria, blisters, angioedema (sudden swelling of the eyelids, face, lips, mouth, tongue or throat, making breathing difficult). The rash may worsen and widespread blisters or peeling of the skin may develop. If a patient experiences these symptoms, treatment with Clazicon should be stopped immediately and urgent medical advice should be sought; the doctor should be informed about the use of this medicine.

Rarely, symptoms of severe hypersensitivity reactions (DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms) have been reported: initially presenting as influenza-like symptoms and facial rash, which subsequently spreads, accompanied by high fever.

Gastrointestinal disorders
Discomfort or abdominal pain, nausea, vomiting, indigestion, diarrhoea, constipation. The occurrence of the above symptoms may be reduced by taking Clazicon as recommended, with food – see section 3, "How to take Clazicon".

Eye disorders
Transient visual disturbances may occur, especially at the beginning of treatment. These are due to changes in blood glucose concentration.

As with other sulfonylurea derivatives, the following events have been reported: significant changes in blood cell counts and allergic vasculitis, decreased sodium concentration in blood (hyponatraemia), signs of liver damage (e.g. jaundice), which in most cases resolved after discontinuation of sulfonylurea derivatives, but in rare cases may lead to life-threatening liver failure.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, patients should inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products, 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.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Clazicon

Keep this medicine out of the sight and reach of children.
No special storage conditions apply for this medicine.
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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. 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.
• 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 division line on both sides, marked with the letter "G" on one side of the division line and the number "60" on the other side of the division line. The tablet can be divided into equal doses.

Pack sizes
Clazicon 30 mg: Blister packs: 60 modified-release tablets.
Clazicon 60 mg: Blister packs: 30, 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