Gliclada

Gliclada, 90 mg, prolonged-release tablets
gliclazide
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

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

Contents of the leaflet:

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 glucose levels (an oral antidiabetic agent belonging to the sulfonylurea derivatives group).
Gliclada is used in the treatment of a certain type of diabetes (type 2 diabetes) in adults, when diet, physical exercise, and weight reduction alone are insufficient to maintain normal blood glucose levels.

2. Important information before using Gliclada

When not to use Gliclada

• if the patient is allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), other drugs of the same class (sulfonylurea derivatives), or other derivatives (hypoglycemic sulfonamides);
• if the patient has insulin-dependent diabetes (type 1);
• if ketone bodies and sugar are present in the urine (this may indicate diabetic ketoacidosis), pre-comatose or comatose states;
• if the patient has severe kidney or liver disease;
• if the patient is taking medicines used to treat fungal infections (miconazole, see section "Gliclada with other medicines");
• if the patient is breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting treatment with Gliclada, discuss it with your doctor or pharmacist. You should follow the treatment plan recommended by your doctor to achieve the desired blood glucose levels. This means not only taking the medicine regularly, but also adhering to your diet, engaging in regular physical exercise, and, if necessary, reducing body weight. During treatment with gliclazide, regular monitoring of blood glucose (and possibly urine glucose) is necessary, as well as measurement of glycated hemoglobin (HbA1c).

The risk of low blood glucose (hypoglycemia) may be increased during the first weeks of treatment. Therefore, close medical supervision is particularly important.

Low blood glucose (hypoglycemia) may occur if:

• the patient eats irregularly or skips meals;
• the patient is fasting;
• the patient is undernourished;
• the patient changes their diet;
• the patient increases physical activity without adequate carbohydrate intake;
• the patient consumes alcohol, especially when skipping meals;
• the patient is taking other medicines or natural remedies at the same time;
• the patient takes too high a dose of gliclazide;
• the patient has specific hormonal disorders (thyroid, pituitary gland, or adrenal cortex dysfunction);
• kidney or liver function is severely impaired.

If the patient has low blood glucose, the following symptoms may occur: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, impaired concentration, reduced alertness and reaction time, depression, disorientation, speech or vision disturbances, tremors, sensory disturbances, dizziness, weakness.

Additional symptoms may include: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain radiating to adjacent body parts (angina pectoris).

If blood glucose continues to decrease, severe confusion (delirium), seizures, loss of consciousness, shallow breathing, slow heartbeat, or loss of consciousness may occur.

In most cases, symptoms of low blood glucose disappear quickly when the patient consumes sugar, e.g., glucose tablets, sugar cubes, sweet fruit juice, or sweetened tea. Therefore, it is important to always carry sugar-containing products (glucose tablets, sugar cubes). Note that artificial sweeteners are ineffective. Contact your doctor or nearest hospital if sugar intake does not help or if symptoms recur.

Symptoms of low blood glucose may not appear, may be mild or develop slowly, or the patient may not be aware that blood glucose has dropped. This may occur in elderly patients or in those taking certain medicines (e.g., those acting on the central nervous system or beta-blockers).

In stressful situations (e.g., accidents, surgery, fever, etc.), your doctor may temporarily switch treatment to insulin therapy.

Symptoms of high blood glucose (hyperglycemia) may occur if gliclazide has not sufficiently lowered blood glucose, if the patient has not followed the doctor's treatment plan, if the patient has taken products containing St. John's wort (Hypericum perforatum) (see section "Gliclada with other medicines"), or during particularly stressful situations. Symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced activity. If these symptoms occur, the patient should contact their doctor or pharmacist.

Glucose disturbances (low and high blood glucose), especially in elderly patients, may occur when gliclazide is taken concomitantly with antibiotics known as fluoroquinolones. In such cases, the doctor will emphasize the importance of monitoring blood glucose levels.

If a patient or a family member has previously been diagnosed with congenital glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormal red blood cells), a decrease in hemoglobin levels and destruction of red blood cells (hemolytic anemia) may occur. Consult your doctor before taking this medicinal product.

Cases of acute porphyria have been reported during treatment with other sulfonylurea derivatives in patients with porphyria (inherited genetic disorders with accumulation of porphyrins or porphyrin precursors in the body).

Children and adolescents

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

Gliclada with other medicines

Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

The blood glucose-lowering effect of gliclazide may be enhanced, and symptoms of low blood glucose may occur, when any of the following medicines are taken:

• other medicines used to treat high blood glucose (oral antidiabetic drugs, GLP-1 receptor agonists, or insulin);
• antibiotics (e.g., 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 blockers);
• medicines used to treat depression (MAO inhibitors);
• painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen);
• medicines containing alcohol.

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

• medicines used to treat central nervous system disorders (chlorpromazine);
• anti-inflammatory medicines (corticosteroids);
• medicines used to treat asthma or administered during childbirth (intravenous salbutamol, ritodrine, terbutaline);
• medicines used to treat breast diseases, severe menstrual bleeding, and endometriosis (danazol);
• herbal preparations containing St. John's wort (Hypericum perforatum).

Glucose disturbances (low and high blood glucose), especially in elderly patients, may occur when Gliclada is taken concomitantly with antibiotics known as fluoroquinolones.

Gliclada may enhance the effect of anticoagulant medicines (e.g., warfarin). Consult your doctor before starting any other medicinal product. If you go to the hospital, 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 beverages. Alcohol consumption is not recommended, as it may alter diabetes control in an unpredictable manner.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she is pregnant, or plans to become pregnant while taking this medicine, she should inform her doctor, who may recommend more appropriate treatment.

Gliclada is not recommended during pregnancy.

Gliclada must not be used during breastfeeding.

Driving and using machines

If blood glucose is too low (hypoglycemia) or too high (hyperglycemia), or if vision disturbances occur due to abnormal blood glucose levels, the ability to concentrate or react may be impaired. Remember that the patient may pose a risk to themselves or others (e.g., when driving a car or operating machinery). Consult your doctor about the ability to drive:

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

Gliclada 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 take Gliclada

Dosage
Always take this medicine exactly as directed by your doctor or pharmacist. If you are unsure,
ask your doctor or pharmacist for advice.
The dose is determined by the doctor, depending on blood and urine glucose levels.
Any changes due to external factors (e.g. weight loss, change in lifestyle, stress) or improved
control of blood glucose levels may require adjustment of gliclazide dosage.
The recommended dose is 30 mg to 120 mg of gliclazide taken once daily with breakfast. The
exact dose depends on the individual response to treatment.
The tablet may be divided into three equal parts, allowing administration of the following doses:
30 mg (one third of a tablet), 60 mg (two thirds of a tablet), 90 mg (one whole tablet), and 120 mg
(one whole tablet plus one third of another tablet).
The tablet may also be divided into three equal parts for easier swallowing.
In combination therapy with Gliclada, extended-release tablets with metformin, an alpha-glucosidase
inhibitor, a thiazolidinedione, a dipeptidyl peptidase-IV inhibitor, a GLP-1 receptor agonist, or insulin,
the appropriate dose of each medicine will be individually determined by the doctor.
If the patient notices high blood glucose levels despite taking the medicine as prescribed, they
should consult their doctor or pharmacist.

Route and method of administration
Oral administration
To remove the tablet from the packaging:

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

How to divide the Gliclada 90 mg tablet:
The tablet is marked with two division lines, allowing it to be split into three equal parts.

4. Divide the tablet manually along the division lines. Hold the tablet between your thumb and index finger close to the division line corresponding to the required dose, as shown in figure 4. Do not divide the tablet in any other way. Swallow the tablet or tablet portion(s) whole with a glass of water during breakfast (preferably at the same time every day). Do not chew or crush. Always eat a meal after taking this medicine.

Taking more Gliclada than recommended
If too many tablets are taken, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose are those of low blood sugar (hypoglycaemia), as described in section 2.
In such cases, eating sugar (4 to 6 sugar cubes) or drinking a sweetened beverage, followed by a snack or meal, may help. If the patient is unconscious, contact a doctor immediately and call emergency services. The same applies if someone, for example a child, accidentally takes this medicine. Do not give food or drink to an unconscious person. Ensure that someone is always informed and able to contact a doctor in case of an emergency.

Missing a dose of Gliclada
It is important to take the medicine every day, as regular use ensures better effectiveness. However, if a dose of Gliclada is missed, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Gliclada
Since diabetes treatment usually lasts a lifetime, consult your doctor before stopping this 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most commonly observed adverse effect is low blood sugar (hypoglycaemia).
Objective and subjective symptoms are described in the section "Warnings and precautions".
If these symptoms are left untreated, they may progress to drowsiness, loss of consciousness or coma.
If the low blood sugar is severe or prolonged, even if temporarily controlled by sugar intake, you should immediately consult a doctor.

Gastrointestinal disorders
Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea and constipation. These symptoms can be reduced by taking Gliclada prolonged-release tablets with food, as recommended.

Blood disorders
Reduction in blood cell counts (e.g. platelets, red and white blood cells) may cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually resolve after discontinuation of treatment.

Skin disorders
Skin 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 breathing difficulties) have been observed.
Rash may progress to extensive blistering or lead to skin peeling.
If such symptoms occur, discontinue use of Gliclada immediately, seek medical advice without delay and inform the doctor about use of this medicine.
Rarely, symptoms of severe hypersensitivity reactions (DRESS) have been reported, initially presenting as influenza-like symptoms and facial rash which subsequently spreads, accompanied by high fever.

Liver disorders
Isolated cases of impaired liver function, which may cause yellowing of the skin and eyes, have been observed. If these symptoms occur, contact a doctor immediately. Symptoms usually resolve after discontinuation of the medicine. The doctor will decide whether treatment should be discontinued.

Eye disorders
Transient visual disturbances may occur, especially at the beginning of treatment. This effect is related to changes in blood glucose concentration.

As with other sulfonylurea derivatives, cases of marked blood cell count changes and allergic vasculitis have been observed, as well as reduction in blood sodium concentration (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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the 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 the specified month.
No special storage conditions are required for this medicinal product.
Medicines must 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 packaging and other information

What Gliclada contains

• The active substance in Gliclada is gliclazide. Each prolonged-release tablet contains 90 mg of gliclazide.
• The other ingredients are: hypromellose, monohydrate lactose, colloidal anhydrous silica, magnesium stearate. See section 2 "Gliclada contains lactose". What Gliclada looks like and contents of the pack Gliclada is a white to almost white, biconvex, capsule-shaped tablet, with two dividing lines around the tablet. The tablet can be divided into equal doses. Tablet dimensions: length 17.0–17.5 mm and thickness 4.6–5.4 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 blisters, in a cardboard box. Not all pack sizes may be marketed. Marketing Authorisation 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 authorised for marketing in the European Economic Area countries under the following names:

For further information on medicinal product names in other European Economic Area countries, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. +48 22 57 37 500