Gliclazide Krka

PACKAGE LEAFLET

Package leaflet: Information for the patient

Gliclazide Krka 30 mg modified-release tablets

gliclazide
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Gliclazide Krka is and what it is used for
2. What you need to know before taking Gliclazide Krka
3. How to take Gliclazide Krka
4. Possible side effects
5. How to store Gliclazide Krka
6. Contents of the pack and other information

1. What Gliclazide Krka is and what it is used for

Gliclazide Krka is a medicine that lowers blood sugar levels (oral antidiabetic drugs belonging to the sulfonylurea group).
Gliclazide Krka is used in certain forms of diabetes (type 2 diabetes mellitus) in adults when diet, exercise, and weight loss do not provide adequate control of blood sugar levels.

2. What you need to know before taking Gliclazide Krka

Do not take Gliclazide Krka

• if you are allergic to gliclazide or to any of the excipients of this medicine (listed in section 6) or to other medicines of the same group (sulfonylureas) or to related medicines (hypoglycemic sulfonamides).
• if you have insulin-dependent (type 1) diabetes.
• if you have ketones or sugar in your urine (this may indicate diabetic ketoacidosis), pre-coma or diabetic coma.
• if you have severe kidney or liver disease.
• if you are taking medicines for fungal infections (miconazole, see section “Other medicines and Gliclazide Krka”).
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Inform your doctor or pharmacist before taking Gliclazide Krka.
To achieve appropriate blood sugar levels, you must follow the treatment plan prescribed by your doctor. This means, in addition to regular tablet intake, you must follow a proper diet, exercise regularly, and, when necessary, reduce weight.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine sugar levels) as well as your glycated hemoglobin (HbA_) is required.
In the first weeks of treatment, the risk of developing low blood sugar levels (hypoglycemia) may increase. It is therefore vital that you are closely monitored by your doctor.
Low blood sugar levels (hypoglycemia) may occur:

• if you eat meals irregularly or skip meals completely,
• if you are fasting,
• if you are malnourished,
• if you change your diet,
• if you increase physical activity without a corresponding increase in carbohydrate intake,
• if you drink alcohol, especially if you have also skipped a meal,
• if you take other medicines or herbal remedies concurrently,
• if you take high doses of gliclazide,
• if you suffer from certain hormone-related disorders (thyroid, pituitary or adrenal cortex dysfunction),
• if kidney or liver function is severely impaired.

If you experience low blood sugar levels, you may develop the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, poor concentration, reduced alertness and reaction time, depression, confusion, visual or speech disturbances, tremor, sensory disturbances, dizziness and fatigue. The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden severe chest pain that may radiate to nearby areas (angina pectoris). If blood sugar levels continue to drop, you may experience marked confusion (delirium), develop cerebral seizures, lose self-control, have weakened breathing, slowed heartbeat, or lose consciousness.

In most cases, symptoms of low blood sugar disappear quickly after consuming some form of sugar, e.g. glucose tablets, sugar cubes, sweet fruit juice, sugared tea. You should therefore always carry sugar in some form (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. If taking sugar does not help or if symptoms recur, contact your doctor or the nearest hospital.
Symptoms of low blood sugar may be absent, less obvious, develop slowly, or you may not realize in time that your blood sugar levels have dropped.
This may occur if you are an elderly patient taking certain medicines (e.g. those acting on the central nervous system or beta-blockers).
If you are under stress (e.g. accidents, surgery, fever, etc.), your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) may occur when gliclazide has not sufficiently lowered blood sugar, when you have not followed your prescribed treatment plan, when you are taking preparations containing St John's wort (Hypericum perforatum) (see section “Other medicines and Gliclazide Krka”), or during particular stress situations. These may include thirst, frequent need to urinate, dry mouth, dry itchy skin, skin infections, and reduced performance.
If these symptoms occur, you should contact your doctor or pharmacist.
Changes in blood glucose (low blood sugar and high blood sugar) may occur when gliclazide is taken concomitantly with medicines belonging to a class of antibiotics called fluoroquinolones, particularly in elderly patients. In this case, your doctor will remind you of the importance of monitoring blood glucose.
If you have a family history or know you have an inherited deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency (a red blood cell abnormality), a reduction in hemoglobin levels and breakdown of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.
Cases of acute porphyria have been reported with other sulfonylureas in patients with porphyria (inherited genetic disorders characterized by accumulation of porphyrins or precursors in the body).

Children and adolescents
Gliclazide Krka is not recommended for the treatment of diabetes in children and adolescents under 18 years of age.

Other medicines and Gliclazide Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The blood sugar-lowering effect of gliclazide may be enhanced, and signs of low blood sugar may occur, when taking any of the following medicines:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists, or insulin),
• antibiotics (e.g. sulfonamides, clarithromycin),
• medicines for high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• medicines for fungal infections (miconazole, fluconazole),
• medicines for stomach or duodenal ulcers (H_-receptor antagonists),
• medicines for depression (monoamine oxidase inhibitors),
• painkillers or anti-rheumatic drugs (ibuprofen, phenylbutazone),
• medicines containing alcohol.

The blood glucose-lowering effect of gliclazide may be weakened, and blood sugar levels may rise, when taking any of the following medicines:

• medicines for disorders of the central nervous system (chlorpromazine),
• medicines that reduce inflammation (corticosteroids),
• medicines for asthma,
• or those used during labor (intravenous salbutamol, ritodrine, and terbutaline administered by injection),
• medicines used to treat breast disorders, heavy menstrual bleeding, and endometriosis (danazol),
• preparations containing St John's wort – Hypericum perforatum.

Changes in blood glucose (low blood sugar and high blood sugar) may occur when Gliclazide Krka is taken concomitantly with medicines belonging to a class of antibiotics called fluoroquinolones, particularly in elderly patients.
Gliclazide Krka may enhance the effect of medicines that reduce blood clotting (e.g. warfarin).
Consult your doctor before starting any new medicine. If you are admitted to hospital, inform the medical staff that you are taking Gliclazide Krka.

Gliclazide Krka with food, drinks and alcohol
Gliclazide Krka may be taken with food and non-alcoholic drinks.
Alcohol consumption is not recommended, as it may unpredictably affect your diabetes control.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine so that an appropriate treatment can be prescribed.
Gliclazide Krka is not recommended during pregnancy.
You must not take Gliclazide Krka while breastfeeding.

Driving and using machines
If your blood sugar levels are too low (hypoglycemia) or too high (hyperglycemia), or if you develop visual disturbances due to these conditions, your ability to concentrate or react may be impaired. Always keep in mind that you may endanger yourself and others (e.g. when driving a car or operating machinery). Ask your doctor whether you may drive if:

• you have frequent episodes of low blood sugar (hypoglycemia),
• you have few or no symptoms warning of hypoglycemia.

Gliclazide Krka contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Gliclazide Krka

Dosage
Always take Gliclazide Krka exactly as your doctor or pharmacist has instructed you. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose based on your blood sugar levels and, if applicable, sugar levels in your urine. Any changes in external factors (e.g. weight loss, changes in lifestyle, stress) or improvements in blood sugar control may require adjustments in the dose of gliclazide.
The recommended starting dose is one tablet once daily.
The usual dose ranges from 1 to a maximum of 4 tablets taken as a single dose at breakfast. The exact dose depends on your response to treatment.
If combination therapy with Gliclazide Krka and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin is initiated, your doctor will determine the appropriate dose of each medicine for you individually.
If you notice that your blood sugar levels remain high despite taking the medicine as prescribed, you should contact your doctor or pharmacist.

Method of administration
For oral use.
Swallow the tablets whole. Do not chew them.
Take the tablet(s) with a glass of water at breakfast time, preferably at the same time each day. You must always eat a meal after taking the tablet(s).

If you take more Gliclazide Krka than you should
If you take more tablets than prescribed, contact your doctor or the nearest hospital emergency department immediately. Signs of overdose are those of low blood sugar (hypoglycemia), as described in section 2. Symptoms may be relieved by immediately consuming sugar (4–6 sugar cubes) or sugary drinks, followed by a snack or substantial meal. If the patient is unconscious, inform a doctor immediately and call emergency services. The same applies if someone, for example a child, has accidentally ingested the product. Do not give food or drink to an unconscious person.
Ensure that there is always an informed person available who can call a doctor in case of emergency.

If you forget to take Gliclazide Krka
It is important to take the medicine every day so that regular treatment remains effective. However, if you forget to take a dose of Gliclazide Krka, take the next dose at your usual time.
Do not take a double dose to make up for the missed dose.

If you stop taking Gliclazide Krka
Since diabetes treatment is generally long-term, you must discuss with your doctor before stopping the medicine. Stopping treatment may lead to increased blood sugar levels (hyperglycemia), increasing the risk of developing diabetes-related complications.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The most common side effect observed is low blood sugar levels (hypoglycaemia). For signs and symptoms, see section "Warnings and precautions".
If these symptoms are not treated, they may progress to drowsiness, loss of consciousness, or possibly coma. If a low blood sugar episode is severe or prolonged, even if controlled by consuming sugar, seek immediate medical assistance.

Liver disorders
There have been isolated reports of altered liver function, which may cause yellowing of the skin and eyes. If this occurs, consult your doctor immediately. Symptoms usually disappear when you stop taking the medicine. Your doctor will decide whether treatment should be discontinued.

Skin disorders
Skin reactions such as rash, redness, itching, urticaria, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat which may cause breathing difficulties).
The rash may progress to widespread blistering or skin peeling.
If you develop this condition, stop taking Gliclazide Krka, seek urgent medical advice and inform the doctor that you are taking this medicine.
Rarely, signs of a severe hypersensitivity reaction (DRESS) have been reported, initially presenting as flu-like symptoms and facial rash, followed by widespread rash with high fever.

Blood disorders
Decrease in blood cell count (e.g. platelets, red blood cells and white blood cells), which may cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually resolve when treatment is discontinued.

Gastrointestinal disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhoea and constipation have been reported. These effects are reduced when Gliclazide Krka is taken with food, as recommended.

Visual disturbances
Your vision may be affected for a short period, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.

As with other sulphonylureas, the following side effects have been observed:
cases of severe changes in blood cell counts and allergic inflammation of blood vessel walls, reduction of sodium in the blood (hyponatraemia), symptoms of liver impairment (e.g. jaundice), which in most cases resolved upon discontinuation of sulphonylureas, but in isolated cases may lead to life-threatening liver failure.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gliclazide Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, the bottle and the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gliclazide Krka contains

• The active substance is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
• The excipients are monohydrate lactose, hypromellose, calcium carbonate, anhydrous colloidal silica, magnesium stearate (See section 2 “Gliclazide Krka contains lactose”).

Description of the appearance of Gliclazide Krka and package contents
The modified-release tablets are white, oval, biconvex tablets.
Gliclazide Krka is available in blisters in packs of 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 120 or 180 tablets, or in bottles containing 90, 120 or 180 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, 8501 Slovenia

Local representative for Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milan, Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, 8501 Slovenia

This medicinal product is authorised in the European Economic Area countries under the following names:

Package leaflet: Information for the patient

Gliclazide Krka 60 mg modified-release tablets

gliclazide
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Gliclazide Krka is and what it is used for
2. What you need to know before taking Gliclazide Krka
3. How to take Gliclazide Krka
4. Possible side effects
5. How to store Gliclazide Krka
6. Contents of the pack and other information

1. What Gliclazide Krka is and what it is used for

Gliclazide Krka is a medicine that reduces blood sugar levels (an oral antidiabetic medicine belonging to the sulfonylurea group).
Gliclazide Krka is used in certain forms of diabetes in adults (type 2 diabetes mellitus) when diet, physical exercise, and weight loss alone do not achieve an adequate effect in maintaining blood sugar at the correct level.

2. What you need to know before taking Gliclazide Krka

Do not take Gliclazide Krka

• if you are allergic to gliclazide or to any of the other ingredients of this medicine (listed in section 6) or to other medicines of the same group (sulfonylureas) or to related medicines (hypoglycemic sulfonamides);
• if you have insulin-dependent diabetes (type 1);
• if you have ketones and sugar in your urine (this may indicate diabetic ketoacidosis), pre-coma or diabetic coma;
• if you have severe liver or kidney dysfunction;
• if you are taking medicines for fungal infections (miconazole, see section "Gliclazide Krka and other medicines");
• if you are breastfeeding (see section "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Talk to your doctor or pharmacist before taking Gliclazide Krka.
To achieve adequate blood sugar levels, you must follow the treatment plan prescribed by your doctor.
This includes not only regular intake of tablets, but also adherence to an appropriate diet, physical
exercise, and, if necessary, weight loss.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine sugar)
and also glycated hemoglobin (HbA1c) values is required.
The risk of low blood sugar levels (hypoglycemia) is higher during the first weeks of treatment.
Therefore, close medical supervision is essential.
Low blood sugar (hypoglycemia) may occur:

• if meals are irregular or completely skipped,
• during fasting,
• in case of malnutrition,
• if your diet is changed,
• if physical activity increases without adequate increase in carbohydrate intake,
• if consuming alcoholic beverages, especially when combined with lack of food,
• if taking other medicines or herbal remedies concomitantly,
• if the dose of gliclazide is too high,
• in case of certain hormonal disorders (dysfunctions of the thyroid, pituitary or adrenal cortex),
• if kidney or liver function is severely impaired.

If you experience low blood sugar, the following symptoms may occur: headache, excessive hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, poor concentration, reduced alertness and reaction time, depression, confusion, speech and vision disturbances, tremor, sensory disturbances, dizziness and feeling of weakness. The following signs and symptoms may also occur: sweating, moist skin, anxiety, irregular or rapid heartbeat, increased blood pressure, and sudden severe chest pain radiating to nearby areas (angina pectoris).

If blood sugar levels continue to drop, severe confusion (delirium), seizures, loss of self-control, shallow breathing, and slowed heartbeat may develop. You may lose consciousness and fall into a coma. The clinical picture of severe hypoglycemia may resemble that of a stroke.
In most cases, symptoms of low blood sugar disappear rapidly after ingesting sugar, for example glucose tablets, sugar cubes, sweet fruit juice, or sugared tea.
Therefore, you should always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Contact your doctor or go to the nearest hospital if sugar intake does not help or if symptoms recur.
Symptoms of low blood sugar may be absent, less evident, slow to appear, or you may not notice in time that your blood sugar level has dropped. This may occur in elderly patients treated with certain types of medicines (e.g. those acting on the central nervous system and beta-blockers).
It may also occur in certain endocrine disorders (e.g. certain thyroid dysfunctions, pituitary or adrenal insufficiency).
In case of particular physical stress conditions (e.g. injury, surgery, fever, etc.), your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) may occur when gliclazide has not yet sufficiently lowered blood sugar, when you do not follow your prescribed treatment plan, when taking St. John's wort (Hypericum perforatum) preparations (see "Other medicines and Gliclazide Krka"), or during particular stress situations. Symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced performance.
If you experience these symptoms, contact your doctor or pharmacist.
Blood sugar disturbances (low and high blood sugar levels) may occur when gliclazide is taken concomitantly with antibiotics known as fluoroquinolones, especially in elderly patients. In such cases, your doctor will remind you of the importance of monitoring blood glucose.
If you or someone in your family has the inherited condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency (a blood red cell abnormality), hemolysis (breakdown of red blood cells) and reduced hemoglobin levels (hemolytic anemia) may occur. Contact your doctor before taking this medicine.
Cases of acute porphyria have been reported with other sulfonylureas in patients with porphyria (inherited genetic disorders with accumulation of porphyrins or their precursors in the body).

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

Other medicines and Gliclazide Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The blood sugar-lowering effect of gliclazide may be enhanced and signs of low blood sugar may occur when taking any of the following medicines:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP1 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 for fungal infections (miconazole, fluconazole)
• medicines for gastroduodenal ulcers (H2 receptor antagonists)
• medicines for depression (monoamine oxidase inhibitors)
• painkillers and anti-rheumatic drugs (phenylbutazone, ibuprofen)
• medicines containing alcohol

The blood sugar-lowering effect of gliclazide may be weakened and blood sugar levels may rise when taking any of the following medicines:

• medicines for disorders of the central nervous system (chlorpromazine)
• medicines that reduce inflammation (corticosteroids)
• medicines for asthma or used during labor (intravenous salbutamol, ritodrine, terbutaline)
• medicines for breast disorders, heavy menstrual bleeding and endometriosis (danazol)
• St. John's wort preparations - Hypericum perforatum

Blood sugar disturbances (low and high blood sugar levels) may occur when Gliclazide Krka is taken concomitantly with antibiotics known as fluoroquinolones, especially in elderly patients.
Gliclazide Krka may enhance the effect of medicines that reduce blood clotting (e.g. warfarin).
Consult your doctor before starting any new medicine. If hospitalized, inform medical staff that you are taking Gliclazide Krka.

Gliclazide Krka with food, drinks and alcohol
Gliclazide Krka may be taken with food and non-alcoholic drinks.
Alcohol consumption is not recommended, as it may unpredictably affect diabetes control.

Pregnancy and breastfeeding
Gliclazide Krka is not recommended during pregnancy. If you are pregnant or breastfeeding, or suspect you are pregnant or are planning to become pregnant, consult your doctor so that a more suitable treatment can be prescribed for you.
You must not take Gliclazide Krka while breastfeeding.

Driving and using machines
Your ability to concentrate and react may be impaired if your blood sugar level is too low (hypoglycemia) or too high (hyperglycemia), or if visual disturbances occur due to these conditions. Be aware that you could harm yourself or others (e.g. when driving vehicles or operating machinery). Ask your doctor whether you can drive if:

• you have frequent episodes of low blood sugar (hypoglycemia),
• you have mild or no symptoms indicating low blood sugar (hypoglycemia).

Gliclazide Krka contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Gliclazide Krka

Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Your doctor will determine the dose based on your blood sugar levels and, if possible, urine sugar levels. Changes in external factors (for example, weight loss, changes in lifestyle, stress) or improvements in blood sugar control may require adjustments in the dose of gliclazide.
The recommended dose is one modified-release tablet of 30 mg up to two modified-release tablets of 60 mg (maximum 120 mg) taken as a single dose at breakfast. The dose depends on the response to treatment.
If combination therapy with Gliclazide Krka modified-release tablets and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl-peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin is initiated, your doctor will determine the appropriate dose for each medicine according to your individual condition.
If you notice that your blood sugar levels remain high despite taking the medicine as prescribed, contact your doctor or pharmacist.

Method of administration
For oral use.
Swallow the tablet(s) whole, without chewing or breaking.
Take your tablet(s) with a glass of water during breakfast (preferably at the same time every day).
You must always eat a meal after taking your tablet(s).

If you take more Gliclazide Krka than you should
If you have taken too many tablets, contact your doctor or the nearest emergency department immediately. Signs of overdose and of low blood sugar (hypoglycaemia) are described in section 2. Symptoms can be relieved by immediately taking sugar (4 to 6 sugar cubes) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, contact your doctor immediately or call emergency services. Do the same if someone else, for example a child, has taken the medicine by mistake. Do not give food or drink to unconscious patients.
Ensure that someone who is informed is always available to call a doctor in an emergency.

If you forget to take Gliclazide Krka
It is important that you take this medicine every day, as regular treatment works best. However, if you forget to take a dose of Gliclazide Krka, take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Gliclazide Krka
Since diabetes treatment usually lasts for life, you must discuss with your doctor before stopping this medicine. Stopping treatment may lead to high blood sugar levels (hyperglycaemia), increasing the risk of developing diabetes complications.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The assessment of side effects is based on their frequency.

Common (may affect up to 1 in 10 people):
The most commonly observed side effect is low blood sugar (hypoglycaemia) (see Warnings and precautions for symptoms and signs).
If left untreated, these symptoms may progress to drowsiness, loss of consciousness, or eventually coma. If an episode of low blood sugar is severe or prolonged, even if temporarily controlled by sugar intake, immediate medical assistance must be sought.

Uncommon (may affect up to 1 in 100 people):
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide Krka modified-release tablets are taken with meals as recommended.

Rare (may affect up to 1 in 1,000 people):
Blood disorders
Decreases in blood cell counts (e.g. platelets, red and white blood cells) have been reported, which may cause paleness, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually resolve upon 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 reported. The skin rash may progress to widespread blistering or skin peeling.
If you develop this condition, stop taking Gliclazide Krka immediately, seek urgent medical advice, and inform the doctor that you are taking this medicine.
Very rarely, signs of severe hypersensitivity reactions (DRESS) have been reported: initially presenting as flu-like symptoms and facial rash, followed by widespread rash with high fever.

Hepatic disorders
Isolated cases of abnormal liver function tests have been reported, which may cause yellowing of the skin and eyes (jaundice). If this occurs, consult your doctor immediately. These symptoms usually resolve when the medicine is discontinued. Your doctor will decide whether to discontinue treatment.

Eye disorders
Your vision may be temporarily affected, especially at the beginning of treatment. This effect is due to fluctuations in blood sugar levels.

As with other sulphonylureas, the following adverse events have been observed very rarely (may affect up to 1 in 10,000 people):
severe changes in blood cell counts, allergic inflammation of blood vessel walls (vasculitis), reduction in blood sodium levels (hyponatraemia), and signs of liver impairment (e.g. jaundice). These usually resolve after discontinuation of the sulphonylurea, but in isolated cases may lead to potentially fatal liver failure.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gliclazide Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gliclazide Krka contains

• The active substance is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
• The excipients are hypromellose, monohydrate lactose, anhydrous colloidal silica and magnesium stearate (See section 2 “Gliclazide Krka contains lactose”).

Description of the appearance of Gliclazide Krka and pack contents
White to off-white, oval, biconvex tablets, 13 mm in length and 3.5 - 4.9 mm thick.
Gliclazide Krka is available in packs of 14, 15, 28, 30, 56, 60, 84, 90, 120 or 180 modified-release tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative for Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

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 in the Member States of the European Economic Area under the following names:

PACKAGE LEAFLET

Package leaflet: information for the user

Gliclazide Krka 90 mg modified-release tablets

gliclazide
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Gliclazide Krka is and what it is used for
2. What you need to know before taking Gliclazide Krka
3. How to take Gliclazide Krka
4. Possible side effects
5. How to store Gliclazide Krka
6. Contents of the pack and other information

1. What Gliclazide Krka is and what it is used for

Gliclazide Krka is a medicine that lowers blood sugar levels (an oral antidiabetic medicine belonging to the sulfonylurea group).
Gliclazide Krka is used in adults for certain types of diabetes (type 2 diabetes mellitus) when diet, physical exercise, and weight loss alone are not sufficiently effective in maintaining blood sugar levels at an appropriate level.

2. What you need to know before taking Gliclazide Krka

Do not take Gliclazide Krka:

• if you are allergic to gliclazide or to any of the excipients of this medicine (listed in section 6), or to any medicine of the same group (sulfonylureas) or to related medicines (sulfonamide hypoglycemics);
• if you have insulin-dependent (type 1) diabetes;
• if you have ketones and sugar in your urine (this may indicate diabetic ketoacidosis), pre-coma or diabetic coma;
• if you have severe liver or kidney disease;
• if you are taking medicines for fungal infections (miconazole, see section “Other medicines and Gliclazide Krka”);
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Gliclazide Krka.
You must follow the treatment plan prescribed by your doctor to achieve appropriate blood sugar levels. This includes, in addition to regular tablet intake, following an appropriate diet, exercising, and, when necessary, losing weight.
During treatment with gliclazide, it is necessary to regularly monitor your blood glucose levels (and possibly urine glucose) as well as glycated hemoglobin (HbA1c).
During the first week of treatment, there may be an increased risk of low blood sugar levels (hypoglycemia). Therefore, close medical monitoring is required.
Low blood sugar levels (hypoglycemia) may occur:

• if you eat irregularly or skip meals,
• if you are fasting,
• if you are malnourished,
• if you change your diet,
• if you increase your physical activity without a corresponding increase in carbohydrate intake,
• if you drink alcohol, especially in combination with skipped meals,
• if you take other medicines or herbal remedies at the same time,
• if you take too high a dose of gliclazide,
• if you have a specific hormone-related syndrome (dysfunctions of the thyroid gland, pituitary gland, or adrenal cortex),
• if your kidney or liver function is severely reduced.

If you have low blood sugar levels, you may experience the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, agitation, aggression, poor concentration, reduced alertness and reaction time, depression, confusion, speech and vision disturbances, tremors, sensory disturbances, dizziness, and impotence.

The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden severe chest pain that may radiate to nearby areas (angina pectoris).
If blood sugar levels continue to drop, you may experience marked confusion (delirium), seizures, loss of coordination, shallow breathing, slowed heartbeat, or loss of consciousness.
In most cases, symptoms of hypoglycemia disappear very quickly when you consume some form of sugar, for example, glucose tablets, sugar lumps, sugary juice, or sweetened tea.
Therefore, you should always carry some form of sugar with you (glucose tablets, sugar lumps). Remember that artificial sweeteners are not effective. Contact your doctor or the nearest hospital if taking sugar does not help or if symptoms recur.
Symptoms of hypoglycemia may be absent, less pronounced, or develop very slowly, or you may not perceive in time that your blood sugar level has dropped. This may occur if you are an elderly patient taking certain medicines (e.g., those acting on the central nervous system and beta-blockers).
If you are under stress (e.g., accident, surgery, fever, etc.), your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar levels (hyperglycemia) may occur when gliclazide has not yet sufficiently lowered blood sugar, when the prescribed treatment plan is not followed, when you take St. John's wort (Hypericum perforatum) (see section “Other medicines and Gliclazide Krka”), or during particular stress situations. These symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced performance.
If you experience these symptoms, you should contact your doctor or pharmacist.
Blood glucose disturbances (low and high blood sugar levels) may occur when gliclazide is taken concurrently with a class of antibiotics called fluoroquinolones, particularly in elderly patients. In such cases, your doctor will remind you of the importance of monitoring blood glucose.
If you have a family history or are aware of having hereditary glucose-6-phosphate dehydrogenase (G6PD) deficiency (a red blood cell abnormality), hemolytic anemia (a drop in hemoglobin and breakdown of red blood cells) may occur. Consult your doctor before taking this medicine.

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

Other medicines and Gliclazide Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The blood sugar-lowering effect of gliclazide may be enhanced, and signs of low blood sugar may occur when taking the following medicines:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists, or insulin);
• antibiotics (e.g., sulfonamides, clarithromycin);
• medicines for high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril);
• medicines for fungal infections (miconazole, fluconazole);
• medicines for stomach or duodenal ulcers (H-\receptor antagonists);
• medicines for depression (monoamine oxidase inhibitors);
• painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The blood sugar-lowering effect of gliclazide may be weakened, and increased blood sugar levels may occur when taking any of the following medicines:

• medicines for disorders of the central nervous system (chlorpromazine);
• medicines to reduce inflammation (corticosteroids);
• medicines for asthma or used during childbirth (intravenous salbutamol, ritodrine, terbutaline);
• medicines for breast disorders, excessive menstrual bleeding, and endometriosis (danazol);
• St. John's wort preparations (Hypericum perforatum).

Blood glucose disturbances (low and high blood sugar levels) may occur when Gliclazide Krka is prescribed concurrently with a class of antibiotics called fluoroquinolones, especially in elderly patients.

Gliclazide Krka may enhance the effect of medicines that reduce blood clotting (e.g., warfarin).
Consult your doctor before starting treatment with other medicines. If you are admitted to hospital, inform the medical staff that you are taking Gliclazide Krka.

Gliclazide Krka with food, drinks, and alcohol
Gliclazide Krka may be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended as it may unpredictably affect diabetes control.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning a pregnancy, consult your doctor so that they can prescribe the most appropriate treatment for you.
Gliclazide Krka is not recommended during pregnancy.
You must not take Gliclazide Krka while breastfeeding.

Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar level is too low (hypoglycemia) or too high (hyperglycemia), or if you experience visual disturbances as a result of these conditions.
Be aware that you may put yourself or others at risk (e.g., when driving a vehicle or operating machinery). Ask your doctor if you can drive if:

• you have frequent episodes of low blood sugar (hypoglycemia),
• you have few or no symptoms indicating low blood sugar (hypoglycemia).

Gliclazide Krka contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Gliclazide Krka

Dosage
Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose according to your blood sugar levels and possibly your urine sugar levels.
Changes due to external factors (e.g. weight loss, changes in lifestyle, stress) or improvement in blood sugar levels may require adjustment of the gliclazide dose.
The recommended dose is 30 mg up to 120 mg of gliclazide modified-release tablets taken as a single dose at breakfast. This depends on your response to treatment.
The tablet can be divided into three equal parts to ensure administration of each of the following doses:
a dose of 30 mg (take one-third of a tablet), a dose of 60 mg (take two-thirds of a tablet), a dose of 90 mg (take one whole tablet), and a dose of 120 mg (take one whole tablet plus one-third of another tablet).
You may divide the tablet into three equal parts for easier intake.
If combination therapy with Gliclazide Krka modified-release tablets and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin is initiated, your doctor will individually determine the correct dose of each medicine for you.
If you notice high blood sugar levels despite taking the medicine as prescribed, you must contact your doctor or pharmacist.

Method of administration
Oral use

How to remove the tablet from the packaging:

1. Hold the blister by the edges, bend along the perforations and separate one blister cell from the rest by gently tearing along the perforations around it.
2. Lift the edge of the foil and completely remove the film.
3. Take the tablet in your hand.

How to divide the Gliclazide Krka tablet:
The tablet is marked with two break lines so that it can be divided into three equal parts.

4. Break the tablet by hand along the score lines. Hold the tablet between thumb and index finger close to the score line for your required dose, as shown in figure 4. Do not divide the tablet in any other way.

Swallow the tablet or a third(s) of the tablet whole with a glass of water at breakfast time (and preferably at the same time every day).
Do not chew or crush.
You should always consume a meal after taking this medicine.

If you take more Gliclazide Krka than you should
If you take too many tablets, contact your doctor or the nearest emergency department immediately.
The signs of an overdose and of low blood sugar (hypoglycaemia) are described in section 2.
Symptoms can be relieved immediately by taking sugar (4 to 6 sugar cubes) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, contact your doctor immediately or call emergency services. The same applies if someone (e.g. a child) has taken the product accidentally. Unconscious patients must not be given food or drink.
Ensure that there is always an informed person available who can call the doctor in case of emergency.

If you forget to take Gliclazide Krka
It is important that the medicine is taken every day regularly for the treatment to be effective.
However, if you forget to take a dose of Gliclazide Krka, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Gliclazide Krka
Since diabetes treatment is usually lifelong, you must discuss with your doctor before stopping treatment with this medicine. Stopping treatment may cause high blood sugar levels (hyperglycaemia), which increases the risk of developing diabetes complications.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The assessment of side effects is based on their frequency.
The most commonly observed adverse effect is low blood sugar (hypoglycaemia) (for symptoms and signs, see section “Warnings and precautions”).
If left untreated, these symptoms could progress to drowsiness, loss of consciousness or, eventually, coma. If an episode of hypoglycaemia is severe or prolonged, even if temporarily controlled by taking sugar, contact your doctor immediately.
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhoea and constipation. These effects are reduced when Gliclazide Krka modified-release tablets are taken with meals as recommended.
Blood disorders
Decreased number of blood cells (e.g. platelets, red blood cells and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually disappear when treatment is discontinued.
Skin disorders
Skin reactions such as rash, redness, itching, urticaria and angioedema (rapid swelling of tissues such as the eyelids, face, lips, mouth, tongue or throat which may cause breathing difficulties) have been reported. The rash may progress to widespread blisters or skin peeling.
Very rarely, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and skin rash on the face, followed by widespread rash with high fever.
Liver disorders
There have been isolated cases of abnormal liver function, which may cause yellowing of the skin and eyes. If this occurs, consult your doctor immediately. Symptoms generally disappear if treatment is stopped. Your doctor will decide whether to discontinue treatment.
Eye disorders
Your vision may be temporarily affected, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.
As with other sulphonamides, the following adverse events have been observed:
cases of severe changes in blood cell counts and allergic inflammation of blood vessel walls (vasculitis), reduction in sodium levels in the blood (hyponatraemia), symptoms of liver failure (e.g. jaundice), which in most cases disappear after discontinuation of the sulphonylurea, but which in rare cases may lead to life-threatening liver failure.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gliclazide Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gliclazide Krka contains

• The active substance is gliclazide. Each modified-release tablet contains 90 mg of gliclazide.
• The other ingredients are hypromellose, monohydrate lactose, anhydrous colloidal silica and magnesium stearate. See section 2 “Gliclazide Krka contains lactose”.

Description of the appearance of Gliclazide Krka and contents of the pack
White to off-white, capsule-shaped, biconvex tablets with two score lines around the tablet.
The tablet can be divided into equal doses.
Tablet dimensions: length of 17.0 – 17.5 mm and width of 4.6 – 5.4 mm.
Gliclazide Krka is available in boxes containing 10 x 1, 30 x 1, 40 x 1 or 60 x 1 modified-release tablet in single-dose perforated blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative for Italy:
KRKA Farmaceutici Milano s.r.l., Viale Achille Papa 30, 20149 Milano, Italy

Responsible manufacturer for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Str.5, 27472 Cuxhaven, Germany

This medicinal product is authorized in the European Economic Area countries under the following names: