GLICLAZIDE 30 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

1. Gliclazide Krka 30 mg modified-release tablets
   1. What is Gliclazide Krka and what is it used for
   2. What you need to know before you take 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
2. Gliclazide Krka 60 mg modified-release tablets
   1. What is Gliclazide Krka and what is it used for
   2. What you need to know before you take 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
3. Gliclazide Krka 90 mg modified-release tablets
   1. What is Gliclazide Krka and what is it used for
   2. What you need to know before you take 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

Gliclazide Krka 30 mg modified-release tablets

gliclazide

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even 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 you take 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 is Gliclazide Krka and what is it used for

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

2. What you need to know before you take Gliclazide Krka

Do not take Gliclazide Krka

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

Warnings and precautions
Tell 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 means, in addition to regularly taking the tablet, you must follow a dietary regime, exercise and, if necessary, lose weight.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly in the urine) and also of your glycated hemoglobin (HbA ) is necessary.
In the first weeks of treatment, the risk of developing low blood sugar levels (hypoglycemia) may increase. It is therefore vital that you are carefully monitored by your doctor.
A low blood sugar level (hypoglycemia) can occur:

• if you eat meals irregularly or skip them altogether,
• if you are fasting,
• if you are malnourished,
• if you change your diet,
• if you increase your physical activity without adequate increase in carbohydrate intake,
• if you drink alcohol, especially if you have also skipped a meal,
• if you take other medicines or natural remedies at the same time,
• if you take high doses of gliclazide,
• if you suffer from particular hormone-induced disorders (functional disorders of the thyroid, pituitary or adrenal cortex),
• if your kidney or liver function is severely impaired. If you suffer from a low blood sugar level, you may develop the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, poor concentration, reduced alertness and reaction times, depression, confusion, visual or speech disturbances, tremor, sensory disturbances, dizziness and fatigue. The following signs and symptoms may also develop: sweating, clammy 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 fall, you may experience significant confusion (delirium), develop seizures, lose self-control, your breathing may weaken and your heartbeat may slow down, you may lose consciousness.

In most cases, the symptoms of a low blood sugar level resolve very quickly when you consume some form of sugar, e.g. glucose tablets, sugar cubes, sweet fruit juice, sugared tea. Therefore, you should always carry sugar with you 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.
The symptoms of a low blood sugar level may be absent, less obvious or develop very slowly, or you may not realize in time that your blood sugar levels have dropped.
This can happen if you are an elderly patient taking certain medications (e.g. those that act on the central nervous system or beta-blockers).
If you are in a stressful situation (e.g. accidents, 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 lowered blood sugar sufficiently, when you have not adhered to the treatment plan prescribed by your doctor, if you are taking preparations based on St. John's Wort (Hypericum perforatum) (see paragraph “Other medicines and Gliclazide Krka”) or in particular stressful situations. These may include thirst, frequent urination, dry mouth, dry skin with itching, skin infections and reduced performance.
If you experience these symptoms, you should contact your doctor or pharmacist.
Changes in glucose levels in the blood (low blood sugar levels and high blood sugar levels) may occur when gliclazide is prescribed in conjunction with antibiotics belonging to a class called fluoroquinolones, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.
If you have a family history or if you know you have a hereditary deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD) (red blood cell abnormality), a reduction in hemoglobin levels and red blood cell breakdown (hemolytic anemia) may occur. Contact your doctor before taking this medicine.
Cases of acute porphyria have been described with other sulfonylureas, in patients affected by porphyria (inherited genetic diseases with 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 the age of 18 years.

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 strengthened and signs of low blood sugar levels may occur when you take one of the following medicines:

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

The blood glucose lowering effect of gliclazide may be weakened and increases in blood sugar levels may occur when you take one of the following medicines:

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

Changes in glucose levels in the blood (low blood sugar levels and high blood sugar levels) may occur when Gliclazide Krka is taken in conjunction with antibiotics belonging to a class called fluoroquinolones, especially in elderly patients.
Gliclazide Krka may increase the effect of medicines that reduce blood clotting (e.g. warfarin).
Consult your doctor before starting to take another 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 can be taken with food and non-alcoholic beverages.
Consumption of alcohol is not recommended as it may alter the control of your diabetes in an unpredictable way.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor for advice before taking this medicine so that they can prescribe a more appropriate treatment.
Gliclazide Krka is not recommended for use during pregnancy.
You should not take Gliclazide Krka during breastfeeding.

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

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

Gliclazide Krka contains lactose
If you have been diagnosed with lactose intolerance by your doctor, contact them before taking this medicine.

3. How to take Gliclazide Krka

Dosage
Always take Gliclazide Krka exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
The dose is determined by your doctor, depending on your blood sugar levels and possibly
in your urine. Any changes in external factors (e.g. weight loss, changes in lifestyle, stress) or any
improvements in blood sugar control may require a modification in the doses of gliclazide.
The recommended initial dose is one tablet once a day.
The usual dose may vary from 1 up to a maximum of 4 tablets in a single dose at
breakfast. This depends on the response to treatment.
If a combination therapy of Gliclazide Krka with metformin, an alpha
glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor
agonist or insulin is started, your doctor will determine the appropriate dose of each medicine for you
personally.
If you notice that your blood sugar levels are high even when you take the medicine as prescribed,
you should contact your doctor or pharmacist.

Route of administration and method of administration
Oral use.
Swallow the tablets whole. Do not chew them.
Take the tablet(s) with a glass of water at breakfast, preferably
always at the same time of day. You must always consume a meal after taking the tablet(s).

If you take more Gliclazide Krka than you should
If you take more tablets, contact your doctor or the nearest hospital emergency room immediately. The signs of an overdose are those of low blood sugar (hypoglycemia)
described in paragraph 2. The symptoms can be relieved by consuming sugar (4-6
cubes) or sugary drinks immediately, followed by a substantial snack or meal. If the patient is unconscious, inform the doctor immediately and call emergency services. The same must
be done if someone, e.g. a child, has ingested the product unintentionally. Do not give food or drinks to unconscious patients.
It is important to ensure that there is always a person informed who can call a doctor in case of
emergency.

If you forget to take Gliclazide Krka
It is important that you take the medicine every day so that regular treatment is 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 a missed dose.

If you stop taking Gliclazide Krka
Because diabetes treatment is generally long-term, you should discuss it with your doctor
before stopping taking the medicine. Stopping may lead to an increase in
blood sugar levels (hyperglycemia) which increases the risk of developing complications of
diabetes.
If you have any doubts 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 everybody gets them.
The most common side effect observed is low blood sugar levels
(hypoglycemia). For signs and symptoms, see section “Warnings and precautions”.
If these symptoms are not treated, they can progress to drowsiness, loss of consciousness or
possibly coma. If an episode of low blood sugar is severe or prolonged, even if
controlled by consuming sugar, you should seek immediate medical assistance.

Liver disorders
There have been isolated reports of liver function changes, which can cause
yellowing of the skin and eyes. If this occurs, consult your doctor immediately. The
symptoms usually disappear if you stop taking the medicine. The doctor will decide whether to
discontinue treatment.

Skin disorders
Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of the
tissues such as eyelids, face, lips, mouth, tongue or throat that can cause difficulty breathing).
The rash may progress to widespread blistering or peeling of the skin.
If you develop this disorder, stop taking Gliclazide Krka, seek urgent medical advice
and tell them that you are taking this medicine.
Exceptionally, signs of a severe hypersensitivity reaction (DRESS) have been reported,
initially as flu-like symptoms and a rash on the face followed by widespread rash with high temperature.

Blood disorders
Decrease in the number of blood cells (e.g. platelets, red blood cells and white blood cells) which
can cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually
disappear when treatment is stopped.

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

Vision disorders
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 sulfonylureas, the following side effects have been observed:
cases of severe changes in the number of blood cells and allergic inflammation of the walls of the
blood vessels, reduced sodium levels in the blood (hyponatremia), symptoms of impaired liver function (e.g.
jaundice), which in the majority of cases disappeared with the suspension of sulfonylureas, but in
isolated cases may lead to life-threatening liver failure.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
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 which is stated on the blister, bottle and carton
after EXP.. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gliclazide Krka contains

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

Description of the appearance of Gliclazide Krka and contents of the pack
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 of 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 Milano, Italy

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:

Gliclazide Krka 60 mg modified-release tablets

gliclazide

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 is Gliclazide Krka and what is it used for

Gliclazide Krka is a medicine that reduces blood sugar levels (an antidiabetic medicine to be taken orally, belonging to the group of sulfonylureas).
Gliclazide Krka is used in some forms of diabetes in adults (type 2 diabetes mellitus), when diet, 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 you take 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 other related medicines (sulfonamide hypoglycemic agents);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), pre-coma or diabetic coma;
• if you have severe liver or kidney dysfunction;
• if you are taking medicines for the treatment of fungal infections (miconazole, see the section "Gliclazide Krka and other medicines");
• if you are breastfeeding (see the 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 therapeutic plan prescribed by
your doctor. This means, in addition to regularly taking the tablets, following an appropriate
diet, exercising and, if necessary, losing weight.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly in urine) and also of glycated hemoglobin levels (HbA1c) is necessary.
The risk of having low blood sugar levels (hypoglycemia) is greater in the
first weeks of treatment. Therefore, it is essential that you are carefully monitored by
the doctor.
Cases of low blood sugar (hypoglycemia) can occur:

• if meal intake is irregular or if meals are skipped completely,
• in case of fasting,
• in case of malnutrition,
• if you change your diet,
• in case of increased physical activity without an adequate increase in carbohydrate intake,
• in case of consumption of alcoholic beverages, especially if combined with lack of food,
• if you are taking other medicines or natural remedies at the same time,
• in case of too high doses of gliclazide,
• in case of particular hormonal disorders (functional disorders of the thyroid, pituitary or adrenal cortex),
• if kidney or liver function is severely impaired. If you suffer from low blood sugar, the following symptoms may occur: headache, excessive hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, poor concentration, reduced alertness and reactivity, depression, confusion, speech and vision disorders, tremor, sensory disturbances, dizziness and feeling of powerlessness. The following signs and symptoms may also occur: sweating, clammy skin, anxiety, irregular or rapid heartbeat, increased blood pressure and severe sudden chest pain that may radiate to nearby areas (angina pectoris).

If blood sugar levels continue to drop, a significant state
of confusion (delirium), convulsions, loss of self-control, shallow breathing and slowing
of the heartbeat can occur, you may lose consciousness and it is possible to enter a coma. The clinical picture of a
severe reduction in blood sugar levels can resemble that of a stroke.
In most cases, the symptoms of low blood sugar disappear very quickly when you
ingest sugar, e.g. glucose tablets, sugar cubes, sweet fruit juice, 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 go to the nearest
hospital if ingesting sugar does not help or if symptoms recur.
The symptoms of low blood sugar may be absent or less evident, or may manifest slowly, or you may not notice in time that your blood sugar level has dropped. This can happen in the case
of elderly patients treated with certain types of medicines (for example those that act on
the central nervous system and beta-blockers).
It can also happen in the case of particular types of endocrine system disorders (e.g. some pathologies
of thyroid function and pituitary and adrenal insufficiency).
In case of particular conditions of physical stress (for example injury, surgery, fever,
etc.) the doctor may temporarily decide to switch to insulin therapy.
Symptoms of high blood sugar levels (hyperglycemia) can occur when gliclazide
has not yet sufficiently reduced blood sugar, when you do not follow the treatment plan prescribed by
your doctor, if you take St. John's Wort preparations ( Hypericum

perforatum) (see "Other medicines and Gliclazide Krka"), or in particular stressful situations. The
symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections
and decreased performance.
If these symptoms occur, contact your doctor or pharmacist.
Disturbances of blood sugar (low and high blood sugar levels) can occur when
Gliclazide Krka is taken at the same time as medicines belonging to the class of antibiotics
called fluoroquinolones, especially in elderly patients. In this case, your doctor will remind you
of the importance of monitoring blood sugar.
If you or someone in your family has the hereditary condition known as glucose-6-
phosphate dehydrogenase (G6PD) deficiency (blood red blood cell abnormality), a
decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia) may occur. Contact your
doctor before taking this medicine.
Cases of acute porphyria have been described with other sulfonylureas, in patients affected by porphyria (inherited
genetic diseases with accumulation of porphyrins or 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 potentiated and signs of low blood sugar may occur when you take one of the following
medicines:

• other medicines used to treat high blood sugar levels (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 the treatment of fungal infections (miconazole, fluconazole)
• medicines for the treatment of gastric and duodenal ulcers (H2 receptor antagonists)
• medicines to treat depression (monoamine oxidase inhibitors)
• pain relievers and anti-rheumatic drugs (phenylbutazone, ibuprofen)
• medicines containing alcohol

The blood sugar-lowering effect of gliclazide may be weakened and blood sugar levels may increase when you take one of the following
medicines:

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

Disturbances of blood sugar (low and high blood sugar levels) can occur when
Gliclazide Krka is taken at the same time as medicines belonging to the class of antibiotics
called fluoroquinolones, especially in elderly patients.
Gliclazide Krka may increase the effect of medicines that reduce blood clotting (for
example warfarin).
Consult your doctor before starting to take another medicine. If you are hospitalized
tell the medical staff that you are taking Gliclazide Krka.

Gliclazide Krka with food, drinks and alcohol
Gliclazide Krka can be taken with food and non-alcoholic beverages.
Consumption of alcohol is not recommended as it can alter the control of diabetes in an
unpredictable manner.

Pregnancy and breastfeeding
Gliclazide Krka is not recommended for use during pregnancy. If you are pregnant or breastfeeding, if you suspect or
are planning a pregnancy, ask your doctor for advice so that they can prescribe you
a more suitable treatment.
You should not take Gliclazide Krka while breastfeeding.

Driving and using machines
Your ability to concentrate and react may be affected if your blood sugar level is too low (hypoglycemia) or too high (hyperglycemia) or if you experience vision disorders as a result of these conditions. Keep in mind that you could harm yourself or others (e.g. by driving vehicles or using machinery). Ask your doctor if you can drive a
vehicle 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 lactose intolerance, contact them before taking
this medicine.

3. How to take Gliclazide Krka

Dosage
Take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.
The dose is determined by the doctor based on blood sugar levels and possibly in the urine.
Changes in external factors (for example, weight loss, changes in lifestyle, stress) or
improvements in blood sugar control may require adjustments to 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) in a single dose at breakfast. The dose depends
on the response to treatment.
If combination therapy with Gliclazide Krka modified-release tablets with
metformin, an alpha glucosidase inhibitor, a thiazolidinedione, a dipeptidyl-
peptidase-4 inhibitor, a GLP1 receptor agonist or insulin is started, the doctor will determine the appropriate dose for each medicine
for your case.
If you notice that your blood sugar levels are high even though you are taking the medicine as
prescribed, contact your doctor or pharmacist.

Method of administration
For oral use
Swallow the tablet(s) whole, in one piece. Do not chew or break.
Swallow your tablet(s) with a glass of water during breakfast (and
preferably every day at the same time).
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 room immediately. The
signs of an overdose and of low blood sugar (hypoglycemia) are described in
paragraph 2. The symptoms can be counteracted by immediately taking sugar (4 to 6 sugar lumps) or
sugary drinks, followed by a substantial snack or meal. If the patient is unconscious
inform the doctor immediately or call emergency services. Do the same if someone,
for example a child, has taken the medicine unintentionally. Do not administer
food or drinks to unconscious patients.
Make sure there is always a person informed beforehand who can call a
doctor in case of emergency.

If you forget to take Gliclazide Krka
It is important that you take the medicine every day as regular treatment works best.
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 treatment for diabetes usually lasts for life, you should discuss this with your
doctor before stopping taking this medicine. Stopping it can cause high blood sugar levels (hyperglycemia), which increases the risk of developing complications of diabetes.
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 everybody gets 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 (hypoglycemia) (for
symptoms and signs see Warnings and precautions).
These symptoms, if not treated, can progress to drowsiness, loss of consciousness or
eventually coma. If an episode of low blood sugar is severe or prolonged, even if it is
temporarily controlled by the ingestion of sugar, immediate medical assistance should be sought.

Uncommon(may affect up to 1 in 100 people):

Gastrointestinal disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation. These effects are reduced
when Gliclazide Krka modified-release tablets are taken with meals as recommended.

Rare(may occur in up to 1 in 1,000 people):

Blood disorders
Decreases in the number of blood cells (for example, platelets, red blood cells and
white blood cells) have been reported, which can cause pallor, prolonged bleeding, bruising, sore throat and fever.
These symptoms usually disappear with discontinuation of treatment.

Skin disorders
Skin reactions such as rash, redness, itching, hives, blisters,
angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat which can
cause difficulty breathing) have been reported. The rash may progress to widespread blistering or
scaling of the skin.
If this disorder develops, stop taking Gliclazide Krka, seek urgent medical advice
and tell them that you are taking this medicine.
Signs of severe hypersensitivity reactions (DRESS) have been reported exceptionally: initially
as flu-like symptoms and rash on the face, followed by widespread rash with
high fever.

Liver disorders
There have been isolated cases of abnormal liver function tests, which can cause yellowing
of the skin and eyes. If this occurs, consult your doctor immediately. These symptoms
generally disappear when the medicine is discontinued. The doctor will decide whether to stop the
treatment.

Eye disorders
Your vision may be altered for a short period, especially at the beginning of treatment.
This effect is due to variations in blood sugar levels.
As with other sulfonylureas, the following adverse events have been observed very rarely (may
occur in up to 1 in 10,000 people):
cases of severe changes in the number of blood cells and allergic inflammation of the walls
of blood vessels, reduction of sodium in the blood (hyponatremia), symptoms of impaired
liver function (for example jaundice), which have regressed in most cases after discontinuation
of the sulfonylurea but which, in isolated cases, can lead to potentially fatal liver failure.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through
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 which is stated on the blister and the packaging after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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, lactose monohydrate, 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, oval, biconvex tablets, with a length of 13 mm and a thickness of
3.5 - 4.9 mm.
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 Authorisation 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 designations:

Gliclazide Krka 90 mg modified-release tablets

gliclazide

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 is Gliclazide Krka and what is it used for

Gliclazide Krka is a medicine that reduces blood sugar levels (oral anti-diabetic medicine, belonging to the sulfonylurea group).
Gliclazide Krka is used in adults for certain forms of diabetes (type 2 diabetes mellitus)
when diet, exercise and weight loss alone are not sufficiently effective in
maintaining blood sugar levels at a correct level.

2. What you need to know before you take Gliclazide Krka

Do not take Gliclazide Krka:

• if you are allergic to gliclazide or any of the excipients of this medicine (listed in section 6), or to any medicine of the same group (sulfonylureas) or to other related medicines (sulfonamide hypoglycemic agents);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma;
• if you have a severe liver or kidney disease;
• if you are taking medicines for the treatment of fungal infections (miconazole, see paragraph “Other medicines and Gliclazide Krka”);
• if you are breastfeeding (see paragraph “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 means, in addition to regularly taking the tablet, also following
an appropriate diet, exercising and, if necessary, reducing your weight.
During treatment with gliclazide, blood glucose levels (and possibly urine) and also glycated hemoglobin (HbA1c) must be monitored regularly.
In the first week of treatment, the risk of having a reduction in blood sugar levels (hypoglycemia) may increase. Therefore, close medical supervision is necessary.
Low blood sugar levels (hypoglycemia) can occur:

• if you eat food irregularly or if you skip meals,
• if you are fasting,
• if you are malnourished,
• if you change your diet,
• if you increase your physical activity without an appropriate increase in carbohydrate intake,
• if you drink alcohol, especially in combination with skipping meals,
• if you take other medicines or natural remedies at the same time,
• if you take too high doses of gliclazide,
• if you suffer from a particular hormone-induced syndrome (functional disorders of the thyroid gland, pituitary gland or adrenal cortex),
• if your kidney or liver function is severely impaired. 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, visual and speech disturbances, tremor, sensory disturbances, dizziness and impotence.

The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden severe chest pain that may radiate to nearby areas (angina pectoris).
If blood sugar levels continue to decrease, you may suffer from significant confusion
(delirium), develop convulsions, lose control, breathing may be shallow and the heartbeat
slowed, you may lose consciousness.
In most cases, the symptoms of hypoglycemia disappear very quickly when
you consume some form of sugar, for example, glucose tablets, sugar lumps,
sugary juice, sugary tea.
You should therefore 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 noticeable or develop very slowly, or you may not
be aware in time that your blood sugar level has dropped. This can happen if you are an
elderly patient taking certain medications (e.g. those that act on the central nervous
system and beta-blockers).
If you are in stressful situations (e.g. accident, surgery, fever, etc.), your doctor may
temporarily switch you to insulin therapy.
Symptoms of high blood sugar levels (hyperglycemia) can occur when gliclazide
has not yet sufficiently reduced blood sugar, when you have not followed the treatment plan prescribed by your doctor, if you take St. John's wort preparations ( Hypericum

perforatum) (see section “Other medicines and Gliclazide Krka”) or in particular stressful 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.
Disturbances in blood glucose levels (low and high blood sugar levels) can occur
when gliclazide is prescribed at the same time as a class of antibiotics called
fluoroquinolones, especially 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 are aware of having a hereditary deficiency of glucose-6-phosphate
dehydrogenase (G6PD) (an abnormality of red blood cells), a decrease in hemoglobin levels and the breakdown of red blood cells (hemolytic anemia) 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The effect of gliclazide in lowering blood sugar levels may be strengthened and
signs of such lowering may occur when the following medicines are taken:

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

The effect of gliclazide in lowering blood sugar levels may be weakened and
an increase in blood sugar levels may occur when one of the following
medicines is taken:

• medicines for the treatment of disorders of the nervous system (chlorpromazine);
• medicines to reduce inflammation (corticosteroids);
• medicines for the treatment of asthma or used during childbirth (salbutamol intravenously, ritodrine, terbutaline);
• medicines for the treatment of breast diseases, excessive menstrual bleeding and endometriosis (danazol)
• St. John's wort preparations - Hypericum perforatum.Disturbances in blood glucose levels (low and high blood sugar levels) may occur when Gliclazide Krka is prescribed at the same time as a class of antibiotics called fluoroquinolones, especially in elderly patients.

Gliclazide Krka may increase the effect of medicines that reduce blood clotting (for
example, 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 can be taken with food and non-alcoholic beverages.
It is not recommended to drink alcohol as it can alter diabetes control in an unpredictable way.

Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, suspect you are pregnant or are planning a
pregnancy, ask your doctor for advice so they can prescribe the most suitable treatment for you.
Gliclazide Krka is not recommended during pregnancy.
You should 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 have visual disturbances as
a result of these conditions.
Be aware that you may endanger yourself or others (e.g. when driving a vehicle or
using machinery). Ask your doctor if you can drive if:

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

Gliclazide Krka contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Gliclazide Krka

Dosage
Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.
The dose is determined by your doctor depending on your blood sugar levels and possibly
your urine.
Changes due to external factors (e.g. weight loss, lifestyle changes, stress) or
improvement in blood sugar levels may require an adjustment of the doses of
gliclazide.
The recommended dose is 30 mg up to 120 mg of Gliclazide modified-release tablets in one
single dose at breakfast. This depends on the response to treatment.
The tablet can be divided into three equal parts to ensure the intake 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 and one third of another tablet).
You can also divide the tablet into three equal parts for easier intake.
If combination therapy of Gliclazide Krka modified-release tablets with
metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl
peptidase 4 inhibitor, a GLP-1 receptor agonist or insulin is started, the doctor will determine the correct dose of each
medicine individually for you.
If you notice that blood sugar levels are high, even if you are taking the medicine as
prescribed, you should 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 a blister cell from the rest of the blister by gently tearing along the perforations around it.
• 2. Lift the foil and remove it completely.

• 3. Take the tablet in your hand.

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

• 4. Divide the tablet by hand along the score lines. Hold the tablet between your thumb and index finger near the score line for your dose of medicine as shown in figure 4. Do not divide the tablet differently .

Swallow the tablet or one-third(s) of the tablet in one piece with a glass of water at
breakfast time (and preferably at the same time each 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 room immediately. The
signs of an overdose and of low blood sugar (hypoglycemia) 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, inform the
doctor or call emergency services immediately. The same should be done if someone, e.g. a child,
has taken the product unintentionally. Unconscious patients should not be given food or drinks.
It is necessary to ensure that there is always a person informed 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 a missed dose.

If you stop taking Gliclazide Krka
Since treatment for diabetes is usually lifelong, you should discuss this with your doctor before
stopping treatment with this medicine. Stopping may cause high blood sugar levels (hyperglycemia), which increase the risk of developing diabetes complications.
If you have any questions about using 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 side effect is low blood sugar
(hypoglycemia) (for symptoms and signs see section “Warnings and precautions”).
If not treated, these symptoms may progress to drowsiness, loss of consciousness, or,
eventually, coma. If an episode of hypoglycemia is severe or prolonged, even if it is temporarily
controlled by taking sugar, contact your doctor immediately.

Gastrointestinal disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhea 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 can cause paleness, prolonged bleeding, bruising, sore throat
and fever have been reported. These symptoms usually disappear when treatment is stopped.

Skin disorders
Skin reactions such as rash, redness, itching, urticaria, angioedema (rapid
swelling of the tissues, such as eyelids, face, lips, mouth, tongue or throat that can cause difficulty
breathing) have been reported. The rash may progress to widespread blisters or peeling of the skin.
Exceptionally, signs of severe hypersensitivity reactions (DRESS) have been reported: initially
as flu-like symptoms and rash on the face, followed by widespread rash
with high temperature.

Liver disorders
There have been isolated cases of abnormal liver function, which can cause yellowing of the skin
and eyes. If this occurs, consult your doctor immediately. Symptoms generally
disappear if treatment is stopped. The doctor will decide whether to stop treatment.

Eye disorders
Your vision may be affected for a short time, especially at the beginning of treatment. This
effect is due to changes in blood sugar levels.
As with other sulfonylureas, the following adverse events have been observed:
cases of severe alterations in the number of blood cells and allergic inflammation of the wall of the
blood vessels, reduced sodium in the blood (hyponatremia), symptoms of liver failure (e.g.
jaundice) which in most cases disappear after stopping the sulfonylurea, but which
can lead, in isolated cases, to life-threatening liver failure.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell
your doctor or pharmacist. You can also report side effects directly through
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 which is stated on the blister and the packaging after
EXP. The expiry date refers to the last day of the month.
This medicine does not require particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gliclazide Krka contains

• The active ingredient is gliclazide. Each modified-release tablet contains 90 mg of gliclazide.
• The other ingredients are hypromellose, lactose monohydrate, 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
tablets in perforated single-dose blisters.
Not all pack sizes may be marketed.

Marketing Authorisation 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 responsible 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 authorised in the Member States of the European Economic Area with the following
denominations: