Package Leaflet: Information for the Patient

Gliclazide Krka 30 mg Modified Release Tablets

Read this leaflet carefully before you start to take this medicine,because it contains important information for you.

• Keep this leaflet, as 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 harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Gliclazida Krka is a medication that reduces blood sugar levels (oral antidiabetic medicationbelonging to the sulfonilureas group).

Gliclazida Krka is used for the treatment of a type of diabetes (type 2 diabetes mellitus) in adults, when diet, physical exercise, and weight loss alone do not have an adequate effect to maintain blood sugar levels at suitable levels.

Do not take Gliclazida Krka

• if you are allergic (hypersensitive) to gliclazide or to any of the other ingredients of this medicine (listed in section 6), to other medicines in the same group (sulfonilureas), or to other related medicines (sulfonamide hypoglycemic agents),
• if you have insulin-dependent diabetes (type 1),
• if you have ketones and sugar in your urine (which may mean you have diabetic ketoacidosis), precoma or diabetic coma,
• if you have severe liver or kidney disorders,
• if you are receiving treatment for fungal infections (miconazole, see section “Other medicines and Gliclazida Krka”),
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gliclazida Krka.

You must follow the treatment prescribed by your doctor to achieve adequate blood sugar levels. This means that, in addition to regular intake of the tablets, you must control your diet, exercise regularly and, if necessary, lose weight.

During treatment with gliclazide, regular control of blood sugar levels (and possibly urine) and also hemoglobin A1c (HbA1c) is required.

During the first weeks of treatment, there may be an increased risk of low blood sugar (hypoglycemia). Therefore, it is essential that your doctor closely monitors you.

Low blood sugar (hypoglycemia) may occur:

• if you take meals irregularly or skip them,
• if you are fasting,
• if you are malnourished,
• if you change your diet,
• if you increase physical activity without an appropriate increase in carbohydrate intake,
• if you drink alcohol, especially if you have missed a meal,
• if you take other medicines or natural remedies at the same time,
• if you take high doses of gliclazide,
• if you have endocrine disorders (thyroid, pituitary or adrenal gland disorders),
• if your renal or hepatic function is severely impaired.

If your blood sugar levels drop, you may experience the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, nervousness, irritability, decreased concentration, decreased alertness and reaction time, depression, confusion, speech and visual disturbances, tremors, sensory disturbances, dizziness and feeling of helplessness.

Other signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure and severe and sudden chest pain that may spread to adjacent areas (angina pectoris).

If blood sugar levels continue to drop, you may feel considerable confusion (delirium), develop seizures, loss of control, shallow breathing and a slower heart rate, which may lead to loss of consciousness.

In most cases, symptoms of low blood sugar disappear quickly when sugar is taken in any form, e.g. glucose tablets, sugar cubes, sugary drinks, sweet tea. You should always carry some form of sugar (glucose tablets, sugar cubes) with you. Remember that artificial sweeteners are not effective. Contact your doctor or the nearest hospital if taking sugar does not work or if symptoms recur.

It is possible that symptoms of low blood sugar may not appear, appear slowly or not be recognized in time that blood sugar has dropped.

This may happen if you are an elderly patient taking certain medications (e.g. central nervous system-acting drugs and beta-blockers).

If you are experiencing stress (e.g. accidents, surgery, fever, etc.), your doctor may temporarily change your treatment to insulin.

Symptoms of high blood sugar (hyperglycemia) may appear when gliclazide does not sufficiently lower blood sugar, when you do not follow the treatment prescribed by your doctor, if you are taking preparations containing St. John's Wort (Hypericum perforatum) (see section “Other medicines and Gliclazida Krka”) or in special situations of stress. Symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections and decreased activity.

If these symptoms occur, contact your doctor or pharmacist.

Alterations in blood glucose levels (low blood sugar and high blood sugar) may occur when gliclazide is prescribed at the same time as other medicines belonging to a class of antibiotics called fluoroquinolones, especially in elderly patients. In this case, your doctor will remind you of the importance of controlling your blood glucose levels.

If you have a family history or know of any hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormality of red blood cells), hemoglobin deficiency and collapse of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.

Cases of acute porphyria have been described with other sulfonilureas in patients with porphyria (genetic disorders that cause accumulation of porphyrins and porphyrin precursors in the body).

Children and adolescents

Gliclazida Krka is not recommended for use in children or adolescents under 18 years of age.

Other medicines and Gliclazida Krka

Inform your doctor or pharmacist if you are using, have used recently or may need to use other medicines.

The hypoglycemic effect (ability to lower blood sugar) of gliclazide may be increased and signs of low blood sugar may appear when taking any 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 to treat high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• medicines to treat fungal infections (miconazole, fluconazole),
• medicines to treat stomach or duodenal ulcers (H2 receptor antagonists),
• medicines to treat depression (monoamine oxidase inhibitors),
• analgesics (to treat pain) or anti-inflammatory agents (ibuprofen, phenylbutazone),
• medicines containing alcohol.

The hypoglycemic effect of gliclazide may be decreased and blood sugar levels may increase if taking any of the following medicines:

• medicines to treat central nervous system disorders (chlorpromazine),
• medicines to reduce inflammation (corticosteroids),
• medicines to treat asthma or used during childbirth (salbutamol intravenously, ritodrine and terbutaline),
• medicines to treat chest diseases, heavy menstrual bleeding and endometriosis (danazol),
• preparations containing St. John's Wort (Hypericum perforatum).

When a medicine belonging to the class of antibiotics called fluoroquinolones is taken at the same time as gliclazide, alterations in blood glucose levels (low blood sugar and high blood sugar) may occur, especially in elderly patients.

Gliclazide may potentiate the effect of medicines that reduce blood coagulation (e.g. warfarin).

Consult your doctor before starting to take another medicine. If you visit the hospital, inform the medical team that you are taking Gliclazida Krka.

Taking Gliclazida Krka with food, drinks and alcohol

Gliclazida Krka can be taken with food and non-alcoholic drinks.

It is not recommended to consume alcohol as it may unpredictably alter blood sugar control.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor to prescribe a more suitable treatment for you.

Gliclazida Krka is not recommended during pregnancy.

You should not take Gliclazida Krka 30 mg modified-release tablets while breastfeeding.

Driving and operating machines

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

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

Gliclazida Krka contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Dose

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the dose based on your blood sugar level and possibly in urine. Changes in external factors (e.g., weight loss, lifestyle change, stress) or improvements in blood sugar control may require a change in the dose of gliclazide.

The recommended starting dose is one tablet per day.

The usual dose may vary from one to four tablets at a maximum, taken once a day during breakfast. This depends on the response to treatment.

If treatment with Gliclazida Krka is initiated in combination with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, the doctor will determine the individual suitable dose of each medication.

If you notice that your blood levels are high despite taking the medication as prescribed, you should contact your doctor or pharmacist.

Route and form of administration

Oral route.

Swallow the tablets whole. Do not chew the tablets.

Take your tablet(s) with a glass of water during breakfast, preferably at the same time every day. You must always eat after taking the tablet(s).

If you take more Gliclazida Krka than you should

If you have taken too many tablets,contact your doctor orthe nearest hospital's Emergency Services immediately.The signs of overdose are decreased blood sugar levels (hypoglycemia) described in section 2. Symptoms can be prevented by taking sugar (4 to 6 sugar cubes) or sweetened drinks directly, followed by a snack or substantial meal. If the patient is unconscious, inform a doctor and call emergency services. The same should be done if someone, for example, a child, has taken the medication unintentionally. Unconscious people should not take food or drink.

You should ensure that there is always an informed person who can notify the doctor in case of an emergency.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Gliclazida Krka

It is essential to take your medication regularly every day so that it works better.

However,if you forget to take your dose of Gliclazida Krka, take your next dose at the usual time.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Gliclazida Krka

Since diabetes treatment is usually lifelong, you should consult your doctor before stopping this medication. Stopping treatment could cause an increase in blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most frequently observed side effect is low blood sugar (hypoglycemia).For signs and symptoms, see “Warnings and precautions”.

If you do not treat these symptoms, they may progress to drowsiness, loss of consciousness, or the possibility of coma. If a hypoglycemic episode is severe or prolonged, even if it is temporarily controlled by sugar intake, you should receive immediate medical attention.

Liver disorders

Abnormal liver function has been reported, which can cause yellowing of the skin and eyes. If this occurs, seek medical attention immediately. These symptoms usually disappear if the medication is discontinued. Your doctor will decide whether to discontinue treatment.

Skin disorders

Reactions on the skin such as rash, redness, itching, formation of rashes (urticaria), blisters, angioedema (rapid inflammation of tissues such as eyelids, face, lips, mouth, tongue, or throat that may lead to respiratory difficulties) have been observed. The rash may progress to widespread blistering or skin peeling.

If you develop this, stop taking Gliclazida Krka, contact your doctor immediately, and inform them that you are taking this medication.

Exceptionally, severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a skin rash on the face, followed by a generalized skin rash with high fever.

Blood disorders

Reduction of blood cells (e.g., platelets, white blood cells, and red blood cells) has been reported. This can cause pallor, prolonged bleeding, hematomas, sore throat, and fever.

These symptoms usually disappear if treatment is discontinued.

Gastrointestinal disorders

Abdominal pain, nausea, indigestion, diarrhea, and constipation have been reported.

These effects are reduced if Gliclazida Krka is taken with a meal 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.

Like other sulfonylureas, the following side effects have been observed: severe changes in the number of blood cells and inflammatory allergic reactions to the blood vessel walls, reduction of sodium in the blood (hyponatremia), symptoms of liver insufficiency (e.g., jaundice), which in most cases disappear if treatment is discontinued with them, but may cause severe liver failure in isolated cases.

Reporting of side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Gliclazida Krka

• The active ingredient is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
• The other components are: lactose monohydrate, hypromellose, calcium carbonate, anhydrous colloidal silica, and magnesium stearate. See section 2 “Gliclazida Krka contains lactose”.

Appearance of the product and contents of the pack

The modified-release tablets are white, oval, and biconvex.

Gliclazida Krka is available in blisters in boxes of 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 120, or 180 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura, 10, Pta Baja, Oficina 1, 28108, Alcobendas, Madrid, Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of thissummary of product characteristics: December 2020

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/