GLICLAZIDA KRKA 30 mg PROLONGED-RELEASE TABLETS

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

Do not take Gliclazide Krka

• if you are allergic (hypersensitive) to gliclazide or any of the other ingredients of this medicine (listed in section 6), to other medicines of the same group (sulfonylureas), or to other related medicines (hypoglycemic sulfonamides),
• if you have insulin-dependent diabetes (type 1),
• if you have ketone bodies and sugar in the urine (may indicate 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 Gliclazide Krka"),
• if you are breast-feeding (see section "Pregnancy and breast-feeding").

Warnings and precautions

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

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

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

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

Low blood sugar (hypoglycemia) can 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 skipped 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 kidney or liver function is severely impaired.

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

Additionally, the following signs and symptoms may 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 experience considerable confusion (delirium), develop convulsions, loss of self-control, shallow breathing, and a slower heart rate, which can lead to loss of consciousness.

In most cases, the symptoms of low blood sugar disappear quickly when sugar is taken in any form, e.g., glucose tablets, sugar cubes, sugary juice, sugary tea. You should, therefore, 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 the symptoms recur.

It is possible that the symptoms of low blood sugar may not be apparent, may appear slowly, or you may not realize in time that your blood sugar level has dropped.

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

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

The symptoms of high blood sugar (hyperglycemia) may appear when gliclazide has not sufficiently lowered blood sugar, when you have not followed the treatment prescribed by your doctor, if you are taking preparations containing St. John's Wort (Hypericum perforatum) (see section "Other medicines and Gliclazide Krka"), or in special stressful situations. The 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 (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 monitoring your blood glucose.

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

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

Children and adolescents

Gliclazide Krka is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Gliclazide Krka

Tell your doctor or pharmacist if you are using, have recently used, or might 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 drugs:

• 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 (H2 receptor antagonists),
• medicines for treating depression (monoamine oxidase inhibitors),
• analgesics (for pain) or anti-rheumatics (ibuprofen, phenylbutazone),
• medicines containing alcohol.

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

• medicines for treating central nervous system disorders (chlorpromazine),
• medicines for reducing inflammation (corticosteroids),
• medicines for treating asthma or used during childbirth (intravenous salbutamol, ritodrine, and terbutaline),
• medicines for treating 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 (low blood sugar and high blood sugar) may occur, especially in elderly patients.

Gliclazide may enhance the effect of medicines that reduce blood clotting (e.g., warfarin).

Consult your doctor before starting to take another medicine. If you go to the hospital, inform the medical staff that you are taking Gliclazide Krka.

Taking Gliclazide Krka with food, drinks, and alcohol

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

Alcohol consumption is not recommended as it may alter diabetes control in an unpredictable way.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Gliclazide Krka is not recommended during pregnancy.

You should not take Gliclazide Krka 30 mg modified release tablets while breast-feeding.

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 develop visual problems as a result of these conditions. Bear in mind that you may put yourself and others at risk (e.g., when driving or using machines). Ask your doctor whether you can drive if:

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

Gliclazide Krka contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Gliclazide Krka

Dose

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

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

The recommended initial dose is one tablet per day.

The usual dose may vary from one to four tablets as a maximum, in a single intake during breakfast. It depends on the response to treatment.

If combination treatment 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 individual dose of each medicine.

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

Method and route of administration

Oral use.

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 each day. You must always eat after taking the tablet(s).

If you take more Gliclazide Krka than you should

If you have taken too many tablets, contact your doctor or the nearest hospital emergency department immediately. The signs of overdose are low blood sugar levels (hypoglycemia) described in section 2. The symptoms can be avoided by taking sugar (4 to 6 sugar cubes) or sugary drinks directly, followed by a snack or substantial meal. If the patient is unconscious, inform a doctor and call the emergency services. The same action should be taken if someone, e.g., a child, has taken the medicine unintentionally. Unconscious persons should not take food or drink.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Gliclazide Krka

It is important to take your medicine regularly every day for it to work better.

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

Do not take a double dose to make up for forgotten doses.

If you stop taking Gliclazide Krka

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

If you have any further questions on 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 frequently observed side effect is low blood sugar levels (hypoglycemia). For signs and symptoms, see "Warnings and precautions".

If these symptoms are not treated, they can progress to drowsiness, loss of consciousness, or even coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by sugar intake, you should receive immediate medical attention.

Liver disorders

Isolated cases of abnormal liver function have been reported, which can cause yellowing of the skin and eyes. If this occurs, consult your doctor immediately. These symptoms usually disappear if the medicine is discontinued. Your doctor will decide whether you should stop treatment.

Skin disorders

Skin reactions such as rash, redness, itching, formation of eruptions (rash), blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat that can lead to breathing difficulties), have been observed. The rash may progress to blistering or peeling of the skin.

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

Exceptionally, cases of severe hypersensitivity reactions (DRESS) have been reported: initially as symptoms similar to flu and a skin rash on the face, and then a generalized skin rash with high fever.

Blood disorders

Reduced blood cell count (e.g., platelets, white and red blood cells) has been reported. This can cause paleness, prolonged bleeding, bruising, sore throat, fever.

These symptoms usually disappear when treatment is discontinued.

Gastrointestinal disorders

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

These effects are reduced if Gliclazide Krka is taken with a meal as recommended.

Eyes disorders

Your vision may be affected for a short period, especially at the start 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 blood cell count and inflammatory allergic reactions of blood vessel walls, reduced sodium levels in the blood (hyponatremia), symptoms of liver failure (e.g., jaundice), which in most cases disappear when treatment with these medicines is discontinued, but may cause severe liver failure in isolated cases.

Reporting of side effects

If you experience any of the side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Gliclazida Krka

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

Appearance of the Product and Container Content

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

Gliclazida Krka is available in blister packs 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 Manufacturer

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

Further information about this medicinal product can be obtained from 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 under the following names:

Date of the last revision of this leaflet: December 2020

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