GLICLAZIDA KRKA 60 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Gliclazida Krka 60 mg Modified Release Tablets EFG

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Gliclazida Krka is a medicine that lowers blood sugar levels (oral antidiabetic medicine belonging to the sulfonylurea group).

Gliclazida Krka is used to treat a type of diabetes (type 2 diabetes mellitus) in adults, when diet, exercise, and weight loss alone do not have an adequate effect on blood sugar levels.

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

Do not take Gliclazida Krka

• if you are allergic to gliclazide or 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 (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 Gliclazida Krka"),
• if you are breast-feeding (see section "Pregnancy and breast-feeding").

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 the recommended 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 too high a dose of gliclazide,
• if you have endocrine disorders (thyroid, pituitary, or adrenal disorders),
• if your kidney or liver function is severely impaired.

If your blood sugar levels drop, you may experience the following symptoms: headache, increased hunger, nausea, vomiting, fatigue, sleep disturbances, nervousness, aggression, loss of concentration, decreased alertness and reaction time, depression, confusion, speech and visual disturbances, 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 slower heart rate, which can lead to loss of consciousness and possibly coma. The clinical profile of severe hypoglycemia may resemble a heart attack.

In most cases, the symptoms of low blood sugar disappear quickly when sugar is taken in any form, e.g., glucose tablets, sugary drinks, or sugary tea. You should always carry some form of sugar with you (glucose tablets or sugary drinks). 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 the symptoms of low blood sugar may not appear, may appear slowly, or you may not notice 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).

It can also happen if you have certain endocrine disorders (e.g., thyroid, pituitary, or adrenal disorders).

If you are under stress (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 prescribed treatment, if you are taking preparations containing St. John's Wort (Hypericum perforatum) (see section "Other medicines and Gliclazida Krka"), or in special stress situations. 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), a decrease in hemoglobin levels 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 sulfonylureas in patients with porphyria (hereditary 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 due to the lack of data.

Other medicines and Gliclazida 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 (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 like captopril or enalapril),
• medicines for fungal infections (miconazole, fluconazole),
• medicines for stomach or duodenal ulcers (H2 receptor antagonists),
• medicines for depression (monoamine oxidase inhibitors),
• analgesics (for pain) or anti-rheumatics (phenylbutazone, ibuprofen),
• 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 central nervous system disorders (chlorpromazine),
• medicines to reduce inflammation (corticosteroids),

• medicines for asthma or used during childbirth (intravenous salbutamol, ritodrine, and terbutaline),
• medicines for 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 Gliclazida Krka.

Taking Gliclazida Krka with food, drinks, and alcohol

Gliclazida 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

Gliclazida Krka is not recommended during pregnancy. 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.

You should not take Gliclazida Krka while breast-feeding.

Driving and using machines

Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycemia) or too high (hyperglycemia), or if you develop visual problems as a result of these conditions. Be aware 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 low blood sugar (hypoglycemia).

Gliclazida Krka contains lactose

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

3. How to take Gliclazida Krka

Dose

Follow exactly the instructions for administration 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 levels 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 dose is one 30 mg modified-release tablet up to two 60 mg modified-release tablets (maximum 120 mg) in a single dose during breakfast, depending on the response to treatment.

If combination therapy with Gliclazida Krka modified-release tablet 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, contact your doctor or pharmacist.

Method of administration

Oral use.

Swallow the tablet(s) whole. Do not chew or crush.

Take the tablet(s) with a glass of water during breakfast (and preferably at the same time each day). You must 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 or the nearest hospital emergency department immediately. The signs of overdose are low blood sugar levels (hypoglycemia) described in section 2. Symptoms can be avoided by taking sugar (4 to 6 sugar lumps) or sugary drinks directly, followed by a snack or substantial meal. If the patient is unconscious, inform a doctor and call emergency services immediately. The same applies if someone, e.g., a child, has taken the medicine unintentionally. Unconscious persons should not take food or drink.

You should 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 Gliclazida 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 Gliclazida 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 Gliclazida Krka

Since diabetes treatment is usually for life, you should consult your doctor before stopping this medicine. Stopping treatment could cause high 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 evaluation of side effects is based on their frequency.

Common (may affect up to 1 in 10 people)

The most frequently observed side effect is low blood sugar (hypoglycemia). (see "Warnings and precautions" for signs and symptoms).

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

Uncommon (may affect up to 1 in 100 people)

Gastrointestinal disorders

Abdominal pain, feeling of nausea, indigestion, diarrhea, and constipation. These effects are reduced if Gliclazida Krka is taken with a meal as recommended.

Rare (may affect up to 1 in 1,000 people)

Blood disorders

Reduced blood cell count (e.g., platelets, white and red blood cells) has been reported. This can cause pallor, prolonged bleeding, hematomas, sore throat, fever. These symptoms usually disappear when treatment is discontinued.

Skin disorders

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

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

Exceptionally, signs 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.

Liver disorders

Isolated reports of abnormal liver function have been noted, which can cause yellowing of the skin and eyes. If this occurs, contact your doctor immediately. These symptoms usually disappear when the medicine is discontinued. Your doctor will decide whether to discontinue treatment.

Eye 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 very rarely (may affect up to 1 in 10,000 people):

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 can 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: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazida 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. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Gliclazide Krka

• The active ingredient is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
• The other ingredients are hypromellose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate. See section 2 "Gliclazide Krka contains lactose".

Appearance of the Product and Package Contents

White, oblong, biconvex tablet, 13 mm long and 3.5 mm - 4.9 mm thick.

Gliclazide Krka is available in boxes of 14, 15, 28, 30, 56, 60, 84, 90, 120 or 180 modified-release tablets in blisters.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

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

Manufacturer

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

or

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

You can request more information about this medicinal product by contacting the local representative of the Marketing Authorisation Holder:

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

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom under the following names:

Date of the Last Revision of this Leaflet:December 2020

“Detailed and up-to-date 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/”