Package Leaflet: Information for the Patient

Gliclazide Krka 60 mg Modified Release Tablets

Read this leaflet carefully before you start taking 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 give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

Gliclazida Krka is a medication that reduces blood sugar levels (an oral antidiabetic medication belonging 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 to gliclazide or any of the other ingredients of this medicine (see section 6), or to other medicines in the same group (sulfonilureas) or to other related medicines (sulfonamides hypoglycemics),
• if you have insulin-dependent diabetes (type 1),
• if you have ketones and sugar in your urine (this 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 the recommended blood sugar levels. This means that, in addition to regular intake of the tablets, you must control your diet, exercise regularlyand, if necessary, lose weight.

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

During the first weeks of treatment, the risk of a drop in blood sugar levels (hypoglycaemia) may increase. Therefore, it is essential that your doctor closely monitors you.

Blood sugar levels may drop:

• if you take meals irregularly or skip them,
• 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 if you have missed a meal,
• if you take other medicines or natural remedies at the same time,
• if you take too high doses of gliclazide,
• if you have endocrine disorders (thyroid, pituitary or adrenal cortex disorders),
• if your renal or hepatic 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, irritability, decreased concentration, decreased alertness and reaction time, depression, confusion, speech and visual disturbances, tremors, sensory disturbances, dizziness and feeling of helplessness.

You may also experience the following signs and symptoms: 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 a significant confusion (delirium), develop seizures, loss of self-control, shallow breathing and slower heart rate, which may lead to loss of consciousness and possibly coma. The clinical profile of a severe drop in blood sugar may resemble a heart attack.

In most cases, symptoms of low blood sugar disappear very quickly when sugar is taken in any form, e.g. glucose tablets, sugar lumps, sugary drinks, sweet tea. You should always carry some form of sugar (glucose tablets, sugar lumps) 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 reappear.

You may not experience symptoms of low blood sugar, or they may appear slowly or you may not realize in time that your blood sugar has dropped. This can happen if you are an elderly patient taking certain medicines (e.g. central nervous system-acting drugs and beta-blockers).

This can also happen if you have certain endocrine disorders (e.g. thyroid function disorders and anterior pituitary disorders or adrenal insufficiency).

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 (hyperglycaemia) may appear when gliclazide does not sufficiently lower blood sugar, when you do not follow the treatment prescribed by your doctorif you are taking preparations containing St. John's Wort (Hypericum perforatum) (see section “Other medicines and Gliclazida Krka”) or in special cases 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), a decrease in haemoglobin levels and collapse of red blood cells (haemolytic anaemia) may occur. Contact your doctor before taking this medicine.

Cases of acute porphyria have been described with other sulfonylureas 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 due to the lack of data.

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 hypoglycaemic effect (ability to lower blood sugar levels) of gliclazide may increase 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 drugs (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The hypoglycaemic effect of gliclazide may decrease and increase blood sugar levels if any of the following medicines are taken:

• 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 clotting (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 affect blood sugar control.

Pregnancy and breastfeeding

Gliclazida Krka is not recommended during pregnancy.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.

You should not take Gliclazida Krka while breastfeeding.

Driving and operating machines

Your ability to concentrate or react may be impaired if your blood sugar levels are too low (hypoglycaemia), too high (hyperglycaemia) 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 (hypoglycaemia),
• you have mild or no signs of low blood sugar (hypoglycaemia).

Gliclazida Krka contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult 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 dose is one modified-release tablet of 30 mg to two modified-release tablets of 60 mg (maximum 120 mg) in a single dose taken during breakfast. Depending on the response to treatment.

If combined treatment 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, the doctor will determine the individual suitable dose of each medication.

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

Method of administration

Oral route.

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

Take the tablet(s) with a glass of water during breakfast (and preferably at the same hour every day). You should 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 or the nearest hospital emergency department immediately. 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 sweet drinks directly, followed by a snack or substantial meal. If the patient is unconscious, inform a doctor and call emergency services immediately. 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 may cause side effects, although not everyone will experience them.

The assessment of side effects is based on their frequency.

Frequent(may affect up to 1 in 10 people)

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.

Infrequent (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

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

Skin disorders

Reactions on the skin such as rash, redness, itching, formation of blisters (urticaria), blisters, angioedema (rapid inflammation of tissues such as eyelids, face, lips, mouth, tongue, or throat that may lead to respiratory difficulties). 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 medicine.

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

Liver disorders

Abnormalities in liver function have been reported, which may cause yellowing of the skin and eyes. If this occurs, visit your doctor immediately. These symptoms usually disappear if the medication is discontinued. Your doctor will decide whether to discontinue treatment.

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

cases of severe changes in blood cell counts and inflammatory allergic reactions of the blood vessel walls, reduction of sodium in the blood (hyponatremia), symptoms of liver insufficiency (e.g., jaundice), which in most cases disappear when treatment is discontinued with them, but may cause severe liver failure in isolated cases.

Reporting of side effects

If you experience any of these 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.

Keep this medication out 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 point at 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 60 mg of gliclazide.
• The other components are hypromellose, lactose monohydrate, anhydrous colloidal silica, magnesium stearate. See section 2 “Gliclazida Krka contains lactose”.

Appearance of the product and contents of the pack

White, oblong, biconvex tablet, 13 mm in length and 3.5 mm – 4.9 mm in thickness.

Gliclazida 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 Authorization Holder

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

Responsible for manufacturing

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 medicine by contacting 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 medicine is authorized in the member states of the European Economic Area and in the United Kingdom with the following names:

Last review date of this leaflet:December 2020

“Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ ”