GLICLAZIDE VIATRIS 30 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

GliclazideViatris30 mg modified-release tablets EFG

gliclazide

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

1. What Gliclazide Viatris is and what it is used for

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

Gliclazide is used to treat a specific type of diabetes (type 2 diabetes mellitus) in adults, when diet, physical exercise, and weight loss alone do not have the desired effect.

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

Do not take Gliclazide Viatris

• 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 (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 "Use of other medicines and Gliclazide Viatris").
• if you are breast-feeding.

Tell your doctor or pharmacist if any of the above applies to you.

Warnings and precautions

You should only take this medicine if you have a regular food intake (including breakfast). It is important that your carbohydrate intake is regular, due to the increased risk of low blood sugar levels (hypoglycemia) if you delay or skip a meal, or if you consume an inadequate amount of food or if the food has a low carbohydrate content.

During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine) is necessary. Your doctor may ask for blood tests to check your hemoglobin A1c (HbA1c).

You should follow the treatment plan prescribed by your doctor in order to achieve the recommended blood sugar levels. This means taking the tablets regularly, as well as following a diet and exercise plan, and if necessary, losing weight.

In the first few weeks of treatment, the risk of low blood sugar levels (hypoglycemia) may increase. Therefore, it is essential that you are carefully monitored by your doctor.

You may experience low blood sugar levels (hypoglycemia):

• if you take your meals irregularly or skip a meal,
• if you are fasting,
• if you are malnourished,
• if you change your diet,
• if you increase your physical activity without an adequate increase in carbohydrate intake,
• if you drink alcohol, especially if you also skip a meal,
• if you are taking any other medicine or remedies at the same time,
• if you take high doses of gliclazide,
• if you have hormone-induced disorders (thyroid, pituitary, or adrenal disorders),
• if your kidney or liver function is severely impaired.

If you experience low blood sugar levels, you may have the following symptoms: headache, intense hunger, pallor, weakness, fatigue, nausea, vomiting, tiredness, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, decreased alertness and reaction time, depression, confusion, speech or visual disorders, tremors, sensory disturbances, dizziness, impotence. The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, and severe, sudden chest pain that may radiate to nearby areas (angina pectoris).

If your blood sugar levels continue to drop, you may experience significant confusion (delirium), develop convulsions, lose self-control, have shallow breathing, and a slower heart rate, and you may become unconscious, possibly leading to coma.

In most cases, the symptoms of low blood sugar levels disappear quickly when you consume some form of sugar, such as sugar cubes, sweet juices, or sweet tea. Therefore, you should always have some sugar available (sugar cubes). Remember that sweeteners are not effective. Contact your doctor or the nearest hospital if the symptoms do not improve after taking sugar.

It is possible that the symptoms of low blood sugar levels may go unnoticed, develop slowly, or that you may not realize in time that your blood sugar level has dropped.

This can occur if you are an elderly patient and are taking certain medicines (e.g., those that act on the central nervous system and beta-blockers). It can also happen if you have certain endocrine system disorders (e.g., certain thyroid, pituitary, or adrenal disorders).

If you are in stressful situations (e.g., accidents, surgery, infections with fever, etc.), your doctor may temporarily change your therapy to insulin.

The symptoms of high blood sugar levels (hyperglycemia) may appear when gliclazide has not yet sufficiently lowered your blood sugar levels, when you have not followed the treatment prescribed by your doctor, if you take St. John's Wort preparations (Hypericum perforatum) (see section "Other medicines and Gliclazide Viatris"), or in special stressful situations. The symptoms of high blood sugar levels may include thirst, frequent urination, dry mouth, dry skin with itching, skin infections, and decreased performance.

If you experience these symptoms, you should contact your doctor or pharmacist.

Changes in blood sugar levels (low and high blood sugar levels) may occur when gliclazide is prescribed with 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 sugar levels.

If you have a family history or know you have a hereditary condition of glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormal red blood cells), you may experience a decrease in hemoglobin levels and red blood cell destruction (hemolytic anemia). Contact your doctor before taking this medicine.

There have been reports of acute porphyria 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 should not be used to treat diabetes in children and adolescents under 18 years of age.

Other medicines and Gliclazide Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

The effectiveness and safety of gliclazide may be affected if taken at the same time as other medicines. Conversely, other medicines may be affected if taken at the same time as gliclazide.

The effect of lowering blood sugar levels of gliclazide may increase, leading to signs of low blood sugar levels, when taken with 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 for treating high blood pressure and heart failure (beta-blockers, angiotensin-converting enzyme inhibitors (ACE) such as captopril or enalapril),
• medicines for treating fungal infections (miconazole, fluconazole),
• medicines for treating indigestion and stomach or duodenal ulcers (H2 receptor antagonists such as ranitidine),
• medicines for treating depression (monoamine oxidase inhibitors such as selegiline, phenelzine),
• painkillers or anti-rheumatic medicines (ibuprofen, phenylbutazone),
• medicines containing alcohol.
• medicines for treating high cholesterol (fibrates),
• medicines for treating fever or pain (salicylates).

The effect of lowering blood sugar levels of gliclazide may decrease, increasing blood sugar levels, when taken with any of the following medicines:

• medicines for treating central nervous system disorders (chlorpromazine),
• medicines that reduce inflammation (glucocorticoids such as hydrocortisone, prednisolone),
• medicines for treating asthma (salbutamol, when administered by injection),
• medicines used during childbirth (ritodrine and terbutaline when administered by injection),
• medicines for treating breast disorders, heavy menstrual bleeding, and endometriosis (danazol),
• St. John's Wort preparations (Hypericum perforatum), used to treat depression.

Changes in blood sugar levels (low and high blood sugar levels) may occur when gliclazide is taken at the same time as medicines belonging to a class of antibiotics called fluoroquinolones. Therefore, it is essential to monitor blood sugar levels.

Gliclazide may increase the effect of warfarin (a medicine that inhibits blood clotting).

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

Gliclazide Viatris with food, drinks, and alcohol

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

Alcohol consumption is not recommended, as it may unpredictably alter your diabetes control and even lead to coma.

Pregnancy and breast-feeding

Gliclazide is not recommended if you are pregnant.

You should not take gliclazide while breast-feeding.

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

Driving and using machines

Gliclazide has no known influence on the ability to drive and use machines. However, 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 disorders as a result of these situations. This may happen more frequently at the start of treatment with gliclazide. Be aware that you may put yourself or others at risk (e.g., when driving a car or using machines). Consult your doctor if you can drive a vehicle in case you:

• experience frequent episodes of hypoglycemia,
• experience few symptoms of hypoglycemia or they go unnoticed.

Gliclazide Viatris 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 Viatris

Dose

Follow exactly the administration instructions of this medicine given by your doctor. Ask your doctor or pharmacist if you have any doubts.

The dose of gliclazide is determined by your doctor, depending on your blood sugar levels and, possibly, urine levels. Changes in external factors (e.g., weight reduction, change in lifestyle, stress) or improvements in blood sugar control may require changes in the dose of gliclazide.

The recommended initial dose is one tablet (30 mg) once a day. The dose may vary from one to a maximum of four tablets (30 to 120 mg) in a single dose with breakfast. This depends on the response to treatment.

If blood sugar control is not adequate, your doctor may increase your dose in successive steps, usually separated by at least 1 month.

If combination therapy with gliclazide 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 correct dose of each medicine for you.

Contact your doctor or pharmacist if you notice that your blood sugar levels are still high or have dropped too much, despite taking this medicine as prescribed by your doctor.

Method and route of administration

Oral use.

Swallow the gliclazide tablets whole with a glass of water during breakfast, preferably at the same time each day. You should always eat after or while taking your tablets. It is also important not to skip any meals while taking gliclazide.

Do not crush or chew your tablets. If you do, there is a risk that you may experience an overdose because the medicine will be absorbed into your body very quickly.

Use in children and adolescents

Gliclazide is not recommended for use in children and adolescents, as there are no available data.

If you take more Gliclazide Viatris than you should

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

Make sure that there is always someone informed who can call the doctor in case of emergency.

In case of overdose or accidental ingestion, call the Toxicology Information Service immediately, Tel. 915620420.

If you forget to take Gliclazide Viatris

If you have forgotten to take a dose, take the next dose the following day.

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

If you stop taking Gliclazide Viatris

If you stop or interrupt treatment, you should be aware that blood sugar control will worsen. Stopping treatment may cause an increase in blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications. If any change is necessary, it is essential that you contact your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Tell your doctor immediatelyif you experience any of the following adverse effects, which can be serious:

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

• Decrease in the number of red or white blood cells, or platelets in the blood, which can cause fatigue, shortness of breath, or pallor, fever, severe chills, sore throat, or mouth ulcers (reduction of white blood cells), bleeding or bruising, or nosebleeds more easily than normal.
• Inflammation of the liver (hepatitis), which can cause nausea, vomiting, loss of appetite, feeling of general discomfort, fever, itching, yellowing of the skin and eyes (jaundice), pale stools, dark urine.
• Severe skin reactions, including redness of the skin, appearance of blisters on the lips, eyes, or mouth, skin peeling, fever (Stevens-Johnson syndrome and toxic epidermal necrolysis); exceptionally, signs of severe allergic reactions (DRESS [Drug Reaction with Eosinophilia and Systemic Symptoms]) have been reported, initially as flu-like symptoms and facial rash, followed by a prolonged rash and high fever.
• Angioedema, which can cause rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat, which can produce difficulty breathing.

Frequency not known(cannot be estimated from the available data):

• Symptoms of severe allergic reaction, which can include skin rash, difficulty breathing, wheezing.

You should stop treatment. Your doctor will tell you how to do it.

Other adverse effects

Frequent(may affect up to 1 in 10 people):

Hypoglycemia (low blood sugar level). For symptoms and signs, see section 2 "Warnings and precautions". If these symptoms are not treated, they can progress to drowsiness, loss of consciousness, and possibly coma. You should seek medical attention immediately if the episode of low blood sugar is severe or prolonged, even if it is temporarily controlled with sugar intake. The symptoms of hypoglycemia commonly include: intense hunger, exhaustion, nervousness, aggression, lack of concentration, depression, and confusion.

Other symptoms may include:

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

• Abdominal pain.
• Nausea.
• Vomiting.
• Indigestion.
• Diarrhea.
• Constipation.

These effects are reduced when gliclazide is taken with food, as recommended.

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

• Decrease in the number of blood cells (e.g., platelets and red blood cells) that can cause pallor, prolonged bleeding, bruising, fatigue, headache, shortness of breath, or dizziness. These symptoms usually disappear when treatment is discontinued.
• Skin reactions, such as skin rash, redness, itching, urticaria, and blisters.
• Altered liver parameters.
• Your vision may be affected for a short time, especially at the start of treatment. This effect is due to changes in blood sugar levels.

These effects disappear gradually when the medicine is stopped.

Frequency not known(cannot be estimated from the available data)

• Allergic inflammation of the blood vessel walls.
• Low sodium levels in the blood, which can cause confusion, fatigue, loss of appetite, restlessness, or irritability, muscle weakness, cramps, or uncontrolled movements.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Gliclazide Viatris

Keep out of sight and reach of children.

Expiry date

Do not use this medicine after the expiry date stated on the blister, carton, and tablet container. The expiry date is the last day of the month indicated.

Blister packs - Do not store above 30°C.

Bottles - This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Gliclazide Viatris

• The active ingredient is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
• The other ingredients are: lactose monohydrate (see section 2, "Gliclazide Viatris contains lactose"), hypromellose, calcium carbonate, anhydrous colloidal silica, magnesium stearate.

Appearance ofGliclazide Viatrisand package contents

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

Gliclazide Viatris is available in packs of 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 120, or 180 tablets and in containers of 90, 120, or 180 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan Hungary Kft

H-2900 Komarom

Mylan utca 1

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this leaflet:March 2025

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