Patient Information Leaflet: Information for the Patient

GliclazideViatris30 mg Modified Release EFG Tablets

Gliclazide

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

2. What you need to know before you start taking Gliclazide Viatris

3. How to take Gliclazide Viatris

4. Possible side effects

5. Storage of Gliclazide Viatris

6. Contents of the pack and additional information

GliclazidaViatrisis a medication that lowers blood sugar levels (oral antidiabetic medication belonging to the sulfonilureas group).

Gliclazida is used to treat a specific type of diabetes (type 2 diabetes mellitus) in adults, when diet, physical exercise, and weight reduction alone are not effective enough.

Do not take GliclazidaViatris

• If you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), or to other medicines in the same group (sulfonilureas), or to other related medicines (sulfamidas hypoglycemic).
• If you have diabetes dependent on insulin (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 damage.
• If you are receiving treatment for fungal infections (miconazole, see section “Use of other medicines and GliclazidaViatris”).
• If you are breastfeeding.

Inform your doctor or pharmacist if any of the above warnings affect you.

Warnings and precautions

You should only take this medicine if you have a regular intake of food (including breakfast). It is essential that your carbohydrate intake is regular, as there is an increased risk of a drop in blood sugar levels (hypoglycemia) if you delay or skip a meal, 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 in urine) is necessary. Your doctor may request blood tests to control your hemoglobin A1c (HbA1c).

You should follow the treatment plan prescribed by your doctor to achieve the recommended blood sugar levels. This means, taking the tablets regularly, in addition to diet and exercise and, if necessary, weight loss.

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

You may have a drop in blood sugar levels (hypoglycemia):

• if you take 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 a corresponding increase in carbohydrate intake,
• if you drink alcohol, especially if you also omit a meal,
• if you are taking any other medicine or herbal remedies at the same time,
• if you take high doses of gliclazide,
• if you have special hormone-related disorders (thyroid, pituitary or adrenal gland disorders),
• if your renal or hepatic function is severely impaired.

If you experience a drop in blood sugar levels, you may have the following symptoms: headache, intense hunger, pallor, weakness, fatigue, nausea, vomiting, tiredness, drowsiness, sleep disturbances, restlessness, irritability, difficulty concentrating, decreased alertness and reaction time, depression, confusion, speech or visual disturbances, 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 and 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 control, have shallow breathing, and a slower heart rate, and may become unconscious, possibly leading to coma.

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

The symptoms of a drop in blood sugar levels may go unnoticed, develop slowly, or not be recognized in time that your blood sugar levels have dropped.

This may occur if you are an elderly patient and are taking certain medications (e.g., those affecting the central nervous system and beta blockers). It may also happen if you have certain endocrine system disorders (e.g., certain thyroid and pituitary gland disorders and adrenal insufficiency).

If you are in a state of stress (e.g., accidents, operations, infections with fever, etc.), your doctor may temporarily change your insulin therapy.

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

If these symptoms appear, contact your doctor or pharmacist.

The alteration of blood glucose 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 glucose levels.

If you have a family history or know that you have a hereditary deficiency of glucose 6-phosphate dehydrogenase (G6PD) (abnormal red blood cells), a decrease in hemoglobin levels and red blood cell rupture (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 the accumulation of porphyrins and porphyrin precursors in the body).

Children and adolescents

Gliclazide should not be used for the treatment of diabetes in children and adolescents under 18 years old.

Other medicines and GliclazidaViatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including herbal remedies or those purchased without a prescription.

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

The effect of gliclazide to decrease blood sugar levels may increase, resulting in the symptoms of hypoglycemia, when taken with any of the following medicines:

• other medicines used to treat high blood sugar levels (oral antidiabetic drugs, GLP-1 receptor agonists) or insulin,
• antibiotics (e.g., sulfamides, clarithromycin),
• medicines to treat high blood pressure and heart failure (beta blockers, ACE inhibitors, such as captopril or enalapril),
• medicines to treat fungal infections (miconazole, fluconazole),
• medicines to treat indigestion and stomach or duodenal ulcers (H2 receptor antagonists, such as ranitidine),
• medicines to treat depression (monoamine oxidase inhibitors, such as selegiline, phenelzine),
• analgesics or anti-inflammatory drugs (ibuprofen, phenylbutazone),
• medicines containing alcohol.

The effect of gliclazide to decrease blood sugar levels may be weakened, resulting in an increase in blood sugar levels, when taken with any of the following medicines:

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

The alteration of blood glucose levels (low and high blood sugar levels) may occur when gliclazide and fluoroquinolone antibiotics are taken at the same time, so it is essential to monitor blood glucose levels.

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

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

GliclazidaViatriswith food, drinks, and alcohol

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

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

Pregnancy and breastfeeding

Gliclazida is not recommended if you are pregnant.

You should not take gliclazida while breastfeeding.

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor may prescribe a more suitable treatment for you.

Driving and operating machinery

Gliclazida has no known influence on the ability to drive and operate machinery. However, your concentration or reaction time may be affected if your blood sugar levels are too low (hypoglycemia) or too high (hyperglycemia) or if you develop visual disturbances as a result of these situations. This may occur more frequently at the beginning of gliclazida treatment. Be aware that you may put yourself or others at risk (e.g., driving a car or operating machinery). Consult your doctor if you can drive a vehicle in the following situations:

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

GliclazidaViatriscontains lactose

If your doctor has indicated that you have a lactose intolerance, consult with him before taking this medicine.

Dose

Follow exactly the administration instructions of this medication indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The dose of gliclazide is determined by the doctor, depending on the levels of sugar in your blood and possibly in urine. Changes in external factors (for example, weight loss, lifestyle change, 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, at least one month apart.

If you start a combined therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will determine the correct dose of each medication for you.

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

Route and form of administration

Oral route.

Swallow the gliclazide tablets whole with a glass of water during breakfast, preferably at the same time every day. Always eat afterwards 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 of overdose because the medication will be absorbed by 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 Gliclazida Viatris than you should

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

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

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

If you forgot to take Gliclazida Viatris

If you forgot to take a dose, take the next dose the next day.

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

If you interrupt the treatment with Gliclazida Viatris

If you interrupt or stop treatment, be aware that blood sugar control will worsen.Stopping treatment may cause an increase in blood sugar (hyperglycemia), which increases the risk of developing complications from diabetes.It is very important to contact your doctor if any changes are necessary.

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.

Inform your doctor immediatelyif you experience any of the following side effects, which may be serious:

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

• Decreased number of red or white blood cells, or platelets in the blood, which may cause fatigue, shortness of breath or paleness, fever, chills, sore throat or mouth ulcers (decreased white blood cells), bleeding or bruising, or nosebleeds.
• Liver inflammation (hepatitis), which may cause nausea, vomiting, loss of appetite, general feeling of discomfort, fever, itching, yellowing of the skin and eyes (jaundice), light-colored stools, dark-colored 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); in exceptional cases, severe allergic reactions (DRESS [drug reaction with eosinophilia and systemic symptoms]), initially presenting as flu-like symptoms and facial rash, followed by prolonged rash and high fever.
• Angioedema, which may cause rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat, which may cause difficulty breathing.

Unknown frequency(cannot be estimated from available data):

• Serious allergic reaction symptoms, which may include skin rash, difficulty breathing, wheezing.

You should discontinue treatment. Your doctor will instruct you on how to do so.

Other side effects

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

Hypoglycemia (low blood sugar). For symptoms and signs, see section 2 "Warnings and precautions". If these symptoms are not treated, they may progress to drowsiness, loss of consciousness, and possibly coma. You should seek immediate medical attention if the episode of low blood sugar is severe or prolonged, even if it is temporarily controlled with sugar intake.Symptoms of hypoglycemia commonly include: intense hunger, fatigue, nervousness, irritability, 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):

• Decreased number of blood cells (e.g. platelets and red cells) which may cause paleness, 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 beginning of treatment. This effect is due to changes in blood sugar levels.

These effects disappear gradually when the medication is discontinued.

Unknown frequency(cannot be estimated from available data)

• Inflammatory allergic reaction of blood vessel walls.
• Low sodium levels in the blood, which may cause confusion, fatigue, loss of appetite, restlessness or irritability, muscle weakness, cramps, or uncontrollable movements.

Reporting of side effects:

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

Keep out of the sight and reach of children.

Expiration Date

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

Blister packs - Do not store at a temperature above 30°C.

Bottles - This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at your local SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Gliclazida Viatris

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

Appearance of Gliclazida Viatris and contents of the packaging

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

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

Only some sizes of packaging may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Germany Gliclazide Qualimed 30 mg Tabletten mit veränderter Wirkstofffreisetzung

Spain Gliclazida Viatris 30 mg comprimidos de liberación modificada EFG

Greece Gliclazide/Mylan Δισκ?ο ελεγχ?μενης αποδ?σμευσης 30mg /TAB

Last review date of this leaflet: February 2022

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