Gliclazide Viatris 30 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

GliclazidaViatris 30 mg modified-release tablets EFG

gliclazide

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Gliclazida Viatris is and what it is used for
2. What you need to know before taking Gliclazida Viatris
3. How to take Gliclazida Viatris
4. Possible adverse effects
5. How to store Gliclazida Viatris
6. Contents of the pack and other information

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

Gliclazida Viatris is a medicine that lowers blood sugar levels (an oral antidiabetic agent 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 reduction alone do not provide adequate control.

2. What you need to know before taking Gliclazida Viatris

Do not take Gliclazida Viatris

• If you are allergic to gliclazide or to any of the other components of this medicine (listed in section 6), or to other medicines of the same group (sulfonylureas), or to related medicines (hypoglycemic sulfonamides).
• If you have insulin-dependent diabetes (type 1).
• If you have ketones and sugar in your urine (this may indicate diabetic ketoacidosis), pre-coma, or diabetic coma.
• If you suffer from severe liver or kidney impairment.
• If you are receiving treatment for fungal infections (miconazole, see section “Use of other medicines and Gliclazida Viatris”).
• If you are breastfeeding.

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

Warnings and precautions

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

Regular monitoring of blood sugar levels (and possibly urine) is necessary during treatment with gliclazide. Your doctor may request blood tests to monitor your glycated hemoglobin (HbA1c).

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

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

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

• if you eat irregularly or skip meals,
• 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 skip meals,
• if you are taking other medicines or herbal remedies at the same time,
• if you take high doses of gliclazida,
• if you have specific hormone-related disorders (thyroid, pituitary, or adrenal cortex dysfunction),
• if you have severely impaired kidney or liver function.

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

If your blood sugar continues to drop, you may experience marked confusion (delirium), seizures, loss of self-control, shallow breathing, slowed heart rate, unconsciousness, and possibly coma.

In most cases, symptoms of low blood sugar disappear rapidly when sugar is consumed, for example, sugar lumps, sweet juices, or sweetened tea. Therefore, you should always have some form of sugar (such as sugar lumps) readily available. Remember that artificial sweeteners are not effective. Contact your doctor or the nearest hospital if symptoms do not resolve after taking sugar.

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

This may occur if you are elderly and taking certain medicines (e.g., those acting on the central nervous system or beta-blockers). It may also happen if you have certain endocrine disorders (e.g., certain thyroid or anterior pituitary disorders or adrenal insufficiency).

If you are under stress (e.g., accidents, surgery, infections with fever, etc.), your doctor may temporarily switch your therapy to insulin.

Symptoms of high blood sugar (hyperglycemia) may appear when gliclazida has not sufficiently lowered blood sugar, when you do not follow your prescribed treatment, if you take St. John’s wort (Hypericum perforatum) preparations (see section ‘Other medicines and Gliclazida Viatris’), or during special stress situations. Symptoms of high blood sugar may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced performance.

If these symptoms occur, contact your doctor or pharmacist.

Changes in blood glucose levels (low and high blood sugar) may occur when gliclazida is prescribed together with certain antibiotics called fluoroquinolones, especially in elderly patients. In such cases, your doctor will remind you of the importance of monitoring your blood glucose 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), a decrease in hemoglobin levels and rupture of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.

Cases of acute porphyria have been reported with other sulfonylureas in patients with porphyria (inherited genetic disorders causing accumulation of porphyrins and porphyrin precursors in the body).

Children and adolescents

Gliclazida must not be used for the treatment of diabetes in children and adolescents under 18 years of age.

Other medicines and Gliclazida Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal medicines or those obtained without a prescription.

The effectiveness and safety of gliclazida may be altered if taken at the same time as other medicines. Conversely, other medicines may be affected when taken together with gliclazida.

The blood sugar-lowering effect of gliclazida may increase, leading to signs of low blood sugar, when taken with any of the following medicines:

• 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 and heart failure (beta-blockers, angiotensin-converting enzyme (ACE) inhibitors such as captopril or enalapril),
• medicines for fungal infections (miconazole, fluconazole),
• medicines for indigestion and stomach or duodenal ulcers (H2 receptor antagonists such as ranitidine),
• medicines for depression (monoamine oxidase inhibitors such as selegiline, phenelzine),
• painkillers or anti-rheumatic medicines (ibuprofen, phenylbutazone),
• medicines containing alcohol,
• medicines for high cholesterol (fibrates),
• medicines for fever or pain (salicylates).

The blood sugar-lowering effect of gliclazida may be reduced, thereby increasing blood sugar levels, when taken with any of the following medicines:

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

Changes in blood glucose levels (low and high blood sugar) may occur when fluoroquinolone antibiotics are taken together with gliclazida; therefore, it is important to monitor blood glucose levels.

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

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

Gliclazida Viatris with food, drinks, and alcohol

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

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

Pregnancy and breastfeeding

Gliclazida is not recommended if you are pregnant.

You must not take gliclazida while breastfeeding.

If you are pregnant or 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 using machines

Gliclazida has no known influence on the ability to drive and use machines. However, your concentration or reaction ability may be affected if your blood sugar level is too low (hypoglycemia) or too high (hyperglycemia), or if you develop visual disturbances as a result of these conditions. This may occur more frequently at the beginning of treatment with gliclazida. Be aware that you may endanger yourself or others (e.g., when driving a car or operating machinery). Consult your doctor about whether you may drive if you:

• have frequent episodes of hypoglycemia,
• have few or no symptoms of hypoglycemia, or if symptoms go unnoticed.

Gliclazida Viatris contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Gliclazida Viatris

Dosage

Follow exactly the instructions for use of this medicine given by your doctor. Consult 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 on sugar in your urine. Changes in external factors (for example, weight loss, changes in lifestyle, stress) or improvements in blood sugar control may require adjustments in the dose of gliclazide.

The recommended starting dose is one tablet (30 mg) once daily. The dose may range from one to a maximum of four tablets (30 to 120 mg) taken as a single dose with breakfast. This depends on your response to treatment.

If blood glucose control is not adequate, your doctor may increase your dose in successive steps, usually separated by at least one 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 appropriate dose of each medicine for you.

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

Route and method of administration

Oral use.

Swallow the gliclazide tablets whole with a glass of water during breakfast, preferably at the same time each day. You must 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 of overdose because the medicine will be absorbed into your body too quickly.

Use in children and adolescents

Gliclazida 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 department immediately. Symptoms of overdose are those of low blood sugar (hypoglycaemia) described in section 2. Symptoms may be relieved by immediately taking sugar (4 to 6 sugar lumps) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, inform the doctor immediately and call emergency services. The same should be done if someone, for example a child, has accidentally taken the medicine. Do not give food or drink to unconscious persons.

You should ensure that there is always an informed person available who can call the doctor in case of emergency.

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

If you forget to take Gliclazida Viatris

If you forget 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 Gliclazida Viatris

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

If you have any further questions about 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 everyone will experience them.

Tell your doctor immediately if you experience any of the following adverse effects, which may be serious:

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

• Decrease in the number of red blood cells, white blood cells, or platelets in the blood, which may cause tiredness, shortness of breath or paleness, fever, severe chills, sore throat or mouth ulcers (reduction in white blood cells), bleeding or bruising more easily than normal, or nosebleeds.
• Inflammation of the liver (hepatitis), which may cause nausea, vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes (jaundice), pale stools, or dark-coloured urine.
• Severe skin reactions, including redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (Stevens-Johnson syndrome and toxic epidermal necrolysis); very rarely, signs of severe allergic reactions (DRESS [Drug Reaction with Eosinophilia and Systemic Symptoms]) have been reported, 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, possibly leading to breathing difficulties.

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

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

You must stop treatment. Your doctor will advise you on how to do this.

Other adverse effects

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

Hypoglycaemia (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 temporarily controlled by sugar intake. Symptoms of hypoglycaemia commonly include: intense hunger, exhaustion, nervousness, aggression, difficulty concentrating, depression and confusion.

Other symptoms may include:

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

• Abdominal pain.
• Nausea.
• Vomiting.
• Indigestion.
• Diarrhoea.
• 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 blood cells (e.g. platelets and red blood cells), which may cause paleness, prolonged bleeding, bruising, tiredness, headache, shortness of breath or dizziness. These symptoms usually disappear when treatment is stopped.
• Skin reactions such as skin rash, redness, itching, hives and blisters.
• Altered liver parameters.
• Your vision may be briefly affected, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.

These effects gradually disappear when the medicine is discontinued.

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

• Allergic inflammation of the wall of blood vessels.
• Low sodium levels in the blood, which may cause confusion, tiredness, loss of appetite, restlessness or irritability, muscle weakness, cramps or uncontrollable 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazide Viatris

Keep out of the sight and reach of children.

Expiry date

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

Blister packs - Do not store above 30°C.

Bottles - This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your local pharmacy. If you are unsure, please consult your pharmacist on how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Gliclazida Viatris

• The active substance 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, magnesium stearate.

Appearance of Gliclazida Viatris and contents of the pack

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

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

Only certain 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

Date of the most recent review of this leaflet: March 2025

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