Package Leaflet: Information for the User

Gliclazide SUN 60 mg Modified Release Tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

- Keep this package 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 yours, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this package leaflet. See section 4.

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

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

3. How to take Gliclazide SUN

4. Possible side effects

5. Storage of Gliclazide SUN

6. Contents of the pack and additional information

Gliclazida is a medication thatreduces blood sugar levels (oral antidiabetic medication that belongs to the sulfonilureas group).

Gliclazida is used for the treatment of a certain form of diabetes in adults (type 2 diabetes mellitus), when diet, exercise, and weight loss alone do not have an adequate effect to maintain blood sugar levels at suitable levels.

Do not take Gliclazida SUN:

- If you are allergic to gliclazide, or to 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 (sulfonamides hypoglycemic);

- If you have insulin-dependent diabetes (type 1 diabetes);

- 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 taking medicines to treat fungal infections (miconazole, see "Use of other medicines");

- If you are breastfeeding (see "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

You must monitor the treatment prescribed by your doctor to achieve adequate blood sugar levels. This means that, in addition to regular intake of tablets, you must monitor your diet, exercise regularly, and, when necessary, reduce your weight.

During treatment with gliclazide, regular monitoring of your blood sugar levels (and possibly urine) is required, and also hemoglobin A1c (HbA1c) is necessary.

During the first weeks of treatment, there may be an increased risk of having low blood sugar (hypoglycemia). Therefore, close medical supervision is necessary.

Low blood sugar levels (hypoglycemia) may 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 your physical activity without an adequate increase in carbohydrate intake,

- If you drink alcohol, especially in combination with skipping meals,

- If you take other medicines or natural remedies at the same time,

- If you take too high doses of gliclazide,

- If you have hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland, or adrenal cortex),

- If your kidney or liver function is severely impaired.

If you have low blood sugar levels, you may have the following symptoms:

Headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, agitation, aggression, lack of concentration, decreased alertness and reaction time, depression, confusion, speech and visual disturbances, tremors, sensory disturbances, dizziness, and helplessness.

You may also experience the following signs and symptoms: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden and severe chest pain that may spread to nearby areas (angina pectoris).

If blood sugar levels continue to drop, you may experience a great confusion (delirium), develop convulsions, lose control, your breathing may become shallow, and your heart rate may slow down, leading to unconsciousness.

In most cases, symptoms of low blood sugar levels disappear quickly when you take sugar in any form, such as glucose tablets, sugar cubes, sweetened juice, or sweet tea.

Therefore, you should always carry something with you to take sugar (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. If sugar intake does not help or symptoms recur, please contact your doctor or the nearest hospital.

Symptoms of low blood sugar levels may not appear, be mild, develop slowly, or you may not realize in time that your blood sugar level has dropped. This can happen in elderly patients taking certain medications (e.g., those affecting the central nervous system and beta-blockers).

If you are under stress (e.g., accidents, surgical interventions, fever, etc.), your doctor may temporarily change your treatment to insulin.

Symptoms of high blood sugar (hyperglycemia) may appear when gliclazide has not yet reduced blood sugar levels sufficiently, when you have not followed the treatment prescribed by your doctor, if you take preparations containing St. John's Wort (Hypericum perforatum) (see section "Other medicines andGliclazida SUN 60 mg"), or in special situations of stress. Symptoms may include thirst, frequent urination, dry mouth, dry skin with itching, skin infections, decreased activity.

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

If you have a family history or know that you have a hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormality of red blood cells), a decrease in hemoglobin and destruction of red blood cells (hemolytic anemia) may occur. Consult your doctor before taking this medicine.

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 monitoring your blood glucose levels.

Children and adolescents

This medicine is not recommended for use in children and adolescents due to lack of data.

Use of Gliclazida SUN with other medicines

Inform your doctor or pharmacist if you are taking,have taken recently, or may need to takeany other medicine.

The effect of gliclazide on blood sugar levels may be enhanced and signs of low blood sugar levels may appear when taking any of the following medicines:

- Other medicines used to treat high blood sugar levels (oral antidiabetics, GLP1 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 or anti-inflammatory drugs (phenylbutazone, ibuprofen),

- Medicines containing alcohol.

- 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 Gliclazida SUN 60 mg, alterations in blood glucose levels (low blood sugar and high blood sugar) may occur, especially in elderly patients.

The effect of gliclazide on blood sugar levels may be weakened and blood sugar levels may increase when taking any of the following medicines:

- 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 used to treat chest diseases, heavy menstrual bleeding, and endometriosis (danazol).

Gliclazide may increase the effect of medicines that reduce blood clotting (e.g., warfarin).

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

Taking Gliclazida SUN with food, drinks, and alcohol

This medicine can be taken with meals and non-alcoholic drinks.

Consuming alcohol is not recommended, as it may unpredictably alter your diabetes control.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, or if you plan to become pregnant, consult your doctor before using this medicine.

Pregnancy:

It is not recommended to take gliclazide during pregnancy.

Breastfeeding:

You should not take gliclazide if you are breastfeeding.

Consult your doctor or pharmacist before taking any other medicine.

Driving and operating machinery

Your ability to concentrate or react may be impaired if your blood sugar level is too low (hypoglycemia), too high (hyperglycemia), or if you have visual problems due to these conditions. Be aware that you or others (e.g., when driving or operating machinery) may be at risk.

Ask your doctor if you can drive a car if you:

• Have frequent episodes of low blood sugar levels (hypoglycemia).
• Have few or no signs to alert you to low blood sugar levels (hypoglycemia).

Gliclazida SUN contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Gliclazida SUN contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The dose is determined by your doctor, depending on your blood sugar levels and possibly in urine.

Changes in external factors (for example, weight loss, change in lifestyle, stress) or improvements in blood sugar control may require a change in the doses of gliclazide.

The recommended dose is half a tablet to two tablets (maximum 120 mg)in a single dose at breakfast time. This depends on the response to treatment.

If you start a combined therapy with this medication and metformin, another anti-diabetic medication (an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin), your doctor will individually determine the suitable dose of each medication for you.

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

Form and route of administration

Oral route.

Swallow half the tablet or the whole tablet. Do not chew or crush. The tablet can be divided into equal parts.

Take the tablet with a glass of water at breakfast time (and preferably at the same time every day).

You must always eat after taking the tablets.

If you take more Gliclazida SUN than you should

If you take too many tablets, contact your doctor or the emergency service of your nearest hospital. The signs of overdose are those indicated for low blood sugar (hypoglycemia) described in section 2.

Symptoms may improve by taking sugar (4 to 6 sugar cubes) or sweet drinks, followed by a snack or a substantial 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 give food or drink to unconscious patients.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount used.

If you forgot to take Gliclazida SUN

It is essential to take the medication every day since regular treatment works better.

However, if you forget to take your dose, take your next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Gliclazida SUN

Since diabetes treatment is usually for life, consult your doctor before interrupting treatment with this medication. Interruption may cause high blood sugar (hyperglycemia) that 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 can cause side effects, although not everyone will experience them.

The most frequently observed side effect is a decrease in blood sugar (hypoglycemia).To see symptoms and signs, see "Warnings and precautions" in the “Section 2 What you need to know before starting to take Glicazida SUN”.

If these symptoms continue without treatment, they can progress to drowsiness, loss of consciousness, or possibly coma. If the episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by consuming sugar, seek immediate medical attention.

Blood disorders

A decrease in the number of blood cells (for example, platelets, red and white blood cells) has been reported.

This can cause:

- paleness

- prolonged bleeding

- bruises

- sore throat

- fever

These symptoms usually disappear when treatment is discontinued.

Liver disorders

There have been isolated reports of abnormal liver function, which can cause yellowing of the skin and eyes. If this happens, go to your doctor immediately. Symptoms usually disappear when treatment is discontinued. Your doctor will decide whether to discontinue treatment.

Skin disorders

The following skin reactions have been reported:

- hives

- redness

- itching

- urticaria

- blisters

- angioedema (rapid inflammation of tissues such as eyelids, face, lips, mouth, tongue, and throat that can cause respiratory difficulty). Hives can progress to generalized blisters or skin peeling. If you develop this, stop taking Gliclazida SUN modified-release tablets, consult a doctor urgently, and tell them that you are taking this medicine.

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

Digestive disorders

- abdominal pain

- nausea, vomiting

- indigestion

- diarrhea

- constipation

These effects can be reduced if Glicazida SUN is taken with a meal, as recommended. See Section 3. "How to take Glicazida SUN 60mg prolonged-release tablets EFG".

Eye disorders

Your vision may be affected for a short period of time, especially at the start of treatment. This effect is due to changes in blood sugar levels.

Like other sulfonylureas, the following adverse effects have been observed: severe alterations in the number of blood cells and allergic inflammation of blood vessel walls, reduction of sodium in the blood (hyponatremia), symptoms of liver insufficiency (e.g. jaundice) that in many cases disappear after withdrawal of the sulfonylurea, but which in isolated cases can progress to potentially fatal liver insufficiency.

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 does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Useor:https://www.notificaram.es. By reporting adverse 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 box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Store below30°C.

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

Composition of GliclazideSUN

- The active ingredient is gliclazide. A tablet contains60 mg of gliclazide, in a modified-release formulation.

The other components are: Lactose monohydrate, Cornstarch pregelatinized, Sodium citrate (E331); Hypromellose (E464);Magnesium stearate.

Appearance of the product and contents of the packaging

The tablets are white or off-white, oval in shape,scored on both sides, engraved with "Z" and "I"on one face and the other face is smooth, with dimensions 15.0 x 7.0 mm.

PVC/Al blister pack containing 30, 60 or 90 modified-release tablets.

PVC/PE/PVDC/Al blister pack containing 30, 60 or 90 modified-release tablets.

HDPE bottle containing 100 modified-release tablets.

The bottle is composed of HDPE, containing a cotton absorbent, with a child-resistant cap and closure line.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue, 87

Hoofddorp - 2132 JH

Netherlands

Responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

Terapia SA, Str. Fabricii nr. 124, Cluj Napoca 400 632, Romania

Local representative:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona.

Spain

Tel: +34 93 342 78 90

This leaflet has been approved in:February 2022

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