GLICLAZIDE SUN 60 mg MODIFIED-RELEASE TABLETS

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

Do not take Gliclazide SUN:

• 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 diabetes);
• If you have ketone bodies 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 taking medicines to treat fungal infections (miconazole, see "Using 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 should monitor the treatment prescribed by your doctor to achieve adequate blood sugar levels. This means that, in addition to taking the tablets regularly, you should also monitor your diet, exercise, and, when necessary, reduce your weight.

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

During the first few weeks of treatment, the risk of low blood sugar (hypoglycemia) may increase. Therefore, close medical monitoring is necessary.

Low blood sugar levels (hypoglycemia) can occur:

• If you take your 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 a dose 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 experience 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 disorders, tremors, sensory disturbances, dizziness, and helplessness.

The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, severe chest pain that may radiate to nearby areas (angina pectoris).

If your blood sugar levels continue to drop, you may experience severe confusion (delirium), develop convulsions, loss of self-control, your breathing may become shallow, and your heart rate may slow down, potentially leading to unconsciousness.

In most cases, the symptoms of low blood sugar disappear quickly when you take sugar in any form, for example, glucose tablets, sugar cubes, sugary juice, sugary tea.

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

The symptoms of low blood sugar levels may not appear, be mild, or develop slowly, or you may not notice in time that your blood sugar level has decreased. This can happen in elderly patients who take certain medicines (e.g., those that act on the central nervous system and beta-blockers).

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

The symptoms of high blood sugar (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 preparations containing St. John's Wort (Hypericum perforatum) (see section "Other medicines and Gliclazide SUN 60 mg"), or in special stress situations. The symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, 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 disorder of glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), you may experience a decrease in hemoglobin levels and destruction of red blood cells (hemolytic anemia). 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

The use of this medicine is not recommended in children and adolescents due to the lack of data.

Using Gliclazide SUN with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The blood sugar-lowering effect of gliclazide may be enhanced, and signs of low blood sugar levels may appear when you take 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),
• Pain relievers or anti-rheumatic medicines (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 Gliclazide SUN 60 mg, alterations in blood glucose levels (low blood sugar and high blood sugar) may occur, especially in elderly patients.

The blood sugar-lowering effect of gliclazide may be weakened, and blood sugar levels may increase when you take any of the following medicines:

• Medicines to treat disorders of the central nervous system (chlorpromazine),
• Medicines to reduce inflammation (corticosteroids),
• Medicines to treat asthma or used during childbirth (intravenous salbutamol, 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. In case of hospitalization, inform the medical staff that you are taking Gliclazide.

Taking Gliclazide SUN with food, drinks, and alcohol

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

Alcohol consumption is not recommended, as it may alter your diabetes control in an unpredictable way.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

Gliclazide should not be taken during pregnancy.

Breastfeeding:

You should not take gliclazide if you are breastfeeding.

Consult your doctor or pharmacist before taking any other medicine.

Driving and using machines

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 have visual problems as a result of these conditions. Bear in mind that you may put yourself or others at risk (e.g., when driving or using machines).

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

• Have frequent episodes of low blood sugar (hypoglycemia).
• Have few or no warning signs of low blood sugar (hypoglycemia).

Gliclazide SUN contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Gliclazide SUN contains sodium

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

3. How to take Gliclazide SUN

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Changes in external factors (e.g., weight loss, change in lifestyle, stress) or improvements in blood sugar control may require a change in the dose 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 combination therapy with this medicine and metformin, another antidiabetic medicine (an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin), your doctor will determine the individual dose of each medicine for you.

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

Form and route of administration

Oral use.

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

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

You should always eat after taking the tablets.

If you take more Gliclazide SUN than you should

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

The symptoms may improve by taking sugar (4 to 6 sugar cubes) or sugary drinks, followed by a snack or a substantial meal. If the patient is unconscious, inform the doctor immediately and call the emergency services. The same should be done if someone, for example, a child, has taken the medicine accidentally. Do not give food or drink to patients who are unconscious.

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

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

If you forget to take Gliclazide SUN

It is important that you take the medicine every day, as 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 make up for forgotten doses.

If you stop taking Gliclazide SUN

Because diabetes treatment is usually for life, you should consult your doctor before stopping treatment with this medicine. Stopping treatment may cause an increase in blood sugar levels (hyperglycemia), which increases the risk of developing complications of diabetes.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

If these symptoms persist without treatment, they may 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 sugar intake, you should seek immediate medical attention.

Blood disorders

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

This can cause:

• pallor
• prolonged bleeding
• bruises
• sore throat
• fever

These symptoms usually disappear when treatment is discontinued.

Liver disorders

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

Skin disorders

The following skin reactions have been reported:

• rash
• redness
• itching
• hives
• blistering
• angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, and throat, which can cause breathing difficulties). The rash may progress to generalized blisters or skin peeling. If you develop this, stop taking Gliclazide SUN modified-release tablets, consult a doctor urgently, and tell them that you are taking this medicine.

Exceptionally, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as symptoms similar to flu and a rash on the face, then a prolonged rash with high fever.

Gastrointestinal disorders

• abdominal pain
• nausea, vomiting
• indigestion
• diarrhea
• constipation

These effects may be reduced if you take Gliclazide SUN with a meal, as recommended. See Section 3. "How to take Gliclazide SUN 60 mg modified-release tablets EFG".

Eyeball disorders

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

As with other sulfonylureas, the following side effects have been observed: severe disorders of blood cell counts and allergic inflammation of blood vessel walls, decreased sodium levels in the blood (hyponatremia), symptoms of liver failure (e.g., jaundice) that in many cases disappear after discontinuation of the sulfonylurea, but in isolated cases may progress to potentially fatal liver failure.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazida SUN

Keep this medicine out of the sight and reach of children.

Do not use this medicine 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 below 30°C. Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE Point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Gliclazida SUN

• The active ingredient is gliclazide. One tablet contains 60 mg of gliclazide, in a modified-release formulation.

The other components are: Lactose monohydrate, Pregelatinized corn starch, Sodium citrate (E331); Hypromellose (E464); Magnesium stearate.

Appearance of the Product and Package Contents

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.

Blister pack type consisting of OPA/Al/PVC/Al containing 30, 60, or 90 modified-release tablets.

Blister pack type consisting of PVC/PE/PVDC/Al containing 30, 60, or 90 modified-release tablets.

The HDPE bottle pack contains 100 modified-release tablets.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue, 87

Hoofddorp - 2132 JH

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH 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

Phone: +34 93 342 78 90

This leaflet was approved in:February 2022

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