Prospecto:Information for the Patient

Gliclazida Aurovitas 60 mg Modified Release EFG Tablets

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you, as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

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

2.What you need to knowbeforestarting totake Gliclazida Aurovitas

3.How to take Gliclazida Aurovitas

4.Possible adverse effects

5Storage of Gliclazida Aurovitas

6.Contents of the package and additional information

Gliclazidais a medication that reduces blood sugar levels (oral antidiabetic medication belonging to the sulfonilureas group). Gliclazidais used in a certain type of diabetes in adults (type 2 diabetes mellitus), when diet, physical exercise, and weight loss alone are not sufficient to ensure normal blood sugar levels.

Do not takeGliclazida Aurovitas

• 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 (sulfonylureas), or to other related medicines (sulfonylurea hypoglycemics);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (which may mean you have diabetic ketoacidosis), a precoma or diabetic coma;
• if you have severe renal or hepatic impairment;
• if you are receiving medicines for the treatment of fungal infections (miconazole), see section “Use of other medicines”;
• if you are breastfeeding (see section “Pregnancy and lactation”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gliclazida Aurovitas.

You should follow the treatment prescribed by your doctor to achieve adequate blood sugar levels. This means that, in addition to regular intake of the tablets, you should control your diet, exercise regularly and, if necessary, lose weight.

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

In the first weeks of treatment, the risk of having low blood sugar levels (hypoglycemia) may increase. Close clinical supervision is especially necessary.

Low blood sugar levels (hypoglycemia) may occur:

• if you do not maintain a regularity in meals 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 if you skip meals;
• if you take other medicines or natural remedies at the same time;
• if you take too high doses of gliclazide;
• if you have certain hormonal disorders (functional alterations of the thyroid gland, pituitary gland or adrenal cortex);
• if your renal or hepatic function is severely impaired;

If you experience 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, visual and speech disturbances, tremors, sensory disturbances, dizziness, and vulnerability.

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

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

In most cases, symptoms of low blood sugar levels disappear quickly after consuming any form of sugar (e.g. glucose tablets, sugar cubes, sweetened juice, tea with sugar).

Therefore, you should always carry something sweet with you (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 acting on the central nervous system and beta-blockers).

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

Symptoms of high blood sugar levels (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 and Gliclazida Aurovitas”), or in special situations of stress. They may include thirst, frequent urination, dry mouth, dry skin with itching, skin infections, and decreased performance.

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

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 controlling your blood glucose levels.

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

Cases of acute porphyria have been described with other sulfonylureas in patients with porphyria (genetic disorders that cause accumulation of porphyrins and porphyrin precursors in the body).

Children and adolescents

Gliclazide is not recommended for use in children due to the lack of data.

Other medicines and Gliclazida Aurovitas

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

The hypoglycemic effect of gliclazide may be potentiated and signs of low blood sugar levels may appear when taking one of the following medicines:

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

The hypoglycemic effect of gliclazide may be reduced and blood sugar levels may increase if you take one of the following medicines:

• medicines for treating central nervous system disorders (chlorpromazine),
• anti-inflammatory medicines (corticosteroids),
• medicines for treating asthma or used during delivery (salbutamol intravenously, ritodrine, and terbutaline),
• medicines for treating breast disorders, heavy menstrual bleeding, and endometriosis (danazol).
• 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, alterations in blood glucose levels (low blood sugar and high blood sugar) may occur, especially in elderly patients.

Gliclazide may increase the effect of medicines that reduce blood coagulation (warfarin).

Consult your doctor before using any other medicine. If you enter a hospital, inform the staff that you are taking gliclazide.

Taking Gliclazida Aurovitas with food, drinks, and alcohol

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

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

Pregnancy and lactation

The use of gliclazide during pregnancy is not recommended. If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor before using this medicine.

You should not use gliclazide if you are breastfeeding.

Driving and operating machinery

If your blood sugar levels drop too low (hypoglycemia), or increase too much (hyperglycemia), or if you experience visual problems due to these disorders, your ability to concentrate or react may be affected. Be aware that you or others (e.g. when driving or operating machinery) may be at risk. Consult your doctor if you can drive in the following cases:

• if you have frequent episodes of low blood sugar levels (hypoglycemia),
• if you have mild or no signs that warn you of low blood sugar levels (hypoglycemia).

Gliclazida Aurovitas contains lactose.

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

Dose

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

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

Adjustments in gliclazide doses may be required due to changes in external factors (weight loss, lifestyle change, stress) or improvements in blood sugar control.

The recommended daily dose of Gliclazida Aurovitas 60 mg is half to two tablets (maximum 120 mg) in a single dose with breakfast. This depends on the response to treatment.The tablet can be divided into equal parts.

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 individually determine the appropriate dose of each medication for you.

Contact your doctor or pharmacist if you notice that your blood sugar levels are high despite taking this medication as prescribed by your doctor.

Form and routes of administration

Oral route.

Swallow half of the tablet or the entire tablet. Do not chew or crush.

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

Always eat after taking the tablet.

If you take moreGliclazida Aurovitasthan you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. The symptoms of overdose are those of low blood sugar (hypoglycemia) described in section 2. Symptoms may improve by taking sugar (4 to 6 sugar cubes) or sweetened drinks immediately, 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 by accident. 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.

If you forgot to takeGliclazida Aurovitas

It is essential to take your medication every day since regular treatment is more effective.

However, if you forget to take a dose of gliclazide, take the next dose at the usual time.

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

If you interrupt the treatment withGliclazida Aurovitas

Since diabetes treatment is usually lifelong, you should consult your doctor before stopping this medication. Stopping treatment 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.

Contact your doctor immediately if you experience any of the following symptoms

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

• Skin reactions such as skin rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat that may cause difficulty breathing). The skin rash may progress to widespread blistering or skin peeling. If you develop these conditions, stop taking gliclazide, seek urgent medical attention, and inform your doctor that you are taking this medicine. In exceptional cases, severe hypersensitivity reactions (DRESS) have been reported: initially as symptoms similar to the flu and a skin rash on the face, followed by a generalized skin rash with high fever.
• Abnormal liver function, changes in your liver (which may cause yellowing of the skin and eyes). If you experience this, seek immediate medical attention. These symptoms usually resolve when treatment is discontinued. Your doctor will decide if it is necessary to discontinue treatment.

Unknown frequency(cannot be estimated from available data):

• Severe hypoglycemia (low blood sugar). For symptoms and signs of hypoglycemia, see the "Warnings and Precautions" section. If these symptoms are not treated, they may progress to drowsiness, loss of consciousness, or possibly coma.You should seek immediate medical attentionif the episode of low blood sugar is severe or prolonged, even if it is temporarily controlled with sugar intake.

Like other sulfonylureas, the following adverse reactions have been observed: cases of severe changes in blood cell counts and allergic inflammation of blood vessel walls, decreased sodium in the blood (hyponatremia), symptoms of liver insufficiency (e.g., jaundice) that in most cases resolved after withdrawal of the sulfonylurea, but in isolated cases may lead to liver insufficiency with vital threat.

Other possible side effects

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

• Hypoglycemia (low blood sugar). For symptoms and signs, see the "Warnings and Precautions" section.

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

• Gastrointestinal disorders including abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation.

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

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

• Decrease in blood cell count (e.g., platelets, red and white blood cells) that may cause pallor, prolonged bleeding, bruises, sore throat, and fever. These symptoms usually resolve when treatment is discontinued.
• Your vision may be temporarily affected, especially at the start of treatment. This effect is due to changes in blood sugar levels.

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 theSpanish System of Pharmacovigilance ofmedicaments for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the carton and in the blister, after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofGliclazida Aurovitas

• The active ingredient is gliclazida.

Each modified-release tablet contains 60 mg of gliclazida.

• The other components are: calcium carbonate, hypromellose 2208 (100mPas and 4000mPas controlled-release grade), lactose monohydrate, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and contents of the pack

Modified-release tablet.

Gliclazida Aurovitas 60 mg modified-release tablets EFG:

White to off-white, uncoated, biconvex, oblong tablet, approximately 15.1 x 7.1 mm in size, engraved with ‘G’ and ‘60’ on either side of the groove on one face and a groove on the other face.

The tablet can be divided into equal doses.

Gliclazida Aurovitas 60 mg modified-release tablets EFG are available in blisters.

Pack sizes:

Blister pack:

For 60 mg:30, 60, and 90 modified-release tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer responsible

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

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

France:Glicazide Arrow Generiques 60 mg, modified-release tablet

Italy:Gliclazide Aurobindo

Netherlands:Gliclazide Aurobindo Retard 60 mg, tablets with regulated release

Portugal:Gliclazida Generis Phar

Spain:Gliclazida Aurovitas 60 mg modified-release tablets EFG

Last review date of this leaflet:January 2023

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)