Package Insert: Information for the User

Gliclazide TecniGen 60 mg Modified Release EFG Tablets

Read this package insert carefully before starting to take this medication, because

it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

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

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

Gliclazida is 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 TecniGen

• 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 (sulfamidas hypoglycemic);
• If you have diabetes dependent on insulin (type 1);
• If you have ketones and sugar in the 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 and Gliclazida TecniGen”;
• If you are breastfeeding (see section “Pregnancy and lactation”).

Warnings and precautions

Consult your doctor before starting to take gliclazide.

You must 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 must 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. A very close clinical supervision is especially necessary.

Low blood sugar levels (hypoglycemia) may appear:

• 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 suffer from 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, aggressiveness, 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 heart rate or irregular heart rhythm, 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 a great confusion (delirium), suffer convulsions, loss of self-control, your breathing may become shallow and your heart rate may slow down, and you may become unconscious.

In most cases, the symptoms of low blood sugar levels disappear quickly after consuming sugar, for example, glucose tablets, sugar cubes, sweet juice, or sweet tea.

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 reappear, please contact your doctor or the nearest hospital.

The 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 in a state of stress (accidents, surgical interventions, fever, etc.), your doctor may temporarily change your treatment to insulin.

The 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), or in special situations of stress. They may include thirst, dry mouth, dry skin with itching, skin infections, decreased performance, and frequent urination.

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

Abnormalities 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 level 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 sulfonilureas 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 TecniGen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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 (sulfamides, clarithromycin),
• medicines for treating high blood pressure or heart failure (beta-blockers, IECAs 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 drugs (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, abnormalities 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 gliclazida.

Taking Gliclazida TecniGen 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

Gliclazide is not recommended for use during pregnancy. If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor for a more suitable treatment for you.

You should not use gliclazida if you are breastfeeding.

Driving and operating machines

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

The recommended daily dose is half a tablet to 2 tablets (maximum 120 mg) taken once with breakfast. This depends on the response to treatment.The tablet can be divided into equal parts.

Gliclazide is for oral use. Take the tablet(s) with a glass of water at breakfast (preferably at the same time every day). Swallow your tablets whole. Swallow half the tablet or the whole tablet at once. Do not chew or crush. Always eat after taking the tablet(s).

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 suitable 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.

If you takemore Gliclazida TecniGen than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency service immediately. 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 sweet 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 give food or drink 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeGliclazida TecniGen

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 TecniGen

Since diabetes treatment is usually lifelong, you should consult your doctor before stopping this medication. Stopping treatment could cause high blood sugar (hyperglycemia) that increases the risk of developing diabetes complications.

If you have any other doubts about the use of this product, 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 low blood sugar (hypoglycemia). For symptoms and signs, see the section “Warnings and precautions”.

If these symptoms are not treated, they may progress to drowsiness, loss of consciousness, or 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.

Liver disorders:

Isolated cases of abnormal liver function have been reported, which can cause yellowing of the skin and eyes. If you experience this, seek immediate medical attention. These symptoms usually disappear when treatment is discontinued. Your doctor will decide if it is necessary to discontinue treatment.

Skin disorders:

Reports of skin reactions such as skin rash, erythema, itching, hives, blisters, and angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat that can cause difficulty breathing) have been reported. The skin rash can evolve to widespread blistering or skin peeling.

If you develop these disorders, stop taking gliclazide, seek urgent medical attention, and inform your doctor that you are taking this medicine.

Exceptionally, reports of severe hypersensitivity reactions (DRESS) have been noted: initially as symptoms similar to the flu and a skin rash on the face, followed by a generalized skin rash with high fever.

Blood disorders:

Reports of decreases in the number of blood cells (e.g., platelets, white blood cells, and red blood cells) have been reported, which can cause pallor, prolonged bleeding, hematomas, sore throat, and fever. These symptoms usually disappear when treatment is discontinued.

Gastrointestinal disorders:

Abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These effects are reduced when gliclazide is taken with meals, as recommended.

Eye disorders:

Your vision may be temporarily affected, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.

Like other sulfonylureas, the following adverse reactions have been observed: severe changes in the number of blood cells and allergic inflammation of blood vessel walls, decreased sodium in the blood (hyponatremia), symptoms of liver insufficiency (e.g., jaundice) that in most cases disappeared after withdrawal of the sulfonylurea, but in isolated cases may lead to liver insufficiency with life-threatening risk.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Use: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 packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Gliclazida TecniGen

• The active ingredient is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
• The other components are lactose monohydrate, cornstarch, hypromellose, magnesium stearate.

Appearance of the product and content of the packaging

Gliclazida TecniGen 60 mg are white or off-white, oval-shaped, prolonged-release tablets with the inscription “C” on one face and “55” on the other side of the groove and the corresponding groove on the other face.

Gliclazida TecniGen is presented in packaging of 30 and 60 tablets.

Gliclazida TecniGen 60 mg is available in a high-density polyethylene (HDPE) bottle with an aluminum induction seal and a child-resistant screw cap, which contains 30 and 60 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Arroyo de la Vega Industrial Estate,

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Tecnimede – Sociedade Técnico-Medicinal S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

O

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande, 2, Abrunheira, 2710 – 089 Sintra

Portugal

Last review date of this leaflet:June 2022

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