GLICLAZIDE TECNIGEN 60 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Gliclazide TecniGen 60 mg modified-release tablets EFG

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

Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Gliclazide TecniGen and what is it used for
2. What you need to know before you take Gliclazide TecniGen
3. How to take Gliclazide TecniGen
4. Possible side effects
5. Storage of Gliclazide TecniGen
6. Contents of the pack and other information

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

Gliclazide is a medicine that lowers blood sugar levels (an oral antidiabetic medicine belonging to the sulfonylurea group).

Gliclazide is used in a certain type of diabetes in adults (type 2 diabetes mellitus), when diet, physical exercise, and weight loss alone are not adequate to maintain normal blood sugar levels.

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

Do not takeGliclazide TecniGen

• 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);
• If you have ketone bodies and sugar in your urine (which may mean you have diabetic ketoacidosis), pre-coma, or diabetic coma;
• If you have severe kidney or liver damage;
• If you are taking medicines for the treatment of fungal infections (miconazole), see section "Using other medicines and Gliclazide TecniGen";
• If you are breastfeeding (see section "Pregnancy and breastfeeding").

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 taking the tablets regularly, you must control your diet, exercise, and, if necessary, lose weight.

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

In the first few weeks of treatment, the risk of having low blood sugar levels (hypoglycemia) may increase. Clinical monitoring is especially necessary.

Low blood sugar levels (hypoglycemia) may occur:

• If you do not maintain regular 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 a dose of gliclazide,
• If you have certain hormonal disorders (functional disorders of the thyroid gland, pituitary gland, or adrenal cortex),
• If your kidney or liver function is severely impaired,

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

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

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

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

Therefore, you should always carry some sugar with you (glucose tablets, sweets). 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 very slowly, or you may not realize 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 (accidents, surgical interventions, fever, etc.), your doctor may temporarily switch you to insulin treatment.

The symptoms of high blood sugar levels (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 TecniGen"), or in special stress situations. 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.

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.

If you have a family history or know you have a hereditary disorder of glucose-6-phosphate dehydrogenase (G6PD) deficiency (a disorder of 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 (hereditary 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 Gliclazide TecniGen

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

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

• 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-rheumatics (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The hypoglycemic effect of gliclazide may be reduced, and blood sugar levels may increase if you take any of the following drugs:

• medicines for treating disorders of the central nervous system (chlorpromazine),
• anti-inflammatory medicines (corticosteroids),
• medicines for treating asthma or used during childbirth (intravenous salbutamol, 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 clotting (warfarin).

Consult your doctor before taking any other medicine. If you are hospitalized, inform the staff that you are taking gliclazide.

Taking Gliclazide TecniGen with food, drinks, and alcohol

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

Alcohol consumption is not recommended, as it may unpredictably alter your diabetes control.

Pregnancy and breastfeeding

The use of gliclazide is not recommended during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor to prescribe a more suitable treatment for you.

You should not use gliclazide if you are breastfeeding.

Driving and using machines

If your blood sugar levels drop too low (hypoglycemia) or rise too high (hyperglycemia), or if you experience visual problems as a result of these disorders, your ability to concentrate or react may be impaired. Keep in mind that you may put yourself or others at risk (e.g., when driving or operating machinery).

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 symptoms that warn you of low blood sugar levels (hypoglycemia).

Gliclazide TecniGen contains lactose

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

3. How to take Gliclazide TecniGen

Dose

Follow exactly the administration instructions of this medicine 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 urine. Adjustments in the doses of gliclazide may be necessary due to changes in external factors (weight loss, lifestyle changes, stress) or improvements in blood sugar control.

The recommended daily dose is half a tablet to 2 tablets (maximum 120 mg) in a single intake 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 the tablet(s) whole. Swallow the half tablet or the whole tablet(s) at once. Do not chew or crush. You should always eat after taking the tablet(s).

If you start combination therapy with gliclazide and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will determine the suitable dose of each medicine for you individually.

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

If you take more Gliclazide TecniGen than you should

If you take too many tablets, contact your doctor or the emergency department of the nearest hospital immediately. The symptoms of overdose are those of low blood sugar levels (hypoglycemia) described in section 2. The symptoms may improve after taking sugar (4 to 6 sweets) or sugary drinks, followed by a substantial snack or 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 unconscious people. Ensure that there is always an informed person 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Gliclazide TecniGen

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

If you stop taking Gliclazide TecniGen

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

If you have any further questions on the use of this product, 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 levels (hypoglycemia). For symptoms and signs, see section "Warnings and precautions".

If these symptoms are not treated, they could progress to drowsiness, loss of consciousness, or possibly coma. You should seek immediate medical attention if the episode of low blood sugar levels 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, consult your doctor immediately. These symptoms usually disappear after stopping treatment. Your doctor will decide if it is necessary to stop your treatment.

Skin disorders:

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

If you develop these disorders, stop taking gliclazide, 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 those of the flu and a rash on the face, and then a widespread rash with high fever.

Blood disorders:

Decreases in the number of blood cells (e.g., platelets, white blood cells, and red blood cells) have been reported, which can cause paleness, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually disappear after stopping treatment.

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 start of treatment. This effect is due to changes in blood sugar levels.

As with 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 levels in the blood (hyponatremia), symptoms of liver failure (e.g., jaundice) that in most cases disappeared after withdrawal of the sulfonylurea but may rarely lead to life-threatening liver failure.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. 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: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazide TecniGen

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

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, and magnesium stearate.

Appearance of the Product and Package Contents

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

Gliclazida TecniGen is available in packages 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, containing 30 and 60 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Tecnimede – Sociedade Técnico-Medicinal S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

Or

Atlantic Pharma – Produções Farmacêuticas SA

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

Portugal

Date of the Last Revision of this Leaflet:June 2022

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