GLICLAZIDE NORMON 60 mg PROLONGED-RELEASE TABLETS

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

Do not take Gliclazide Normon:

• if you are allergic to gliclazide, or to 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 the urine (which may indicate that you have diabetic ketoacidosis), precoma, or diabetic coma;
• if you have severe kidney or liver disease;
• if you are taking medicines for the treatment of fungal infections (miconazole) (see section "Other medicines and Gliclazide Normon 60 mg");
• if you are breast-feeding (see section "Pregnancy and breast-feeding").

If you have any doubts, consult your doctor or pharmacist before taking Gliclazide Normon.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Gliclazide Normon

You must follow the treatment prescribed by your doctor to achieve adequate blood sugar levels. This means that, in addition to regular tablet intake, 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 hemoglobin A1c is necessary.

In the first few weeks of treatment, the risk of low blood sugar levels (hypoglycemia) may increase. Close 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 adequate 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 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, 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), convulsions, loss of self-control, shallow breathing, and slowed heart rate, which can lead to unconsciousness.

In most cases, the symptoms of low blood sugar disappear quickly after consuming sugar (e.g., glucose tablets, sugar cubes, sugary drinks, sweet tea).

Therefore, you should always carry some sugar 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.

The symptoms of low blood sugar may not appear, be mild, or develop very slowly, or you may not notice in time that your blood sugar level has decreased. This can happen in elderly patients taking certain medicines (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 switch you to insulin treatment.

The symptoms of high blood sugar (hyperglycemia) may appear when gliclazide has not yet sufficiently lowered blood sugar, 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 Normon 60 mg"), 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 sugar levels (low 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 sugar levels.

If you have a family history or know that 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).

Gliclazide Normon 60 mg is not recommended for use in children due to the lack of data.

Other medicines and Gliclazide Normon 60 mg

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines.

The hypoglycemic effect of gliclazide may be enhanced, and signs of low blood sugar 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-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 medicines:

• medicines for treating central nervous system disorders (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 Normon 60 mg, alterations in blood sugar levels (low and high blood sugar) may occur, especially in elderly patients.

Gliclazide Normon 60 mg 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 medical staff that you are taking Gliclazide Normon 60 mg prolonged-release tablets.

Taking Gliclazide Normon 60 mg with food, drinks, and alcohol

Gliclazide Normon 60 mg can be taken with meals and non-alcoholic drinks.

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

Pregnancy and breast-feeding

The use of Gliclazide Normon 60 mg is not recommended during pregnancy.

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

You should not use Gliclazide Normon 60 mg during breast-feeding.

Driving and using machines

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycemia or hyperglycemia, such as vision disturbances. This can be dangerous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor if it is advisable to drive or use machines.

Please ask your doctor if you can drive if:

• you have frequent episodes of low blood sugar (hypoglycemia),
• you do not have signs that warn you of low blood sugar or they are mild (hypoglycemia).

Important information about some of the ingredients of Gliclazide Normon 60 mg

Gliclazide Normon 60 mg 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 Normon

Dose

Follow exactly the administration instructions of this medicine given 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.

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

The recommended daily dose is 30 to 120 mg (maximum 120 mg) in a single intake with breakfast. This depends on the response to treatment. For doses that cannot be achieved with this medicine, other presentations of gliclazide are available.

Gliclazide Normon 60 mg prolonged-release tablets is for oral use. The score line must not be used to divide the tablet. Take the tablet(s) with a glass of water at breakfast (preferably at the same time each day). Swallow the tablet(s) whole. Do not chew or crush. You should always eat after taking the tablet(s).

If you start combination therapy with Gliclazide Normon 60 mg 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 appropriate dose of each medicine for you.

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 Normon 60 mg than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. 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).

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 sugar cubes) 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 (e.g., a child) has taken the medicine accidentally. Do not give food or drink to unconscious persons.

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

If you forget to take Gliclazide Normon 60 mg

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 Normon 60 mg prolonged-release tablets, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Gliclazide Normon 60 mg

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 (hypoglycemia). For symptoms and signs, see 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, consult your doctor immediately. These symptoms usually disappear after stopping treatment. Your doctor will decide whether 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 Normon 60 mg, 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, and then a generalized rash with high fever.

Blood disorders

Decreases in blood cell count (e.g., platelets, red and white blood cells) have been reported, which can cause pallor, 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 Normon 60 mg is taken with meals, as recommended.

Eyeball 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 count 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 in isolated cases may lead to life-threatening liver failure.

Reporting of side effects

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

5. Storage of Gliclazide Normon

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition ofGliclazida Normon

• The active ingredient is gliclazida. Each tablet contains 60 mg of gliclazida.
• The other components are: Lactose monohydrate, corn starch, hypromellose, and magnesium stearate.

Appearance of the Product and Container Content

The prolonged-release tablets of Gliclazida Normon 60 mg are oval-shaped and white to off-white in color, scored on both sides, one of which is engraved with "C" on one side and "55" on the other side of the score, while the other side is smooth, with approximate dimensions of 14.00 mm x 6.50 mm.

The score line should not be used to divide the tablet.

The tablets are packaged in aluminum/aluminum blisters and are presented in cardboard boxes of 60 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the Last Revision of this Leaflet: April 2025

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