GLICLAZIDE NORMON 30 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Gliclazide Normon 30 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 and other information:

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

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

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

This medicine 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 maintain normal blood sugar levels.

2. What you need to know before you take Gliclazide Normon 30 mg Modified Release Tablets

Do not take Gliclazide Normon 30 mg Modified Release Tablets

• 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 the urine (which may indicate that you have diabetic ketoacidosis), precoma, or diabetic coma.
• If you have severe kidney or liver impairment.
• If you are taking medicines for the treatment of fungal infections (miconazole), see section “Using other medicines”.
• If you are breast-feeding.

If you think you are affected by any of the above situations, inform your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gliclazide Normon 30 mg Modified Release Tablets.

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, it is necessary to monitor your blood sugar level (and possibly urine) and also your hemoglobin A1c (HbA1c, fasting plasma glucose).

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

Low blood sugar levels (hypoglycemia) may occur:

• If you do not maintain 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 kidney or liver function is severely impaired.

If you suffer from low blood sugar, you may experience the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, drowsiness, 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, and severe and sudden chest pain that may spread to neighboring areas (angina pectoris).

If your blood sugar levels continue to drop, you may experience severe confusion (delirium), suffer from 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 after consuming sugar, for example, glucose tablets, sugar cubes, sugary juice, or sugary 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 the 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 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 in a stressful situation (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 reduced 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 30 mg Modified Release Tablets”), or in special stressful 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 (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.

If you have a family history or know that you have a hereditary disorder of glucose-6-phosphate dehydrogenase (G6PD) deficiency (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 sulfonylureas in patients with porphyria (hereditary genetic disorders that cause accumulation of porphyrins and porphyrin precursors in the body).

Children and adolescents

Gliclazide Normon 30 mg Modified Release Tablets are not recommended for use in children due to the absence of data.

Other medicines and Gliclazide Normon 30 mg Modified Release Tablets

Tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription.

The hypoglycemic effect (ability to lower blood sugar) of gliclazide may be enhanced, and signs of low blood sugar may appear when taking any 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 such as ranitidine),
• Medicines for treating depression (monoamine oxidase inhibitors),
• Pain relievers (for pain) or anti-rheumatics (ibuprofen, phenylbutazone),
• Medicines containing alcohol,
• Preparations containing St. John's Wort (Hypericum perforatum).

The hypoglycemic effect of gliclazide may decrease, 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).

When a medicine belonging to the class of antibiotics called fluoroquinolones is taken at the same time as Gliclazide Normon, alterations in blood glucose (low blood sugar and high blood sugar) may occur, especially in elderly patients.

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

Consult your doctor before using any other medicine. If you are hospitalized, inform the staff that you are taking Gliclazide Normon 30 mg Modified Release Tablets.

Taking Gliclazide Normon 30 mg Modified Release Tablets with food, drinks, and alcohol

Gliclazide Normon 30 mg Modified Release Tablets can be taken with food and non-alcoholic drinks.

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

Pregnancy and breast-feeding

The use of Gliclazide Normon is not recommended during pregnancy. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not take this medicine while breast-feeding.

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 conditions, your ability to concentrate or react may be impaired. Be aware 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 (hypoglycemia),
• If you have mild or no symptoms of low blood sugar (hypoglycemia).

Gliclazide Normon 30 mg Modified Release Tablets contain sodium

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

3. How to take Gliclazide Normon 30 mg Modified Release Tablets

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

The recommended daily dose is one to four tablets (maximum 120 mg) in a single dose with breakfast. This depends on the response to treatment.

This medicine is for oral use. Take the tablet(s) with a glass of water at breakfast (preferably at the same time every day). Swallow the tablets whole. 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 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 than you should

If you take too many tablets, contact your doctor or pharmacist immediately, with the Emergency Department of the nearest hospital, or call the Toxicology Information Service (Tel.: 91 562 01 20) indicating the medicine and the amount taken. The symptoms of overdose are those of low blood sugar (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, for example, a child, has taken the medicine accidentally. Do not give food or drink to unconscious people.

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

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 this medicine, 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

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 (hyperglycemia), which increases the risk of developing diabetes complications.

If you have any other questions about 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). 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 breathing difficulties) have been reported. The rash may evolve into widespread blistering or skin peeling.

If you develop these disorders, stop taking Gliclazide Normon, consult a doctor urgently, and tell them that you are taking this medicine.

Exceptionally, cases 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 generalized rash with high fever.

Blood disorders:

Decreases in the number of blood cells (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 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 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. Storing Gliclazide Normon

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

This medicine does not require special storage conditions.

Store in the original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and medicines you no longer need to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines that are no longer needed. This will help protect the environment.

6. Packaging Content and Additional Information

Gliclazida Normon Composition

• The active ingredient is gliclazida. Each modified-release tablet contains 30 mg of gliclazida.
• The other components are: mannitol (E-421), stearic acid, carnauba wax, disodium phosphate, hypromellose, magnesium stearate, anhydrous colloidal silica (E-551), macrogol 4000, talc, and titanium dioxide (E-171).

Product Appearance and Packaging Content

The modified-release tablets are white, oval, and biconvex.

Gliclazida Normon is available in boxes of 60 tablets.

Marketing Authorization Holder:

LABORATORIOS NORMON, S.A.

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

Manufacturer:

VALPHARMA INTERNATIONAL S.p.A.

Via G. Morgagni, 2

61016 Pennabilli

Pesaro Italy

or

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Spain

Date of the Last Revision of this Leaflet:July 2025

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/