Gliclazide Normon 30 mg modified-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Gliclazida Normon 30 mg modified-release tablets EFG

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

Gliclazida is a medicine that lowers blood sugar levels (an oral antidiabetic agent 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 starting to take Gliclazida Normon 30 mg modified-release tablets

Do not take Gliclazida Normon 30 mg modified-release tablets

• 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 related medicines (hypoglycemic sulfamides);
• If you have insulin-dependent diabetes (type 1).
• If you have ketones and sugar in your urine (which may indicate diabetic ketoacidosis), pre-coma, or diabetic coma.
• If you have severe renal or hepatic impairment.
• If you are receiving antifungal medications (miconazole); see section “Other medicines and Gliclazida Normon 30 mg modified-release tablets”.
• If you are breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gliclazida Normon 30 mg modified-release tablets.

You must follow the treatment prescribed by your doctor to achieve appropriate blood glucose levels. This means that, in addition to taking the tablets regularly, you should control your diet, exercise, and lose weight if necessary.

During treatment with gliclazide, monitoring of your blood glucose level (and possibly urine glucose) and also your glycated hemoglobin (HbA1c, fasting plasma glucose) is required.

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

Low blood sugar levels (hypoglycemia) may occur:

• If you do not maintain regular meal times or skip meals
• If you are fasting
• If you are malnourished
• If you change your diet
• If you increase your physical activity without a corresponding 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 (thyroid gland dysfunction, pituitary or adrenal cortex disorders)
• If you have severely impaired renal or hepatic function.

If you experience low blood sugar, you may have the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, decreased alertness and reaction time, depression, confusion, visual disturbances, speech difficulties, tremor, sensory disturbances, dizziness, and weakness.

The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, and sudden, severe chest pain that may spread to nearby areas (angina pectoris).

If blood sugar levels continue to fall, you may experience severe confusion (delirium), seizures, loss of self-control, shallow breathing, and slowed heartbeat, potentially leading to unconsciousness.

In most cases, symptoms of low blood sugar resolve quickly after consuming sugar, for example glucose tablets, sugar lumps, sweetened fruit juice, or sweetened tea.

Therefore, you should always carry a source of sugar with you (glucose tablets, sugar lumps). 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 may not appear, may be mild or develop slowly, or you may not notice in time that your blood sugar level has dropped.

This may occur in elderly patients taking certain medications (e.g., those acting on the central nervous system and beta-blockers).

In stressful situations (e.g., accidents, surgery, fever, etc.), your doctor may temporarily switch you to insulin treatment.

Symptoms of high blood sugar (hyperglycemia) may appear when gliclazide has not yet sufficiently reduced blood sugar, when you do not follow your prescribed treatment, when you take preparations containing St. John’s wort (Hypericum perforatum) (see section “Other medicines and Gliclazida Normon 30 mg modified-release tablets”), or during special stress situations. Symptoms may include thirst, dry mouth, dry and itchy skin, skin infections, reduced performance, and frequent urination.

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

Blood glucose disturbances (low and high blood sugar) may occur when gliclazide is prescribed together with 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 you have a hereditary disorder of glucose-6-phosphate dehydrogenase (G6PD) deficiency (a red blood cell disorder), 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 reported with other sulfonylureas in patients with porphyria (inherited genetic disorders causing accumulation of porphyrins and porphyrin precursors in the body).

Children and adolescents

Gliclazida Normon 30 mg modified-release tablets are not recommended for use in children due to lack of data.

Other medicines and Gliclazida Normon 30 mg modified-release tablets

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

The hypoglycemic effect (ability to lower blood sugar) of gliclazide may be enhanced, leading to signs of low blood sugar, when taken with any of the following drugs:

• Other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists, or insulin),
• Antibiotics (sulfonamides, clarithromycin),
• Medicines for high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• Antifungal medicines (miconazole, fluconazole),
• Medicines for stomach or duodenal ulcers (H2 receptor antagonists such as ranitidine),
• Medicines for depression (monoamine oxidase inhibitors),
• Painkillers (analgesics) or anti-rheumatic drugs (ibuprofen, phenylbutazone),
• Medicines containing alcohol,
• Preparations containing St. John’s wort (Hypericum perforatum).

The hypoglycemic effect of gliclazide may decrease, increasing blood sugar levels, when taken with any of the following medicines:

• Medicines for disorders of the central nervous system (chlorpromazine),
• Anti-inflammatory medicines (corticosteroids),
• Medicines for asthma or used during childbirth (intravenous salbutamol, ritodrine, terbutaline),
• Medicines for 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 Gliclazida Normon, disturbances in blood glucose (low and high blood sugar) may occur, especially in elderly patients.

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

Consult your doctor before using any other medicine. If you are admitted to hospital, inform the staff that you are taking Gliclazida Normon 30 mg modified-release tablets.

Taking Gliclazida Normon 30 mg modified-release tablets with food, drinks, and alcohol

Gliclazida Normon 30 mg modified-release tablets can be taken with food and non-alcoholic beverages.

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

Pregnancy and breastfeeding

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

You must not take this medicine while breastfeeding.

Driving and using machines

If your blood sugar level drops too low (hypoglycemia) or rises too high (hyperglycemia), or if you experience visual disturbances due to these conditions, your ability to concentrate or react may be impaired. Be aware that you or others could be put 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 warning signs of low blood sugar (hypoglycemia).

Gliclazida Normon 30 mg modified-release tablets contain sodium

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

3. How to take Gliclazida Normon 30 mg modified-release tablets

Dosage

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The dose will be determined by your doctor, depending on your blood sugar levels and possibly on sugar in the urine. Dose adjustments of gliclazide may be necessary due to changes in external factors (weight loss, changes in lifestyle, or stress) or improvements in blood sugar control.

The recommended daily dose is one to four tablets (maximum 120 mg) taken once daily with breakfast. This depends on your 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 each day). Swallow the tablets whole. Do not chew or crush. You must always eat after taking the tablet(s).

If combination therapy with gliclazide and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin is initiated, your doctor will individually 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.

If you take more Gliclazida Normon than you should

If you take too many tablets, contact your doctor or pharmacist immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service (Tel.: 91 562 01 20), indicating the medicine and the amount taken. Symptoms of overdose are those of low blood sugar (hypoglycaemia) described in section 2. Symptoms may improve by immediately 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 emergency services. The same applies if someone, for example a child, has accidentally taken the medicine. Do not give food or drink to unconscious persons.

Ensure that there is always an informed person available who can call the doctor in an emergency.

If you forget to take Gliclazida Normon

It is important to 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 Gliclazida Normon

Since diabetes treatment is usually lifelong, you must consult your doctor before stopping this medicine. Stopping treatment may cause an increase in blood sugar (hyperglycaemia), increasing the risk of developing diabetes complications.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most frequently observed adverse effect is low blood sugar (hypoglycaemia). 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 by sugar intake.

Hepatic disorders:

Isolated cases of abnormal liver function have been reported, which may cause yellowing of the skin and eyes. If you experience this, consult your doctor immediately. These symptoms usually resolve upon discontinuation of treatment. Your doctor will decide whether it is necessary to stop your treatment.

Skin disorders:

Skin reactions such as rash, erythema, itching, hives, blisters, and angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may cause breathing difficulties) have been reported. The skin rash may progress to the formation of widespread blisters or skin peeling.

If you develop any of these disorders, stop taking Gliclazida Normon, consult a doctor urgently, and inform them that you are taking this medicine.

Rarely, signs of serious hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a skin rash on the face, followed by a generalized rash with high fever.

Blood disorders:

Decreases in blood cell counts (e.g. platelets, red and white blood cells) have been reported, which may cause paleness, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually resolve when treatment is discontinued.

Gastrointestinal disorders:

Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazida Normon 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.

As with other sulphonylureas, 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 blood (hyponatraemia), symptoms of liver failure (e.g. jaundice), which in most cases resolved after withdrawal of the sulphonylurea, but in isolated cases may lead to life-threatening liver failure.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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.

This medicine does not require any special storage conditions.

Store in the original packaging.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gliclazida Normon

• The active substance is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
• 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).

Appearance of the product and contents of the pack

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

Gliclazida Normon is available in boxes containing 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

47864 Pennabilli

Rimini - Italy

or

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Spain

Date of the most recent revision of this leaflet: July 2025

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