GLICLAZIDE AUROVITAS 60 mg MODIFIED-RELEASE TABLETS

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

Do not take Gliclazide Aurovitas

• 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 damage;
• if you are taking medicines for the treatment of fungal infections (miconazole), see section "Use of other medicines";
• if you are breast-feeding (see section "Pregnancy and lactation").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gliclazide Aurovitas.

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. 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 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 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 spread to adjacent areas (angina pectoris).

If your blood sugar levels continue to drop, you may experience severe confusion (delirium), have convulsions, lose 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 any form of sugar (e.g., glucose tablets, sugar cubes, sugary juice, sugary 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 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 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 Aurovitas"), or in special stress situations. They may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections, and decreased performance.

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

Glucose alterations in the blood (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 sugar.

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).

Children and adolescents

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

Other medicines and Gliclazide Aurovitas

Tell your doctor or pharmacist if 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 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 decrease, 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, glucose alterations in the blood (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 admitted to the hospital, inform the staff that you are taking gliclazide.

Taking Gliclazide Aurovitas with food, drinks, and alcohol

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

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

Pregnancy and lactation

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 before taking this medicine.

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 (hypoglycemia),
• if you have mild or no symptoms of low blood sugar (hypoglycemia).

Gliclazide Aurovitas 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 Aurovitas

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.

Adjustments in the doses 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 of Gliclazide Aurovitas 60 mg is half a tablet to two tablets (maximum 120 mg) in a single dose with breakfast. This depends on the response to treatment. The tablet can be divided into equal parts.

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 started, your doctor will determine the appropriate 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.

Form and route of administration

Oral route.

Swallow half a tablet or the whole tablet(s). Do not chew or crush.

Take the tablet(s) with a glass of water at breakfast (preferably at the same time each day).

You should always eat after taking the tablet(s).

If you take more Gliclazide Aurovitas than you should

If you take too many tablets, contact your doctor or the emergency department of the nearest hospital or call the Toxicology Information Service, telephone 91 562 04 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 by 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 Aurovitas

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 forgotten doses.

If you stop taking Gliclazide Aurovitas

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 further 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.

Contact a doctor immediately if you experience any of the following symptoms

Rare(may affect up to 1 in 1,000 people):

• Skin reactions such as rash, redness, 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 skin rash may evolve into blistering widespread 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 flu and a skin rash on the face, and then a widespread skin rash with high fever.
• Abnormal liver function, changes in your liver (which can cause yellowing of the skin and eyes). If you experience this, go to your doctor immediately. These symptoms usually disappear when treatment is discontinued. Your doctor will decide whether it is necessary to discontinue your treatment.

Frequency not known(cannot be estimated from the available data):

• Severe hypoglycemia (low blood sugar). For symptoms and signs of hypoglycemia, 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 attentionif the episode of low blood sugar is severe or prolonged, even if it is temporarily controlled with sugar intake.

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 lead to life-threatening liver failure in isolated cases.

Other possible side effects

Common(may affect up to 1 in 10 people):

• Hypoglycemia (low blood sugar). For symptoms and signs, see section "Warnings and precautions".

Uncommon(may affect up to 1 in 100 people):

• Gastrointestinal disorders, including abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation.

These effects are reduced when gliclazide is taken with meals, as recommended.

Rare(may affect up to 1 in 1,000 people):

• Decrease in blood cell count (e.g., platelets, red or white blood cells) that can cause pallor, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually disappear when treatment is discontinued.
• Your vision may be temporarily affected, especially at the start of treatment. This effect is due to changes in blood sugar levels.

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 them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazida Aurovitas

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 on the blister, after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofGliclazida Aurovitas

• The active ingredient is gliclazide.

Each modified-release tablet contains 60 mg of gliclazide.

• The other ingredients are: calcium carbonate, hypromellose 2208 (100mPa.s and 4000mPa.s controlled release grade), lactose monohydrate, magnesium stearate, and anhydrous colloidal silica.

Appearance of the Product and Package Contents

Modified-release tablet.

Gliclazida Aurovitas 60 mg modified-release tablets EFG:

Biconvex, uncoated, white to off-white, oblong tablet, approximately 15.1 x 7.1 mm in size, scored with 'G' and '60' on either side of the break line on one face and a break line on the other face.

The tablet can be divided into equal doses.

Gliclazida Aurovitas 60 mg modified-release tablets EFG are available in blisters.

Package Sizes:

Blister Pack:

For 60 mg:30, 60, and 90 modified-release tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorized in the Member States of the European Economic Area under the following names:

France: Glicazide Arrow Generiques 60 mg, comprimé à libération modifiée

Italy: Gliclazide Aurobindo

Netherlands: Gliclazide Aurobindo Retard 60 mg, tabletten met gereguleerde afgifte

Portugal: Gliclazida Generis Phar

Spain: Gliclazida Aurovitas 60 mg modified-release tablets EFG

Date of the Last Revision of this Leaflet:January 2023

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