Gliclazide Aurovitas 60 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Gliclazida Aurovitas 60 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Gliclazida Aurovitas

3. How to take Gliclazida Aurovitas

4. Possible side effects

5. Storage of Gliclazida Aurovitas

6. Contents of the pack and other information

1. What Gliclazida Aurovitas 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). Gliclazida 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 taking Gliclazida Aurovitas

Do not take Gliclazida Aurovitas

• 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 kidney or liver impairment;
• if you are receiving medications for fungal infections (miconazole), see section “Use of other medicines”;
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Gliclazida Aurovitas.

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

During treatment with gliclazide, periodic monitoring of your blood sugar levels (and possibly urine sugar) and also your glycated hemoglobin (HbA1c) is required.

In the first weeks of treatment, the risk of low blood sugar levels (hypoglycemia) may increase. Close clinical supervision is especially necessary during this time.

Low blood sugar levels (hypoglycemia) may occur:

• if you do not maintain regular meal times or skip meals, or 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 herbal remedies at the same time,
• if you take excessively high doses of gliclazida,
• if you have certain hormonal disorders (dysfunction of the thyroid gland, pituitary gland, or adrenal cortex),
• if you have severely impaired kidney or liver function.

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

The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, 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 consciousness, shallow breathing, and slowed heartbeat, potentially leading to unconsciousness.

In most cases, symptoms of low blood sugar resolve quickly after consuming any form of sugar (e.g., glucose tablets, sugar cubes, sugary juice, sweetened 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.

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

If you are under stress (accidents, surgery, fever, etc.), your doctor may temporarily switch you to insulin treatment.

Symptoms of high blood sugar (hyperglycemia) may appear when gliclazida has not yet sufficiently lowered blood sugar, when you do not follow your prescribed treatment, if you take preparations containing St. John's wort (Hypericum perforatum) (see section “Other medicines and Gliclazida Aurovitas”), or during special stress situations. These may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced performance.

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

Other medicines and Gliclazida Aurovitas

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

The hypoglycemic effect of gliclazida may be enhanced, and signs of low blood sugar may appear, when taking any of the following medicines:

• 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),
• medicines for fungal infections (miconazole, fluconazole),
• medicines for stomach or duodenal ulcers (H2 receptor antagonists),
• medicines for depression (monoamine oxidase inhibitors),
• painkillers or anti-rheumatic medicines (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The hypoglycemic effect of gliclazida may be reduced, leading to increased blood sugar levels, when taking any of the following medicines:

• medicines for central nervous system disorders (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),
• 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 gliclazida, disturbances in blood glucose (low and high blood sugar) may occur, especially in elderly patients.

Gliclazida may enhance 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.

Taking Gliclazida Aurovitas with food, drinks, and alcohol

Gliclazida may be taken with meals and non-alcoholic drinks.

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

Pregnancy and breastfeeding

The use of gliclazida 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 using this medicine.

You must not use gliclazida if you are breastfeeding.

Driving and using machines

If your blood sugar level drops too low (hypoglycemia) or rises too high (hyperglycemia), or if you experience visual problems due to these conditions, your ability to concentrate or react may be impaired. Bear in mind that you could endanger yourself or others (e.g., when driving or operating machinery). Consult your doctor if you may 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 Aurovitas contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Gliclazida Aurovitas

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.

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

The recommended daily dose of Gliclazida Aurovitas 60 mg is half a tablet to two tablets (maximum 120 mg) taken as a single dose with breakfast. This depends on the response to treatment. The tablet may be divided into equal parts.

If combination therapy with gliclazide and metformina, 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.

Method and route of administration

Oral use.

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

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

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

If you take more Gliclazida Aurovitas than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. Symptoms of overdose are those of low blood sugar (hypoglycemia) 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 should be done 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 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 Gliclazida Aurovitas

Since diabetes treatment is usually lifelong, you must consult your doctor before stopping this medicine. Stopping treatment may cause an increase in blood sugar (hyperglycemia), 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 experiences 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 which may cause difficulty breathing) have been reported. The skin rash may progress to the formation of widespread blisters or peeling of the skin. If you develop these disorders, stop taking gliclazide, consult a doctor urgently, and inform them that you are taking this medicine. Very rarely, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a skin rash on the face, followed by generalized rash with high fever.
• Abnormal liver function, changes in your liver (which may cause yellowing of the skin and eyes). If you experience this, seek medical attention immediately. These symptoms usually disappear when treatment is stopped. Your doctor will decide whether it is necessary to discontinue your treatment.

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

• Severe hypoglycaemia (low blood sugar). For symptoms and signs of hypoglycaemia, see section “Warnings and precautions”. If these symptoms are not treated, they may progress to drowsiness, loss of consciousness or possibly coma. You must seek immediate medical attention if the episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by sugar intake.

As with other sulfonylureas, the following adverse reactions have been observed: cases of serious changes in blood cell counts and allergic inflammation of blood vessel walls, decrease in blood sodium (hyponatremia), symptoms of liver failure (e.g. jaundice), which in most cases resolved after discontinuation of the sulfonylurea, but in isolated cases may lead to life-threatening liver failure.

Other possible adverse effects

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

• Hypoglycaemia (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, diarrhoea and constipation.

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

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

• Decrease in blood cell counts (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually resolve when treatment is discontinued.
• Your vision may be temporarily affected, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazide Aurovitas

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 on the blister, after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Gliclazida Aurovitas

• The active substance is gliclazide.

Each modified-release tablet contains 60 mg of gliclazide.

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

Nature of the product and contents of the container

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, engraved with 'G' and '60' on either side of the score line on one side and a score line on the other side.

The tablet can be divided into equal doses.

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

Pack sizes:

Blister pack:

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

Only some 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 medicinal product is authorised in the Member States of the European Economic Area (EEA) 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 comprimidos de liberación modificada EFG

Date of the most recent revision of this leaflet: January 2023

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