Gliclazide Sun 60 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gliclazida SUN 60 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, 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 effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What Gliclazida SUN 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 to treat a certain form of diabetes in adults (type 2 diabetes mellitus), when diet, exercise, and weight loss alone do not provide adequate effect in maintaining blood sugar levels within an appropriate range.

2. What you need to know before taking Gliclazida SUN

Do not take Gliclazida SUN:

• 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 sulfonamides);
• If you have insulin-dependent diabetes (type 1 diabetes);
• If you have ketone bodies and sugar in your urine (this may indicate diabetic ketoacidosis), pre-coma or diabetic coma;
• If you have severe liver or kidney impairment;
• If you are taking medicines to treat fungal infections (miconazole, see "Other medicines and Gliclazida SUN");
• If you are breastfeeding (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

You must monitor the treatment prescribed by your doctor to achieve appropriate blood sugar levels. This means that, in addition to taking the tablets regularly, you must also follow a proper diet, exercise, and reduce your weight if necessary.

During treatment with gliclazide, regular monitoring of your blood sugar levels (and possibly urine sugar) is required, as well as measurement of glycated hemoglobin (HbA1c).

During the first weeks of treatment, the risk of low blood sugar levels (hypoglycemia) may increase. Therefore, close medical monitoring is necessary.

Low blood sugar levels (hypoglycemia) may occur:

• If you eat irregularly 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 in combination with skipped meals,
• If you take other medicines or herbal remedies at the same time,
• If you take too high a dose of gliclazide,
• If you have hormone-related disorders (dysfunction of the thyroid gland, pituitary gland, or adrenal cortex),
• If your kidney or liver function is severely impaired.

If your blood sugar levels are low, you may experience the following symptoms:

Headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggressiveness, difficulty concentrating, reduced alertness and slowed reaction time, depression, confusion, speech and vision disturbances, trembling, sensory disturbances, dizziness, and helplessness.

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 drop, you may become severely confused (delirium), have seizures, lose consciousness, your breathing may become shallow, and your heartbeat may slow down, potentially leading to unconsciousness.

In most cases, symptoms of low blood sugar disappear rapidly after taking sugar in any form, such as glucose tablets, sugar cubes, sweetened juice, or sugared 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 happen in elderly patients taking certain medicines (e.g., those acting on the central nervous system and beta-blockers).

If you are under stress (e.g., 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 SUN 60 mg”), or during special stress situations. Symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced activity.

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

If you have a family history or know you have a hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a red blood cell abnormality), a decrease in hemoglobin levels and destruction of red blood cells (hemolytic anemia) may occur. Consult your doctor before taking this medicine.

Changes in blood glucose (low and high blood sugar) may occur when gliclazida is prescribed together with other medicines belonging to a class of antibiotics called fluoroquinolones, especially in elderly patients. In such cases, your doctor will emphasize the importance of monitoring your blood glucose.

Children and adolescents

Use of this medicine is not recommended in children and adolescents due to lack of data.

Taking Gliclazida SUN with other medicines

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

The blood sugar-lowering 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, GLP1 receptor agonists, or insulin),
• Antibiotics (e.g., 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,
• 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 SUN 60 mg, changes in blood glucose (low and high blood sugar) may occur, especially in elderly patients.

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

• Medicines for disorders of the central nervous system (chlorpromazine),
• Medicines to reduce inflammation (corticosteroids),
• Medicines for asthma or used during childbirth (intravenous salbutamol, ritodrine, terbutaline),
• Medicines used to treat chest diseases, heavy menstrual bleeding, and endometriosis (danazol).

Gliclazida may increase the effect of medicines that reduce blood clotting (e.g., warfarin).

Consult your doctor before taking any other medicine. If you are admitted to hospital, inform healthcare staff that you are taking Gliclazida.

Taking Gliclazida SUN with food, drinks, and alcohol

This medicine may be taken with food and non-alcoholic drinks.

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy:

Gliclazida is not recommended during pregnancy.

Breastfeeding:

You should not take gliclazida if you are breastfeeding.

Consult your doctor or pharmacist before taking any other medicine.

Driving and using machines

Your ability to concentrate or react may be reduced if your blood sugar is too low (hypoglycemia) or too high (hyperglycemia), or if you experience visual disturbances due to these conditions. Be aware that you may put yourself and others at risk (e.g., when driving or operating machinery).

Ask your doctor if you may drive if:

• You have frequent episodes of low blood sugar (hypoglycemia).
• You have few or no warning signs of low blood sugar (hypoglycemia).

Gliclazida SUN contains lactose

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

Gliclazida SUN contains sodium

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

3. How to take Gliclazida SUN

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

The dose is determined by your doctor, depending on your blood sugar levels and possibly on urine glucose levels.

Changes in external factors (e.g. weight loss, changes in lifestyle, stress) or improvements in blood sugar control may require a change in the dose of gliclazide.

The recommended dose is half a tablet to two tablets (maximum 120 mg) taken as a single dose at breakfast time. This depends on your response to treatment.

If combination therapy with this medicine and metformin or another antidiabetic medicine (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 individual dose of each medicine for you.

If you notice that your blood sugar levels are high despite taking this medicine as prescribed, contact your doctor or pharmacist.

Method and route of administration

Oral use.

Swallow half a tablet or the whole tablet(s) whole. Do not chew or crush. The tablet may be divided into equal parts.

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

You should always eat after taking the tablets.

If you take more Gliclazida SUN than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department. Signs of overdose are those described for low blood sugar (hypoglycaemia) in section 2.

Symptoms may be relieved by taking sugar (4 to 6 sugar lumps) or sugary drinks, followed by a snack or a substantial 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 patients.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Telephone 915 620 420, stating the medicine and the amount taken.

If you forget to take Gliclazida SUN

It is important that you take the medicine every day, as regular treatment works best.

However, if you forget to take your dose, take your next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Gliclazida SUN

Since diabetes treatment is usually lifelong, you must consult your doctor before stopping treatment with this medicine. Stopping treatment may cause an increase in blood sugar (hyperglycaemia), 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 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 "Warnings and precautions" in “Section 2 What you need to know before starting to take Gliclazide SUN”.

If these symptoms continue untreated, they may progress to drowsiness, loss of consciousness, or possibly coma. If a low blood sugar episode is severe or prolonged, even if temporarily controlled by sugar intake, you must seek immediate medical attention.

Blood disorders

A decrease in the number of blood cells (e.g. platelets, red and white blood cells) has been reported.

This may cause:

• paleness
• prolonged bleeding
• bruising
• sore throat
• fever

These symptoms usually disappear when treatment is discontinued.

Liver disorders

There have been isolated reports of abnormal liver function, which may cause yellowing of the skin and eyes (jaundice). If this occurs, go immediately to your doctor. Symptoms generally resolve upon discontinuation of treatment. Your doctor will decide whether to discontinue treatment.

Skin disorders

The following skin reactions have been reported:

• rash
• redness
• itching
• hives
• blisters
• angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue and throat, which may cause breathing difficulties). The rash may progress to generalized blisters or skin peeling. If you develop any of these symptoms, stop taking Gliclazide SUN modified-release tablets, 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 facial rash, followed by a prolonged rash with high fever.

Gastrointestinal disorders

• abdominal pain
• nausea, vomiting
• indigestion
• diarrhoea
• constipation

These effects may be reduced if Gliclazide SUN is taken with food, as recommended. See Section 3. "How to take Gliclazide SUN 60mg prolonged-release tablets EFG".

Eye disorders

Your vision may be affected for a short period, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.

As with other sulfonylureas, the following adverse effects have been observed: cases of severe blood cell count abnormalities and allergic inflammation of blood vessel walls, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (e.g. jaundice), which in many cases resolve after discontinuation of the sulfonylurea, but which, in isolated cases, may progress to potentially fatal 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazide SUN

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 EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C. Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you are in doubt, 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 SUN

• The active substance is gliclazide. One tablet contains 60 mg of gliclazide in a modified release formulation.

The other components are: Monohydrate lactose, pregelatinized corn starch, sodium citrate (E331); hypromellose (E464); magnesium stearate.

Appearance of the product and contents of the pack

The tablets are white or almost white, oval-shaped, scored on both sides, marked with "Z" and "I" on one side and the other side smooth, with dimensions 15.0 x 7.0 mm.

Blister pack composed of OPA/Al/PVC/Al containing 30, 60 or 90 modified release tablets.

Blister pack composed of PVC/PE/PVDC/Al containing 30, 60 or 90 modified release tablets.

HDPE bottle pack containing 100 modified release tablets.

The bottle is composed of HDPE, containing a cotton absorbent, with a child-resistant closure cap and tamper-evident band.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue, 87

Hoofddorp - 2132 JH

The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

or

Terapia SA, Str. Fabricii nr. 124, Cluj Napoca 400 632, Romania

Local representative:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona, Spain

Tel: +34 93 342 78 90

This leaflet was approved on: February 2022

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