Prospecto: information for the user

Gliclazida Teva 60 mg modified-release tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

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

2.What you need to know before starting to take Gliclazida Teva

3.How to take Gliclazida Teva

4.Possible adverse effects

5.Storage of Gliclazida Teva

6.Contents of the package and additional information

Gliclazida Teva is a medication that reduces blood sugar levels (oral antidiabetic medication belonging to the sulfonilureas group).

Gliclazida Teva is used for the treatment of a certain form of diabetes in adults (type 2 diabetes mellitus), when diet, exercise, and weight loss alone do not have an adequate effect to maintain blood sugar levels at suitable levels.

Do not take Gliclazida Teva:

• If you are allergic to gliclazide, or to any of the other ingredients of this medicine (listed in section 6), or to other medicines in the same group (sulfonilureas), or to other related medicines (sulfonamides hypoglycemic);
• If you have insulin-dependent diabetes (type 1 diabetes);
• If you have ketones and sugar in your urine (this may mean that you have diabetic ketoacidosis, precoma, or diabetic coma),
• If you have severe liver or kidney damage;
• If you are taking medicines to treat fungal infections (miconazole, see "Other medicines and Gliclazida Teva");
• If you are breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

You must monitor the treatment prescribed by your doctor to achieve adequate blood sugar levels. This means that, in addition to regular intake of the tablets, you must control your diet, exercise regularly, and, if necessary, lose weight.

During treatment with gliclazide, regular monitoring of your blood sugar levels (and possibly urine) is required, and also hemoglobin A1c (HbA1c) is necessary.

During the first weeks of treatment, there may be an increased risk of having a low blood sugar level (hypoglycemia). Therefore, close medical supervision is necessary.

Low blood sugar levels (hypoglycemia) may occur:

• If you take meals irregularly 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 in combination with skipping meals;
• If you take other medicines or natural remedies at the same time;
• If you take too high doses of gliclazide;
• If you have hormone-related disorders (functional disorders of the thyroid gland, pituitary gland, or adrenal cortex);
• If your kidney or liver function is severely impaired.

If you have low blood sugar levels, you may experience the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, agitation, aggression, lack of concentration, decreased alertness and reaction time, depression, confusion, speech and visual disturbances, tremors, sensory disturbances, dizziness, and helplessness.

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

If blood sugar levels continue to drop, you may experience severe confusion (delirium), develop seizures, lose control, your breathing may become shallow, and your heart rate may slow down, leading to unconsciousness.

In most cases, symptoms of low blood sugar levels disappear quickly when you take sugar in any form, such as glucose tablets, sugar cubes, fruit juice, or sweet tea.

Therefore, you should always carry something with you to take sugar (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. If taking sugar does not help or symptoms reappear, please contact your doctor or the nearest hospital.

Symptoms of low blood sugar levels may not appear, be mild, develop slowly, or you may not realize in time that your blood sugar level has dropped. This can happen in elderly patients taking certain medications (e.g., those affecting the central nervous system and beta-blockers).

If you are under stress (e.g., accidents, surgical interventions, fever, etc.), your doctor may temporarily change your treatment to insulin.

Symptoms of high blood sugar levels (hyperglycemia) may appear when gliclazide has not yet reduced blood sugar levels sufficiently, when you have not followed the treatment prescribed by your doctor, if you take preparations containing St. John's Wort (Hypericum perforatum), or in special situations of stress. Symptoms may include thirst, frequent urination, dry mouth, dry skin with itching, skin infections, decreased activity.

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

When Gliclazida Teva is prescribed at the same time as other medicines that belong to a class of antibiotics called fluoroquinolones, especially in elderly patients, blood sugar level alterations (low blood sugar and high blood sugar) may occur. In this case, your doctor will remind you of the importance of monitoring your blood sugar levels.

If you have a family history or know that you have a hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormality of red blood cells), a decrease in hemoglobin 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 sulfonilureas in patients with porphyria (genetic disorders that cause accumulation of porphyrins and porphyrin precursors in the body).

Children and adolescents

This medicine is not recommended for use in children and adolescents due to lack of data.

Other medicines and Gliclazida Teva

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

The blood sugar-lowering effect of gliclazide may be enhanced and signs of low blood sugar levels may appear when taking any of the following medicines:

• Other medicines used to treat high blood sugar levels (oral antidiabetics, GLP-1 receptor agonists, or insulin),
• Antibiotics (e.g., sulfonamides, clarithromycin),
• Medicines to treat high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• Medicines to treat fungal infections (miconazole, fluconazole),
• Medicines to treat stomach or duodenal ulcers (H2 receptor antagonists),
• Medicines to treat depression (monoamine oxidase inhibitors),
• Analgesics or anti-inflammatory drugs (phenylbutazone, ibuprofen),
• Medicines containing alcohol.

The blood sugar-lowering effect of gliclazide may be weakened and blood sugar levels may increase when taking any of the following medicines:

• Medicines to treat central nervous system disorders (chlorpromazine),
• Medicines to reduce inflammation (corticosteroids),
• Medicines to treat asthma or used during childbirth (salbutamol intravenously, ritodrine, and terbutaline),
• Medicines used to treat chest diseases, 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 Teva, blood sugar level alterations (low blood sugar and high blood sugar) may occur, especially in elderly patients.

This medicine 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 a hospital, inform the healthcare staff that you are taking Glicazida.

Taking Gliclazida Teva with food, drinks, and alcohol

This medicine can be taken with meals and non-alcoholic drinks.

Consuming alcohol is not recommended, as it may unpredictably alter your diabetes control.

Pregnancy and breastfeeding

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

Gliclazida is not recommended during pregnancy. If you plan to become pregnant, consult your doctor, as he may prescribe a more suitable treatment for you.

You should not take this medicine if you are breastfeeding.

Driving and operating machinery

Your ability to concentrate or react may be impaired if your blood sugar level is too low (hypoglycemia), too high (hyperglycemia), or if you have visual problems due to these conditions. Be aware that you or others (e.g., when driving or operating machinery) may be at risk.

Ask your doctor if you can drive a car if you:

• Have frequent episodes of low blood sugar levels (hypoglycemia).
• Have few or no signs that alert you to low blood sugar levels (hypoglycemia).

Gliclazida Teva contains lactose

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is

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

Changes in external factors (for example, weight loss, change in lifestyle, stress) or improvements in blood sugar control may require a change in the doses of gliclazide.

The recommended daily dose of gliclazide is from half a tablet to two tablets of 60 mg (maximum 120 mg) in a single dose at breakfast time. This depends on the response to treatment.

If you start a combined therapy of Gliclazida Teva with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will determine the suitable dose of each medication individually for you.

Contact your doctor or pharmacist if you notice that your blood sugar levels are high despite taking the medication as prescribed by your doctor.

Form and route of administration

Oral route.

Swallow the half tablet or the whole tablet at once. Do not chew or crush.

Take the tablets with a glass of water at breakfast time (and preferably at the same time every day).

You must always eat after taking the tablets.

Gliclazida Teva can be divided into equal doses.

If you take more Gliclazida Teva than you should

If you take too many tablets, contact your doctor or the emergency service of your nearest hospital. The signs of overdose are those indicated for low blood sugar (hypoglycemia) described in section 2.

Symptoms may improve by taking sugar (4 to 6 sugar cubes) or sweet drinks, followed by a snack or a substantial meal. If the patient is unconscious, inform your doctor immediately and call emergency services. The same should be done if someone, for example a child, has taken the medication accidentally.

Do not give food or drink to patients who are unconscious.

Make sure that there is always someone informed who can call your doctor in case of an emergency.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount used.

If you forgot to take Gliclazida Teva

It is essential to take the medication every day since 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 compensate for the missed doses.

If you interrupt treatment with Gliclazida Teva

Since diabetes treatment is usually for life, you should consult your doctor before interrupting treatment with this medication. Interruption may cause high blood sugar (hyperglycemia) that increases the risk of developing diabetes complications.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

The most frequently observed side effect is a decrease in blood sugar (hypoglycemia). To see symptoms and signs, see section 2 "Warnings and Precautions".

If these symptoms continue without treatment, they may progress to drowsiness, loss of consciousness, or possibly coma. If the episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by consuming sugar, seek immediate medical attention.

Liver disorders

There have been isolated reports of abnormal liver function, which can cause yellowing of the skin and eyes. If this occurs, go immediately to your doctor. Symptoms usually disappear when treatment is stopped. Your doctor will decide whether to stop treatment.

Skin disorders

The following skin reactions have been reported:

• Rash, redness, itching, urticaria, angioedema (rapid inflammation of tissues such as eyelids, face, lips, mouth, tongue, and throat that may cause respiratory difficulty). The rash may progress to generalized blisters or skin peeling.
• If you develop these disorders, stop taking Gliclazida Teva, consult a doctor urgently, and tell them that you are taking this medicine.
• Exceptionally, severe hypersensitivity reactions (DRESS) have been reported: initially as symptoms similar to the flu and a skin rash, and then a generalized skin rash with high fever.

Blood disorders

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

• Pallor
• Prolonged bleeding
• Hematomas
• Throat pain
• Fever

These symptoms usually disappear when treatment is stopped.

Gastrointestinal disorders

• Abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation.

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

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.

Like other sulfonylureas, the following side effects have been observed:

• Severe alterations in the number of blood cells and allergic inflammation of blood vessel walls
• Reduction of sodium in the blood (hyponatremia)
• Symptoms of liver insufficiency (e.g., jaundice) that in many cases disappear after withdrawal of the sulfonylurea, but in isolated cases may progress to potentially fatal liver insufficiency.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Gliclazide Teva Composition

• The active ingredient is gliclazide.

Each modified-release tablet contains 60 mg of gliclazide.

• The other components are:

Intragranular: Lactose monohydrate, hypromellose (HPMC K100 LV) (E464), hypromellose (HPMC K4M CR) (E464)

Extragranular: Lactose monohydrate, hypromellose (HPMC K100 LV) (E464), hypromellose (HPMC K4M CR) (E464), magnesium stearate (E572).

Product appearance and packaging contents

The 60 mg modified-release tablets are white, biconvex, oval, scored on both sides, engraved with “GLI” and “60” on both sides of the score on both sides, and have dimensions of 15.0 x 7.0 mm.

PVC-PVDC/Al or PVC/Al blisters of 10, 30, 60, or 120 modified-release tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 EBuilding Albatros B 1st floor

28108 Alcobendas (Madrid)

Spain

Responsible manufacturer

Merckle GmbH

Ludwig-Merckle-Straβe 3,

Blaubeuren 89143

Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25,

Zagreb 10000

Croatia

or

Balkanpharma – Dupnitsa AD;

3 Samokovsko Shoose Str.,

Dupnitsa, 2600

Bulgaria

This medicinal product is authorized in the following Member States of the European Economic Area with the following names:

Austria:Gliclazid ratiopharm 60 mg Retardtabletten

Bulgaria:Diglical ER 60 mg tablets

Estonia:Gliclazide Teva

Latvia:Gliclazide Teva 60 mg ilgstošas darbibas tabletes

Lithuania:Gliclazide Teva 60 mg pailginto atpalaidavimo tabletes

Poland:Gliklazyd Teva

Portugal:Gliclazida Ratiopharm, 60 mg, Comprimidos de libertação prolongada

Romania:GLICLAZIDA TEVA 60 mg comprimate cu eliberaremodificata

Hungary:Gliclazide Teva 60 mg módosított hatóanyagleadású tabletta

Italy:GLICLAZIDE TEVA 60 mg compresse

Netherlands:Gliclazide retard Teva 60 mg, tabletten met gereguleerde afgifte

Spain:Gliclazida Teva 60 mg comprimidos de liberación modificada EFG

Last revision date of this leaflet:January 2022

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

You can access detailed and updated information on this medicinal product by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81121/P_81121.html

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