Gliclazide Teva 60 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gliclazide Teva 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; 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 may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Gliclazida Teva is a medicine that lowers blood sugar levels (an oral antidiabetic medicine belonging to the sulfonylurea group).

Gliclazida Teva is used to treat a certain type of diabetes in adults (type 2 diabetes mellitus), when diet, exercise, and weight loss alone do not provide adequate control of blood sugar levels.

2. What you need to know before taking Gliclazida Teva

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 of the same group (sulfonylureas), or to related medicines (hypoglycemic sulfonamides);
• If you have insulin-dependent diabetes (type 1 diabetes);
• If you have ketones and sugar in your urine (this may indicate diabetic ketoacidosis), pre-coma or diabetic coma;
• If you have severe liver or kidney problems;
• 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

Talk to your doctor or pharmacist before starting this medicine.

You must follow your doctor's treatment plan to achieve proper blood sugar levels. This means that, in addition to taking the tablets regularly, you should manage your diet, exercise, and, if necessary, lose weight.

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

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

Low blood sugar (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 if combined with skipped meals,
• If you take other medicines or herbal remedies at the same time,
• If you take too high a dose of gliclazida,
• If you have hormone-related disorders (thyroid, pituitary, or adrenal gland dysfunction),
• 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, agitation, aggression, difficulty concentrating, reduced alertness and slowed reaction time, depression, confusion, speech and visual 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 spreading to nearby areas (angina pectoris).

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

In most cases, symptoms of low blood sugar disappear quickly after taking sugar in any form, such as glucose tablets, sugar lumps, sugary juice, or sweetened tea.

Therefore, you should always carry some sugar with you (glucose tablets, sugar lumps). Remember that artificial sweeteners are not effective. If taking sugar does not help or symptoms return, 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, when you take preparations containing St. John's wort (Hypericum perforatum) (see section "Other medicines and Gliclazida Teva"), 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, contact your doctor or pharmacist.

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 remind you of the importance of monitoring your blood glucose.

If you have a family history or know you have a hereditary disorder called glucose-6-phosphate dehydrogenase (G6PD) deficiency (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.

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

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

Other medicines and Gliclazida Teva

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

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 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),
• Painkillers or anti-rheumatic medicines (phenylbutazone, ibuprofen),
• Medicines containing alcohol.

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

• Medicines to treat disorders of the central nervous system (chlorpromazine),
• Medicines to reduce inflammation (corticosteroids),
• Medicines to treat asthma or used during childbirth (intravenous salbutamol, ritodrine, 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, changes in blood glucose (low 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 hospital, inform healthcare staff that you are taking Gliclazida.

Taking Gliclazida Teva with food, drinks, and alcohol

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

Drinking alcohol is not recommended, as it may unpredictably affect your diabetes control.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 they may prescribe a more suitable treatment for you.

You must not take this medicine if you are breastfeeding.

Driving and using machines

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

Ask your doctor if you can drive if:

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

Gliclazida Teva contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Gliclazida Teva

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in 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 sugar in urine.

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 daily dose of gliclazide is half a tablet to two 60 mg tablets (maximum 120 mg) taken as a single dose at breakfast time. This depends on your response to treatment.

If combination therapy with Gliclazida Teva 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 determine the appropriate dose of each individual medicine for you.

Contact your doctor or pharmacist if you notice that your blood sugar levels remain high despite taking the medicine as prescribed.

Method and route of administration

Oral use.

Swallow the half tablet or the whole tablet whole, without chewing or crushing.

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

You must always eat after taking the tablets.

Gliclazida Teva may 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 nearest hospital emergency department immediately. Signs of overdose are those described for low blood sugar (hypoglycemia) in section 2.

Symptoms may be improved by taking sugar (4 to 6 sugar cubes) or sugary drinks, followed by a snack or a substantial meal. If the patient is unconscious, inform a 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.

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

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

If you forget to take Gliclazida Teva

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 Teva

Because diabetes treatment is usually lifelong, you must consult your doctor before stopping treatment with this medicine. Stopping treatment may cause increased 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 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 2 "Warnings and precautions".

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, seek immediate medical attention.

Hepatic disorders

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

Skin disorders

The following skin reactions have been reported:

• Rash, redness, itching, urticaria, 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 conditions, stop taking Gliclazida Teva, consult a doctor urgently, and inform them that you are taking this medicine.
• Rarely, signs of serious hypersensitivity reactions (DRESS) have been reported: initially flu-like symptoms and a skin rash, followed by generalized skin rash with high fever.

Blood disorders

A decrease in blood cell counts (e.g. platelets, red blood cells and white blood cells) has been reported. This may cause:

• Pallor
• Prolonged bleeding
• Bruising
• Sore throat
• 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 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.

As with other sulphonylureas, 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 sulphonylurea, but 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazide Teva

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 pack 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. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gliclazida Teva

• The active substance is gliclazide.

Each modified-release tablet contains 60 mg of gliclazide.

• The other components are:

Intragranular: Monohydrate lactose, hypromellose (HPMC K100 LV) (E464), hypromellose (HPMC K4M CR) (E464)

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

Nature of the product and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas (Madrid)

Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 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 under 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 eliberare modificata

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

Date of the most recent revision of this leaflet: January 2022

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the packaging. 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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