GLICLAZIDE TEVA 60 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Gliclazide Teva 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Gliclazide Teva is used to treat a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet, exercise, and weight loss alone do not have an adequate effect on blood sugar levels.

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

Do not take Gliclazide Teva:

• 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 diabetes);
• If you have ketone bodies and sugar in the urine (this may mean that you are suffering from diabetic ketoacidosis), precoma, or diabetic coma;
• If you have severe liver or kidney disorders;
• If you are taking medicines to treat fungal infections (miconazole, see "Other medicines and Gliclazide Teva");
• If you are breast-feeding (see "Pregnancy and breast-feeding").

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 taking the tablets regularly, you must control your diet, exercise, and, if necessary, lose weight.

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

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

Low blood sugar levels (hypoglycemia) can 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 a dose of gliclazide,
• If you have hormone-induced 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 disorders, tremors, sensory disturbances, dizziness, and helplessness.

Additionally, the following signs and symptoms may occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, severe chest pain that may radiate to nearby areas (angina pectoris).

If your blood sugar levels continue to drop, you may experience severe confusion (delirium), develop convulsions, loss of self-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 very quickly when sugar is taken in any form, for example, glucose tablets, sugar cubes, sugary juice, sugary tea.

Therefore, you should always carry something sweet 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 levels 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 who take certain medicines (e.g., those that act on the central nervous system and beta-blockers).

If you are under stress (e.g., 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 your blood sugar levels, 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 Teva"), or in special stress situations. The symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, decreased activity.

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

Alterations in blood glucose levels (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 glucose levels.

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 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

The use of this medicine is not recommended in children and adolescents due to the lack of data.

Other medicines and Gliclazide Teva

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

The blood sugar-lowering effect of gliclazide 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 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),
• Pain relievers or anti-rheumatic medicines (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 disorders of the central nervous system (chlorpromazine),
• Medicines to reduce inflammation (corticosteroids),
• Medicines to treat asthma or used during childbirth (intravenous salbutamol, 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 Gliclazide Teva, alterations in blood glucose levels (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. In case of hospitalization, inform the medical staff that you are taking Gliclazide.

Taking Gliclazide Teva with food, drinks, and alcohol

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

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Gliclazide is not recommended during pregnancy. If you are planning 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 breast-feeding.

Driving and using machines

Your ability to concentrate or react may be impaired if your blood sugar level is too low (hypoglycemia) or too high (hyperglycemia), or if you have visual problems as a result of these conditions. Keep in mind that you may put yourself or others at risk (e.g., when driving or using machinery).

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

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

Gliclazide Teva contains lactose

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

3. How to take Gliclazide Teva

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 recommended dose is

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

Changes in external factors (e.g., weight loss, change 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 tablets of 60 mg (maximum 120 mg) in a single dose at breakfast time. This depends on the response to treatment.

If you start combination therapy with Gliclazide Teva and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will determine the appropriate dose of each medicine individually for you.

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

Form and route of administration

Oral use.

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

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

You should always eat after taking the tablets.

Gliclazide Teva can be divided into equal doses.

If you take more Gliclazide Teva than you should

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

The symptoms may improve 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 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 patients who are unconscious.

You should ensure that there is always an informed person who can call the 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 medicine and the amount used.

If you forget to take Gliclazide Teva

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

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 Gliclazide Teva

Since diabetes treatment is usually for life, you should consult your doctor before stopping treatment with this medicine. Stopping treatment may cause an increase in blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications.

If you have any further questions on 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.

The most frequently observed side effect is low blood sugar (hypoglycemia). For symptoms and signs, see section 2 "Warnings and precautions".

If these symptoms persist without treatment, they may evolve into 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 sugar intake, you should seek immediate medical attention.

Liver disorders

Isolated reports of abnormal liver function have been noted, which can cause yellowing of the skin and eyes. If this happens to you, go to your doctor immediately. The symptoms usually disappear when treatment is discontinued. Your doctor will decide whether to discontinue treatment.

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 that can cause breathing difficulties). The rash may progress to generalized blisters or skin peeling.
• If you develop these disorders, stop taking Gliclazide Teva, 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, 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
• Bruising
• Sore throat
• Fever

These symptoms usually disappear when treatment is discontinued.

Gastrointestinal disorders

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

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

Eye disorders

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

As with other sulfonylureas, the following side effects have been observed:

• cases of severe disorders of blood cell counts and allergic inflammation of blood vessel walls
• reduction of sodium in the blood (hyponatremia)
• symptoms of liver failure (e.g., jaundice) that in many cases disappear after discontinuation of the sulfonylurea, but that, in isolated cases, can progress to potentially fatal liver failure.

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 side effects 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. Storing Gliclazide Teva

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 blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Gliclazida Teva

• 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 Container Content

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 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 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 1ª planta

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 European Economic Area Member States 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 darbības 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 modificată

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 last revision of this leaflet:January 2022

Detailed and updated 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 updated information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (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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