Gliclazide Teva 30 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Gliclazide Teva 30 mg modified-release tablets EFG

Package leaflet contents:

1. What Gliclazida Teva 30 mg modified-release tablets are and what they are used for

2. What you need to know before taking Gliclazida Teva 30 mg modified-release tablets

3. How to take Gliclazida Teva 30 mg modified-release tablets

4. Possible side effects

5. How to store Gliclazida Teva 30 mg modified-release tablets

6. Contents of the pack and other information

1. What Gliclazida Teva 30 mg modified-release tablets are and what they are used for

Gliclazida Teva 30 mg modified-release tablets is a medicine that lowers blood sugar levels (an oral antidiabetic medicine belonging to the sulfonylurea group).

Gliclazida Teva 30 mg modified-release tablets are used to treat a type of diabetes (type 2 diabetes mellitus) in adults, when diet, physical exercise, and weight loss alone do not provide adequate control of blood sugar levels.

2. What you need to know before taking Gliclazida Teva 30 mg modified-release tablets

Do not take Gliclazida Teva

• If you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), 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 (which may indicate diabetic ketoacidosis), pre-coma, or diabetic coma.
• If you have severe liver or kidney problems.
• If you are receiving treatment for fungal infections (miconazole, see section “Other medicines and Gliclazida Teva”).
• If you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

You must follow your doctor's prescribed treatment to achieve appropriate blood sugar levels. This means, in addition to taking the tablets regularly, carefully managing your diet, engaging in physical exercise, and, if necessary, losing weight.

Regular monitoring of blood sugar levels (and possibly urine sugar) is required during treatment with gliclazide. Your doctor may want to perform blood tests to monitor glycosylated hemoglobin (HbA1c, fasting plasma glucose).

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

Low blood sugar (hypoglycemia) may occur:

• If you eat meals irregularly or skip meals
• If you are fasting
• If you are malnourished
• If you change your diet
• If you increase physical activity without a corresponding increase in carbohydrate intake
• If you drink alcohol, especially if you have skipped a meal
• If you take other medicines or herbal remedies at the same time
• If you take high doses of gliclazida
• If you have endocrine disorders (thyroid, pituitary, or adrenal cortex disorders)
• If your kidney or liver function is severely impaired.

If your blood sugar drops, you may experience the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, nervousness, aggression, reduced concentration, decreased alertness and reaction time, depression, confusion, speech and visual disturbances, trembling, sensory disturbances, dizziness, and a feeling of weakness.

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

If blood sugar levels continue to fall, you may experience significant confusion (delirium), seizures, loss of coordination, shallow breathing, and a slower heart rate, which may lead to loss of consciousness.

In most cases, symptoms of low blood sugar disappear rapidly after taking sugar in any form, e.g., glucose tablets, sugar lumps, sugary juice, or sweetened tea. You should therefore always carry some form of sugar with you (glucose tablets, sugar lumps). Remember that artificial sweeteners (e.g., saccharin) are not effective. Contact your doctor or the nearest hospital if taking sugar does not work or if symptoms recur.

Symptoms of low blood sugar may not appear, may be less obvious, may develop slowly, or you may not notice in time that your blood sugar has dropped.

This may happen if you are an elderly patient taking certain medicines (e.g., drugs acting on the central nervous system or beta-blockers).

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

Symptoms of high blood sugar (hyperglycemia) may occur if gliclazide is not sufficiently lowering your blood sugar, if you do not follow your prescribed treatment, if you are taking St. John’s wort (Hypericum perforatum) preparations (see section “Other medicines and Gliclazida Teva”), or during special stress situations. These 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 (high or low blood sugar levels) may occur when gliclazide is taken together with antibiotics called fluoroquinolones, especially in elderly patients. In such cases, your doctor will emphasize the importance of monitoring your blood glucose.

If you have a family history or are aware of a hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a red blood cell abnormality, decreased hemoglobin levels, and breakdown of red blood cells [hemolytic anemia]), these may occur. Contact 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

Its use is not recommended in the treatment of diabetes in children 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 medicines.

The hypoglycemic effect (ability to lower blood sugar) of gliclazide may be increased, 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).
• Painkillers (analgesics) or anti-rheumatic medicines (ibuprofen, phenylbutazone).
• Medicines containing alcohol.

The hypoglycemic effect of gliclazide may decrease and blood sugar levels may rise when taking any of the following medicines:

• Medicines to treat disorders of the central nervous system (chlorpromazine).
• Medicines to reduce inflammation (glucocorticoids).
• Medicines to treat asthma or used when there is a threat of premature labor (intravenous salbutamol, ritodrine, terbutaline).
• Medicines to treat chest conditions, heavy menstrual bleeding, and endometriosis (danazol).
• Preparations with St. John’s wort (Hypericum perforatum).

Changes in blood glucose (low blood sugar and high blood sugar) may occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as Gliclazida, especially in elderly patients.

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

Consult your doctor before starting any other medicine. If you go to the hospital, inform the doctors and nurses that you are taking Gliclazida Teva 30 mg modified-release tablets.

Taking Gliclazida Teva 30 mg modified-release tablets with food, drinks, and alcohol

Gliclazida Teva 30 mg modified-release tablets can be taken with food and non-alcoholic drinks.

Alcoholic drinks are not recommended, as they may unpredictably affect diabetes control.

Pregnancy and breastfeeding

Gliclazida Teva is not recommended during pregnancy.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor for a more suitable treatment.

You must not take Gliclazida Teva while breastfeeding.

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 develop visual problems as a result of these conditions. Be aware that this may endanger your safety or that of others (e.g., when driving or operating machinery). Ask your doctor whether you can drive if:

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

Gliclazida Teva contains lactose

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

3. How to take Gliclazida Teva 30 mg modified-release tablets

Dosage

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Your doctor will determine the dose of this medicine depending on your blood and urine sugar 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 starting dose is one tablet per day. The usual dose may range from one to four tablets maximum, taken as a single dose during breakfast. This depends on the response to treatment.

If combination therapy with Gliclazida Teva 30 mg modified-release tablets 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 individual dose for each medicine.

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

Method of administration

Oral use.

Swallow the tablets whole. Do not chew the tablets.

Take your tablets with a glass of water at breakfast, preferably at the same time each day. You must always eat after taking the tablet.

If you take more Gliclazida Teva 30 mg modified-release tablets than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. Signs of overdose include low blood sugar levels (hypoglycaemia), as described in section 2. Symptoms can be prevented by taking sugar (4 to 6 sugar cubes) or sugary drinks directly, followed by a snack or substantial meal. If the patient is unconscious, inform a doctor and call emergency services. The same action should be taken 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 alert a doctor in case of emergency.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Gliclazida Teva 30 mg modified-release tablets

It is important that you take this medicine every day, as it works best when taken regularly. However, if you forget to take your dose of Gliclazida Teva, 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 30 mg modified-release tablets

Because diabetes treatment is usually lifelong, you must consult your doctor before stopping this treatment. Stopping it may cause an increase in blood sugar levels (hyperglycaemia), which could increase the risk of diabetes-related 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 assessment of adverse effects is based on their frequency.

The most frequently observed adverse effect is a decrease in blood sugar levels (hypoglycaemia) (for symptoms and signs, see Section “Warnings and precautions”). If you do not treat these symptoms, they may progress to stupor, loss of consciousness, or even coma. If a low blood sugar episode is severe or prolonged, even if temporarily controlled by sugar intake, you should seek immediate medical attention.

Gastrointestinal disorders

Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These adverse effects decrease when Gliclazida Teva 30 mg modified-release tablets are taken with a meal, as recommended.

Blood disorders

Decrease in the number of blood cells (e.g. platelets, red blood cells, and white blood cells), leading to reported cases of pallor, prolonged bleeding, bruising, sore throat, and fever.

Skin disorders

Skin reactions have been observed, such as skin rash, redness, itching, hives, blisters, and angioedema (rapid swelling of tissues such as eyelids, lips, mouth, tongue, or throat, which may lead to breathing difficulties). The skin rash may progress to widespread rash or skin peeling.

If you develop any of these disorders, stop taking Gliclazida Teva 30 mg, consult a doctor urgently, and inform them that you are taking this medicine.

Rarely, signs of serious hypersensitivity reactions (DRESS) have been reported, initially presenting with flu-like symptoms and facial rashes that later progress to widespread rashes and fever.

Hepatic disorders

Isolated cases of abnormal liver function tests and liver changes (which may cause yellowing of the skin and eyes) have been reported. If you notice this effect, consult your doctor immediately. These symptoms usually resolve when you stop taking this medicine. Your doctor will decide whether you should discontinue treatment.

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 rarely been observed (may affect up to 1 in 10,000 patients):

Very rare cases of changes in blood cell counts and inflammatory allergic reactions of blood vessel walls, and reduction in blood sodium (hyponatremia) have been described. Rarely, signs and symptoms of liver failure (e.g. jaundice) have been observed, which in most cases resolve upon discontinuation of treatment, but may lead to severe liver failure in isolated cases.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 30 mg prolonged-release tablets

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and carton. 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. Ask your pharmacist how to dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, please consult your pharmacist on the proper disposal of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gliclazida Teva 30 mg modified-release tablets

• The active substance is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.

• The other components are: lactose monohydrate, hypromellose, calcium carbonate, anhydrous colloidal silica, and magnesium stearate (See section 2 “Gliclazida Teva contains lactose”).

Appearance of the product and contents of the pack

The modified-release tablets are white, oval-shaped, and biconvex.

Gliclazida Teva 30 mg modified-release tablets are available in packs of 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 120, and 180 tablets, and in bottles containing 90, 120, or 180 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

TEVA PHARMA S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor
28108 Alcobendas (Madrid), Spain

Manufacturer:

KRKA, d.d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto
Slovenia

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Germany: Gliclada modified release tablets 30 mg
Austria: Gliclada modified release tablets 30 mg
Czech Republic: Glyclada modified release tablets 30 mg
Denmark: Gliclazide Krka 30 mg modified release tablets
Slovakia: Gliclada modified release tablets 30 mg
Estonia: Gliclada 30 mg
France: Gliclada 30 mg comprimé à libération modifiée
Greece: δισκία παρατεταμένης αποδέσμευσης
Ireland: Gliclazide Krka 30 mg modified release tablets
Italy: Gliclada modified release tablets 30 mg
Latvia: Gliclada modified release tablets 30 mg
Lithuania: Gliclada modified release tablets 30 mg
Poland: Gliclada
Portugal: Gliclazide Krka 30 mg modified release tablets
United Kingdom: NAZDOL MR 30 mg modified release tablets

Date of the most recent review of this leaflet: December 2020

Detailed and up-to-date 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/