GLICLAZIDE TEVA 30 mg MODIFIED-RELEASE TABLETS

Introduction

Patient Information Leaflet

Gliclazide Teva 30 mg modified-release tablets EFG

Contents of the pack:

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

1. What you need to know before you take Gliclazide Teva 30 mg modified-release tablets

1. How to take Gliclazide Teva 30 mg modified-release tablets
2. Possible side effects
3. Storing Gliclazide Teva 30 mg modified-release tablets
4. Contents of the pack and other information

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

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

Gliclazide Teva 30 mg modified-release tablets are used to treat a type 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 30 mg modified-release tablets

Do not take Gliclazide 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 other related medicines (hypoglycemic sulfonamides).
• If you have insulin-dependent diabetes (type 1).
• If you have ketone bodies and sugar in your urine (which may indicate diabetic ketoacidosis), pre-coma or diabetic coma.
• If you have severe liver or kidney disease.
• If you are receiving treatment for fungal infections (miconazole, see section "Other medicines and Gliclazide Teva").
• If you are breast-feeding (see section "Pregnancy and breast-feeding").

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

You should monitor the treatment prescribed by your doctor to achieve adequate blood sugar levels. This means, in addition to taking the tablets regularly, also taking care of your diet, exercising and, if necessary, losing weight.

During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine) is required. Your doctor may want to perform blood tests to monitor hemoglobin A1c (HbA1c, fasting plasma glucose).

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

Low blood sugar (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 physical activity without an appropriate increase in carbohydrate intake
• If you drink alcohol, especially if you have skipped a meal
• If you take other medicines or natural remedies at the same time
• If you take high doses of gliclazide
• If you have endocrine disorders (thyroid, pituitary or adrenal gland disorders)

• If your kidney or liver function is severely impaired.

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

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

If blood sugar levels continue to drop, you may experience considerable confusion (delirium), develop convulsions, loss of self-control, shallow breathing and slower heart rate, which can lead to loss of consciousness.

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

The symptoms of low blood sugar may not be apparent, may be less obvious, develop slowly or you may not notice in time that your blood sugar level has dropped.

This can happen if you are an elderly patient taking certain medications (e.g., central nervous system-acting drugs and beta-blockers).

If you are experiencing a stressful situation (e.g., accidents, surgery, infections with fever, etc.), your doctor may temporarily change your treatment to insulin.

The symptoms of high blood sugar (hyperglycemia) can occur when gliclazide has not sufficiently lowered blood sugar, when you have not followed the treatment prescribed by your doctor, if you are taking St. John's Wort preparations (Hypericum perforatum) (see section "Other medicines and Gliclazide Teva") or in special stressful situations. These may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections and decreased activity. If these symptoms occur, contact your doctor or pharmacist.

Changes in blood sugar levels (high or low blood sugar levels) can occur when gliclazide is prescribed at the same time as 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 sugar levels.

If you have a family history or know of a hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormality of red blood cells, decreased hemoglobin levels and breakdown of red blood cells (hemolytic anemia)), contact 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

Its use is not recommended in the treatment of diabetes in children due to 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 (ability to lower blood sugar levels) of gliclazide may be increased and signs of low blood sugar may appear when taking any of the following medications:

• Other medicines used to treat high blood sugar levels (oral antidiabetics, GLP-1 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).
• Pain relievers (e.g., ibuprofen, phenylbutazone) or anti-rheumatic medicines.
• Medicines containing alcohol.

The blood sugar-lowering effect of gliclazide may be decreased and blood sugar levels may increase if you take any of the following medications:

• medicines for central nervous system disorders (chlorpromazine).
• medicines to reduce inflammation (glucocorticoids).
• medicines for asthma or used when there is a threat of premature labor (intravenous salbutamol, ritodrine and terbutaline).
• medicines for chest diseases, heavy menstrual bleeding and endometriosis (danazol).
• preparations with St. John's Wort (Hypericum perforatum)

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

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

Consult your doctor before starting to take another medicine. If you go to the hospital, inform the doctor and nurses that you are taking Gliclazide Teva 30 mg modified-release tablets.

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

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

Alcoholic beverages are not recommended as they may alter diabetes control in an unpredictable way.

Pregnancy and breast-feeding

Gliclazide Teva is not recommended during pregnancy.

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

You should not take Gliclazide Teva while 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 develop 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 machines). Ask your doctor if you can drive if:

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

Gliclazide Teva contains lactose

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

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

Dose

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. Ask your doctor or pharmacist if you have any doubts.

Your doctor will determine the dose of this medicine depending on your blood sugar and 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 initial dose is one tablet per day. The usual dose may vary from one to four tablets, taken once daily during breakfast, depending on the response to treatment.

If combination treatment with Gliclazide 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 individual dose of 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 should always eat after taking the tablet.

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

If you take many tablets, contact your doctor or the emergency department of the nearest hospital immediately. The signs of overdose are low blood sugar levels (hypoglycemia) described in section 2. The symptoms can be avoided 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 the emergency services. The same applies if someone, e.g., a child, has taken the medicine unintentionally. Unconscious persons should not take food or drink.

You should ensure that there is always an informed person who can alert the doctor in case of an emergency.

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

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

It is important that you take this medicine every day, as regular treatment works better. However, if you forget to take your dose of Gliclazide 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 Gliclazide Teva 30 mg modified-release tablets

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

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 evaluation of side effects is based on their frequency.

The most frequently observed side effect is low blood sugar (hypoglycemia) (see section "Warnings and precautions" for symptoms and signs). If these symptoms are not treated, they can progress to drowsiness, loss of consciousness or even coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by sugar intake, you should receive immediate medical attention.

Gastrointestinal disorders

Abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation. These side effects decrease when Gliclazide 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), which can cause pallor, prolonged bleeding, bruising, sore throat and fever.

Skin disorders

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

If you develop these disorders, stop taking Gliclazide Teva 30 mg, consult a doctor urgently and tell them that you are taking this medicine.

Exceptionally, signs of severe hypersensitivity reactions (DRESS) have been reported, initially with symptoms similar to those of the flu and facial rash, which then become widespread rash and fever.

Liver disorders

Isolated reports of abnormal liver function tests, changes in the liver (which can cause yellowing of the skin and eyes). If you notice this effect, consult your doctor immediately. These symptoms usually disappear if you stop taking this medicine. Your doctor will decide whether you should stop taking this medicine.

Eyes 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 side effects have been rarely observed (may affect 1 in 10,000 patients)

Rarely, some changes in blood cell counts and allergic inflammatory reactions of blood vessel walls, decreased sodium levels in the blood (hyponatremia) have been reported. Rarely, signs and symptoms of liver failure (e.g., jaundice) have been observed, which in most cases disappear when treatment with these medicines is discontinued, but can cause severe liver failure in isolated cases.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazida Teva 30 mg prolonged-release tablets

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and additional information

Composition of Gliclazida Teva 30 mg prolonged-release tablets

• The active substance is gliclazide. Each prolonged-release tablet contains 30

mg of gliclazide.

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

Appearance and package contents of the product

The prolonged-release tablets are white, oval and biconvex.

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

Not all pack sizes may be marketed.

Marketing authorisation holder:

TEVA PHARMA S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid), Spain

Manufacturer:

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto

Slovenia

This medicine is authorised in the Member States of the European Economic Area 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: δισκ?α παρατεταμ?νης αποδ?σμευσης

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 last revision of this leafletDecember 2020

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