Patient Information Leaflet

Gliclazide Teva 30 mg Modified Release Tablets

1. What is Gliclazide Teva 30 mg Modified Release Tablets and how is it used

2. What you need to know before you start taking Gliclazide Teva 30 mg Modified Release Tablets

3. How to take Gliclazide Teva 30 mg Modified Release Tablets

4. Possible side effects

5. Storage of Gliclazide Teva 30 mg Modified Release Tablets

6. Contents of the pack and additional information.

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

Gliclazida Teva 30 mg modified-release tablets is used for the treatment of a type of diabetes (type 2 diabetes mellitus) in adults, when diet, physical exercise and weight loss alone do not have an adequate effect to maintain blood sugar levels at correct levels.

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 in the same group (sulfonilureas) or to other related medicines (sulfonamides hypoglycemic).
• If you have insulin-dependent diabetes (type 1).
• If you have ketones and sugar in your urine (it may mean that you have diabetic ketoacidosis), precoma or diabetic coma.
• If you have severe liver or kidney disorders.
• 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

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

You must monitor the treatment prescribed by your doctor to achieve the right level of blood sugar. This means, in addition to taking the tablets regularly, in addition to taking care of your diet, practicing physical exercise and, if necessary, reducing your weight.

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

During the first weeks of treatment, there may be an increased risk of low blood sugar (hypoglycemia). Therefore, medical follow-up is necessary.

Low blood sugar (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 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 renal or hepatic 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, irritability, decreased concentration, decreased alertness and reaction time, depression, confusion, speech and visual disturbances, tremors, sensory disturbances, dizziness and feeling of uselessness.

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

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

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

Symptoms of low blood sugar may not appear, may be less obvious, develop slowly or may not be noticed in time that blood sugar has fallen.

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

If you are experiencing stress (e.g. accidents, surgical procedures, infections with fever, etc.), your doctor may change the treatment temporarily to insulin.

Symptoms of high blood sugar (hyperglycemia) may occur when gliclazide does not lower blood sugar enough, when treatment prescribed by your doctor is not followed, if you are taking St. John's Wort preparations (see section “Other medicines and Gliclazida Teva”) or in special situations of stress. These may include thirst, frequent urination, dry mouth, dry skin with itching, skin infections and decreased activity. If these symptoms occur, contact your doctor or pharmacist.

Abnormalities in blood glucose levels (high or low blood sugar) may occur when a fluoroquinolone antibiotic is taken at the same time as Gliclazida, especially in elderly patients. In this case, your doctor will remind you of the importance of controlling your blood glucose levels.

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

It is not recommended for use in the treatment of diabetes in children 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 hypoglycemic effect of gliclazide may be increased and signs of low blood sugar may appear when taking any of the following drugs:

- Other medicines used to treat high blood sugar levels (oral antidiabetics, GLP-1 receptor agonists) or insulin.

- Antibiotics (e.g. sulfonamides, clarithromycin).

- Medicines for treating high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril).

- Medicines for treating fungal infections (miconazole, fluconazole).

- Medicines for treating stomach or duodenal ulcers (H2 receptor antagonists).

- Medicines for treating depression (monoamine oxidase inhibitors).

- Analgesics (for pain) or antirheumatics (ibuprofen, phenylbutazone).

- Medicines containing alcohol.

The hypoglycemic effect of gliclazide may be decreased and blood sugar levels may increase if taking any of the following medicines:

• Medicines for treating central nervous system disorders (chlorpromazine).
• Medicines for reducing inflammation (glucocorticoids).
• Medicines for treating asthma or used when there is a threat of premature birth (salbutamol intravenously, ritodrine and terbutaline).
• Medicines for treating chest diseases, heavy menstrual bleeding and endometriosis (danazol).
• Preparations with St. John's Wort (Hypericum perforatum)

Abnormalities in blood glucose levels (low blood sugar and high blood sugar) may occur when a fluoroquinolone antibiotic is taken at the same time as Gliclazida, 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 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 alter blood sugar control in an unpredictable way.

Pregnancy and breastfeeding

Gliclazida Teva is not recommended during pregnancy.

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

You should not take Gliclazida Teva while breastfeeding.

Driving and operating machines

Your ability to concentrate or react may be impaired if your blood sugar level is too low (hypoglycemia), too high (hyperglycemia) or if you develop visual problems as a result of these conditions. Be aware 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.

Gliclazida Teva contains lactose

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

Dose

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Your doctor will determine the dose of this medication based on your blood sugar and urine levels. Changes in external factors (e.g. weight loss, lifestyle changes, 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 vary from one to four tablets at a maximum, taken once a day in the morning. This depends on the response to treatment.

If treatment is initiated 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, your doctor will determine the individual suitable dose for each medication.

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

Administration Form

Oral route.

Swallow the tablets whole. Do not chew the tablets.

Take your tablets with a glass of water in the morning, preferably at the same time every day. You should always eat after taking the tablet.

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

If you take many tablets, contact your doctor or the nearest hospital emergency department immediately. Signs of overdose are described in section 2. Symptoms can be prevented by taking sugar (4 to 6 sugar cubes) or sweet drinks directly, followed by a snack or substantial meal. If the patient is unconscious, inform a doctor and call emergency services. The same procedure should be followed if someone, for example a child, has taken the medication unintentionally. Unconscious people should not be given food or drink.

Ensure that there is always an informed person who can notify 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, phone 91 562 04 20, indicating the medication and the amount ingested.

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

It is essential to take this medication every day as regular treatment works best. 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 compensate for the missed doses.

If you interrupt treatment with Gliclazida Teva 30 mg modified-release tablets

Since diabetes treatment is usually lifelong, you should consult your doctor before interrupting this treatment. Stopping treatment could cause an increase in blood sugar levels (hyperglycemia), which may increase the risk of complications related to diabetes.

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

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

The assessment of side effects is based on their frequency.

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

Gastrointestinal disorders

Abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These side 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) due to which paleness, prolonged bleeding, ecchymoses, sore throat, and fever have been reported.

Skin disorders

Skin reactions such as skin rash, redness, itching, hives, blisters, angioedema (rapid inflammation of tissues such as eyelids, lips, mouth, tongue, or throat that may lead to respiratory difficulties). The skin rash may progress to spread virulently or to peel off the skin.

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

Exceptionally, severe signs of hypersensitivity reactions (DRESS) have been reported, initially with symptoms similar to the flu and facial eruptions that later become widespread and fever.

Hepatic disorders

Abnormal liver function tests, changes in the liver (may cause yellow skin and eyes). If this effect is observed, consult your doctor immediately. These symptoms usually disappear if this medicine is discontinued. Your doctor will decide whether you should discontinue this medicine

Ocular disorders

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

Like other sulfonylureas, the following side effects have been rarely described (may affect 1 in 10,000 patients)

Very rarely, some changes in blood cell counts and inflammatory allergic reactions to the blood vessel walls have been described, reduction of sodium in the blood (hyponatremia). Rarely, signs and symptoms of liver insufficiency (e.g. jaundice) have been observed, which in most cases disappear when treatment is discontinued, but may cause severe liver failure in isolated cases.

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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

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

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Glyclazide Teva 30 mg Modified Release Tablets Composition

- The active ingredient is glyclazide. Each modified release tablet contains 30

mg of glyclazide.

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

Appearance of the Product and Contents of the Package

The modified release tablets are white, oval and biconvex.

Glyclazide Teva 30 mg Modified Release Tablets are available in packs of 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 120 or 180 tablets and in bottles of 90, 120 or 180 tablets.

Only some package 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

Responsible for Manufacturing:

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto

Slovenia

This medicine is authorized in the member states of the European Economic Area with 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 tablet with modified release

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

Last Review Date of this LeafletDecember 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/