GLICLAZIDE TAD 30 mg MODIFIED-RELEASE TABLETS

Introduction

Leaflet: information for the patient

Gliclazida TAD 30mg modified-release tablets EFG

Read the entire leaflet carefully before starting to take thismedication,as it contains important informationfor you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Gliclazida TAD and what is it used for
2. What you need to know before taking Gliclazida TAD
3. How to take Gliclazida TAD
4. Possible side effects

5 Storage of Gliclazida TAD

1. Package contents and additional information

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

Gliclazida TAD is a medication used to reduce blood sugar levels (oral antidiabetic medication).

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

2. What you need to know before taking Gliclazida TAD

Do not take Gliclazida TAD

• if you are allergic (hypersensitive) to gliclazide, other sulfonylureas, sulfonamides, or any of the other components of this medication (listed in section 6.),
• if you have insulin-dependent diabetes (type 1),
• if you have ketone bodies and sugar in the urine (which may indicate 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 "Taking other medications"),
• if you are breastfeeding (see section "Pregnancy and breastfeeding").

If you think you are affected by any of the above situations, inform your doctor, nurse, or pharmacist.

Warnings and precautions

You should only take this medication if your food intake is regular (including breakfast). It is essential that your carbohydrate intake is regular due to the increased risk of low blood sugar levels (hypoglycemia) if a meal is delayed or skipped, if an inadequate amount of food is consumed, or if the meal is low in carbohydrates.

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.

You should monitor the treatment prescribed by your doctor to achieve the recommended blood sugar level. This means taking the tablets regularly, as well as following your diet and exercising.

During the first few weeks of treatment, the risk of low blood sugar levels (hypoglycemia) may increase. Therefore, it is vital that your doctor closely monitors you.

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 physical activity without an appropriate increase in carbohydrate intake,
• if you drink alcohol, especially if you have skipped a meal,
• if you take other medications 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 your blood sugar levels drop, you may experience the following symptoms: headache, intense hunger, pallor, weakness, exhaustion, nausea, vomiting, fatigue, drowsiness, sleep disorders, nervousness, aggression, loss of concentration, decreased alertness and reaction time, depression, confusion, speech and visual disorders, tremors, sensory disturbances, dizziness, and feelings of helplessness. You may also experience the following signs and symptoms: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, and severe, sudden chest pain that may radiate to adjacent areas (angina pectoris).

If your blood sugar levels continue to drop, you may experience considerable confusion (delirium), develop seizures, loss of self-control, shallow breathing, and a slower heart rate, which can lead to loss of consciousness and coma. The clinical profile of severe hypoglycemia may resemble a stroke.

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

It is possible that the symptoms of low blood sugar may not appear, may appear 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). It can also happen when you have certain endocrine disorders (e.g., thyroid function disorders, pituitary gland disorders, or adrenal insufficiency).

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) may appear when gliclazide has not sufficiently reduced blood sugar levels, when you have not followed the treatment prescribed by your doctor, or in special situations of stress. The symptoms may include thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and decreased activity.

If these symptoms occur, contact your doctor or pharmacist.

If you have a family history or know of a hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a red blood cell abnormality), hemolysis (breakdown of red blood cells) can occur. Contact your doctor before taking this medication.

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

Gliclazida TAD should not be used to treat diabetes in children and adolescents under 18 years of age.

Taking Gliclazida TAD with other medications

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medication.

The effectiveness and safety of Gliclazida TAD may be affected if taken at the same time as other medications. Similarly, the action of other medications may be affected if taken at the same time as Gliclazida TAD.

The hypoglycemic effect (ability to lower blood sugar levels) of gliclazide may be increased, and signs of low blood sugar levels may appear when taken with any of the following medications:

• other medications used to treat high blood sugar levels (oral antidiabetics, GLP-1 receptor agonists) or insulin,
• antibiotics (e.g., sulfonamides, clarithromycin),
• medications for high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• medications for fungal infections (miconazole, fluconazole),
• medications for stomach upset and stomach or duodenal ulcers (H2 receptor antagonists such as ranitidine),
• medications for depression (monoamine oxidase inhibitors),
• pain relievers or anti-rheumatic medications (ibuprofen, phenylbutazone),
• medications containing alcohol.

The hypoglycemic effect of gliclazide may be decreased, and blood sugar levels may increase if taken with any of the following medications:

• medications for central nervous system disorders (chlorpromazine),
• medications to reduce inflammation (glucocorticoids),
• medications for asthma (salbutamol administered by injection),
• medications used when there is a threat of premature labor (ritodrine and terbutaline intravenously),
• medications for chest diseases, heavy menstrual bleeding, and endometriosis (danazol).

Gliclazide may enhance the anticoagulant effect during simultaneous treatment with warfarin (a medication that inhibits blood clot formation).

Consult your doctor before starting to take another medication. If you go to the hospital, inform your doctor and nurses that you are taking Gliclazida TAD.

Taking Gliclazida TAD with food, drinks, and alcohol

Gliclazida TAD can be taken with food and non-alcoholic drinks.

Avoid consuming alcohol, as it can alter diabetes control in an unpredictable way and even lead to coma.

Pregnancy and breastfeeding

Gliclazida TAD is not recommended during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

You should not take Gliclazida TAD 30 mg modified-release tablets while breastfeeding.

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 hypoglycemia,
• you have a fever or do not have symptoms of hypoglycemia.

Gliclazida TAD contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Gliclazida TAD

Dose

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will determine the dose of Gliclazida TAD based 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 starting 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 your blood sugar level is not adequately controlled, your doctor may increase the dose in successive steps, usually leaving at least one month between adjustments.

If combination treatment with Gliclazida TAD 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 of each medication.

If you think the effect of Gliclazida TAD is too strong or too weak, inform your doctor or pharmacist.

Method of administration

Swallow the tablets whole with a glass of water during breakfast, preferably at the same time each day. Do not chew the tablets. You should always eat after taking the tablet(s). It is essential that you do not skip any meals while taking Gliclazida TAD.

If you take more Gliclazida TAD than you should

In case of overdose or taking an additional dose of gliclazide, contact your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. 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 action should be taken if someone, e.g., a child, has taken the medication unintentionally. Unconscious persons should not be given food or drink.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Gliclazida TAD

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 TAD

If you stop treatment, you should be aware that your blood sugar control may worsen. If any changes are needed, it is absolutely essential that you contact your doctor first.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The evaluation of side effects is based on their frequency.

Common (may affect up to 1 in 10 people):

Hypoglycemia (low blood sugar level). For symptoms and signs, see Section "Warnings and precautions". 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 temporarily controlled by sugar intake, you should receive immediate medical attention.

Uncommon (may affect up to 1 in 100 people):

• Abdominal pain
• Nausea
• Vomiting
• Indigestion
• Diarrhea
• Constipation.

These side effects decrease when Gliclazida TAD is taken with a meal, as recommended.

Rare (may affect up to 1 in 1,000 people):

• Decrease in blood cell count (e.g., platelets, red blood cells, and white blood cells), which can cause pallor, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually disappear when treatment is discontinued.
• Skin reactions such as rash, redness, itching, and formation of eruptions (hives), angioedema (rapid inflammation of tissues such as eyelids, lips, mouth, tongue, or throat that can lead to breathing difficulties). The skin eruption can evolve into widespread blistering or skin peeling. Exceptionally, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a skin rash on the face and then a generalized skin rash with high fever.
• Abnormal liver function tests, changes in the liver (can cause yellowing of the skin and eyes). If you notice this effect, consult your doctor immediately.
• 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.

These effects usually disappear when treatment is discontinued.

As with other sulfonylureas, the following rare side effects have been observed (may affect up to 1 in 10,000 patients):

Changes in blood cell count and allergic inflammatory reactions of blood vessel walls, decreased sodium levels in the blood (hyponatremia) have been very rarely described.

Rarely, signs and symptoms of liver failure (e.g., jaundice) have been observed, which in most cases disappear when treatment with gliclazide is discontinued but can lead to severe liver failure in isolated cases.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use, Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Gliclazida TAD

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the blister pack, bottle, and carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medications in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition ofGliclazida TAD

• The active ingredient is gliclazida. Each modified-release tablet contains 30 mg of gliclazida.
• The other components are: lactose monohydrate, hypromellose, calcium carbonate, colloidal anhydrous silica, and magnesium stearate.

Appearance of the Product and Packaging Content

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

Gliclazida TAD is available in blister packs in boxes of 60 tablets.

Marketing Authorization Holder

TAD Pharma GmbH, Heinz Lohmann Straße 5, 27472 Cuxhaven, Germany

Manufacturer

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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid

Date of the last revision of thisleaflet: March 2021

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/