Package Leaflet:Information for the Patient

Gliclazide TAD 30mg Modified Release EFG Tablets

Read this leaflet carefully before you start taking thismedicine, because it contains important informationfor you.

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

-This medicine has been prescribed for youonlyand should not be given to others even if they havethe same symptomsas you, as it may harm them.

• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know beforestartingto take Gliclazide TAD

3.How to take Gliclazide TAD

4.Possible side effects

5Storage of Gliclazide TAD

6.Contents of the pack and additional information

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

Gliclazida TAD 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 suitable levels.

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 ketones and sugar in your urine (which may indicate diabetic ketoacidosis), precoma, or diabetic coma,
• if you have severe liver or kidney damage,
• if you are receiving treatment for fungal infections (miconazole, see section “Taking other medicines”),
• 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 you have a regular intake of food (including breakfast). It is essential that your carbohydrate intake is regular, as there is an increased risk of low blood sugar (hypoglycemia) if you delay or skip a meal, consume an inadequate amount of food, or eat a meal low in carbohydrates.

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

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

During the first weeks of treatment, there may be an increased risk of low blood sugar (hypoglycemia). Therefore, it is vital that your doctor closely monitors you.

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 your physical activity without a corresponding 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 renal or hepatic function is severely impaired.

If your blood sugar levels drop, you may experience the following symptoms: headache, intense hunger, pallor, weakness, fatigue, nausea, vomiting, drowsiness, sleep disturbances, nervousness, irritability, decreased concentration, decreased alertness and reaction time, depression, confusion, speech and visual disturbances, 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 and sudden chest pain that may radiate to adjacent areas (angina pectoris).

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

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

You may not experience symptoms of low blood sugar, or they may appear slowly, or you may not realize that your blood sugar has dropped.

This may happen if you are an elderly patient taking certain medications (e.g., central nervous system-acting medications and beta-blockers) or if you have certain endocrine disorders (e.g., thyroid, pituitary, or adrenal gland disorders).

Your doctor may temporarily change your treatment to insulin if you are experiencing stress (e.g., accidents, surgery, infections with fever, etc.).

Symptoms of high blood sugar (hyperglycemia) may appear when gliclazide does not lower your blood sugar sufficiently, when you do not follow your prescribed treatment, or in special situations of stress. Symptoms may include thirst, frequent urination, dry mouth, dry skin with itching, skin infections, and decreased activity.

If you experience these symptoms, contact your doctor or pharmacist.

If you have a family history or know of a hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormality of red blood cells), hemoglobin deficiency, and collapse of red blood cells (hemolytic anemia), contact your doctor before taking this medication.

Cases of acute porphyria have been described with other sulfonylureas in patients with porphyria (genetic disorders that cause the accumulation of porphyrins and porphyrin precursors in the body).

Children and adolescents

Gliclazida TAD should not be used to treat diabetes in children or adolescents under 18 years old.

Taking Gliclazida TAD with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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) of gliclazide may increase and signs of low blood sugar may appear when taking any of the following medications:

• other medications used to treat high blood sugar (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 indigestion and stomach or duodenal ulcers (H2 receptor antagonists such as ranitidine),
• medications for depression (monoamine oxidase inhibitors),
• analgesics (for pain) or antirheumatics (ibuprofen, phenylbutazone),
• medications containing alcohol.

The hypoglycemic effect of gliclazide may decrease and increase blood sugar levels if taking any of the following medications:

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

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

Consult your doctor before starting another medication. If you visit the hospital, inform the 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 beverages.

Avoid consuming alcohol as it may unpredictably alter your diabetes control and even lead to coma.

Pregnancy and breastfeeding

Gliclazida TAD is not recommended during pregnancy. If you are pregnant, 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 operating machinery

Your ability to concentrate or react may be impaired if your blood sugar levels are too low (hypoglycemia), too high (hyperglycemia), or if you develop visual problems due to these conditions. Be aware that you may put yourself or others at risk (e.g., when driving or operating machinery). Ask your doctor if you can drive if:

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

Gliclazida TAD contains lactose

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

Dose

Follow exactly the administration instructions for this medication 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, lifestyle change, stress) or improvements in blood sugar control may require a change in the dose of gliclazida.

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 during breakfast. This depends on the response to treatment.

If blood sugar levels are not adequately controlled, your doctor may increase the dose in successive steps, leaving at least one month between adjustments.

If 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 individual adequate dose of each medication.

If you estimate that the action of Gliclazida TAD is too strong or too weak, inform your doctor or pharmacist.

Administration form

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

If you take more Gliclazida TAD than you should

In case of overdose or taking an additional dose of gliclazida, contact your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.. The signs of overdose are decreased blood sugar levels (hypoglycemia) described in section 2. Symptoms can be prevented by taking sugar (4 to 6 sugar cubes) or sweetened drinks directly, followed by a snack or substantial meal. If the patient is unconscious, inform a doctor and call emergency services. You must act in the same way if someone, for example, a child, has taken the medication without realizing it. Unconscious people should not take food or drink.

You must 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 forgot 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 compensate for the missed doses.

If you interrupt treatment with Gliclazida TAD

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

If you have any other doubts 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 evaluation of side effects is based on their frequency.

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

Hypoglycemia (low blood sugar level). For symptoms and signs, see the "Warnings and Precautions" section. If these symptoms are not treated, they may progress to drowsiness, loss of consciousness, or the possibility of coma. If a severe or prolonged episode of low blood sugar levels occurs, even if temporarily controlled by sugar intake, you should seek immediate medical attention.

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

These effects usually disappear if treatment is discontinued.

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

Very rarely, some changes in blood cell counts and inflammatory allergic reactions of the blood vessel walls, reduction of sodium in the blood (hyponatremia) have been described.

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 of these side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, Website:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

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

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofGliclazida TAD

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

Appearance of the product and content of the packaging

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

Gliclazida TAD is available in blisters in boxes of 60 tablets.

Holder of the marketing authorization

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

Responsible for manufacturing

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

You can request more information about this medication by contacting 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 review of thisleaflet: March 2021

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/