Package Insert: Information for the Patient

Gliclazide Stada 30 mg Modified Release EFG Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Gliclazida Stada is a medication that reduces blood sugar levels (oral antidiabetic medication belonging to the sulfonilureas group).

Gliclazida Stada is used in a certain type of diabetes in adults (type 2 diabetes mellitus), when diet, physical exercise, and weight loss alone are not sufficient to ensure normal blood sugar levels.

Do not take Gliclazida Stada:

• If you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6) or to any other medicine in the same group (sulfonilureas), or to other related medicines (sulfonamidas hypoglycémicas).
• If you have diabetes dependent on insulin (Type 1).
• If you have ketones and sugar in your urine (which may mean you have diabetic ketoacidosis), a precoma or diabetic coma.
• If you have severe kidney or liver disease.
• If you are taking medicines for fungal infections (miconazol - see section: “Other medicines and Gliclazida Stada”).
• If you are breastfeeding (see section: “Pregnancy and lactation”).

Warnings and precautions

Consult your doctor before starting to take Gliclazida Stada.

You must follow the treatment prescribed by your doctor to achieve suitable blood sugar levels. This means, in addition to regular intake of the tablets, you must control your diet, exercise physically, and, if necessary, lose weight.

During treatment with gliclazide, it is necessary to monitor your blood sugar level (and possibly in urine) and also your hemoglobin A1c (HbA1c).

During the first weeks of treatment, there may be an increased risk of having low blood sugar levels (hypoglycemia). Therefore, it is necessary to have careful medical monitoring.

Low blood sugar levels (hypoglycemia) may appear:

If you experience a drop in blood sugar, you may experience the following symptoms:

Headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, agitation, aggression, difficulty concentrating, decreased alertness and reaction time, depression, confusion, visual and speech disturbances, tremors, sensory disturbances, dizziness, and vulnerability. You may also experience the following signs and symptoms: sweating, moist skin, anxiety, rapid or irregular heartbeats, high blood pressure, sudden and severe chest pain that may radiate to nearby areas (angina pectoris).

If blood sugar levels continue to drop, you may experience a great confusion (delirium), seizures, loss of self-control, your breathing may become shallow, and your heart rate may slow down, leading to unconsciousness.

In most cases, symptoms of low blood sugar disappear quickly when you consume any form of sugar, e.g., glucose tablets, sugar cubes, sweetened juice, or sweet tea. You should carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Contact your doctor or the nearest hospital if sugar intake does not help or if symptoms recur.

Symptoms of low blood sugar may not appear, be mild, develop slowly, or you may not realize in time that your blood sugar levels have dropped. This can happen if you are an elderly patient and are taking certain medications (e.g., those acting on the central nervous system and beta-blockers).

If you are in stressful situations (accidents, surgical interventions, fever, etc.), your doctor may temporarily change your treatment to one with insulin.

Symptoms of high blood sugar levels (hyperglycemia) may appear when gliclazide does not sufficiently reduce blood sugar levels, if you do not follow the treatment prescribed by your doctor, if you take preparations of St. John's Wort (Hypericum perforatum) (see section "Other medicines and Gliclazida Stada"), or in special stress situations. These may include thirst, frequent urination, dry mouth, dry skin with itching, skin infections, and decreased performance.

If these symptoms appear, contact your doctor or pharmacist.

Alterations in blood glucose levels (low blood sugar and high blood sugar) may occur when gliclazide is prescribed at the same time as medicines belonging to 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 glucose levels.

If you have a family history or know that you have a hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormality of red blood cells), a reduction in hemoglobin levels and destruction of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.

Children and adolescents

Gliclazida Stada is not recommended for use in children and adolescents due to the absence of data.

Other medicines and Gliclazida Stada

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

The hypoglycemic effect of gliclazide may increase, and signs of low blood sugar levels 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 treating hypertension or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril).
• medicines for treating fungal infections (miconazol, fluconazol).
• medicines for treating stomach or duodenal ulcers (H2 receptor antagonists).
• medicines for treating depression (monoamine oxidase inhibitors).
• medicines containing alcohol.

The hypoglycemic effect of gliclazide may decrease, leading to an increase in blood sugar levels, when taking any of the following medications:

• medicines for treating central nervous system disorders (chlorpromazine).
• medicines for reducing inflammation (corticosteroids).
• medicines for treating asthma or used during delivery (salbutamol intravenously, ritodrina, and terbutaline).
• medicines for treating breast disorders, heavy menstrual bleeding, and endometriosis (danazol).
• Preparations of St. John's Wort (Hypericum perforatum)

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

Gliclazide may increase the effects of medicines that decrease blood coagulation (e.g., warfarin).

Consult your doctor before using any other medicine. In case of hospital admission, inform the healthcare staff that you are taking Gliclazida Stada.

Taking Gliclazida Stada with food, drinks, and alcohol

Gliclazida Stada can be taken with meals and non-alcoholic beverages. It is recommended not to drink alcohol during treatment with gliclazide as it may unpredictably alter your diabetes control.

Pregnancy and lactation

Gliclazida Stada is not recommended during pregnancy. If you plan to become pregnant or become pregnant, consult your doctor before taking this medicine, as they may prescribe a more suitable treatment for you.

You should not take Gliclazida Stada if you are breastfeeding.

Driving and operating machinery

Your ability to concentrate and react may be affected if your blood sugar is very low (hypoglycemia), or too high (hyperglycemia), or if you experience visual disturbances due to these conditions. Be aware that you or others may be put in danger (e.g., while driving or operating machinery).

Consult your doctor if you can drive if:

• You have frequent episodes of low blood sugar (hypoglycemia).
• You do not show signs that warn you of low blood sugar (hypoglycemia) or these are mild.

Dosage

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.

The dosage is determined by your doctor, depending on your blood levels and possibly urine levels.

Changes in external factors (e.g., weight loss, lifestyle changes, stress) or improvements in blood sugar control may require changes in the dosage of gliclazide.

The recommended daily dose is 1 to 4 tablets (maximum 120 mg) in a single dose at breakfast time. This depends on the response to treatment.

If your doctor initiates a combination treatment of Gliclazida with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will decide on the appropriate dose of each medication for you individually.

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

Route and form of administration

Gliclazida is for oral use.

Take your medication with a glass of water at breakfast time (and preferably at the same time every day). Swallow your tablet whole. Do not crush or chew it.

Always eat a meal after taking your tablets.

If you take more Gliclazida Stada than you should

If you have taken too many tablets, contact your doctor or the nearest emergency hospital immediately. The signs of overdose are those indicated for low blood sugar (hypoglycemia) described in section 2. Symptoms may improve by taking sugar (4 to 6 lumps) or sweet drinks, followed by a substantial snack or meal.

If the patient is unconscious, call the emergency service and inform the doctor immediately. The same should be done if someone, for example, a child, takes the product unintentionally. Do not give food or drink to unconscious patients. Ensure that there is always an informed person who can call 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 Stada

It is essential to take your medication regularly every day for it to work better.

However, if you have forgotten to take one dose of Gliclazida, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Gliclazida Stada

Since diabetes treatment is usually lifelong, you should consult your doctor before stopping this medication. Stopping treatment could cause an increase in blood sugar (hyperglycemia), which increases the risk of developing diabetes complications.

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

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

The most frequently observed side effect is low blood sugar (hypoglycemia).For signs and symptoms, see “Warnings and precautions.”

If symptoms are not treated, they may progress to drowsiness, loss of consciousness, or possibly coma. If a severe or prolonged episode of low blood sugar occurs, even if temporarily controlled with sugar intake, seek immediate medical attention.

Liver disorders

Isolated abnormalities in liver function have been reported, which may cause yellowing of the skin and eyes. If this occurs, seek immediate medical attention. These symptoms usually disappear if the medicine is discontinued. Your doctor will decide whether to discontinue treatment.

Skin disorders

The following skin reactions have been reported:

• Rash.
• Redness.
• Itching.
• Hives.
• Angioedema (rapid swelling of tissues such as eyelids, face, lips, tongue, or throat that may cause breathing difficulties). The rash may progress to generalized blistering or skin peeling.

Exceptionally, severe hypersensitivity reactions (DRESS) have been reported:

Initially as flu-like symptoms and subsequently as a facial rash with widespread rash and high fever.

Blood disorders

Reduced blood cells (e.g., platelets, white blood cells, and red blood cells) have been reported, which may cause:

• Pallor.
• Prolonged bleeding.
• Hematomas.
• Throat pain.
• Fever

These symptoms usually disappear if treatment is discontinued

Gastrointestinal disorders

• Abdominal pain.
• Nausea.
• Indigestion.
• Dysentery.
• Constipation

These effects are reduced if Gliclazida Stada is taken with a meal as recommended.

Vision 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.

Like other sulfonylureas, the following adverse effects have been observed: severe changes in the number of blood cells and allergic inflammation of blood vessel walls, reduced sodium in the blood (hyponatremia), liver symptoms (e.g., jaundice) that in most cases disappeared after discontinuation of sulfonylureas, but in isolated cases may cause fatal liver failure.

Communication and side effects:

If you experienceany 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 the Spanish System for Pharmacovigilance of Medicines for Human Use. https:/www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store at a temperature above25oC.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Gliclazida Stada

The active ingredient is gliclazide.

Each modified-release tablet contains 30 mg of gliclazide.

The other components are:

Calcium dihydrogen phosphate, povidone K30, hypromellose, and magnesium stearate (E470b).

Appearance of the product and contents of the packaging

Gliclazida Stada 30 mg are white or off-white, capsule-shaped, biconvex tablets, 9.8 mm x 4.3 mm in size, engraved with "30" on one face and smooth on the other face.

Gliclazida Stada 30 mg modified-release tablets are available in blisters packaged in boxes of 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 98, 100, 112, 120, 180, and 500 tablets.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern(Barcelona)

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel,

Co. Tipperary

Ireland

Last review date of this leaflet: March 2017

The 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