GLICLAZIDA STADA 30 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Gliclazida Stada 30 mg Modified Release Tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult 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 or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

Package Contents and Additional Information

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

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

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.

2. What you need to know before taking Gliclazida Stada

DO NOT take Gliclazida Stada:

• If you are allergic to gliclazide or any of the other components of this medication (listed in section 6) or to any medication in the same group (sulfonylureas), or to other related medications (hypoglycemic sulfonamides).
• 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 kidney or liver disease.
• If you are taking medications for the treatment of fungal infections (miconazole - see section: "Other medications and Gliclazida Stada").
• If you are breastfeeding (see section: "Pregnancy and breastfeeding").

Warnings and Precautions

Consult your doctor before starting to take Gliclazida Stada.

You should follow the treatment prescribed by your doctor to achieve adequate blood sugar levels. This means, in addition to taking the tablets regularly, you should control your diet, exercise, and, if necessary, lose weight.

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

During the first few weeks of treatment, the risk of low blood sugar levels (hypoglycemia) may increase. For this reason, careful medical monitoring is necessary.

Low blood sugar levels (hypoglycemia) may occur:

• if you do not maintain regular meals or skip them.
• if you are fasting.
• if you are malnourished.
• if you change your diet.
• if you increase your physical activity without an adequate increase in carbohydrate intake.
• if you drink alcohol, especially if you also skip meals.
• if you take other medications or natural remedies at the same time.
• if you take very high doses of gliclazide.
• if you have certain hormonal disorders (functional alterations of the thyroid gland, pituitary gland, or adrenal cortex).
• if your liver or kidney function is severely impaired.

If you experience low blood sugar, you may have 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 disorders, dizziness, and vulnerability. You may also experience the following signs and symptoms: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, severe chest pain that may radiate to nearby areas (angina pectoris).

If blood sugar levels continue to drop, you may experience severe confusion (delirium), convulsions, loss of self-control, shallow breathing, and a slowed heart rate, which can lead to unconsciousness.

In most cases, the symptoms of low blood sugar disappear quickly when you consume any form of sugar, 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 are not effective. Contact your doctor or the nearest hospital if sugar intake does not help or if the symptoms recur.

The symptoms of low blood sugar may not appear, be mild, or develop slowly, or you may not notice in time that your blood sugar levels have dropped. This can occur if you are an elderly patient and are taking certain medications (e.g., those that act 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 insulin.

The symptoms of high blood sugar levels (hyperglycemia) may appear when gliclazide has not sufficiently reduced blood sugar, if you do not follow the treatment prescribed by your doctor, if you take St. John's Wort preparations (Hypericum perforatum) (see section "Other medications and Gliclazida Stada"), or in special stressful situations. These may include thirst, frequent urination, dry mouth, dry and itchy skin, 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 medications 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 medication.

Children and Adolescents

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

Other Medications and Gliclazida Stada

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

The hypoglycemic effect 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 treating high blood pressure or heart failure (beta-blockers, angiotensin-converting enzyme inhibitors such as captopril or enalapril).
• medications for treating fungal infections (miconazole, fluconazole).
• medications for treating stomach or duodenal ulcers (H2 receptor antagonists).
• medications for treating depression (monoamine oxidase inhibitors).
• medications containing alcohol.

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

• medications for treating central nervous system disorders (chlorpromazine).
• medications for reducing inflammation (corticosteroids).
• medications for treating asthma or used during childbirth (intravenous salbutamol, ritodrine, and terbutaline).
• medications for treating breast disorders, heavy menstrual bleeding, and endometriosis (danazol).
• St. John's Wort preparations (Hypericum perforatum)

Alterations in blood glucose levels (low blood sugar and high blood sugar) may occur when taking a medication 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 medications that reduce blood coagulation (e.g., warfarin).

Consult your doctor before using any other medication. If you are hospitalized, inform the medical 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 Breastfeeding

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

You should not take Gliclazida Stada if you are breastfeeding.

Driving and Using Machines

Your ability to concentrate and react may be impaired if your blood sugar is too low (hypoglycemia) or too high (hyperglycemia) or if you experience visual disturbances due to these conditions. Keep in mind that you may put yourself or others at risk (e.g., when driving or operating machinery).

Consult your doctor if you can drive if:

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

3. How to Take Gliclazida Stada

Dose

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The dose is determined by your doctor, depending on your blood sugar 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 dose 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 combination treatment with Gliclazida and 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 on an individual basis.

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

Route and Method of Administration

Gliclazide is for oral use.

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

You should always eat a meal after taking your tablet(s).

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. The symptoms may improve by taking sugar (4 to 6 sugar cubes) or sugary 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, e.g., 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 Forget to Take Gliclazida Stada

It is important 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 make up for the forgotten doses.

If You Stop Taking Gliclazida Stada

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

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 experiences them.

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

If left untreated, the symptoms may progress to drowsiness, loss of consciousness, or possibly coma. If an episode of low blood sugar is severe or prolonged, even if temporarily controlled with sugar intake, you should seek immediate medical attention.

Liver Disorders

Isolated cases of abnormal liver function have been reported, which can cause yellowing of the skin and eyes. If this occurs, consult your doctor immediately. These symptoms usually disappear if the medication is discontinued. Your doctor will decide whether to discontinue treatment.

Skin Disorders

Skin reactions have been reported, such as:

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

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

Initially as flu-like symptoms and later as a rash on the face with widespread rash and high temperature.

Blood Disorders

A reduction in blood cells (e.g., platelets, white blood cells, and red blood cells) has been reported. This can cause:

• Pallor.
• Prolonged bleeding.
• Bruising.
• Sore throat.
• Fever

These symptoms usually disappear when treatment is discontinued.

Gastrointestinal Disorders

• Abdominal pain.
• Feeling of nausea.
• Indigestion.
• Diarrhea.
• Constipation.

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

Visual Disorders

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.

As with other sulfonylureas, the following side effects have been observed: cases of severe changes in blood cell counts and allergic inflammation of blood vessel walls, reduction of sodium in the blood (hyponatremia), symptoms of liver disorders (e.g., jaundice) that in most cases disappeared after discontinuation of the sulfonylureas but in isolated cases may cause liver failure that can be fatal.

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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use. https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Gliclazida Stada

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

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

Do not store above 25°C.

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medications in the SIGRE collection point at the 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. Package Contents and Additional Information

Composition of Gliclazida Stada

The active ingredient is gliclazide.

Each modified-release tablet contains 30 mg of gliclazide.

The other components are:

Dihydrate calcium hydrogen phosphate, povidone K30, hypromellose, and magnesium stearate (E470b).

Appearance of the Product and Package Contents

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel,

Co. Tipperary

Ireland

Date of the Last Revision of this Leaflet: March 2017

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