GLICLAZIDA STADA 60 mg MODIFIED-RELEASE TABLETS

2. What you need to know before you take Gliclazida Stada

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 other medicines of the same group (sulfonylureas), or to other related medicines (hypoglycemic sulfonamides);

• If you have insulin-dependent diabetes (type 1);
• If you have ketone bodies and sugar in your urine (which may indicate that you have diabetic ketoacidosis), pre-coma, or diabetic coma;
• If you have severe kidney or liver impairment;
• If you are taking medicines for the treatment of fungal infections (miconazole, see section "Using Gliclazida Stada with other medicines");
• If you are breast-feeding (see section "Pregnancy, breast-feeding, and fertility").

Warnings and precautions

Consult your doctor before starting to take Gliclazida Stada.

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

During treatment with gliclazide, periodic monitoring of your blood sugar level (and possibly urine) and hemoglobin A1c is necessary. In the first few weeks of treatment, the risk of low blood sugar levels (hypoglycemia) may increase. Close clinical monitoring is especially 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 skip meals,
• if you take other medicines or natural remedies at the same time,
• if you take too high a dose of gliclazide,
• if you have certain hormonal disorders (functional disorders of the thyroid gland, pituitary gland, or adrenal cortex),
• if your kidney or liver function is severely impaired,

If you experience low blood sugar levels, you may have the following symptoms:

Headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, agitation, aggression, lack of concentration, decreased alertness and reaction time, depression, confusion, visual and speech disturbances, tremors, sensory disorders, dizziness, and vulnerability.

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

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

In most cases, the symptoms of low blood sugar levels disappear quickly after consuming sugar, e.g., glucose tablets, sugar cubes, sugary juice, sugary tea.

Therefore, you should always carry some sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. If sugar intake does not help or the symptoms recur, please contact your doctor or the nearest hospital.

The symptoms of low blood sugar levels may not appear, be mild, or develop very slowly, or you may not notice in time that your blood sugar level has decreased. This can happen in elderly patients who take certain medicines (e.g., those that act on the central nervous system and beta-blockers).

If you are under stress (e.g., accidents, surgical interventions, fever, etc.), your doctor may temporarily switch you to insulin treatment.

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

If these symptoms appear, you should contact your doctor or pharmacist.

Changes in blood sugar levels (low blood sugar levels and high blood sugar levels) 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 sugar levels.

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

Children and adolescents

Gliclazide is not recommended for use in children due to the lack of data.

Using Gliclazida Stada with other medicines

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

The blood sugar-lowering effect of gliclazide may be enhanced, and signs of low blood sugar levels may appear when taking one of the following medicines:

• 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),
• painkillers or anti-rheumatic medicines (phenylbutazone, ibuprofen),

• medicines containing alcohol.

The blood sugar-lowering effect of gliclazide may be reduced, and blood sugar levels may increase if you take any of the following medicines:

• medicines for treating disorders of the central nervous system (chlorpromazine),

• anti-inflammatory medicines (corticosteroids),
• medicines for treating asthma or used during childbirth (intravenous salbutamol, ritodrine, and terbutaline),
• medicines for treating breast disorders, heavy menstrual bleeding, and endometriosis (danazol),
• St. John's Wort preparations (Hypericum perforatum)

Changes in blood sugar levels (low blood sugar levels and high blood sugar levels) 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.

This medicine may increase the effect of medicines that reduce blood clotting (e.g., warfarin).

Consult your doctor before using any other medicine. If you are hospitalized, inform the medical staff that you are taking gliclazide.

Taking Gliclazida Stada with food, drinks, and alcohol

This medicine can be taken with meals and non-alcoholic drinks.

Alcohol consumption is not recommended, as it may unpredictably alter your diabetes control.

Pregnancy and breast-feeding

Gliclazida Stada is not recommended during pregnancy.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine, as he may prescribe a more suitable treatment for you.

You should not use this medicine during breast-feeding.

Driving and using machines

If your blood sugar levels drop too low (hypoglycemia) or rise too high (hyperglycemia), or if you experience visual problems as a result of these disorders, your ability to concentrate or react may be impaired.

Be aware that you may put yourself or others at risk (e.g., when driving or operating machinery).

Please ask your doctor if you can drive if:

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

Gliclazida Stada contains lactose

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

3. How to take Gliclazida Stada

Dose

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose will be determined by your doctor, depending on your blood sugar levels and possibly urine.

Dose adjustments of gliclazide may be necessary due to changes in external factors (e.g., weight loss, change in lifestyle, stress) or improvements in blood sugar control.

The recommended dose is half a tablet to two tablets (maximum 120 mg) in a single intake with breakfast. This depends on the response to treatment.

If combination therapy with gliclazide 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 dose of each medicine for you.

Contact your doctor or pharmacist if you notice that your blood sugar levels are high despite taking this medicine as prescribed by your doctor.

Method and route of administration

Gliclazide is administered orally.

The tablet can be divided into two equal doses.

Take the tablet(s) with a glass of water at breakfast (preferably at the same time each day).

Swallow the half tablet or the whole tablet(s). Do not chew or crush.

You should always eat after taking the tablet(s).

If you take more Gliclazida Stada than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. 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 medicine and the amount ingested).

The symptoms of overdose are those of low blood sugar levels (hypoglycemia) described in section 2. The symptoms may improve after taking sugar (4 to 6 sugar cubes) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, inform the doctor immediately and call the emergency services. The same should be done if someone, e.g., a child, has taken the medicine accidentally. Do not give food or drink to unconscious persons.

You must ensure that there is always someone informed who can call the doctor in case of an emergency.

If you forget to take Gliclazida Stada

It is important that you take your medicine every day, as regular treatment is more effective.

However, if you forget to take a dose of this medicine, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Gliclazida Stada

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

If these symptoms are not treated, they may progress to drowsiness, loss of consciousness, or possibly coma. You should seek immediate medical attention if the episode of low blood sugar levels is severe or prolonged, even if it is temporarily controlled with sugar intake.

Liver disorders

Isolated cases of abnormal liver function have been reported, which may cause yellowing of the skin and eyes. If you experience this, consult your doctor immediately. These symptoms usually disappear after stopping treatment. Your doctor will decide whether it is necessary to stop your treatment.

Skin disorders

Skin reactions such as:

• Rash.
• Erythema.
• Itching.
• Urticaria.
• Angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat that can cause difficulty breathing). The rash may evolve into widespread blistering or peeling of the skin.

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 fever.

Blood disorders

Decreases in the number of blood cells (e.g., platelets, red and white blood cells) have been reported, which may cause:

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

These symptoms usually disappear after stopping treatment.

Gastrointestinal disorders

• Abdominal pain.
• Nausea, vomiting.
• Indigestion.
• Diarrhea.
• Constipation.

These effects are reduced when gliclazide is taken with meals, as recommended.

Eyes disorders

Your vision may be temporarily affected, especially at the start of treatment. This effect is due to changes in blood sugar levels.

As with other sulfonylureas, the following adverse reactions have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the blood vessel walls, decreased sodium levels in the blood (hyponatremia), symptoms of liver failure (e.g., jaundice) that in most cases disappeared after withdrawal of the sulfonylurea, but in isolated cases may lead to life-threatening liver failure.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazida Stada

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Gliclazida Stada

• The active ingredient is gliclazide.

Each modified-release tablet contains 60 mg of gliclazide.

• The other components are:

Intragranular: lactose monohydrate, hypromellose (HPMC K100 LV) (E464), hypromellose (HPMC K4M CR) (E464).

Extragranular: hypromellose (HPMC K100 LV) (E464), hypromellose (HPMC K4M CR) (E464), magnesium stearate (E572).

Appearance of the Product and Container Content

The 60 mg modified-release tablets are white, biconvex, oval, scored on both sides, engraved with “GLI” and “60” on each side of the score on both sides, and have dimensions of 15.0 x 7.0 mm. The tablets can be divided into equal doses.

Gliclazida Stada 60 mg modified-release tablets are available in blister packs packaged in boxes of 10, 28, 30, 56, 60, 90, 120, 150, and 180 tablets*.

*Some package sizes may only be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36, 1190 Wien

Austria

or

Sanico N.V.

Veedijk 59

2300 Turnhout

Belgium

or

Fairmed Healthcare GmbH

Maria-Goeppert-Straße 3

23562 Lübeck

Germany

or

Laboratori Fundació DAU

Calle Lletra C de la Zona Franca 12-14

Polígono Industrial de la Zona Franca de Barcelona

08040 Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark: Gliclazid STADA 60 mg modified-release tablets

Austria: Gliclazid STADA 60 mg Tabletten mit veränderter Wirkstofffreisetzung

Bulgaria: MADRAS MR 60 mg modified release tablets x 30 tablets

Belgium: Uni Gliclazide EG 60mg tabletten met gereguleerde afgifte

Spain: Gliclazida STADA 60 mg comprimidos de liberación modificada EFG

France: GLICLAZIDE EG 60 mg, comprimé sécable à libération modifiée

Luxembourg: Uni Gliclazide EG 60mg comprimés à libération modifiée

Portugal: Gliclazida Ciclum

Slovenia: Gliklazid STADA 60 mg tablete s prirejenim sprošcanjem

Slovakia: Gliclazide MR Stada

Date of the Last Revision of this Prospectus: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/