GLICLAZIDE SANDOZ 30 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet:information for the patient

Gliclazide Sandoz 30 mg modified-release tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Gliclazide Sandoz and what is it used for
2. What you need to know before you take Gliclazide Sandoz
3. How to take Gliclazide Sandoz
4. Possible side effects
5. Storing Gliclazide Sandoz
6. Contents of the pack and other information

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

Gliclazide is a medicine that lowers blood sugar levels (oral antidiabetic medicine belonging to the sulfonylurea group).

This medicine is used to treat a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet, exercise, and weight loss alone do not have a sufficient effect on maintaining blood sugar levels.

2. What you need to know before you take Gliclazide Sandoz

Do not take Gliclazide Sandoz

• 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 related medicines (hypoglycemic sulfonamides),
• if you have insulin-dependent diabetes(type 1 diabetes),
• if you have ketoacidosis, ketones in the urine, precoma, or diabetic coma,
• if you have severe liveror kidneydisorders,
• if you are taking antifungal medicines(miconazole) (see "Taking Gliclazide Sandoz with other medicines"),
• if you are breast-feeding (see "Pregnancy and breast-feeding").

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Gliclazide Sandoz.

You should follow the treatment plan prescribed by your doctor to achieve adequate blood sugar levels. This means, in addition to taking the tablets regularly, controlling your diet, exercising, and, when necessary, reducing your body weight.

During treatment with gliclazide, regular monitoringof your blood sugar levels (and possibly urine) and hemoglobin A1c is required.

During the first few weeks of treatment, the risk of having a low blood sugar level (hypoglycemia)may increase. Therefore, close medical monitoring is necessary.

Low blood sugar levels (hypoglycemia)can occur:

• if you take your 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 an adequate increase in carbohydrate intake,
• if you drink alcohol, especially in combination with skipping 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 hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland, or adrenal cortex),
• if your kidney or liver function is severely impaired.

If you have low blood sugar levels, you may have the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbance, agitation, aggression, lack of concentration, decreased alertness and reaction time, depression, confusion, speech and visual disorders, tremors, sensory disturbances, dizziness, and helplessness.

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

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

In most cases, the symptoms of low blood sugar disappear quickly when you take sugar in any form, for example, glucose tablets, sugar cubes, sugary drinks, or sugary tea. Therefore, you should always carrysome sugar (glucose tablets, sugar cubes) with you. Remember that artificial sweeteners are not effective. If sugar intake does not help or the symptoms recur, 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 dropped. 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.

Symptoms of high blood sugar levels (hyperglycemia)when:

• gliclazide has not yet sufficiently lowered your blood sugar levels,

you have not followed the treatment plan prescribed by your doctor, if you take St. John's Wort preparations (Hypericum perforatum)or in special stress situations.

The symptomsmay include:

• thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and decreased activity.

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

Changes in blood sugar levels (low blood sugar and high blood sugar) can 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 (abnormality in red blood cells), a decrease in hemoglobin levels and destruction of red blood cells (hemolytic anemia) may occur.

Consult your doctor before taking this medicine.

Children and adolescents

It is not recommendedto use this medicine in children and adolescents due to the lack of data.

Taking Gliclazide Sandoz with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

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

• other medicines for treating high blood sugar levels (oral antidiabetics, GLP-1 receptor agonists, or insulin),
• antibiotics (e.g., sulfonamides and 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),
• analgesics or anti-rheumatics (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The blood sugar-lowering effect of gliclazide may be weakened, and blood sugar levels may increase when taking any of the following medicines:

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

Changes in blood sugar levels (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as gliclazide, especially in elderly patients.

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

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

Taking Gliclazide Sandoz with food, drinks, and alcohol

This medicine can be taken with mealsand non-alcoholic drinks. Alcohol consumption is not recommended, as it can unpredictably alter your diabetes control.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. He may prescribe a more suitable treatment for you.

It is not recommendedto take this medicine during pregnancy.

Do not takethis medicine if you are breast-feeding.

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 have visual problems due to these conditions. Keep in mind that this can be a risk to you or others (e.g., when driving or using machines). Ask your doctor if you can drive a car if:

• you have frequent episodes of low blood sugar levels (hypoglycemia),
• you have few or no warning signs of low blood sugar levels (hypoglycemia).

3. How to take Gliclazide Sandoz

Dose

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Only adults should take this medicine.

The dose is determined by your doctor, depending on your blood sugar levels and possibly urine. Changes in external factors (e.g., weight loss, lifestyle changes, stress) or improvements in blood sugar control may lead to the need for a dose adjustment.

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

If you start combination treatment with gliclazide and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will determine the individual dose of each medicine for you.

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

Form and route of administration

Oral use.

Swallow the tablets whole. Do not chew them.

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

You should always eat after taking the tablets.

If you take more Gliclazide Sandoz than you should

If you take too many tablets, contact your doctor or the emergency department of your nearest hospital.

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 taken.

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

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

If you forget to take Gliclazide Sandoz

It is important that you take the medicine every day, as regular treatment works better.

However, 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 Gliclazide Sandoz

Because diabetes treatment is usually for life, you should consult your doctor before stopping treatment with this medicine. Stopping treatment may lead to 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 "Warnings and precautions" in Section 2 "What you need to know before you take Gliclazide Sandoz".

If these symptoms persist without treatment, they may lead to drowsiness, loss of consciousness, or possibly coma. If the episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by sugar intake, you should seek medical attention immediately.

Other side effects that you may experience while taking this medicine are:

Rare: may affect up to 1 in 1,000 people.

• Decrease in the number of blood cells (e.g., platelets, red and white blood cells) that may cause paleness, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually disappear when treatment is discontinued.

Not known: frequency cannot be estimated from the available data.

• Liver function disorders, which may cause yellowing of the skin and eyes. If this happens to you, go to your doctor immediately. The symptoms usually disappear when treatment is discontinued. Your doctor will decide whether to discontinue treatment.
• Skin reactions such as rash, redness, itching, blisters, and angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat, which can cause difficulty breathing). The rash may progress to generalized blisters or skin peeling. Exceptionally, signs of severe hypersensitivity reactions (DRESS) have been reported, initially as flu-like symptoms and rash on the face, and then a prolonged rash with high temperature.
• Abdominal pain or discomfort, nausea, indigestion, diarrhea, and constipation. These effects are reduced when gliclazide is taken with food as recommended, see section 3 "How to take Gliclazide Sandoz".
• Vision problems: 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:

• severe changes in blood cell counts,
• allergic inflammation of blood vessel walls,
• decrease in sodium levels in the blood (hyponatremia),
• symptoms of liver failure (e.g., jaundice) that in many cases disappear after withdrawal of the sulfonylurea, but in isolated cases may progress to potentially fatal liver failure.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is 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. Storing Gliclazide Sandoz

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

Do not store above 25°C.

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

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. Packaging Content and Additional Information

Composition of Gliclazida Sandoz

• The active ingredient is gliclazide.
• The other components are calcium hydrogen phosphate dihydrate, povidone (E1201), hypromellose (E464), magnesium stearate (E572).

Appearance of the Product and Packaging Content

Modified release tablet.

White to off-white biconvex capsule-shaped tablet without coating, marked with "30" on one side and smooth on the other side.

Gliclazida Sandoz is available in transparent PVC/Aclar-ALU blister packs or transparent PVC-ALU blister packs containing 10, 30, 60, 90, 120 or 180 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57, Ljubljana

1526, Slovenia

Or

Lek S.A.

ul. Domaniewska 50 C

02-672 Warsaw

Poland

or

Salutas Pharma GmbH

Otto-Von-Guericke-Allee 1

39179 Barleben

Germany

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

Belgium: Gliclasan 30 mg tabletten met gereguleerde afgifte

Czech Republic: Gliklazid Sandoz 30 mg

Slovenia: Dizirel

Greece: Glicazide/Sandoz

Croatia: Gliklazid Sandoz 30 mg tablete s prilagodenim oslobadanjem

Netherlands: Gliclazide Sandoz 30 mg, tabletten met gereguleerde afgifte

Hungary: DYACLID 30 mg módosított hatóanyagleadású tabletta

Italy: GLICLAZIDE SANDOZ

Luxembourg: Gliclazide Sandoz 30 mg comprimé à libération modifiée

Portugal: Gliclazida Mesiproc

Sweden: Gliklazid Lek 30 mg tablete spodaljšanim sprošcanjem

Date of the last revision of this leaflet: June 2017.

Detailed 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/