Prospecto:Information for the Patient

Gliclazida Sandoz 30 mg Modified Release Tablets EFG

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

• Keep this prospectus, as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it 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 prospectus. See section 4.

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

2.What you need to knowbeforestarting totake Gliclazida Sandoz

3.How to take Gliclazida Sandoz

4.Possible adverse effects

5.Storage of Gliclazida Sandoz

6.Contents of the package and additional information

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

This medication is used for the treatment of a certain form of diabetes in adults (type 2 diabetes mellitus), when diet, exercise, and weight loss alone are not sufficient to maintain blood sugar levels at adequate levels.

Do not take Gliclazida Sandoz:

• if you are allergic to gliclazide, or to any of the other ingredients of this medicine (listed in section 6), or to other medicines in the same group (sulfonilureas), to other related medicines (sulfonamides hypoglycemic),
• if you haveinsulin-dependent diabetes(type 1 diabetes),
• if you haveketoacidosisandurine sugar(this may mean that you have diabetic ketoacidosis),precomaordiabetic coma,
• if you have severe liver or kidney damage,
• if you are takingmedicines to treat fungal infections(miconazole) (see "Taking Gliclazida Sandoz with other medicines"),
• if you are breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gliclazida Sandoz.

You must observe the treatment prescribed by your doctor to achieve appropriate blood sugar levels. This means, in addition to taking the tablets regularly, controlling your diet, exercising physically, and, when necessary, reducing your body weight.

During treatment with gliclazidea regular controlof your blood sugar levels (and possibly in urine) and also a hemoglobin A1c test is required.

During the first weeks of treatment, there may be an increased risk of having alow blood sugar level (hypoglycemia). Therefore, close medical supervision is necessary.

Low blood sugar levels (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 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 doses of gliclazide,
• if you have hormone-related disorders (functional disorders of the thyroid gland, pituitary gland, or adrenal cortex),
• if your kidney or liver function is severely impaired.

If you have lowblood 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 disturbances, tremor, sensory disturbances, dizziness, and helplessness.

You may also experience the following signs and symptoms:

• sweating, moist skin, anxiety, rapid heart rate or irregular heart rhythm, high blood pressure, severe chest pain that may spread to nearby areas (angina pectoris).

If blood sugar levels continue to fall, you may experience:

• great confusion (delirium), develop convulsions, 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 levels disappear very quickly when you take sugar in any form, for example, glucose tablets, sugar lumps, sugary drinks, or sweet tea. Thereforeyou should always carry something with youcontaining sugar (glucose tablets, sugar lumps). Remember that artificial sweeteners are not effective. If the intake of sugar does not help or the symptoms reappear, contact your doctor or the nearest hospital.

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

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

Symptoms of high blood sugar levels (hyperglycemia)when:

• gliclazide has not reduced blood sugar levels sufficiently,

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

Thesymptomsmay include:

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

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

Alterations in blood glucose levels (low blood sugar and high blood sugar) may occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as gliclazide, especially in elderly patients. In this case, your doctor will remind you of the importance of controlling your blood glucose levels.

If you have a family history or know that you have a hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (anomaly in red blood cells), a decrease in hemoglobin and destruction of red blood cells (hemolytic anemia) may occur.

Consult your doctor before taking this medicine.

Children and adolescents

This medicine is not recommendedfor use in children and adolescents due to lack of data.

Taking Gliclazida Sandoz with other medicines

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medicine.

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

• other medicines to treat high blood sugar levels (oral antidiabetics, GLP1 receptor agonists, or insulin),
• antibiotics (e.g., sulfonamides and clarithromycin),
• medicines to treat high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• medicines to treat fungal infections (miconazole, fluconazole),
• medicines to treat stomach or duodenal ulcers (H2 receptor antagonists),
• medicines to treat depression (monoamine oxidase inhibitors),
• analgesics or anti-inflammatory drugs (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The effect of gliclazide in reducing blood sugar levels may be weakened and high blood sugar levels may increase when taking any of the following medicines:

• medicines to treat central nervous system disorders (chlorpromazine),
• medicines to reduce inflammation (corticosteroids),
• medicines to treat asthma or used during delivery (salbutamol intravenously, ritodrine, and terbutaline),
• medicines to treat chest diseases, heavy menstrual bleeding, and endometriosis (danazol),
• preparations based on St. John's Wort(Hypericum perforatum).

Alterations in blood glucose levels (low blood sugar and high blood sugar) may occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as gliclazida, 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. In case of hospital admission, inform the healthcare staff that you are taking this medicine.

Taking Gliclazida Sandoz with food, drinks, and alcohol

This medicine can be takenwith mealsandnon-alcoholic drinks. The consumption of alcohol is not recommended, as it may unpredictably alter your diabetes control.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine, as they may prescribe a more suitable treatment for you.

This medicine is not recommendedto be taken duringpregnancy.

You should not takethis medicine if you are breastfeeding.

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. Note that this may be hazardous to you or others (e.g., 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 signs that alert you to low blood sugar levels (hypoglycemia).

Dosage

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This includes consulting your doctor or pharmacist again if you are unsure.

This medication should only be taken by adults.

The dosage is determined by your doctor, based on your blood sugar levels and possibly urine levels.A change in external factors (such as weight loss, lifestyle change, stress) or improvements in blood sugar control may lead to a dosage adjustment.

The recommended dosage is 1 to 4 tablets (maximum 120 mg) taken once a day at breakfast time.This depends on your response to treatment.

If you start a combined 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 individually determine the appropriate dosage of each medication for you.

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

Form and route of administration

Oral route.

Swallow the tablets whole. Do not chew them.

Take the tablets with a glass of water at breakfast time (and preferably at the same time every day).

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 services at your nearest hospital.

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.

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 sweetened drinks, followed by a snack or a substantial meal.If the patient is unconscious, inform your doctor immediately and call emergency services.The same should be done if someone, for example a child, has taken the medication accidentally.Do not give food or drink to unconscious patients.

Make sure that there is always someone informed who can call your doctor in case of an emergency.

If you forget to take Gliclazide Sandoz

It is essential to take the medication every day, as regular treatment works best.

However, 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 Gliclazide Sandoz

Since diabetes treatment is usually lifelong, you should consult your doctor before interrupting treatment with this medication.The interruption may cause high blood sugar (hyperglycemia), which increases the risk of developing diabetes complications.

If you have any other questions 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 adecrease in blood sugar levels(hypoglycemia). To see symptoms and signs, see "Warnings and Precautions" in Section 2 “What you need to know before starting to take Gliclazida Sandoz”.

If these symptoms continue without treatment, they may progress 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 consuming sugar, seek immediate medical attention.

Other side effects 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 can cause pallor, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually disappear when treatment is discontinued.

Unknown: the frequency cannot be estimated from available data.

• Liver function alteration, which can cause yellowing of the skin and eyes. If this occurs, go immediately to your doctor. 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 widespread blisters or skin peeling. Exceptionally, severe hypersensitivity reactions (DRESS) have been reported initially as flu-like symptoms and facial rash, followed by a prolonged rash with elevated 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 Gliclazida 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 the number of blood cells,
• Allergic inflammation of blood vessel walls,
• Reduction in sodium levels in the blood (hyponatremia),
• Symptoms of liver insufficiency (e.g. jaundice) that in many cases disappear after withdrawal of the sulfonylurea, but in isolated cases may progress to potentially fatal liver insufficiency.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish 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.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above 25°C.

Do not usethis medicationafter the expiration date that appears onthe boxafter CAD. The expiration date is the last day of the month indicated.

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

Composition of Gliclazida Sandoz

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

Appearance of the product and contents of the package

Modified-release tablet.

White to off-white capsule-shaped tablet without coating, marked with “30” on one face and smooth on the other face.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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 medicine is authorized in the member states of the European Economic Area with the following names:

Belgium: Gliclasan 30 mg tablets with modified release

Czech Republic: Gliklazid Sandoz 30 mg

Slovenia: Dizirel

Greece: Glicazide/Sandoz

Croatia: Gliklazid Sandoz 30 mg tablets with modified release

Netherlands: Gliclazide Sandoz 30 mg, tablets with modified release

Hungary: DYACLID 30 mg modified-release tablet

Italy: GLICLAZIDE SANDOZ

Luxembourg: Gliclazide Sandoz 30 mg modified-release tablet

Portugal: Gliclazida Mesiproc

Sweden: Gliklazid Lek 30 mg tablets with prolonged release

Last review date of this leaflet: June 2017.

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/