Gliclazide Sandoz 30 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Gliclazida 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 and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you get any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

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

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

2. What you need to know before taking Gliclazida Sandoz

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 of the same group (sulfonylureas), or to related medicines (hypoglycemic sulfonamides),
• if you have insulin-dependent diabetes (type 1 diabetes),
• if you have ketone bodies and sugar in the urine (this may indicate diabetic ketoacidosis), pre-coma, or diabetic coma,
• if you have severe disorders of the liver or kidneys,
• if you are taking medicines to treat fungal infections (miconazole) (see "Taking Gliclazida Sandoz with other medicines"),
• if you are breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions

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

You must follow your doctor's prescribed treatment plan to achieve appropriate blood sugar levels. This means, in addition to taking your tablets regularly, managing your diet, exercising, and, when necessary, reducing your body weight.

During treatment with gliclazide, regular monitoring of your blood sugar levels (and possibly urine sugar) is required, as well as measurement of glycated hemoglobin (HbA1c).

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

Low blood sugar levels (hypoglycemia) may occur:

• if you eat irregularly or skip meals,
• if you are fasting,
• if you are malnourished,
• if you change your diet,
• if you increase your physical activity without a corresponding increase in carbohydrate intake,
• if you drink alcohol, especially in combination with skipping meals,
• if you take other medicines or herbal remedies at the same time,
• if you take excessively high doses of gliclazida,
• if you have hormone-related disorders (dysfunctions of the thyroid gland, pituitary gland, or adrenal cortex),
• if your kidney or liver function is severely impaired.

If your blood sugar levels are low, you may experience the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced alertness and slowed reaction time, depression, confusion, speech and visual disturbances, tremors, sensory disturbances, dizziness, and helplessness.

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

If blood sugar levels continue to drop, you may experience severe confusion (delirium), seizures, loss of self-control, shallow breathing, and slowed heartbeat, potentially leading to unconsciousness.

In most cases, symptoms of low blood sugar disappear quickly when sugar is taken in any form, for example glucose tablets, sugar cubes, sugary juice, or sweetened tea. Therefore, you should always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. If sugar intake does not help or symptoms recur, contact your doctor or the nearest hospital.

Symptoms of low blood sugar may not appear, may be mild, develop slowly, or you may not notice in time that your blood sugar has dropped. This may occur in elderly patients taking certain medications (e.g., those acting on the central nervous system or beta-blockers).

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

Symptoms of high blood sugar levels (hyperglycemia) may occur when:

• gliclazida has not yet sufficiently lowered your blood sugar,
• you have not followed your doctor's prescribed treatment,
• you take preparations containing St. John's wort (Hypericum perforatum),
• or during special stress situations.

Symptoms may include:

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

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

Changes in blood glucose (low or high blood sugar) may occur when gliclazide is prescribed together with antibiotics known as fluoroquinolones, especially in elderly patients. In such cases, your doctor will remind you of the importance of monitoring your blood glucose.

If you have a family history or know you have a hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (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

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

Taking Gliclazida Sandoz with other medicines

Tell your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

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

• other medicines to treat high blood sugar (oral antidiabetics, GLP1 receptor agonists, or insulin),
• antibiotics (e.g., sulfonamides, 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),
• painkillers or anti-rheumatic medicines (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The blood sugar-lowering effect of gliclazida may be weakened, leading to increased blood sugar levels, when taking any of the following medicines:

• medicines to treat disorders of the central nervous system (chlorpromazine),
• medicines to reduce inflammation (corticosteroids),
• medicines to treat asthma or used during childbirth (intravenous salbutamol, ritodrine, terbutaline),
• medicines to treat chest diseases, heavy menstrual bleeding, or endometriosis (danazol),
• preparations containing St. John's wort (Hypericum perforatum).

Changes in blood glucose (low or high blood sugar) may occur when a medicine belonging to the class of antibiotics called fluoroquinolones is taken together with 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. If you are admitted to hospital, inform healthcare staff that you are taking this medicine.

Taking Gliclazida Sandoz 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 affect your diabetes control.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 recommended during pregnancy.

You must not take this medicine if you are breastfeeding.

Driving and using machines

Your ability to concentrate or react may be reduced if your blood sugar is too low (hypoglycemia) or too high (hyperglycemia), or if you experience visual disturbances due to these conditions. Be aware that this could be dangerous to you or others (e.g., when driving or operating machinery). Ask your doctor if you can drive if:

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

3. How to take Gliclazida Sandoz

Dosage

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

This medicine should only be taken by adults.

The dosage is determined by your doctor, depending on your blood sugar levels and possibly urine sugar levels. Changes in external factors (for example, weight loss, changes in lifestyle, stress) or improvements in blood sugar control may require an adjustment of dosage.

The recommended dose is 1 to 4 tablets (maximum 120 mg) taken as a single dose at breakfast time. This depends on your 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 individually determine the appropriate dose of each medication.

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

Method 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 must always eat a meal after taking the tablets.

If you take more Gliclazida Sandoz than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

Signs of overdose are those described for low blood sugar (hypoglycemia) in section 2. 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 the doctor immediately and call emergency services. The same should be done if someone, for example a child, has accidentally taken the medicine. Do not give food or drink to unconscious patients.

Ensure that there is always an informed person available who can call a doctor in an emergency.

If you forget to take Gliclazida Sandoz

It is important that you take your medication every day, as regular treatment is most effective.

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 Gliclazida Sandoz

Since diabetes treatment is usually lifelong, you must consult your doctor before stopping treatment with this medicine. 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The most frequently observed adverse effect is low blood sugar (hypoglycaemia). For symptoms and signs, see "Warnings and precautions" in Section 2 “What you need to know before taking Gliclazide Sandoz”.

If these symptoms are left untreated, they may progress to drowsiness, loss of consciousness, or possibly coma. If a low blood sugar episode is severe or prolonged, even if temporarily controlled by sugar intake, seek immediate medical attention.

Other adverse effects you may experience while taking this medicine are:

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

• Decrease in blood cell count (e.g. platelets, red and white blood cells), which may cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually disappear when treatment is stopped.

Not known: frequency cannot be estimated from available data.

• Liver function abnormalities, which may cause yellowing of the skin and eyes. If this occurs, see your doctor immediately. Symptoms usually resolve upon discontinuation of treatment. Your doctor will decide whether treatment should be discontinued.
• Skin reactions such as rash, redness, itching, blisters, and angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat, which may cause breathing difficulties). The rash may progress to widespread blisters or skin peeling. Rarely, signs of severe hypersensitivity reactions (DRESS) have been reported, initially presenting as flu-like symptoms and facial rash, followed by a prolonged rash with high fever.
• Abdominal pain or discomfort, nausea, indigestion, diarrhoea, 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 of time, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.

As with other sulfonylureas, the following adverse effects have been observed:

• serious changes in blood cell counts,
• allergic inflammation of blood vessel walls,
• reduction in blood sodium levels (hyponatraemia),
• signs of liver failure (e.g. jaundice), which in many cases resolve after discontinuation of the sulfonylurea, but in isolated cases may progress to potentially fatal liver failure.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazida 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gliclazida Sandoz

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

Appearance of the product and contents of the pack

Modified-release tablet.

White to off-white, capsule-shaped, biconvex, uncoated tablet, marked with "30" on one side and smooth on the other.

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

Only certain 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 most recent revision of this leaflet: June 2017.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/