REPAGLINIDE SANDOZ 1 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Repaglinide Sandoz 0.5 mg tablets EFG

Repaglinide Sandoz 1 mg tablets EFG

Repaglinide Sandoz 2 mg 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 doubts, 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 not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Repaglinide Sandoz and what is it used for
2. What you need to know before taking Repaglinide Sandoz
3. How to take Repaglinide Sandoz
4. Possible side effects
5. Storage of Repaglinide Sandoz
6. Package contents and additional information

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

Repaglinide Sandoz is an oral antidiabetic medicationthat contains repaglinide, which helps your pancreas produce more insulin and lower your blood sugar (glucose) levels.

Type 2 diabetesis a disease in which the pancreas does not produce enough insulin to control blood sugar levels or in which the body does not respond normally to the insulin it produces.

Repaglinide is used to control type 2 diabetes in adults, as a complement to diet and exercise: treatment should be initiated if diet, physical exercise, and weight reduction alone have not been sufficient to control (or reduce) blood sugar levels.

Repaglinide can also be administered in combination with metformin, another diabetes medication.

It has been shown that repaglinide reduces blood sugar levels, which helps prevent diabetes complications.

2. What you need to know before taking Repaglinide Sandoz

Do not take Repaglinide Sandoz

• if you are allergicto repaglinide or any of the other components of this medication (listed in section 6),
• if you have type 1 diabetes,
• if your blood acid levels have increased (diabetic ketoacidosis),
• if you have severe liver disease,
• if you are taking gemfibrozil(a medication that lowers blood lipid levels).

Warnings and precautions

Consult your doctor before starting to take repaglinide.

• If you have liver problems. Repaglinide is not recommended for patients with moderate liver disease. Repaglinide should not be taken if you have severe liver disease (see "Do not take Repaglinide Sandoz").
• If you have kidney problems. Repaglinide should be taken with caution.
• If you are going to undergo major surgeryor have recently suffered a serious illness or infection. In these circumstances, diabetic control may not be achieved.
• If you are under 18 or over 75 years old. Repaglinide is not recommended. It has not been studied in these age groups.

Consult your doctorif any of the above applies to you, as repaglinide may not be suitable for you. Your doctor will advise you.

Children and adolescents

Do not take this medication if you are under 18 years old.

If you have hypoglycemia (low blood sugar)

You may experience hypoglycemia if your blood sugar levels are too low. This can occur if:

• you take too much repaglinide,
• you engage in more physical exercise than usual,
• you take other medications or have kidney or liver problems (see other sections of section 2, "What you need to know before taking Repaglinide Sandoz").

Warning signs of hypoglycemiaappear suddenly and can include: cold sweat, pale skin, headache, palpitations, nausea, excessive hunger, temporary visual disturbances, fatigue, unusual weakness, nervousness or tremors, anxiety, confusion, and difficulty concentrating.

If your blood sugar levels are low or if you feel you are going to have hypoglycemia:take glucose tablets or a sugary product or drink, and then rest.

When hypoglycemia symptoms disappear or when blood sugar levels stabilize, continue treatment with repaglinide.

Inform others that you are diabeticand if you lose consciousnessdue to hypoglycemia, they should lay you on your side and seek immediate medical attention. They should not give you anything to eat or drink, as you may choke.

• If severe hypoglycemiais not treated, it can cause brain damage (temporary or permanent) and even death.
• If you experience hypoglycemiathat causes you to lose consciousness or if you have repeated hypoglycemic episodes, inform your doctor. You may need to adjust the dose or administration schedule of repaglinide, your diet, or exercise.

If your blood sugar levels are very high

Your blood sugar levels may become very high (hyperglycemia). This can occur:

• if you take too little repaglinide,
• if you have an infection or fever,
• if you eat more than usual,
• if you engage in less physical exercise than usual.

Warning signs of high blood sugarappear gradually. These include: excessive urination, thirst, dry skin, and a feeling of dryness in the mouth. Inform your doctor, as you may need to adjust the dose of repaglinide, your diet, or exercise.

Taking Repaglinide Sandoz with other medications

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

If your doctor prescribes it, you can take repaglinide in combination with metformin, another diabetes medication.

If you are taking gemfibrozil (used to lower blood lipid levels), you should not take repaglinide.

Your body's response to repaglinide may change if you take other medications, especially the following:

• monoamine oxidase inhibitors (MAOIs) (used to treat depression),
• beta-blockers (for the treatment of high blood pressure or heart disease),
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (for the treatment of heart disease),
• salicylates (e.g., aspirin),
• octreotide (for the treatment of cancer),
• non-steroidal anti-inflammatory drugs (NSAIDs) (a type of pain reliever),
• steroids (anabolic steroids and corticosteroids, for anemia or to treat inflammation),
• oral contraceptives (to prevent pregnancy),
• thiazides (diuretics),
• danazol (for the treatment of breast cysts and endometriosis),
• thyroid products (for the treatment of low thyroid hormone levels),
• sympathomimetics (for the treatment of asthma),
• clarithromycin, trimethoprim, rifampicin (antibiotic medications),
• itraconazole, ketoconazole (medications for fungal infections),
• gemfibrozil (to treat high cholesterol and triglyceride levels in the blood),
• cyclosporin (to suppress the immune system),
• deferasirox (to reduce chronic iron overload),
• clopidogrel (to prevent blood clots),
• phenytoin, carbamazepine, phenobarbital (to treat epilepsy),
• St. John's Wort (a herbal remedy).

Taking Repaglinide Sandoz with alcohol

Alcohol may alter the ability of repaglinide to lower blood sugar levels. Be aware of the symptoms of hypoglycemia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take repaglinide if you are pregnant or plan to become pregnant.

Do not take repaglinide during breastfeeding.

Driving and using machines

Your ability to drive and use machines may be affected if your blood sugar levels are low or high. Be aware that you may put yourself or others at risk. Consult your doctor about the possibility of driving a car if:

• you have frequent hypoglycemic episodes,

you have few or no symptoms of hypoglycemia.

3. How to take Repaglinide Sandoz

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

Your doctor will calculate your dose.

• Normally, theinitial doseis 0.5 mg taken immediately before each main meal. The tablets should be taken with a glass of water immediately before or within 30 minutes before each main meal.
• The dose may be adjusted by your doctor up to 4 mg, which should be taken immediately before or within 30 minutes before each main meal. The maximum recommended dose is 16 mg per day.

Do not take more repaglinide than recommended by your doctor.

If you take more Repaglinide Sandoz than you should

If you take too many tablets, your blood sugar levels may become too low and cause hypoglycemia. Please read what hypoglycemia is and how to treat it in the section "If you have hypoglycemia".

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 medication and the amount ingested.

If you forget to take Repaglinide Sandoz

If you forget to take a dose, take the next dose as you normally would, do not take a double dose to make up for the missed doses.

If you interrupt treatment with Repaglinide Sandoz

Be aware that the desired effect is not achieved if you stop taking repaglinide. Your diabetes may worsen. If any change in your treatment is necessary, consult your doctor first.

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 have side effects, although not everyone gets them.

Hypoglycemia

The most common side effect is hypoglycemia, which can affect up to 1 in 10 patients (see "If you have hypoglycemia" in section 2). Hypoglycemic reactions are usually mild or moderate but can occasionally lead to loss of consciousness or hypoglycemic coma. If this happens, you need immediate medical attention.

Allergic reactions

Cases of allergy are very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty breathing, palpitations, dizziness, and sweating may be signs of an anaphylactic reaction. Contact your doctor immediately.

Other side effects

Frequent (may affect up to 1 in 10 patients):

• stomach pain,
• diarrhea.

Rare (may affect up to 1 in 1,000 patients):

• acute coronary syndrome (but may not be due to the medication).

Very rare (may affect up to 1 in 10,000 patients):

• vomiting,
• constipation,
• visual disturbances,
• severe liver problems, abnormal liver function, and increased liver enzymes in the blood.

Frequency not known (cannot be estimated from available data):

• hypersensitivity (such as skin rash, itching, redness, swelling),
• feeling unwell (nausea).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Repaglinide Sandoz

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

This medication does not require special storage conditions.

Shelf life after opening the containers: 6 months.

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

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Repaglinide Sandoz

Repaglinide Sandoz 0.5 mg

The active ingredient is repaglinide. Each tablet contains 0.5 mg of repaglinide.

The other ingredients are: glycerol 85%, meglumine, cornstarch, calcium hydrogen phosphate anhydrous, hydroxypropylcellulose, poloxamer 188, colloidal anhydrous silica, magnesium stearate, potassium polacrilin, and microcrystalline cellulose.

Repaglinide Sandoz 1 mg

The active ingredient is repaglinide. Each tablet contains 1 mg of repaglinide.

The other ingredients are: glycerol 85%, meglumine, cornstarch, calcium hydrogen phosphate anhydrous, hydroxypropylcellulose, poloxamer 188, colloidal anhydrous silica, magnesium stearate, potassium polacrilin, microcrystalline cellulose, and yellow iron oxide (E172).

Repaglinide Sandoz 2 mg

The active ingredient is repaglinide. Each tablet contains 2 mg of repaglinide.

The other ingredients are: glycerol 85%, meglumine, cornstarch, calcium hydrogen phosphate anhydrous, hydroxypropylcellulose, poloxamer 188, colloidal anhydrous silica, magnesium stearate, potassium polacrilin, microcrystalline cellulose, and red iron oxide (E172).

Appearance and packaging of the product

Repaglinide Sandoz 0.5 mg are white, round tablets.

Repaglinide Sandoz 1 mg are yellow, slightly speckled, round tablets with a score line.

Repaglinide Sandoz 2 mg are pale red, slightly speckled, round tablets with a score line.

They are packaged in blister packs containing 30, 60, 90, 120, or 270 tablets and HDPE bottles containing 30, 60, 90, or 250 tablets.

Not all 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

Salutas Pharma GmbH Otto-von-Guericke-Allee 1, 39179 Barleben Germany

or

Lek Pharmaceuticals d.d. Verovškova 57, 1526 Ljubljana Slovenia

or

LEK S.A. Ul.Domaniewska 50 C, 02-672 Warszawa Poland

or

Salutas Pharma GmbH Dieselstrasse 5, 70839 Gerlingen Germany

or

Sandoz S.R.L. Str. Livezeninr. 7A, 540472 Targu-Mures Romania

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

Germany Repaglinid Sandoz 0.5 mg Tabletten Repaglinid Sandoz 1 mg Tabletten Repaglinid Sandoz 2 mg Tabletten

Austria Repaglinid Sandoz 0.5 mg – Tabletten Repaglinid Sandoz 1 mg – Tabletten Repaglinid Sandoz 2 mg – Tabletten

Belgium Repaglinide Sandoz 0.5 mg tabletten Repaglinide Sandoz 1 mg tabletten Repaglinide Sandoz 2 mg tabletten

France REPAGLINIDE SANDOZ 0,5 mg, comprimé REPAGLINIDE SANDOZ 1 mg, comprimé REPAGLINIDE SANDOZ 2 mg, comprimé Italy REPAGLINIDE SANDOZ 0.5 mg compresse REPAGLINIDE SANDOZ 1 mg compresse REPAGLINIDE SANDOZ 2 mg compresse

Sweden Repaglinid Sandoz 0,5 mg tabletter Repaglinid Sandoz 1 mg tabletter Repaglinid Sandoz 2 mg tabletter

Date of the last revision of this package leaflet: December 2016

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