Package Insert: Information for the Patient

Repaglinide Sandoz 0.5 mg Tablets EFG

Repaglinide Sandoz 1 mg Tablets EFG

Repaglinide Sandoz 2 mg Tablets EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Repaglinide Sandoz

3. How to take Repaglinide Sandoz

4. Possible side effects

5. Storage of Repaglinide Sandoz

6. Contents of the pack and additional information

Repaglinida Sandoz is anoral antidiabetic medicationthat contains repaglinide, which helps your pancreas to produce more insulin and lower your blood sugar (glucose).

Type 2 diabetesis a disease in which the pancreas does not produce enough insulin to control the level of sugar in the blood 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 resulted in sufficient control (or reduction) of 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 contributes to preventing diabetes complications

Do not take Repaglinida Sandoz

• if you areallergicto repaglinide or any of the other ingredients of this medication (listed in section 6),
• if you havetype 1 diabetes,
• if your blood acid level has increased (diabetic ketoacidosis),
• if you havesevere liver disease,
• if you are takinggemfibrozil(a medication that lowers blood lipid levels).

Warnings and precautions

Consult your doctor before starting to take repaglinide.

• If you haveliver 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 Repaglinida Sandoz”).
• If you havekidney problems. Repaglinide should be taken with caution.
• If you are about to undergomajor surgeryor have recently had aserious illness or infection. In these circumstances, blood sugar control may not be achieved.
• If you areunder 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 cases apply to you, repaglinide may not be indicated 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 a hypoglycemia (low blood sugar)

You may experience hypoglycemia if your blood sugar level is 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 liver or kidney problems (see other sections of section 2. “What you need to know before taking Repaglinida Sandoz”).

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

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

When the symptoms of hypoglycemia disappear or when blood sugar levels stabilizecontinue treatment with repaglinide.

Inform others that you are diabeticandif you lose consciousnessdue to hypoglycemia, they should lay you on your side and seek immediate medical assistance. Do not give you anything to eat or drink. You could choke.

• If severe hypoglycemia is not treatedit can cause brain damage (temporary or permanent) and even death.
• If hypoglycemia causes you to lose consciousness or if you experience repeated hypoglycemia, inform your doctor. You may need to adjust the amount or dosage of repaglinide, diet, or exercise.

If your blood sugar level is very high

Your blood sugar level may be 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: frequent urination, thirst, dry skin, and a sensation of dryness in the mouth. Inform your doctor. You may need to adjust the amount of repaglinide, diet, or exercise.

Taking Repaglinida Sandoz with other medications

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

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

If you are taking gemfibrozil (used to lower blood lipid levels), do 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 cancer treatment),
• nonsteroidal anti-inflammatory drugs (NSAIDs) (a type of analgesic),
• 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 (antibiotics),
• itraconazole, ketoconazole (antifungal medications),
• gemfibrozil (to treat high cholesterol and triglyceride levels in the blood),
• ciclosporin (to suppress the immune system),
• deferasirox (to reduce chronic iron overload),
• clopidogrel (to prevent blood clot formation,
• phenytoin, carbamazepine, phenobarbital (for epilepsy treatment),
• St. John's Wort (herbal medicine).

Taking Repaglinida Sandoz with alcohol

Alcohol can alter repaglinide's ability to lower blood sugar levels. Remain alert to the warning signs of hypoglycemia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

You should not take repaglinide if you are pregnant or planning to become pregnant.

You should not take repaglinide during breastfeeding.

Driving and operating machinery

Your ability to drive and operate machinery may be affected if your blood sugar level is 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 hypoglycemia,

you have few or no symptoms of hypoglycemia.

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

Your doctor will calculate your dose.

• Normally theinitial doseis 0.5 mg taken exactly before each main meal. The tablets should be taken with a glass of water just 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 just before or within 30 minutes before each main meal. The maximum recommended dose is 16 mg per day.

Do not take more repaglinida than recommended by your doctor.

If you take more Repaglinida Sandoz than you should

If you take too many tablets, your blood sugar level 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Repaglinida Sandoz

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

If you interrupt treatment with Repaglinida Sandoz

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may have adverse effects, although not all people may experience them.

Hypoglycemia

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

Allergy

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

Other Adverse Effects

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

• Abdominal 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, skin swelling),
• Feeling of discomfort (nausea).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special conditions for conservation.

Expiration date after opening the containers: 6 months.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. By doing so, you will help protect the environment.

Composition of Repaglinida Sandoz

Repaglinida Sandoz 0.5 mg

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

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

Repaglinida Sandoz 1 mg

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

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

Repaglinida Sandoz 2 mg

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

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

Appearance of the product and contents of the package

Repaglinida Sandoz 0.5 mg are white, round tablets.

Repaglinida Sandoz 1 mg are yellow, slightly speckled, round tablets with a groove.

Repaglinida Sandoz 2 mg are pale red, slightly speckled, round tablets with a groove.

It is packaged in a blister pack containing 30, 60, 90, 120 or 270 tablets and HDPE bottles containing 30, 60, 90 or 250 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

c/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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.Domaniewska50 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 medicine is authorized in the member states of the European Economic Area with the following names:

GermanyRepaglinid Sandoz 0.5 mg Tabletten Repaglinid Sandoz 1 mg Tabletten Repaglinid Sandoz 2 mg Tabletten

AustriaRepaglinid Sandoz 0.5 mg – Tabletten

Repaglinid Sandoz 1 mg – Tabletten

Repaglinid Sandoz 2 mg – Tabletten

BelgiumRepaglinide Sandoz 0.5 mg tabletten

Repaglinide Sandoz 1 mg tabletten

Repaglinide Sandoz 2 mg tabletten

FranceREPAGLINIDE SANDOZ 0,5 mg, comprimé

REPAGLINIDE SANDOZ 1 mg, comprimé

REPAGLINIDE SANDOZ 2 mg, compriméItalyREPAGLINIDE SANDOZ 0.5 mg compresse

REPAGLINIDE SANDOZ 1 mg compresse

REPAGLINIDE SANDOZ 2 mg compresse

SwedenRepaglinid Sandoz 0.5 mg tabletter

Repaglinid Sandoz 1 mg tabletter

Repaglinid Sandoz 2 mg tabletter

Date of the last review of this leaflet: December 2016

The detailed and updated information on this medicine is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/