Package Leaflet: Information for the Patient

Repaglinide Krka 0.5 mg Tablets EFG

Repaglinide Krka 1 mg Tablets EFG

Repaglinide Krka 2 mg Tablets EFG

repaglinide

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 leaflet. See section 4.

Repaglinida Krka is a medicationoral antidiabetic that contains repaglinidewhich 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.

Repaglinida Krka 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) the level of sugar in the blood.

Repaglinida Krka may also be administered with metformin.

It has been shown that Repaglinida Krka reduces the level of sugar in the blood, which contributes to preventing diabetes complications.

Do not take Repaglinida Krka

• If you are allergic to repaglinide or any of the other ingredients of this medicine (listed in section 6).
• If you have type 1 diabetes.
• If your blood acid level has increased (diabetic ketoacidosis).
• If you have severe liver disease.
• If you are taking gemfibrozil (a medicine that lowers blood fat levels).

Warnings and precautions

Consult your doctor before starting to take Repaglinida Krka:

• If you haveliver problems. Repaglinida Krka is not recommended for patients with moderate liver disease. Repaglinida Krka should not be taken if you have severe liver disease (see Do not take Repaglinida Krka).
• If you havekidney problems. Repaglinida Krka 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 18orover 75years, Repaglinida Krka is not recommended. It has not been studied in these age groups.

Consult your doctor if any of the above cases occur. Repaglinida Krka may not be indicated for you. Your doctor will advise you.

Children and adolescents

Do not take this medicine if you are under 18 years.

If you have a hypoglycaemia (low blood sugar)

You may have a hypoglycaemia if your blood sugar level is too low. This can occur if:

• You take too much Repaglinida Krka.
• You do more physical exercise than usual.
• You take other medicines or have kidney or liver problems (see other sections of section 2.What you need to know before starting to take Repaglinida Krka).

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

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

When the symptoms of hypoglycaemia disappear or when blood sugar levels stabilisecontinue treatment with Repaglinida Krka.

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

• If severe hypoglycaemia is not treatedit may cause brain damage (temporary or permanent) and even death.
• If a hypoglycaemia makes you lose consciousness or if you have repeated hypoglycaemiasinform your doctor. You may need to adjust the amount or dosing schedule of Repaglinida Krka, diet, or exercise.

If your blood sugar level is very high

Your blood sugar level may be very high (hyperglycaemia). This can occur:

• If you take too little Repaglinida Krka,
• If you have an infection or fever,
• If you eat more than usual,
• If you do less exercise than usual.

Warning signs of a high blood sugar levelappear gradually. These include: frequent urination, thirst, dry skin, and a feeling of dryness in the mouth. Inform your doctor. You may need to adjust the amount of Repaglinida Krka, diet, or exercise.

Taking Repaglinida Krka with other medicines

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

If your doctor prescribes it, you can take Repaglinida Krka with metformin, another diabetes medicine.

If you are taking gemfibrozil (used to lower blood fat levels), do not take Repaglinida Krka.

Your body's response to Repaglinida Krka may change if you take other medicines, especially:

• Monamine oxidase inhibitors (MAOIs) (for depression treatment).
• Beta-blockers (for hypertension or heart disease treatment).
• ACE inhibitors (for heart disease treatment).
• Salicylates (e.g. aspirin).
• Octreotide (for cancer treatment).
• Non-steroidal anti-inflammatory drugs (NSAIDs) (a type of analgesic).
• Glucocorticoids (anabolic steroids and corticosteroids, for anemia or to treat inflammation).
• Oral contraceptives (to prevent pregnancy).
• Thiazides (diuretics).
• Danazol (for breast cyst treatment and endometriosis).
• Thyroid products (for low thyroid hormone levels).
• Sympathomimetics (for asthma treatment).
• Clarithromycin, trimethoprim, rifampicin (antibiotics).
• Itraconazole, ketoconazole (antifungal medicines).
• Gemfibrozil (to treat high blood fat levels).
• 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).

Using Repaglinida Krka with alcohol

Alcohol may alter Repaglinida Krka's ability to lower blood sugar levels. Remain alert to hypoglycaemia symptoms.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medicine.

Do not take Repaglinida Krka if you are pregnant or planning to become pregnant.

Do not take Repaglinida Krka if you are breastfeeding.

Driving and operating machines

Your ability to drive cars and operate machines 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 hypoglycaemias
• You have few or no hypoglycaemia symptoms

Repaglinida Krka contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

Your doctor will calculate your dose.

• Normally the initial dose is 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.
• Your 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 Krka than your doctor has recommended.

If you take more Repaglinida Krka than you should

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

If you forget to take Repaglinida Krka

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

If you interrupt treatment with Repaglinida Krka

Be aware that the desired effect will not be achieved if you stop taking Repaglinida Krka. 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 produce adverse effects, although not all people will experience them.

Hypoglycemia

The most frequent adverse effect is hypoglycemia, which may affect up to 1 in 10 people (seeif you have hypoglycemiain 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

Cases of allergy are very rare (may affect up to 1 in 10,000 people). 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 people)

• Abdominal pain
• Diarrhea

Rare(may affect up to 1 in 1,000 people)

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

Very Rare(may affect up to 1 in 10,000 people):

• Vomiting
• Constipation
• Visual disturbances
• Severe liver problems, abnormal liver function such as increased liver enzymes in blood

Frequency Not Known(cannot be estimated with available data)

• Hypersensitivity (such as hives, itching, redness, and swelling)
• Unpleasant sensation (nausea)

Reporting Adverse Effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children

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

Store in the original packaging to protect it from light.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. By doing so, you will help protect the environment.

Composition of Repaglinida Krka

• The active ingredient is repaglinide. Each tablet contains 0.5 mg, 1 mg or 2 mg of repaglinide.
• The other components are microcrystalline cellulose (E460), calcium hydrogen phosphate, croscarmellose sodium, povidone K25, glycerol, magnesium stearate, meglumine, poloxamer, yellow iron oxide (E172) only in 1 mg tablets and red iron oxide (E172) only in 2 mg tablets. See section 2 “Repaglinida Krka contains sodium”.

Appearance of Repaglinida Krka and contents of the package

The 0.5 mg tablets are white, round and biconvex with beveled edges.

The 1 mg tablets are pale yellowish brown, round and biconvex with beveled edges and possible dark spots.

The 2 mg tablets are pink, speckled, round and biconvex with beveled edges and possible dark spots.

Available in packs of 30, 60, 90, 120, 270 or 360 tablets in blisters. Only some package sizes may be marketed.

Holder of the marketing authorization

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible for manufacturingKRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

The detailed information about this medicine is available on the website of the European Medicines Agency (EMA)http://www.ema.europa.eu/.