Repaglinide Krka 1 mg tablets EFG

Package Leaflet: Information for the User

Introduction

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 the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What is Repaglinide Krka and what is it used for?

Repaglinide Krka is an oral antidiabetic medicine containing repaglinide, which helps your pancreas produce more insulin and lower your blood sugar (glucose).

Type 2 diabetes is a condition 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 Krka is used to manage type 2 diabetes in adults, as an addition to diet and exercise. Treatment should be initiated when diet, physical exercise, and weight reduction alone have not been sufficient to control (or lower) blood sugar levels.

Repaglinide Krka may also be given in combination with metformin.

Repaglinide Krka has been shown to reduce blood sugar levels, thereby helping to prevent diabetes-related complications.

2. What you need to know before taking Repaglinide Krka

Do not take Repaglinide Krka

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

Warnings and precautions

Talk to your doctor before taking Repaglinide Krka:

• If you have liver problems. Repaglinide Krka is not recommended for patients with moderate liver disease. Repaglinide Krka should not be taken if you have severe liver disease (see Do not take Repaglinide Krka).
• If you have kidney problems. Repaglinide Krka should be used with caution.
• If you are undergoing major surgery or have recently had 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 Krka is not recommended. It has not been studied in these age groups.

Talk to your doctor if any of the above apply to you. Repaglinide Krka may not be suitable for you. Your doctor will advise you.

Children and adolescents

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

If you experience hypoglycaemia (low blood sugar)

You may experience hypoglycaemia if your blood sugar level becomes too low. This may happen if:

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

Symptoms warning of hypoglycaemia appear suddenly and may include: cold sweat, cold and pale skin, headache, palpitations, nausea, excessive hunger, temporary visual disturbances, fatigue, unusual tiredness and weakness, nervousness or trembling, anxiety, confusion, and difficulty concentrating.

If your blood sugar level is low or if you feel a hypoglycaemic episode coming on: take glucose tablets or a sugary drink or product, then rest.

Once the symptoms of hypoglycaemia have passed or when your blood sugar levels have stabilized, continue treatment with Repaglinide Krka.

Inform others that you are diabetic and that if you lose consciousness due to hypoglycaemia, they should lay you on your side and seek immediate medical help. Do not give you anything to eat or drink, as you could choke.

• If severe hypoglycaemia is not treated, it may cause brain damage (temporary or permanent) and even death.
• If severe hypoglycaemia causes you to lose consciousness or if you experience repeated episodes of hypoglycaemia, inform your doctor. Your dose or dosing schedule of Repaglinide Krka, diet, or exercise routine may need to be adjusted.

If your blood sugar level is very high

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

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

Symptoms warning of very high blood sugar levels develop gradually. These include: frequent urination, thirst, dry skin, and dry mouth. Inform your doctor. Your dose of Repaglinide Krka, diet, or exercise routine may need to be adjusted.

Taking Repaglinide Krka with other medicines

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

If prescribed by your doctor, you may take Repaglinide Krka together with metformin, another medicine for diabetes.

If you are taking gemfibrozil (used to lower fat levels in the blood), you must not take Repaglinide Krka.

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

• Monoamine oxidase inhibitors (MAOIs) (used to treat depression).
• Beta-blockers (used to treat high blood pressure or heart conditions).
• ACE inhibitors (used to treat heart conditions).
• Salicylates (e.g. aspirin).
• Octreotide (used to treat cancer).
• Non-steroidal anti-inflammatory drugs (NSAIDs) (a type of painkiller).
• Steroids (anabolic steroids and corticosteroids, used for anaemia or to treat inflammation).
• Oral contraceptives (used to prevent pregnancy).
• Thiazides (diuretics).
• Danazol (used to treat breast cysts and endometriosis).
• Thyroid products (used to treat low thyroid hormone levels).
• Sympathomimetics (used to treat asthma).
• Clarithromycin, trimethoprim, rifampicin (antibiotics).
• Itraconazole, ketoconazole (medicines for fungal infections).
• Gemfibrozil (used to treat high blood fat levels).
• Ciclosporin (used to suppress the immune system).
• Deferasirox (used to reduce chronic iron overload).
• Clopidogrel (used to prevent blood clots).
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy).
• St. John’s wort (herbal remedy).

Use of Repaglinide Krka with alcohol

Alcohol may alter the ability of Repaglinide Krka to lower blood sugar levels. Be alert to symptoms of hypoglycaemia.

Pregnancy and breastfeeding

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

You must not take Repaglinide Krka if you are pregnant or planning to become pregnant.

You must not take Repaglinide Krka if you are breastfeeding.

Driving and using machines

Your ability to drive or operate machinery may be impaired if your blood sugar level is too low or too high. Be aware that you could put yourself and others at risk. Consult your doctor about whether you can drive if:

• You have frequent hypoglycaemic episodes,
• You have few or no symptoms of hypoglycaemia.

Repaglinide Krka contains sodium

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

3. How to take Repaglinide Krka

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

Your doctor will calculate your dose.

• The usual starting dose is 0.5 mg taken just before each main meal. The tablets should be taken with a glass of water just before or within the 30 minutes prior to each main meal.
• Your doctor may adjust your dose up to 4 mg, which should be taken just before or within the 30 minutes prior to each main meal. The maximum recommended dose is 16 mg per day.

Do not take more Repaglinide Krka than your doctor has recommended.

If you take more Repaglinide Krka than you should

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

If you forget to take Repaglinide Krka

If you forget to take a dose, take your next dose as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Repaglinide Krka

Please note that the desired effect will not be achieved if you stop taking Repaglinide Krka. Your diabetes may worsen. If any change in your treatment is needed, consult your doctor first.

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 can cause adverse effects, although not everyone will experience them.

Hypoglycaemia

The most common adverse effect is hypoglycaemia, which may affect up to 1 in 10 people (see If you have hypoglycaemia in section 2). Hypoglycaemic reactions are usually mild or moderate, but occasionally may lead to loss of consciousness or hypoglycaemic coma. If this occurs, immediate medical assistance is required.

Allergy

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

Other adverse effects

Frequent (may affect up to 1 in 10 people)

• Stomach pain
• Diarrhoea

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

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

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

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

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

• Hypersensitivity (such as rash, itching, redness and swelling)
• Feeling unwell (nausea)

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Repaglinide Krka

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

Do not use this medicine after the expiry date stated on the blister or carton. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Repaglinide Krka

• The active substance 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, sodium croscarmellose, povidone K25, glycerol, magnesium stearate, meglumine, poloxamer, yellow iron oxide (E172) in 1 mg tablets only, and red iron oxide (E172) in 2 mg tablets only. See section 2 “Repaglinide Krka contains sodium”.

Appearance of Repaglinide Krka and contents of the pack

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

The 1 mg tablets are pale yellowish-brown, round, biconvex, with bevelled edges and possible dark specks.

The 2 mg tablets are pink, mottled, round, biconvex, with bevelled edges and possible dark specks.

Available pack sizes are 30, 60, 90, 120, 270 or 360 tablets in blisters. Only certain pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer(s)

KRKA, 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

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this summary:

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