REPAGLINIDE VIATRIS 0.50 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Repaglinida Viatris0.5 mg 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Repaglinida Viatris and what is it used for
2. What you need to know before you take Repaglinida Viatris
3. How to take Repaglinida Viatris
4. Possible side effects
5. Storage of Repaglinida Viatris

1. Contents of the pack and further information

1. What is Repaglinida Viatris and what is it used for

Repaglinida Viatris is an oral antidiabetic that 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 (previously known as non-insulin-dependent diabetes mellitus or maturity-onset diabetes).

Repaglinida Viatris is used to control type 2 diabetes, as a complement to diet and exercise: treatment should be started if diet, physical exercise, and weight reduction alone have not been sufficient to control (or reduce) blood sugar levels. Repaglinida Viatris can also be administered with metformin, another diabetes medication.

2. What you need to know before you take Repaglinida Viatris

Do not takeRepaglinida Viatris:

• 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(insulin-dependent 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).

If any of the above applies to you, tell your doctorand do not take repaglinide.

Warnings and precautions

Talk to your doctor or pharmacist before starting Repaglinida Viatris:

• 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 Repaglinida Viatris).
• If you have kidney problems. Repaglinide should be taken with caution.
• If you are going to have major surgeryor have recently had a serious illness, infection, fever, or injury. In these circumstances, diabetic control may not be achieved.
• If you cannot eat normal amounts of food or feel tired (malnourished or weakened).
• If you are under 18or over 75 years, repaglinide is not recommended. It has not been studied in these age groups.

If you have hypoglycaemia(low blood sugar)

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

• If you take too much repaglinide.
• If you do more exercise than usual.
• If you take other medicines or have kidney or liver problems (see other sections of section 2, What you need to know before you take Repaglinida Viatris).

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

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

When the symptoms of hypoglycaemia disappear or when blood sugar levels stabilize,continue treatment with repaglinide.

Tell others that you are diabeticand if you lose consciousnessdue to hypoglycaemia, 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 hypoglycaemiais not treated, it can cause brain damage (temporary or permanent) and even death.
• If you have hypoglycaemiathat makes you lose consciousness or if you have repeated hypoglycaemias, tell your doctor. You may need to adjust the dose or administration schedule of repaglinide, diet, or exercise.

If your blood sugar level is very high

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

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

Warning symptomsappear gradually. These include: excessive urination, thirst, dry skin, and a dry mouth feeling. Tell your doctor. You may need to adjust the dose of repaglinide, diet, or exercise.

Control of blood glucose or urine levels

While taking this medicine, it is recommended to regularly check your blood glucose or urine levels. Your doctor should also regularly perform blood tests to ensure that the dose of the medicine is suitable for you.

Children and adolescents

This medicine should not be given to children under 18 years of age.

Taking Repaglinida Viatris with other medicines

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

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

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

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

• Monoamine oxidase inhibitors (MAOIs) (for depression treatment).
• Other diabetes medicines (except metformin), including insulin.
• Beta-blockers (for high blood pressure 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 pain reliever).
• Steroids (anabolic steroids and corticosteroids, for anaemia or to treat inflammation).
• Oral contraceptives (to prevent pregnancy).
• Thiazides (diuretics).
• Danazol (for breast cysts and endometriosis treatment).
• Thyroid products (for low thyroid hormone levels treatment).
• Sympathomimetics (for asthma or in cough and cold preparations).
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines).
• Itraconazole, ketoconazole (medicines for fungal infections).
• Ciclosporin (to suppress the immune system).
• Deferasirox (to reduce chronic iron overload).
• Clopidogrel (to prevent blood clots).
• Phenytoin, carbamazepine, phenobarbital, and other barbiturates (for epilepsy treatment).
• St John's Wort (a herbal medicinal plant).

Taking Repaglinida Viatris with food, drinks, and alcohol

Take repaglinide before main meals. Alcohol may alter repaglinide's ability to lower blood sugar levels. Be aware of the symptoms of hypoglycaemia.

Pregnancy and breastfeeding

Do not take repaglinide if you are pregnant, think you may be pregnant, or plan to become pregnant. Consult your doctor as soon as possible if you become pregnant or plan to become pregnant during treatment.

Do not take repaglinide if you are breastfeeding.

Driving and using machines

Your ability to drive or 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 vehicle if:

• You have frequent hypoglycaemias.
• You have few or no symptoms of hypoglycaemia or find it difficult to recognize them.

3. How to take Repaglinida Viatris

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• The recommended initial doseis 0.5 mg taken just 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.
• If you skip a meal (or have an extra meal), you should skip (or add) a dose for that meal.
• The maximum recommended dose is 16 mg per day.

If you take more Repaglinida Viatris than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

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

If you forget to take Repaglinida Viatris

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 forgotten doses.

If you stop taking Repaglinida Viatris

Be aware that the desired effect will not be achieved if you stop taking Repaglinida Viatris. 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking this medicine and contact your doctor or go to the emergency department of your nearest hospital immediately:

• If you have chest pain or discomfort that may spread to your left arm and jaw, along with sweating and a feeling of discomfort or nausea with difficulty breathing (these may be signs of a heart problem, including a heart attack).
• Swelling of the face, lips, nose, and eyelids, difficulty breathing, palpitations, dizziness, sweating (which may be signs of an anaphylactic reaction).
• Hypoglycaemic coma or loss of consciousness (very severe hypoglycaemic reactions, see the section If you have hypoglycaemia).
• If you have fever, pain, joint or muscle inflammation, weight loss, and fatigue (which may be due to inflammation of blood vessels caused by an allergic reaction to the medicine).
• Yellowing of the skin or the whites of the eyes (which may be signs of a liver problem).

Other possible side effects

Common(may affect up to 1 in 10 people):

• Hypoglycaemia (see the section If you have hypoglycaemia). The risk of hypoglycaemia may increase if you take other medicines.
• Stomach pain.
• Diarrhoea.

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

• Vomiting (nausea).
• Constipation.
• Visual disturbances.
• Abnormal liver function, increased liver enzymes in blood, which can be detected in blood tests.

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

• Allergic reactions (such as rashes, itching, skin redness, skin inflammation).
• Feeling unwell (nausea).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Repaglinida Viatris

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Repaglinida Viatris

The active substance is repaglinide. This medicine contains 0.5 mg of repaglinide.

The other ingredients are:

Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, maize starch, potassium polacrilin, povidone, poloxamer 407, meglumine, glycerol, colloidal silicon dioxide, magnesium stearate.

Appearance of the product and pack contents

The tablets are round, with curved edges and white in colour.

Repaglinida Viatris is available in blister packs of 30, 90, 120, 200, or 270 tablets.

It is also available in plastic bottles containing 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturers

Pharmathen S.A.

6, Dervenakion str.

153 51 Pallini

Greece

or

Pharmathen International S.A.

Industrial Park Sapes

Rodopi Prefecture

Block No 5

Rodopi 69300

Greece

or

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1

Hungary

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Belgium Repaglinide Mylan 0.5 mg tablets

Bulgaria Regligen 0.5 mg tablets

Spain Repaglinida Viatris 0.5 mg tablets EFG

Luxembourg Repaglinide Mylan 0.5 mg tablets

Date of last revision of this leaflet:November 2016

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