REPAGLINIDE VIATRIS 1 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Repaglinida Viatris1 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 Repaglinida Viatris and what is it used for
2. What you need to know before taking Repaglinida Viatris
3. How to take Repaglinida Viatris
4. Possible side effects
5. Storage of Repaglinida Viatris
6. Package Contents and Additional 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 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 loss alone have not been sufficient to control (or reduce) blood sugar levels. Repaglinida Viatris can also be administered along with metformin, another diabetes medication.

2. What you need to know before taking Repaglinida Viatris

Do not takeRepaglinida Viatris:

• If you are allergic to repaglinide or any of the other components of this medication (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 medication that lowers blood fat levels).

If any of the above cases apply to you, inform your doctorand do not take repaglinide.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Repaglinida Viatris:

• If you have liver problems. Repaglinida is not recommended for patients with moderate liver disease. Repaglinida should not be taken if you have severe liver disease (see Do not take Repaglinida Viatris).
• If you have kidney problems. Repaglinida should be taken with caution.
• If you are going to undergo major surgeryor have recently suffered 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 old, repaglinida is not recommended. It has not been studied in these age groups.

If you have hypoglycemia(low blood sugar level)

You may experience hypoglycemia if your blood sugar level is too low. This can occur:

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

Warning symptoms of hypoglycemiaappear 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 hypoglycemia:take glucose tablets or a sugary product or drink and then rest.

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

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 repaglinida, 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 repaglinida.
• If you have an infection or fever.
• If you eat more than usual.
• If you engage in less physical exercise than usual.

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

Control of blood glucose or urine levels

While taking this medication, it is recommended to regularly monitor blood glucose or urine levels. Your doctor should also perform regular blood tests to ensure that the medication dose is adequate for you.

Children and adolescents

This medication should not be given to children under 18 years old.

Taking Repaglinida Viatris with other medications

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

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

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

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

• Monoamine oxidase inhibitors (MAOIs) (for depression treatment).
• Other diabetes medications (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 anemia or inflammation treatment).
• 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 cough and cold preparations).
• Clarithromycin, trimethoprim, rifampicin (antibiotics).
• Itraconazole, ketoconazole (antifungal medication).
• Cyclosporin (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 (herbal medicinal plant).

Taking Repaglinida Viatris with food, drinks, and alcohol

Take repaglinida before main meals. Alcohol can alter repaglinida's ability to reduce blood sugar levels. Be aware of the symptoms of hypoglycemia.

Pregnancy and breastfeeding

You should not take repaglinida 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.

You should not take repaglinida if you are breastfeeding.

Driving and using machines

Your ability to drive vehicles 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 vehicle if:

• You have frequent hypoglycemic episodes.
• You have few or no symptoms of hypoglycemia or find it difficult to recognize them.

3. How to take Repaglinida Viatris

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, 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 medication and the amount ingested.

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.

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 interrupt treatment with 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 before making any changes.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

• If you experience chest pain or discomfort that may radiate to the left arm and extend to the jaw, along with sweating and a feeling of discomfort or vomiting 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).
• Hypoglycemic coma or loss of consciousness (very severe hypoglycemic reactions, see the section If you have hypoglycemia).
• If you have a fever, pain, joint or muscle inflammation, weight loss, and fatigue (which may be due to inflammation of the blood vessels caused by an allergic reaction to the medication).
• Yellowing of the skin or the whites of the eyes (which may be signs of a liver problem).

Other possible side effects

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

• Hypoglycemia (see the section If you have hypoglycemia). The risk of hypoglycemia may increase if you take other medications.
• Stomach pain.
• Diarrhea.

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

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

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

• Allergic reactions (such as skin rashes, itching, skin redness, skin inflammation).
• 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 Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Repaglinida Viatris

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

This medication does not require special storage conditions.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. 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 Repaglinida Viatris

The active ingredient is repaglinide. This medication contains 1 mg of repaglinide.

The other components are:

Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, cornstarch, potassium polacrilin, povidone, poloxamer 407, meglumine, glycerol, colloidal silicon dioxide, magnesium stearate, yellow iron oxide (E 172).

Appearance of the product and package contents

The tablets are round, with curved edges and a yellow, smooth, mottled appearance.

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 Authorization Holder and Manufacturer

Marketing Authorization 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 medication from the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Belgium Repaglinide Mylan 1 mg tablets

Bulgaria Regligen 1 mg tablets

Spain Repaglinida Viatris 1 mg tablets EFG

Luxembourg Repaglinide Mylan 1 mg tablets

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

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