Patient Information Leaflet

Repaglinide Viatris1 mg Tablets

Read this 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 are unsure about anything, 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 leaflet. See section 4.

Repaglinida Viatrisis anoral antidiabetic that 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 (previously known asnon-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 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 Viatris may also be administered with metformin, another diabetes medication.

Do not takeRepaglinida Viatris:

• If you are allergic to repaglinide or any of the other ingredients of this medication (listed in section 6).
• If you havetype 1 diabetes(insulin-dependent diabetes).
• If your body has an increased level of acid in the blood (diabetic ketoacidosis).
• If you havesevere liver disease.
• If you are takinggemfibrozil(a medication that lowers blood fat levels).

If any of the above cases occur, inform your doctor and do not take repaglinide.

Warnings and precautions

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

• 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 (seeDo not takeRepaglinida Viatris).
• If you havekidney problems. Repaglinide should be taken with caution.
• If you are about to undergo amajor surgical procedureor have recently had aserious illness, infection, fever, or injury.Under these circumstances, blood sugar control may not be achieved.
• If you cannot eat normal amounts of food or feel tired (malnourished or weakened).
• If you areunder 18orover 75 years old, repaglinide is not recommended. It has not been studied in these age groups.

If you have 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.
• 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 knowbefore starting to takeRepaglinida Viatris).

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

If your blood sugar level is low or if you feel that you are about 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 repaglinide.

Inform others that you are diabeticandthat if you lose consciousnessdue to hypoglycemia, they should lay you on your side and seek immediate medical attention. Do not give you anything to eat or drink, as you may choke.

• If severe hypoglycemiais not treated, it may cause brain damage (transient or permanent) and even death.
• If hypoglycemiacauses you to lose consciousness or if you experience repeated hypoglycemia, inform your doctor. Your doctor may need to adjust the amount or schedule of repaglinide administration, 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 signsappear 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.

Monitoring blood glucose levels or urine

While taking this medication, it is recommended to regularly monitor blood glucose levels or urine. 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 administered to children under 18 years old.

Taking Repaglinida Viatris 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 fat levels), do not take repaglinide.

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

• Monamine oxidase inhibitors (MAOIs) (for depression treatment).
• Other diabetes medications (except metformin), including insulin.
• Beta-blockers (for hypertension or heart disease treatment).
• ACE inhibitors (for heart disease treatment).
• Salicylates (e.g., aspirin).
• Octreotide (for cancer treatment).
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (a type of analgesic).
• Estrogens (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 or in preparations for cough and cold).
• Claritromycin, trimethoprim, rifampicin (antibiotics).
• Itraconazole, ketoconazole (antifungal medication).
• Ciclosporin (to suppress the immune system).
• Deferasirox (to reduce chronic iron overload).
• Clopidogrel (to prevent blood clots).
• Phenobarbital, carbamazepine, phenytoin, and other barbiturates (for epilepsy treatment).
• St. John's Wort (herbal medicine).

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 hypoglycemia symptoms.

Pregnancy and breastfeeding

You should 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.

You should not take repaglinide if you are breastfeeding.

Driving and operating 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 experience frequent hypoglycemia.
• You have few or no hypoglycemia symptoms or find it difficult to recognize them.

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

• The recommended 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.
• 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 miss a meal (or have an extra meal), you should miss (or add) a dose for that meal.
• The maximum recommended dose is 16 mg per day.

If you take more Repaglinide Viatris than you should

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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 Repaglinide Viatris

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 Repaglinide Viatris

Be aware that the desired effect will not be achieved if you stop taking Repaglinide Viatris. 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 medicines, this medicine may cause side effects, although not everyone will experience them.

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

• If you experience chest tightness or pain, which may radiate to the left arm and jaw, accompanied by 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 allergic reaction).
• Coma or loss of consciousness due to hypoglycemia (very severe hypoglycemic reactions, see the sectionHypoglycemia).
• If you experience 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).
• Caution: yellow discoloration of the skin or the white part 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 sectionHypoglycemia). The risk of experiencing hypoglycemia may increase if you take other medicines.
• Stomach pain.
• Diarrhea.

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

• Vomiting (discomfort).
• 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 rashes, itching, skin redness, skin inflammation).
• Discomfort (nausea).

Reporting of side effects

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

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 that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofRepaglinida 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 polacrilex, povidone, poloxamer 407, meglumine, glycerol, colloidal silicon dioxide, magnesium stearate, yellow iron oxide (E 172).

Appearance of the product and contents of the package

The tablets are round, with curved edges outward and a yellow, smooth speckled 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.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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

For more information about this medication, please contact 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 with the following names:

BelgiumRepaglinide Mylan 1 mg tablets

BulgariaRegligen 1 mg tablets

SpainRepaglinida Viatris 1 mg EFG tablets

LuxembourgRepaglinide Mylan 1 mg tablets

Last review date of this leaflet:November2016

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/