Repaglinide Viatris 0.50 mg tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Repaglinide Viatris 0.5 mg tablets EFG

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

• Keep this leaflet. 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 must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Repaglinide Viatris

3. How to take Repaglinide Viatris

4. Possible side effects

5. How to store Repaglinide Viatris

6. Contents of the pack and other information

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

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

Repaglinide Viatris is used to control type 2 diabetes as an adjunct 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 Viatris may also be given in combination with metformin, another diabetes medicine.

2. What you need to know before starting to take Repaglinide Viatris

Do not take Repaglinide Viatris:

• 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 (insulin-dependent 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).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Repaglinide Viatris:

• If you have liver problems. Repaglinide is not recommended for patients with moderate liver disease. Repaglinide must not be taken if you have severe liver disease (see Do not take Repaglinide Viatris).
• If you have kidney problems. Repaglinide should be used with caution.
• If you are undergoing major surgery or have recently had a serious illness, infection, fever, or injury. In these circumstances, diabetic control may not be achieved.
• If you are unable to eat normal amounts of food or feel tired (malnourished or weakened).
• If you are under 18 years old or over 75 years old, repaglinide is not recommended. It has not been studied in these age groups.

If you experience hypoglycaemia (low blood sugar level)

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

• If you take too much repaglinide.
• If you do more physical 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 starting to take Repaglinide Viatris).

Warning symptoms 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 food, and then rest.

Once the symptoms of hypoglycaemia have disappeared or when your blood sugar levels have stabilized, continue treatment with repaglinide.

Inform others that you are diabetic and if you lose consciousness due to hypoglycaemia, they must lay you on your side and seek immediate medical help. Nothing should be given by mouth, as you could choke.

• If severe hypoglycaemia is not treated, it may cause brain damage (temporary or permanent) or even death.
• If you lose consciousness due to hypoglycaemia or suffer repeated episodes, inform your doctor. Your dose or dosing schedule of repaglinide, diet, or exercise may need adjustment.

If your blood sugar level is very high

Your blood sugar level may become very high (hyperglycaemia). This may 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 symptoms develop gradually and include: frequent urination, thirst, dry skin, and dry mouth. Inform your doctor. Your dose of repaglinide, diet, or exercise may need adjustment.

Monitoring of blood or urine glucose levels

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

Children and adolescents

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

Taking Repaglinide Viatris with other medicines

Inform 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 together with metformin, another medicine for diabetes.

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

The effect of repaglinide in your body may change if you take other medicines, especially:

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

Taking Repaglinide Viatris with food, drinks and alcohol

Take repaglinide before main meals. Alcohol may alter repaglinide’s ability to lower blood sugar. Be alert for 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 intend 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 impaired if your blood sugar level is too low or too high. Be aware that you could endanger yourself or others. Consult your doctor about whether you may drive if:

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

3. How to take Repaglinide Viatris

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

• The recommended 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 the dose up to 4 mg, which should be taken just before or within the 30 minutes prior to 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 Repaglinide Viatris than you should

Contact your doctor, pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 would. Do not take a double dose to make up for forgotten doses.

If you stop taking 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 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.

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

• Chest tightness or pain, which may spread to the left arm and extend to the jaw, together 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 (these may be signs of an anaphylactic reaction).
• Hypoglycaemic coma or loss of consciousness (very severe hypoglycaemic reactions, see section If you have a hypoglycaemia).
• Fever, aches, joint or muscle inflammation, weight loss and fatigue (these may be due to inflammation of blood vessels caused by an allergic reaction to the medicine).
• Yellowing of the skin or whites of the eyes (these may be signs of a liver problem).

Other possible adverse effects

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

• Hypoglycaemia (see section If you have a hypoglycaemia). The risk of experiencing hypoglycaemia may increase if you are taking 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 may be detected in blood tests.

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Repaglinide Viatris

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Repaglinida Viatris

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

The other components are:

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

Appearance of the product and contents of the pack

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

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

It is also available in plastic bottles containing 100 tablets.

Only certain 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

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorized in the European Economic Area member states under the following names:

Belgium: Repaglinide Mylan 0.5 mg tabletten
Bulgaria: Regligen 0.5 mg tablets
Spain: Repaglinida Viatris 0,5 mg comprimidos EFG
Luxembourg: Repaglinide Mylan 0.5 mg comprimés

Date of the most recent review of this leaflet: November 2016

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