Prospect: Information for the User

Repaglinide Aurovitas 2 mg Tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Contentsof the prospect

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

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

3.How to take Repaglinide Aurovitas

4.Possible adverse effects

5.Storage of Repaglinide Aurovitas

6.Contents of the package and additional information

This medication is an oral 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.

Repaglinide is used to control type 2 diabetes in adults, 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.

Repaglinide can also be administered with metformin, another diabetes medication.

It has been shown that repaglinide reduces blood sugar levels, which contributes to preventing diabetes complications.

Do not take Repaglinida Aurovitas

•If you areallergicto repaglinide or any of the other components of this medication (listed in section 6).

•If you havetype 1 diabetes.

•If your body has an increased level of acid (diabetic ketoacidosis).

•If you have aserious liver disease.

•If you are takinggemfibrozil(a medication that lowers lipid levels in the blood).

Warnings and precautions

Consult your doctor or pharmacist before starting to take repaglinide.

•If you haveliver problems. Repaglinide is not recommended for patients with moderate liver disease. Repaglinide should not be taken if you have a serious liver disease (see “Do not take Repaglinida Aurovitas”).

•If you havekidney problems. Repaglinide should be taken with caution.

•If you are about to undergomajor surgeryor have recently had aserious illness or infection. In these circumstances, blood sugar control may not be achieved.

•If you areunder 18 or over 75 years old, repaglinide is not recommended. It has not been studied in these age groups.

Consult your doctorif any of the above cases apply to you. Repaglinide may not be indicated for you. Your doctor will advise you.

Children and adolescents

Do not take this medication if you are under 18 years old.

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,

•You engage in more physical exercise than usual,

•You take other medications or have kidney or liver problems (see other sections of section 2. “What you need to know before taking Repaglinida Aurovitas”).

Warning signs of hypoglycemiaappear suddenly and may include: cold sweat, pale and cold skin, headache, palpitations, nausea, excessive appetite, 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 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 stabilizecontinue 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 assistance. Do 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 hypoglycemiacauses you to lose consciousness or if you experience repeated hypoglycemia, inform your doctor. You may need to adjust the dose of repaglinide, your 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 signs of high blood sugarappear 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 dose of repaglinide, your diet, or exercise.

Other medications and Repaglinida Aurovitas

Inform your doctoror 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 take gemfibrozil (used to lower lipid levels in the blood), do not take repaglinide.

The response of your body to repaglinide may change if you take other medications, especially:

•Inhibitors of monoamine oxidase (MAO) (for the treatment of depression).

•Beta-blockers (for the treatment of high blood pressure or heart disease).

•Angiotensin-converting enzyme inhibitors (ACE inhibitors) (for the treatment of heart disease).

•Salicylates (e.g., aspirin).

•Octreotide (for the treatment of cancer).

•Nonsteroidal anti-inflammatory drugs (NSAIDs) (a type of analgesic).

•Glucocorticoids (steroid anabolic and corticosteroids, for anemia or to treat inflammation).

•Oral contraceptives (to prevent pregnancy).

•Thiazides (diuretics).

•Danazol (for the treatment of breast cysts and endometriosis).

•Thyroid products (for the treatment of low thyroid hormone levels).

•Sympathomimetics (for the treatment of asthma).

•Clarithromycin, trimethoprim, rifampicin (antibiotics).

•Itraconazole, ketoconazole (antifungal medications).

•Gemfibrozil (to treat high levels offatin the blood).

•Ciclosporin (to suppress the immune system).

•Deferasirox (to reduce chronic iron overload).

•Clopidogrel (to prevent blood clots).

•Phenobarbital, phenytoin, carbamazepine (for the treatment of epilepsy).

•St. John's Wort (herbal medicine).

Taking Repaglinida Aurovitas with alcohol

Alcohol can alter the ability of repaglinide to lower blood sugar levels. Be aware of the warning signs of hypoglycemia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

You should not take repaglinide if you are pregnant or planning to become pregnant.

You should not take repaglinide during breastfeeding.

Driving and operating machinery

Your ability to drive and 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 car if:

•You have frequent hypoglycemia,

•You have few or no symptoms of hypoglycemia.

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

Your doctor will calculate your dose.

•Normally, the 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. The maximum recommended dose is 16 mg per day.

Do not take more repaglinide than recommended by your doctor.

If you take more Repaglinida Aurovitas than you should

If you take too many tablets, your blood sugar level may become too low and cause hypoglycemia. Read what hypoglycemia is and how to treat it in the section “If you have hypoglycemia”.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Repaglinida Aurovitas

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 Repaglinida Aurovitas

Be aware that the desired effect will not be achieved if you stop taking repaglinide. 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.

Hypoglycemia

The most common side effect is hypoglycemia, which can affect up to 1 in 10 people (see “If you have hypoglycemia” in section 2). Hypoglycemic reactions are usually mild or moderate, but occasionally they can lead to loss of consciousness or hypoglycemic coma. If this occurs, seek immediate medical assistance.

Allergy

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

Other side effects

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

•Abdominal pain.

•Diarrhea.

Rare(can affect up to 1 in 1,000 people):

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

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

•Vomiting.

•Constipation.

•Visual disturbances.

•Severe liver problems, abnormal liver function, and increased liver enzymes in the blood.

Unknown frequency(cannot be estimated from available data):

•Hypersensitivity (such ashives, itching, redness, and skin swelling).

•Unpleasant sensation (nausea).

Reporting 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 Pharmacovigilance of Medicines for Human Use: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 packaging after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Repaglinida Aurovitas

-The active ingredient is repaglinide.Each tablet contains 2 mg of repaglinide.

-The other components are: calcium hydrogen phosphate, povidone, meglumine, poloxamer, 85% glycerol, microcrystalline cellulose (grade 101), microcrystalline cellulose (grade 102), cornstarch, potassium polacrilex, magnesium stearate, and iron oxide red (E172).

Appearance of the product and content of the packaging

Repaglinida Aurovitas 2 mg are orange, speckled, round, biconvex, tablets marked with “H” on one face and “12” on the other face.

It is packaged in a blister containing 90 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Last review date of this leaflet: June 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).