REPAGLINIDE AUROVITAS 1 mg TABLETS

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

Do not take Repaglinide Aurovitas

• If you are allergic to repaglinide or any of the other ingredients of this medication (listed in section 6).
• If you have type 1 diabetes.
• If your body's acid levels have increased (diabetic ketoacidosis).
• If you have a severe liver disease.
• If you are taking gemfibrozil (a medication that lowers blood lipid levels).

Warnings and precautions

Consult your doctor or pharmacist before starting to take repaglinide.

• 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 Repaglinide Aurovitas").
• If you have kidney problems. Repaglinide should be taken with caution.
• If you are going to undergo major surgery or have recently suffered a severe illness or infection. In these circumstances, diabetic control may not be achieved.
• If you are under 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 applies to you. Repaglinide may not be suitable 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 levels are too low. This can happen if:

• you take too much repaglinide,
• you do 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 you take Repaglinide Aurovitas").

Warning signs 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 levels are low or if you feel 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 repaglinide.

Inform others that you are diabeticandif 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 hypoglycemia is not treated, it can cause brain damage (temporary or permanent) and even death.
• If hypoglycemia makes you lose consciousness or if you suffer from repeated hypoglycemia, inform your doctor. You may need to adjust the dose of repaglinide, diet, or exercise.

If your blood sugar levels are too high

Your blood sugar levels may be too high (hyperglycemia). 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 signs of high blood sugar levelsappear gradually. These include: excessive urination, thirst, dry skin, and a feeling of dryness in the mouth. Inform your doctor. You may need to adjust the dose of repaglinide, diet, or exercise.

Other medications and Repaglinide Aurovitas

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

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

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

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

• monoamine oxidase inhibitors (MAOIs) (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).
• non-steroidal anti-inflammatory drugs (NSAIDs) (a type of pain reliever).
• steroids (anabolic steroids 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 (antibiotic medications).
• itraconazole, ketoconazole (medications for fungal infections).
• gemfibrozil (to treat high blood fat levels).
• cyclosporin (to suppress the immune system).
• deferasirox (to reduce chronic iron overload).
• clopidogrel (to prevent blood clots).
• phenytoin, carbamazepine, phenobarbital (for the treatment of epilepsy).
• St. John's Wort (herbal remedy).

Taking Repaglinide Aurovitas with alcohol

Alcohol may alter repaglinide's ability to lower blood sugar levels. Be aware of the symptoms of hypoglycemia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 using machines

Your ability to drive or use machines may be affected if your blood sugar levels are low or high. Be aware that you may be at risk or put 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.

3. How to take Repaglinide Aurovitas

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

Your doctor will calculate your dose.

• Normally, the initial 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 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 Repaglinide Aurovitas than you should

If you take too many tablets, your blood sugar levels 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Repaglinide Aurovitas

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 the forgotten doses.

If you stop taking Repaglinide 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 first.

If you have any further questions on 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 everybody gets 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 can lead to loss of consciousness or hypoglycemic coma. If this happens, seek immediate medical attention.

Allergy

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

Other side effects

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

• Stomach pain.
• Diarrhea.

Uncommon(may affect up to 1 in 1,000 people):

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

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

• Vomiting.
• Constipation.
• Visual disturbances.
• Severe liver problems, abnormal liver function, and increased liver enzymes in blood.

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

• Hypersensitivity (such as rash, itching, redness, and swelling of the skin).
• Feeling unwell (nausea).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Repaglinide Aurovitas

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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and other information

Composition of Repaglinide Aurovitas

• The active ingredient is repaglinide. Each tablet contains 1 mg of repaglinide.
• The other ingredients are: calcium hydrogen phosphate, povidone, meglumine, poloxamer, glycerol 85%, microcrystalline cellulose (grade 101), microcrystalline cellulose (grade 102), corn starch, potassium polacrylate, magnesium stearate, and yellow iron oxide (E172).

Appearance of the product and packaging contents

Repaglinide Aurovitas 1 mg are yellow, round, biconvex tablets, marked with "H" on one face and "11" on the other face.

They are packaged in blisters containing 90 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Date of the last revision of this leaflet: June 2021

Detailed and up-to-date information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).