REPAGLINIDE AUROVITAS 0.5 mg TABLETS

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

Do not take Repaglinida Aurovitas

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

Warnings and precautions

Talk to 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 Repaglinida Aurovitas").
• If you have kidney problems. Repaglinide should be taken with caution.
• If you are going to have major surgery or have just suffered a serious 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.

Talk to 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 medicine if you are under 18 years old.

If you have low blood sugar (hypoglycaemia)

You may have hypoglycaemia if your blood sugar level is too low. This can happen if:

• you take too much repaglinide,
• you do more physical exercise than usual,
• you take other medicines or have kidney or liver problems (see other sections of section 2, "What you need to know before you take Repaglinida Aurovitas").

Warning signs of hypoglycaemiaappear 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 tremor, anxiety, confusion, and difficulty concentrating.

If your blood sugar level is low or if you feel that you are going to have a hypoglycaemic attack:take glucose tablets or a sugary product or drink, and then rest.

When the symptoms of hypoglycaemia disappear or when blood sugar levels stabilise, continue treatment with repaglinide.

Tell others that you are diabeticandif you lose consciousnessdue to hypoglycaemia, 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 hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death.
• If hypoglycaemia makes you lose consciousness or if you have repeated hypoglycaemic attacks, tell your doctor. You may need to adjust the dose of repaglinide, your diet, or your exercise.

If your blood sugar level is too high

Your blood sugar level may be too high (hyperglycaemia). 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 signsof high blood sugar levelsappear gradually. These include: excessive urination, thirst, dry skin, and a dry mouth feeling. Tell your doctor. You may need to adjust the dose of repaglinide, your diet, or your exercise.

Other medicines and Repaglinida Aurovitas

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

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

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

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

• monoamine oxidase inhibitors (MAOIs) (for depression treatment).
• beta-blockers (for high blood pressure or heart disease treatment).
• angiotensin-converting enzyme inhibitors (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 anaemia or to treat inflammation).
• 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 treatment).
• clarithromycin, trimethoprim, rifampicin (antibiotic medicines).
• itraconazole, ketoconazole (antifungal medicines).
• gemfibrozil (to treat high fat levels in the blood).
• ciclosporin (to suppress the immune system).
• deferasirox (to reduce chronic iron overload).
• clopidogrel (to prevent blood clots formation).
• phenytoin, carbamazepine, phenobarbital (for epilepsy treatment).
• St. John's Wort (herbal medicine).

Taking Repaglinida Aurovitas with alcohol

Alcohol may change the ability of repaglinide to lower blood sugar levels. Be aware of the symptoms of hypoglycaemia.

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 medicine.

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 level is too low or too high. Be aware that you could be at risk or put others at risk. Talk to your doctor about the possibility of driving a car if:

• you have frequent hypoglycaemic attacks,
• • you have few or no symptoms of hypoglycaemia.

3. How to take Repaglinida Aurovitas

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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 your doctor has recommended.

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 hypoglycaemia. Read what hypoglycaemia is and how to treat it in the section "If you have low blood sugar (hypoglycaemia)".

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Repaglinida 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 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, talk to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Hypoglycaemia

The most common side effect is hypoglycaemia, which can affect up to 1 in 10 people (see "If you have low blood sugar (hypoglycaemia)" in section 2). Hypoglycaemic reactions are usually mild or moderate, but occasionally they can lead to loss of consciousness or hypoglycaemic coma. If this happens, seek immediate medical attention.

Allergic reactions

Cases of allergy are very rare (may affect up to 1 in 10,000 people). Symptoms such as swelling, difficulty breathing, palpitations, dizziness symptoms, 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.
• Diarrhoea.

Uncommon(may affect up to 1 in 100 people):

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

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

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

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

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

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Repaglinida Aurovitas

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and further information

Composition of Repaglinida Aurovitas

• The active substance is repaglinide. Each tablet contains 0.5 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, and magnesium stearate.

Appearance of the product and pack contents

Repaglinida Aurovitas 0.5 mg are white to off-white, round, biconvex tablets, marked with "H" on one side and "10" on the other side.

They are packaged in blisters containing 90 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this package leaflet: June 2021

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