Repaglinide Aurovitas 0.5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Repaglinide Aurovitas 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 as 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Repaglinide Aurovitas is and what it is used for
2. What you need to know before taking Repaglinide Aurovitas
3. How to take Repaglinide Aurovitas
4. Possible adverse effects
5. How to store Repaglinide Aurovitas
6. Contents of the pack and other information

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

This medicine is an oral antidiabetic agent 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.

Repaglinide is used to control type 2 diabetes in adults, as an adjunct to diet and exercise. Treatment should be initiated when diet, physical activity, and weight reduction alone have not been sufficient to control (or reduce) blood sugar levels.

Repaglinide may also be administered in combination with metformin, another antidiabetic medicine.

Repaglinide has been shown to reduce blood sugar levels, thereby helping to prevent diabetes-related complications.

2. What you need to know before taking Repaglinide Aurovitas

Do not take Repaglinide Aurovitas

• 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.
• If the level of acid 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 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 undergoing major surgery or have recently had a serious illness or infection. In these circumstances, diabetic control may not be achieved.
• If you are under 18 or over 75 years of age, repaglinide is not recommended. It has not been studied in these age groups.

Talk to your doctor if any of the above situations apply 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 of age.

If you experience hypoglycaemia (low blood sugar)

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

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

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 hypoglycaemia coming on: take glucose tablets or a sugary drink or food, and then rest.

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

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

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

If your blood sugar level is very high

Your blood sugar level may become very high (hyperglycaemia). This may occur:

• if you take too little repaglinide,
• if you have an infection or fever,
• if you eat more than usual,
• if you exercise less than usual.

Warning signs of very high blood sugar 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.

Other medicines and Repaglinide Aurovitas

Tell 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 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 treatment of depression).
• beta-blockers (for treatment of high blood pressure or heart conditions).
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (for treatment of heart conditions).
• salicylates (e.g., aspirin).
• octreotide (for cancer treatment).
• non-steroidal anti-inflammatory drugs (NSAIDs) (a type of painkiller).
• steroids (anabolic steroids and corticosteroids, for anaemia or treating 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).
• clarithromycin, trimethoprim, rifampicin (antibiotic medicines).
• itraconazole, ketoconazole (medicines for fungal infections).
• gemfibrozil (for treating high blood fat levels).
• cyclosporine (to suppress the immune system).
• deferasirox (to reduce chronic iron overload).
• clopidogrel (to prevent blood clots).
• phenytoin, carbamazepine, phenobarbital (for treatment of epilepsy).
• St. John's wort (herbal remedy).

Taking Repaglinide Aurovitas with alcohol

Alcohol may alter repaglinide's ability to lower blood sugar. Be alert for symptoms of hypoglycaemia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

You must not take repaglinide during breastfeeding.

Driving and using machines

Your ability to drive and 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 a car if:

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

3. How to take Repaglinide Aurovitas

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

Your doctor will calculate your dose.

• Normally, the 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 your dose up to 4 mg, which should be taken just before or within the 30 minutes prior to 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 level may become too low, causing hypoglycaemia. Read about what hypoglycaemia is and how to treat it in the section “If you have hypoglycaemia”.

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

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 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 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.

Hypoglycaemia

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

Allergy

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

Other adverse effects

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

• Stomach pain.
• Diarrhoea.

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

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

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

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

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

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

Reporting of adverse effects

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

5. Storage of Repaglinide Aurovitas

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

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

6. Contents of the pack and other information

Composition of Repaglinide Aurovitas

• The active substance is repaglinide. Each tablet contains 0.5 mg of repaglinide.
• The other components are: calcium hydrogen phosphate, povidone, meglumine, poloxamer, glycerol 85%, microcrystalline cellulose (grade 101), microcrystalline cellulose (grade 102), corn starch, polacriline potassium, and magnesium stearate.

Appearance of the product and contents of the pack

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

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 most recent revision of this leaflet: June 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).