Repaglinide Aurovitas 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Repaglinide Aurovitas 1 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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; do not pass it on to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 side 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 that contains 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 manage type 2 diabetes in adults, 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 reduce) blood sugar levels.

Repaglinide may also be given 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 used 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 becomes too low. This may occur if:

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

Symptoms warning 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 is about to occur: take glucose tablets or a sugary drink or food, and then rest.

Once the symptoms of hypoglycaemia have subsided or 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 must 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 lead to brain damage (transient or permanent) and even death.
• If hypoglycaemia causes you to lose consciousness or if you experience repeated episodes, 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.

Symptoms warning of very high blood sugar develop gradually and may 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 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).
• clarithromycin, trimethoprim, rifampicin (antibiotics).
• itraconazole, ketoconazole (antifungal medicines).
• gemfibrozil (for treating high blood fat levels).
• ciclosporin (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 breast-feeding

If you are pregnant or breast-feeding, 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 breast-feeding.

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 can drive a car if:

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

3. How to take Repaglinide Aurovitas

Follow exactly the dosing instructions for this medicine as given by your doctor. If you are unsure, 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 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 30 minutes prior to, 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 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 usual. Do not take a double dose to make up for the missed dose.

If you stop taking Repaglinide Aurovitas

Please note 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 gets 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 happens, 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 may not be due to the medicine).

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

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

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

• Hypersensitivity (such as rash, itching, redness and swelling of the skin).
• 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 the 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at the 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 package and other information

Composition of Repaglinide Aurovitas

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

Appearance of the product and contents of the package

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

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 review 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/).