REPAGLINIDE CINFA 2 MG TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

repaglinide cinfa 2 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, 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 cinfa is and what it is used for
2. What you need to know before taking repaglinide cinfa
3. How to take repaglinide cinfa
4. Possible side effects
5. How to store repaglinide cinfa
6. Contents of the pack and other information

1. What repaglinide cinfa is and what it is used for

Repaglinide cinfa is an oral antidiabetic medicine containing repaglinide that 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 (previously known as non-insulin-dependent diabetes mellitus or adult-onset diabetes).

Repaglinide cinfa is used to manage type 2 diabetes in adults, as an addition 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 cinfa may also be given together with metformin, another antidiabetic medicine.

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

2. What you need to know before starting to take repaglinide cinfa

Do not take repaglinide cinfa

• 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 (insulin-dependent diabetes).
• If the acid level in your blood has increased (diabetic ketoacidosis).
• If you have severe liver disease.
• If you are taking gemfibrozil (a medicine that lowers fat levels in the blood).

Warnings and precautions

Talk to your doctor before starting to take repaglinide cinfa

• 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 cinfa).
• 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 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 have hypoglycaemia (low blood sugar)

You may experience hypoglycaemia if your blood sugar level becomes too low. This may 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 in section 2. What you need to know before starting to take repaglinide cinfa).

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 disappeared 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 help. Do not give you anything to eat or drink, as you could choke.

If severe hypoglycaemia is not treated, it may cause brain damage (temporary or permanent) and even death.

If you lose consciousness due to hypoglycaemia 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.

Symptoms of 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.

Taking repaglinide cinfa with other medicines

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 fat levels in the blood), you should not take repaglinide.

The effect of repaglinide in your body may change if you take other medicines, especially:

• monoamine oxidase inhibitors (MAOIs) (for the treatment of depression).
• beta-blockers (for the treatment of high blood pressure or heart conditions).
• ACE inhibitors (for the treatment of heart conditions).
• salicylates (e.g. aspirin).
• octreotide (for the treatment of cancer).
• 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 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 medicines).
• itraconazole, ketoconazole (medicines for fungal infections).
• gemfibrozil (to treat high blood fat levels).
• ciclosporin (to suppress the immune system).
• deferasirox (to reduce chronic iron overload).
• clopidogrel (to prevent blood clots).
• phenytoin, carbamazepine, phenobarbital (to treat epilepsy).
• St. John’s wort (herbal remedy).

Taking repaglinide cinfa with alcohol

Alcohol may alter repaglinide’s ability to lower blood sugar levels. 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 before using this medicine.

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

You must not take repaglinide while breastfeeding.

Driving and using machines

Your ability to concentrate and react may be affected by symptoms caused by hypoglycaemia or hyperglycaemia, such as vision problems. This could be dangerous in situations where these skills are important (e.g., driving or operating machinery). Therefore, consult your doctor to determine whether it is advisable to drive or use machines.

repaglinide cinfa contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take repaglinide cinfa

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor again.

Your doctor will determine your dose.

The recommended 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 daily dose is 16 mg.

Do not take more repaglinide than recommended by your doctor.

If you take more repaglinide cinfa than you should

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

If you take too many tablets, your blood sugar may become too low, causing hypoglycemia.

Please read about what hypoglycemia is and how to treat it in the section “If you have hypoglycemia”.

If you forget to take repaglinide cinfa

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 cinfa

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 experiences them.

Hypoglycaemia

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

Allergy

Cases of allergy are very rare (may affect up to 1 in 10,000 patients). 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 patients)

• Stomach pain.
• Diarrhoea.

Uncommon (may affect up to 1 in 1,000 patients)

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

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

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

Frequency not known (cannot be estimated from available data)

• Hypersensitivity (such as rash, itching, redness and swelling of the skin).
• 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of repaglinide cinfa

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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are 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 pack and other information

Composition of repaglinida cinfa

The active substance is repaglinide. Each tablet contains 2 mg of repaglinide.

The other components are: N-methylglucamine, povidone, polyoxyethylene, microcrystalline cellulose (E-460), sodium carboxymethyl starch (type A) (from potato), magnesium stearate, anhydrous dicalcium phosphate, corn starch, polacriline potassium, red iron oxide (E-172).

Appearance of the product and contents of the pack

repaglinida cinfa 2 mg are red, cylindrical, biconvex tablets marked with the code "R2".

Each pack contains 90 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: June 2020

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73142/P_73142.html

QR code to: https://cima.aemps.es/cima/dochtml/p/73142/P_73142.html