REPAGLINIDA CINFA 2 mg TABLETS

2. What you need to know before you take repaglinida cinfa

Do not take repaglinida cinfa

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

Warnings and precautions

Consult your doctor before starting to take repaglinida 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 repaglinida cinfa).
• If you have kidney problems. Repaglinide should be taken with caution.
• If you are going to undergo major surgeryor have recently 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.

Consult your doctor if 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 experience hypoglycaemia if your blood sugar levels are too low. This can happen if:

• You take too much repaglinida.
• 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 cinfa).

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 levels are 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 your blood sugar levels stabilise, continue treatment with repaglinida.

Inform others that you are diabetic and that if 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 hypoglycaemiais not treated, it can cause brain damage (temporary or permanent) and even death.

If you experience hypoglycaemiathat makes you lose consciousness or if you have repeated hypoglycaemic attacks, inform your doctor. You may need to adjust the dose of repaglinida, your diet, or exercise.

If your blood sugar levels are too high

Your blood sugar levels may be too high (hyperglycaemia). This can happen:

• If you take too little repaglinida.
• 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 dry mouth feeling. Inform your doctor. You may need to adjust the dose of repaglinida, your diet, or exercise.

Taking repaglinida cinfa with other medicines

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

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

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

Your body's response to repaglinida 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).
• 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 (medicines 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 formation).
• phenytoin, carbamazepine, phenobarbital (for epilepsy treatment).
• St. John's Wort (herbal medicine).

Taking repaglinida cinfa with alcohol

Alcohol may alter repaglinida's ability to lower your blood sugar levels. Be aware of the symptoms of hypoglycaemia.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should not take repaglinida if you are pregnant or planning to become pregnant.

You should not take repaglinida during breast-feeding.

Driving and using machines

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycaemia or hyperglycaemia, such as vision disturbances. This can be dangerous in situations where these skills are required (e.g. driving or using machines). Therefore, consult your doctor if it is advisable to drive or use machines.

repaglinida cinfa contains sodium.

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

3. How to take repaglinida cinfa

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor again.

Your doctor will calculate your dose.

The recommended 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 repaglinida than recommended by your doctor.

If you take more repaglinida cinfa than you should

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

If you take too many tablets, your blood sugar levels may become too low and cause hypoglycaemia.

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

If you forget to take repaglinida cinfa

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 cinfa

Keep in mind that the desired effect is not achieved if you stop taking repaglinida. Your diabetes may worsen.

If any change in your treatment is necessary, consult your doctor before stopping treatment. 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 patients (see If you have low blood sugar (hypoglycaemia) in section 2). Hypoglycaemic reactions are normally mild or moderate but can occasionally lead to loss of consciousness or hypoglycaemic coma. If this happens, you need immediate medical attention.

Allergic reactions

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

• Stomach pain.
• Diarrhoea.

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

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

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

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

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

• Hypersensitivity (such as rash, itching, redness, and skin swelling).
• Nausea

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of repaglinida 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 which is stated on the carton after EXP. The expiry date is the last day of the month stated.

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

Appearance of the product and pack contents

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

Each pack contains 90 tablets.

Marketing authorisation holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet:June 2020

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. 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