Leaflet: information for the user

Repaglinide cinfa 2 mg tablets EFG

Read this 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking repaglinide cinfa

3.How to take repaglinide cinfa

4.Possible side effects

5.Storage of repaglinide cinfa

6.Contents of the pack and additional information

repaglinide cinfa is an oral antidiabetic medication that contains repaglinide, which helps your pancreas to produce more insulin and lower your blood sugar (glucose) levels.

Type 2 diabetesis a disease 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 maturity-onset diabetes).

repaglinide cinfa is used to control type 2 diabetes in adults, as a complement to diet and exercise: treatment should be initiated if diet, physical exercise, and weight reduction alone have not been sufficient to control (or reduce) blood sugar levels. repaglinide cinfa may also be administered with metformin, another diabetes medication.

It has been shown that repaglinide cinfa reduces blood sugar levels, which contributes to preventing diabetes complications.

Do not take repaglinide cinfa

Warnings and precautions

Consult your doctor before starting to take repaglinide cinfa

Consult your doctor if any of the above cases occur. Repaglinide may not be indicated for you. Your doctor will advise you.

Children and adolescents

Do not take this medicine if you are under 18 years.

If you have a hypoglycemia (low blood sugar)

You may experience hypoglycemia if your blood sugar level is too low. This can occur 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 taking repaglinide cinfa).

Warning signs of hypoglycemiaappear suddenly and may include: cold sweat, pale and cold skin, headache, palpitations, nausea, excessive appetite, temporary visual disturbances, fatigue, unusual tiredness and weakness, nervousness or tremor, anxiety, confusion, and difficulty concentrating.

If your blood sugar level is low or if you feel you are about to have a hypoglycemia:take glucose tablets or a sugary product or drink and then rest.

When the symptoms of hypoglycemia disappear or when blood sugar levelsstabilizecontinue treatment with repaglinide.

Inform others that you are diabetic and that if you lose consciousnessdue to hypoglycemia, they should lay you on your side and seek immediate medical assistance. Do not give you anything to eat or drink, as you may choke.

Severe hypoglycemianot treated can cause brain damage (temporary or permanent) and even death.

If hypoglycemiacauses you to lose consciousness or if you experience repeated hypoglycemia, inform your doctor. Your doctor may need to adjust your repaglinide dose, diet, or exercise.

If your blood sugar level is very high

Your blood sugar level may be very high (hyperglycemia). This can occur:

• 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 sugarappear gradually. These include: frequent urination, thirst, dry skin, and a feeling of dryness in the mouth. Inform your doctor. You may need to adjust your repaglinide dose, diet, or exercise.

Taking repaglinide cinfa withother medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

If you are taking gemfibrozil (used to lower blood fat levels), do 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 hypertension 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 analgesic).
• steroids (anabolic steroids and corticosteroids, for anemia 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).
• sympathomimetics (for asthma treatment).
• clarithromycin, trimethoprim, rifampicin (antibiotics).
• itraconazole, ketoconazole (antifungal medicines).
• gemfibrozil (to treat high blood fat levels).
• ciclosporin (to suppress the immune system).
• deferasirox (to reduce chronic iron overload).
• clopidogrel (to prevent blood clot formation).
• phenytoin, carbamazepine, phenobarbital (for epilepsy treatment).
• St. John's Wort (herbal medicine).

Taking repaglinide cinfa with alcohol

Alcohol can alter repaglinide's ability to lower blood sugar levels. Remain alert to hypoglycemia symptoms.

Pregnancy and breastfeeding

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

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

Do not take repaglinide during breastfeeding.

Driving and operating machines

Your concentration and reaction abilities may be affected due to hypoglycemia or hyperglycemia symptoms, such as visual disturbances. This can be hazardous in situations where these skills are essential (e.g. driving or operating machines). Consult your doctor if it is recommended to drive or operate machines.

Repaglinide cinfa contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Your doctor will calculate your dose.

The recommended initial dose is 0.5 mg taken exactly before each main meal. The tablets should be taken with a glass of water just before or within 30 minutes before each main meal.

Your doctor may adjust the dose 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 recommended by your doctor.

If you take more Repaglinide Cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

Please read 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 you normally do, do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Repaglinide Cinfa

Be aware that the desired effect will not be achieved if you stop taking Repaglinide. Your diabetes may worsen.

If any change is necessary in your treatment, consult your doctor beforehand. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Hypoglycemia

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

Allergy

Allergic reactions are very rare (may affect 1 in 10,000 patients). Symptoms such as swelling, difficulty breathing, palpitations, symptoms of dizziness, and sweating, may be signs of anaphylactic reaction. Contact your doctor immediately.

Other Adverse Effects

Frequent(may affect up to 1 in 10 patients)

• Abdominal pain.
• Diarrhea.

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

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

Very Rare(may affect 1 in 10,000 patients)

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

Frequency Not Known(cannot be estimated from available data)

• Hypersensitivity (such as hives, itching, redness, and swelling of the skin).
• Nausea.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of repaglinide cinfa

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

The other components are: N-methylglucamine, povidone, polyoxethylene, microcrystalline cellulose (E-460), sodium carboxymethylcellulose (type A) (from potato), magnesium stearate, anhydrous calcium phosphate, cornstarch, potassium polacrilex, red iron oxide (E-172).

Appearance of the product and content of the packaging

repaglinide cinfa 2 mg are red, cylindrical, biconvex tablets marked with the code “R2”.

Each package contains 90 tablets.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta.

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:June 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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