Leaflet: information for the user

Repaglinide pensa 1 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 Repaglinide pensa is and what it is used for

2. What you need to know before you start taking Repaglinide pensa

3. How to take Repaglinide pensa

4. Possible side effects

5. Storage of Repaglinide pensa

6. Contents of the pack and additional information

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

Thetype 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.

Repaglinida is used to control type 2 diabetes as a complement to diet and exercise: treatment should begin if diet, physical exercise, and weight reduction alone have not been sufficient to control (or decrease) blood sugar levels. Repaglinida can also be administered with metformin, another diabetes medication.

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

Do not take Repaglinida pensa

• If you areallergicto repaglinide or any of the other ingredients of the medication (listed in section 6).
• If you havetype 1 diabetes.
• If your body's acid level has increased (diabetic ketoacidosis)
• If you havesevere liver disease.
• If you takegemfibrozil(a medication that lowers blood fat levels).

Warnings and precautions

Consult your doctor or pharmacist before starting to take repaglinide.

• If you haveliver problems. Repaglinide is not recommended for patients with moderate liver disease. Repaglinide should not be taken if you have severe liver disease (seeDo not take Repaglinida pensa).
• If you havekidney problems. Repaglinide should be taken with caution.
• If you are about to undergomajor surgeryor have recently had anillnessorinfection. In these circumstances, blood sugar control may not be achieved.
• If you areunder 18orover 75 years, repaglinide is not recommended. It has not been studied in these age groups.

Consult your doctor ifany of the above cases occur, Repaglinida pensa may not be indicated for you. Your doctor will advise you.

Children and adolescents

Do not take this medication if you are under 18 years old.

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 engage in more physical exercise than usual.
• You take other medications or have kidney or liver problems (see other sections of section2. What you need to know before starting to take Repaglinida pensa).

Warning signs of hypoglycemiaappear suddenly and may include: cold sweat, pale and cold 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 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 levels stabilizecontinue treatment with Repaglinida pensa.

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 hypoglycemiaif not treated, may cause brain damage (temporary or permanent) and even death.
• Recurrent hypoglycemiamay cause loss of consciousness or inform your doctor. You may need to adjust the dose of repaglinide, 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 engage in less physical exercise than usual.

Warning signs of 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 the amount of Repaglinida pensa, diet, or exercise.

Other medications and Repaglinida pensa

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

If your doctor prescribes it, you can take Repaglinida pensa with metformin, another diabetes medication. If you take gemfibrozil (used to lower blood fat levels), do not take Repaglinida pensa.

Your body's response to Repaglinida pensa may change if you take other medications, especially:

• Monamine 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).
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (a type of analgesic).
• Estrogens (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 medications).
• Gemfibrozil (to treat high blood fat levels).
• Ciclosporin (to suppress the immune system).
• Phenobarbital, phenytoin, carbamazepine (for epilepsy treatment).
• St. John's Wort (herbal medicine).
• Deferasirox (to reduce chronic iron overload).
• Clopidogrel (to prevent blood clot formation).

Use of Repaglinida pensa with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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

Do not take Repaglinida pensa if you are breastfeeding.

Driving and operating machinery

Your ability to drive cars and operate machinery may be affected if your blood sugar level is low or high. Be aware that you may put yourself or others at risk. Consult your doctor about the possibility of driving a car if:

• You have frequent hypoglycemia;
• You have few or no hypoglycemia symptoms or find it difficult to recognize them.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Your doctor will calculate your dose.

• Normally theinitial doseis 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 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 pensa than your doctor has recommended.

If you take more Repaglinida pensa than you should

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 sectionif you have hypoglycemia.

If you forget to take Repaglinida pensa

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 Repaglinida pensa

Be aware that the desired effect will not be achieved if you stop taking Repaglinida pensa. Your diabetes may worsen. If any change in your treatment is necessary, 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.

Possible Adverse Effects

Common:may affect up to 1 in 10 patients.

• Hypoglycemia (see section 2If you have hypoglycemia). 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.
• 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 up to 1 in 10,000 patients.

• Allergy. Symptoms such as swelling, difficulty breathing, palpitations, symptoms of dizziness, and sweating that may be signs of anaphylactic reaction. Contact your doctor immediately.
• Vomiting.
• Constipation.
• Visual disturbances.
• Severe liver problems, abnormal liver function, and increased liver enzymes in the blood.

Frequency Not Known:the frequency cannot be estimated from the 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 of 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.

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

This medication does not require special storage conditions.

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at 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 Repaglinida pensa

• The active ingredient is repaglinide. Each Repaglinida pensa 1 mg tablet contains 1 mg of repaglinide.

• The other components (excipients) are: microcrystalline cellulose (E460), calcium hydrogen phosphate, cornstarch, amberlite (potassium polacrilinate), povidone K30 (polyvidone), 85% glycerol, magnesium stearate, meglumine, poloxamer, and yellow iron oxide (E172).

Appearance of the product and content of the packaging

Repaglinida pensa 1 mg tablets are yellow, round, biconvex, and have a partition mark on one face. The tablets can be divided into equal doses.

Repaglinida pensa is available in four presentations in blister packaging. Each package contains 30, 90, 120, or 270 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

PharmaPath S.A.

28is Oktovriou 1, Agia Varvara, 123 51

Greece

Last review date of this leaflet: January 2021

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/