REPAGLINIDE PENSA 2 mg TABLETS

2. What you need to know before taking Repaglinida Pensa

Do not take Repaglinida Pensa

• If you are allergicto repaglinide or any of the other components of the medication (listed in section 6).
• If you have type 1 diabetes.
• If your body's acid level has increased (diabetic ketoacidosis)
• If you have severe liver disease.
• If you are taking gemfibrozil(a medication that lowers blood fat levels).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take 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 Repaglinida Pensa).
• If you have kidney problems. Repaglinide should be taken with caution.
• If you are going to undergo a major surgical procedureor have recently suffered a serious illnessor infection. In these circumstances, diabetic control may not be achieved.
• If you are under 18or over 75 years old, repaglinide is not recommended. It has not been studied in these age groups.

Consult your doctor ifany of the above cases apply to you, as Repaglinida Pensa may not be suitable 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 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 section 2. What you need to know before taking Repaglinida Pensa).

Warning signs of hypoglycemiaappear suddenly and can be: cold sweat, cold and pale skin, headache, palpitations, nausea, excessive hunger, temporary visual disturbances, fatigue, unusual weakness, nervousness or tremors, anxiety, confusion, and difficulty concentrating.

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

When the symptoms of hypoglycemia disappear or when blood sugar levels stabilize, continue 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 attention. They should not give you anything to eat or drink, as you may choke.

• If severe hypoglycemiais not treated, it can cause brain damage (temporary or permanent) and even death.
• If you experience hypoglycemiathat causes you to lose consciousness or if you have repeated hypoglycemic episodes, inform your doctor. You may need to adjust the dose of repaglinide, diet, or exercise.

If your blood sugar level is too high

Your blood sugar level may be too 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 exercise than usual.

Warning signs of high blood sugarappear gradually. These include: excessive 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 recently taken, or may need to take any other medication.

If your doctor prescribes it, you can take Repaglinida Pensa along with metformin, another diabetes medication. If you are taking gemfibrozil (used to lower blood fat levels), you should not take Repaglinida Pensa.

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

• Monoamine oxidase inhibitors (MAOIs) (for the treatment of depression).
• Beta-blockers (for the treatment of high blood pressure or heart disease).
• ACE inhibitors (for the treatment of heart disease).
• Salicylates (e.g., aspirin).
• Octreotide (for the treatment of cancer).
• Non-steroidal anti-inflammatory medications (NSAIDs) (a type of pain reliever).
• Steroids (anabolic steroids and corticosteroids, for anemia 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 medications).
• Itraconazole, ketoconazole (medications for fungal infections).
• Gemfibrozil (to treat high blood fat levels).
• Cyclosporin (to suppress the immune system).
• Phenytoin, carbamazepine, phenobarbital (for the treatment of epilepsy).
• St. John's Wort (herbal medicinal plant).
• Deferasirox (to reduce chronic iron overload).
• Clopidogrel (to prevent blood clots).

Using Repaglinida Pensa with alcohol

Alcohol can alter repaglinide's ability to lower blood sugar levels. Be aware of the symptoms of hypoglycemia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take Repaglinida Pensa if you are pregnant or plan to become pregnant.

Do not take Repaglinida Pensa if you are breastfeeding.

Driving and using machines

Your ability to drive vehicles and use machines 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 hypoglycemic episodes;
• you have few or no symptoms of hypoglycemia or find it difficult to recognize them.

3. How to take Repaglinida Pensa

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor again.

Your doctor will calculate your dose.

• Normally, the initial doseis 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 Pensa than your doctor has recommended.

If you take more Repaglinida Pensa than you should

If you take too many tablets, your blood sugar level 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 Repaglinida Pensa

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 missed doses.

If you stop taking 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 first.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Possible side effects

Common:may affect up to 1 in 10 patients.

• Hypoglycemia (see the section 2 If you have hypoglycemia). Hypoglycemic reactions are normally mild or moderate but may occasionally lead to loss of consciousness or hypoglycemic coma. If this occurs, you need immediate medical attention.
• Stomach 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.

• Allergic reaction. Symptoms such as swelling, difficulty breathing, palpitations, dizziness, and sweating that may be signs of an anaphylactic reaction. Contact your doctor immediately.
• Vomiting.
• Constipation.
• Visual disturbances.
• Serious 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 rash, itching, redness, and swelling of the skin).
• Nausea.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Repaglinida Pensa

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

Do not use this medication after the expiration date stated on the carton and blister pack after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Repaglinida Pensa

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

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

Appearance of the product and package contents

Repaglinida Pensa 2 mg tablets are peach-colored, round, biconvex, and have a score line on one side. The tablets can be divided into equal doses.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

PharmaPath S.A.

28is Oktovriou 1, Agia Varvara, 123 51

Greece

Date of the last revision of this package leaflet:January 2021

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