Repaglinide Pensa 2 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Repaglinida pensa 2 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 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 Repaglinida pensa is and what it is used for
2. What you need to know before taking Repaglinida pensa
3. How to take Repaglinida pensa
4. Possible side effects
5. How to store Repaglinida pensa
6. Contents of the pack and other information

1. What Repaglinida pensa is and what it is used for

Repaglinida pensa is an oral antidiabetic medicine that contains repaglinide, which 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.

Repaglinide is used to control type 2 diabetes 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 lower) blood sugar levels. Repaglinide may also be given in combination with metformin, another antidiabetic medicine.

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

2. What you need to know before taking Repaglinida pensa

Do not take Repaglinida pensa

• 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.
• If the level of acid in your body 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 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 used with caution.
• If you are undergoing major surgery or have recently had a serious illness or serious infection. In these circumstances, adequate 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 situations apply to you, as Repaglinida pensa 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 experience 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 of 2. What you need to know before taking Repaglinida pensa).

Symptoms warning 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 hypoglycaemic episode coming on: take glucose tablets or a sugary drink or food, and then rest.

Once the symptoms of hypoglycaemia have subsided or when blood sugar levels have stabilized, continue treatment with Repaglinida pensa.

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, inform your doctor. You may need to adjust your repaglinide dose, diet, or physical activity.

If your blood sugar level is very high

Your blood sugar level may become very high (hyperglycaemia). This may happen:

• 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 indicating very high blood sugar levels develop gradually. These include: frequent urination, thirst, dry skin, and dry mouth. Inform your doctor. You may need to adjust your dose of Repaglinida pensa, diet, or physical activity.

Other medicines and Repaglinida pensa

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

Your doctor may prescribe Repaglinida pensa to be taken together with metformin, another medicine for diabetes. However, if you are taking gemfibrozil (used to lower blood fat levels), you should not take Repaglinida pensa.

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

• Monoamine oxidase inhibitors (MAOIs) (for treatment of depression).
• Beta-blockers (for treatment of high blood pressure or heart conditions).
• ACE inhibitors (for treatment of heart conditions).
• Salicylates (e.g. aspirin).
• Octreotide (for 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 treatment of breast cysts and endometriosis).
• Thyroid products (for treatment of low thyroid hormone levels).
• Sympathomimetics (for treatment of asthma).
• Clarithromycin, trimethoprim, rifampicin (antibiotics).
• Itraconazole, ketoconazole (medicines for fungal infections).
• Gemfibrozil (for treating high blood fat levels).
• Cyclosporine (to suppress the immune system).
• Phenytoin, carbamazepine, phenobarbital (for treatment of epilepsy).
• St. John's wort (herbal remedy).
• Deferasirox (to reduce chronic iron overload).
• Clopidogrel (to prevent blood clots).

Use of Repaglinida pensa 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 or pharmacist before using this medicine.

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

You must not take Repaglinida pensa if you are breastfeeding.

Driving and use of machines

Your ability to drive or operate machinery may be impaired if your blood sugar level is too low or too high. Be aware that you could endanger yourself or others. Consult your doctor about whether it is safe for you to drive if:

• you have frequent hypoglycaemic episodes;
• you have few or no symptoms of hypoglycaemia or find them difficult to recognize.

3. How to take Repaglinida pensa

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 usual 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 also 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 Repaglinida pensa than your doctor has prescribed.

If you take more Repaglinida pensa than you should

If you take too many tablets, your blood sugar may become too low, causing hypoglycemia. Please read about hypoglycemia and how to treat it in the section If you have a hypoglycemia.

If you forget to take Repaglinida pensa

If you forget to take a dose, take your next dose as usual. Do not take a double dose to make up for the missed dose.

If you stop taking Repaglinida pensa

Please note 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 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 may cause adverse effects, although not everybody gets them.

Possible adverse effects

Frequent: may affect up to 1 in 10 patients.

• Hypoglycaemia (see section 2 If you have hypoglycaemia). 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.
• Stomach pain.
• Diarrhoea.

Rare: may affect up to 1 in 1,000 patients.

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

Very rare: may affect up to 1 in 10,000 patients.

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

Frequency not known: frequency cannot be estimated from the available data.

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

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if these are possible adverse effects 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 Repaglinda pensa

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Repaglinida pensa

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

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

Appearance of the product and contents of the pack

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 pack contains 30, 90, 120, or 270 tablets.

Only certain 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 most recent review of this leaflet: January 2021

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