REPAGLINIDE STADA 0.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Repaglinida STADA 0.5 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Repaglinida Stada and what is it used for
2. What you need to know before you take Repaglinida Stada
3. How to take Repaglinida Stada

1. Possible side effects
2. Storage of Repaglinida Stada

1. Contents of the pack and further information

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

Repaglinida Stada is an oral antidiabetic that contains repaglinide, which helps your pancreas 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).

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

2. What you need to know before you take Repaglinida Stada

Do not take Repaglinida Stada:

• 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 body's acid levels have increased (diabetic ketoacidosis)
• If you have severe liver disease
• If you are taking gemfibrozil(a medication that lowers blood fat levels).

If any of the above applies to you, tell your doctorand do not take Repaglinida Stada.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Repaglinida Stada if:

• You have liver problems. Repaglinida Stada is not recommended for patients with moderate liver disease. Repaglinida Stada should not be taken if you have severe liver disease (see Do not take Repaglinida Stada).

• If you have kidney problems. Repaglinida Stada 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 18or over 75 years, Repaglinida Stada is not recommended. It has not been studied in these age groups.

If you have hypoglycemia

You may experience hypoglycemia (low blood sugar) if your blood sugar levels are too low. This can happen if:

• You take too much Repaglinida Stada

• You do 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 you take Repaglinida Stada).

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 and tiredness, nervousness or tremors, anxiety, confusion, and difficulty concentrating.

If your blood sugar levels are 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 Stada.

Tell others that you are diabeticand 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 makes you lose consciousness or if you suffer from repeated hypoglycemia, tell your doctor. You may need to adjust the dose or administration schedule of Repaglinida Stada, diet, or exercise.

If your blood sugar levels are very high

Your blood sugar levels may be very high (hyperglycemia). This can happen:

• If you take too little Repaglinida Stada

• If you have an infection or fever

• If you eat more than usual
• If you do less exercise than usual.

Warning signsappear gradually. These include: excessive urination, thirst, dry skin, and a feeling of dryness in the mouth. Tell your doctor. You may need to adjust the dose of Repaglinida Stada, diet, or exercise.

Other medications and Repaglinida Stada

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

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

Your body's response to Repaglinida Stada 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)

• Angiotensin-converting enzyme (ACE) inhibitors (for the treatment of heart disease)
• Salicylates (e.g., aspirin)

• Octreotide (for the treatment of cancer)
• Non-steroidal anti-inflammatory drugs (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)
• Deferasirox (to reduce chronic iron overload)
• Clopidogrel (to prevent blood clots)

• Phenytoin, carbamazepine, phenobarbital (for the treatment of epilepsy)
• St. John's Wort (herbal medicinal plant)

Using Repaglinida Stada with food, drinks, and alcohol

Take Repaglinida Stada before main meals. Alcohol can alter Repaglinida Stada's ability to lower blood sugar levels. Be aware of the symptoms of hypoglycemia.

Pregnancy, breastfeeding, and fertility

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

Do not take Repaglinida Stada if you are pregnant or planning to become pregnant. Consult your doctor as soon as possible if you become pregnant or plan to become pregnant during treatment.

Do not take Repaglinida Stada if you are breastfeeding.

Driving and using machines

Your ability to drive or operate machinery may be affected if your blood sugar levels are low or high. Be aware that you may be putting 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 symptoms of hypoglycemia

Repaglinida Stada contains sodium

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

3. How to take Repaglinida Stada

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will calculate your dose.

• The recommended 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 Stada than your doctor has recommended.

If you take more Repaglinida Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 5620420, indicating the medicine and the amount taken.

If you take too many tablets, your blood sugar levels 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 Stada

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 forgotten doses.

If you stop taking Repaglinida Stada

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people)

• Hypoglycemia (see the section If you have hypoglycemiain section 2 of the leaflet). The risk of hypoglycemia may increase if you take other medications.
• Stomach pain.
• Diarrhea.

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

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

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

• Allergic reaction (such as swelling, difficulty breathing, palpitations, symptoms of dizziness, and sweating that can be symptoms of anaphylaxis). Consult your doctor immediately.

• Vomiting.
• Constipation.
• Visual disturbances.

• Severe liver problems, abnormal liver function, and increased liver enzymes in the blood.

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

• Hypoglycemic coma or loss of consciousness (very severe hypoglycemic reactions, see the section If you have hypoglycemia). Contact your doctor immediately.
• Hypersensitivity (such as rash, itching, redness, and swelling).

• Feeling unwell (nausea)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use. https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Repaglinida Stada

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

No special storage conditions are required.

Do not use Repaglinida Stada after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Repaglinida Stada

The active ingredient is repaglinide. Each tablet contains 0.5 mg of repaglinide.

The other ingredients are: microcrystalline cellulose, poloxamer 188, sodium croscarmellose, and magnesium stearate.

Appearance of the product and pack contents

Repaglinida Stada 0.5 mg are white, round, 3.4 mm thick, and biconvex tablets

Repaglinida Stada is available in packs containing 15, 30, 90, 120, 180, or 270 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Manufacturer

STADA Arzneimittel AG,

Stadastr. 2-18,

D-61118 Bad Vilbel,

Germany

or

STADA Arzneimittel GmbH,

Muthgasse 36, 1190 Wien,

Austria

or

Eurogenerics N.V.,

Heizel Esplanade B22, B-1020 Brussels,

Belgium

or

LAMP SAN PROSPERO S.p.A.,

Via della Pace, 25/A,

41030 San Prospero (Modena),

Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

AT: Repaglinid Stada 0,5 mg - Tabletten

BE: Repaglinide EG 0,5 mg tabletten

BG: Indorin 0,5 mg tablets

DE: Repaglinid STADA 0,5 mg Tabletten

ES: Repaglinida STADA 0,5 mg comprimidos EFG

FI: Repaglinid STADA 0,5 mg tabletti

FR: REPAGLINIDE EG 0,5 mg, comprimé

IT: REPAGLINIDE EG 0,5 mg compresse

LU: Repaglinide EG 0,5 mg comprimés

RO: Repaglinida HF 0,5 mg comprimate

SI: Repaglinid STADA HEMOFARM 0,5 mg tablete

SE: Repaglinid STADA 0,5 mg tabletter

NL: Repaglinide STADA 0,5 mg, tabletten

Date of last revision of this leaflet:May 2023

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