Package Insert: Information for the User

Repaglinide STADA 1 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. Possible Adverse Effects
2. Storage of Repaglinide Stada

1. Contents of the Package and Additional Information

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

Type 2 diabetesis a disease in which the pancreas does not produce enough insulin tocontrol the level of sugar in the blood or in which the body does not respond normally to the insulin it produces (previously known asnon-insulin-dependent diabetes mellitus or maturity-onset diabetes).

Repaglinida Stada is used to control type 2 diabetes, 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) the level of sugar in the blood. Repaglinida Stada can also be administered together with metformin, another diabetes medication

Do not take Repaglinida Stada:

• If you are allergic to repaglinide or any of the other ingredients of this medication (listed in section 6).

• If you havetype 1 diabetes(insulin-dependent diabetes)

• If your body has an increased level of acid (diabetic ketoacidosis)
• If you havesevere liver disease
• If you takegemfibrozil(a medication that lowers blood fat levels).

If any of the above cases occur, inform your doctor and do not take Repaglinida Stada.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeRepaglinida Stada if:

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

• Si tienekidney problems. Repaglinida Stada should be taken with caution.

• Si va a undergo amajor surgical procedureor has recently suffered aserious illness or infection.In these circumstances, it may not be possible to achieve good blood sugar control.

• Si esless than 18orover 75 years old, Repaglinida Stada is not recommended. It has not been studied in these age groups.

If you have hypoglycemia

You may experience hypoglycemia (symptoms of low blood sugar) if your blood sugar level is too low. This can occur if:

• Takes too much Repaglinida Stada

• Does more physical exercise than usual

• Takes other medications or has kidney or liver problems (see other sections of section 2.What you need to know before starting to take Repaglinida Stada).

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 tremors, anxiety, confusion, and difficulty concentrating.

If your blood sugar level is low or if you feel you are about to have hypoglycemia:takeglucose 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 Stada.

Inform others that you are diabeticandthat if you lose consciousnessdue to hypoglycemia, they should lay you on your side and seek immediate medical attention. Do 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) andeven death.
• If hypoglycemialeaves you unconscious or if you experience repeated hypoglycemia, inform your doctor. You may need to adjust the amount or schedule of Repaglinida Stada administration, 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 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: frequent urination, thirst, dry skin, and a sensation of dryness in the mouth. Inform your doctor. You may need to adjust the amount of Repaglinida Stada, diet, or exercise.

Other medications and Repaglinida Stada

Inform your doctor or 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 Stada with metformin, another diabetes medication. If you take gemfibrozil (used to lower blood fat levels), do not take Repaglinida Stada.

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

• Inhibitors of monoamine oxidase (IMAO) (for the treatment of depression)
• Beta-blockers (for the treatment of high blood pressure or heart disease)

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

• Octreotide (for the treatment of cancer).
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (a type of analgesic)
• Glucocorticoids (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)
• Claritromycin, trimethoprim, rifampicin (antibiotics)

• Itraconazole, ketoconazole (antifungal medications)
• Gemfibrozil (to treat high blood fat levels)
• Ciclosporin (to suppress the immune system)
• Deferasirox (to reduce chronic iron overload)
• Clopidogrel (prevents blood clots)

• Phenobarbital, carbamazepine, phenytoin (for the treatment of epilepsy)
• St. John's Wort (herbal medicine)

Use of Repaglinida Stada with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

Do not take Repaglinida Stada if you are pregnant or plan 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 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

Repaglinida Stada contains sodium

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

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

Your doctor will calculate your dose.

• Recommended initial 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 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 Toxicological Information Service, phone: 91 5620420, 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 sectionif you have hypoglycemia.

If you forget to take Repaglinida Stada

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 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 beforehand.

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

Like all medications, this medication may have adverse effects, although not everyone will experience them.

Frequent ( may affect up to 1 in 10 people )

• Hypoglycemia (see the section If you have hypoglycemia in the section 2 of the leaflet). The risk of experiencing 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)

• Allergy (such as swelling, difficulty breathing, palpitations, symptoms of dizziness and sweating that may be symptoms of anaphylactic reaction). Consult your doctor immediately.

• Vomiting.
• Constipation.
• Visual disturbances.

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

Frequency unknown (the frequency cannot be estimated from the available data)

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

• Feeling unwell (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 leaflet. You can also report them 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.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Repaglinida Stada

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

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

Appearance of the product and contents of the package

Repaglinida Stada 1 mg are white, round, 3.4 mm thick, biconvex tablets with a "1" in relief.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG,

Stadastr. 2-18,

D-61118 Bad Vilbel,

Germany

or

Stada Arzneimittel GmbH,

Muthgasse 36,

1190 Vienna,

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 with the following names:

AT:Repaglinid Stada 1 mg - Tabletten

BE:Repaglinide EG 1mg tabletten

BG: Indorin 1 mg tablets

DE:Repaglinid STADA 1 mg Tabletten

ES:Repaglinida STADA 1 mg comprimidos EFG

FI:Repaglinid STADA 1 mg tabletti

FR:REPAGLINIDE EG 1 mg, comprimé

IT:REPAGLINIDE EG 1mg compresse

LU:Repaglinide EG 1 mg comprimés

RO: Repaglinida HF 1 mg comprimate

SI:Repaglinid STADA HEMOFARM 1 mg tablete

SE:Repaglinid STADA 1 mg tabletter

NL:Repaglinide STADA 1 mg, tabletten

Last review date of this leaflet:May2023

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/