Repaglinide Stada 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Repaglinide STADA 1 mg tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could 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 Repaglinide STADA is and what it is used for

2. What you need to know before taking Repaglinide STADA

3. How to take Repaglinide STADA

4. Possible side effects

5. How to store Repaglinide STADA

6. Contents of the pack and other information

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

Repaglinida Stada 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 (previously known as non-insulin-dependent diabetes mellitus or adult-onset diabetes).

Repaglinida Stada is used to manage type 2 diabetes as an addition to diet and exercise. Treatment should be started when diet, physical activity, and weight reduction alone have not been sufficient to control (or lower) blood sugar levels. Repaglinida Stada may also be given together with metformin, another diabetes medicine.

2. What you need to know before taking Repaglinide STADA

DO NOT take Repaglinide 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 the acid level 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).

If any of the above apply to you, inform your doctor and do not take Repaglinide STADA.

Warnings and precautions

Talk to your doctor or pharmacist before starting Repaglinide STADA if:

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

• You have kidney problems. Repaglinide STADA should be used with caution.

• You are undergoing major surgery or have recently had a serious illness or infection. In these circumstances, diabetic control may not be achieved.

• You are under 18 or over 75 years of age. Repaglinide STADA is not recommended. It has not been studied in these age groups.

If you experience hypoglycaemia

You may experience hypoglycaemia (symptoms of low blood sugar) if your blood sugar level becomes too low. This may occur if:

• You take too much Repaglinide STADA.

• You do more physical exercise than usual.

• You take other medicines or have kidney or liver problems (see other sections in section 2. What you need to know before taking Repaglinide STADA).

Warning signs 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 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 your blood sugar levels have stabilized, continue treatment with Repaglinide STADA.

Inform others that you are diabetic and 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 severe hypoglycaemia causes you to lose consciousness or if you experience repeated episodes of hypoglycaemia, inform your doctor. Your dose or dosing schedule of Repaglinide STADA, diet, or exercise regimen may need adjustment.

If your blood sugar level is very high

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

• If you take too little Repaglinide STADA.

• If you have an infection or fever.

• If you eat more than usual.

• If you do less exercise than usual.

Warning signs develop gradually and include: frequent urination, thirst, dry skin, and dry mouth. Inform your doctor. Your dose of Repaglinide STADA, diet, or exercise may need adjustment.

Other medicines and Repaglinide STADA

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

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

Your body's response to Repaglinide STADA may change if you take other medicines, especially:

• Monoamine oxidase inhibitors (MAOIs) (used to treat depression).

• Beta-blockers (used to treat high blood pressure or heart conditions).

• ACE inhibitors (used to treat heart conditions).

• Salicylates (e.g. aspirin).

• Octreotide (used to treat cancer).

• Non-steroidal anti-inflammatory drugs (NSAIDs) (a type of painkiller).

• Steroids (anabolic steroids and corticosteroids, used for anaemia or to treat inflammation).

• Oral contraceptives (to prevent pregnancy).

• Thiazides (diuretics).

• Danazol (used to treat breast cysts and endometriosis).

• Thyroid products (used to treat low thyroid hormone levels).

• Sympathomimetics (used to treat asthma).

• Clarithromycin, trimethoprim, rifampicin (antibiotics).

• Itraconazole, ketoconazole (medicines for fungal infections).

• Gemfibrozil (used to treat high blood fat levels).

• Cyclosporine (used to suppress the immune system).

• Deferasirox (used to reduce chronic iron overload).

• Clopidogrel (prevents blood clots).

• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy).

• St. John’s wort (herbal remedy).

Use of Repaglinide STADA with food, drinks and alcohol

Take Repaglinide STADA before main meals. Alcohol may alter the ability of Repaglinide STADA to lower blood sugar. Be alert for symptoms of hypoglycaemia.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not take Repaglinide 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.

You must not take Repaglinide STADA if you are breastfeeding.

Driving and using 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 you can drive if:

• You have frequent hypoglycaemic episodes.

• You have few or no warning symptoms of hypoglycaemia.

Repaglinide STADA contains sodium

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

3. How to take Repaglinida Stada

Follow exactly the instructions for use of this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will calculate your dose.

• The recommended 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 be taken just before or within the 30 minutes prior to each main meal. The maximum recommended dose is 16 mg per day.

Do not take more Repaglinida Stada than your doctor has prescribed.

If you take more Repaglinida Stada than you should

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

If you take too many tablets, your blood sugar may become too low and cause hypoglycemia. Please read about 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

Please note 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 needed, consult your doctor first.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

Frequent (may affect up to 1 in 10 people)

• Hypoglycaemia (see the section If you have hypoglycaemia in section 2 of the leaflet). The risk of experiencing hypoglycaemia may increase if you take other medicines.
• Stomach pain.
• Diarrhoea.

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

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

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

• Allergic reaction (such as swelling, difficulty breathing, palpitations, dizziness and sweating which may be symptoms of an anaphylactic reaction). Consult your doctor immediately.
• Vomiting.
• Constipation.
• Visual disturbances.
• Serious liver problems, abnormal liver function and increased liver enzymes in the blood.

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

• Hypoglycaemic coma or loss of consciousness (very severe hypoglycaemic reactions, see the section If you have hypoglycaemia). Contact your doctor immediately.
• Hypersensitivity (such as rash, itching, redness and swelling).
• Feeling unwell (nausea).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Repaglinide Stada

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Repaglinide Stada

The active substance 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 pack

Repaglinide Stada 1 mg are white, round, biconvex tablets, 3.4 mm thick, with a raised "1" on one side.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area (EEA) member states under 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 1 mg 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

Date of latest revision of this leaflet: May 2023

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