Repaglinide STADA 0.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Repaglinide STADA 0.5 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 you must not give it to other people, even if they have the same symptoms as you, because 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.

Contents of the leaflet:

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 adverse effects
5. How to store Repaglinide STADA
6. Contents of the pack and other information

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

Repaglinida Stada is an oral antidiabetic agent containing 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 (formerly known as non-insulin-dependent diabetes mellitus or adult-onset diabetes).

Repaglinida Stada is used to manage type 2 diabetes as an adjunct to diet and exercise. Treatment should be initiated when diet, physical activity, and weight reduction alone have not been sufficient to control (or reduce) blood sugar levels. Repaglinida Stada may also be administered in combination with metformin, another antidiabetic medication.

2. What you need to know before starting to take Repaglinide Stada

DO NOT take Repaglinide Stada:

• 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 (insulin-dependent 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).

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 to take 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 can happen 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 of section 2. What you need to know before starting to take Repaglinide Stada).

Warning signs of hypoglycaemia appear suddenly and may include: cold sweating, 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 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. Nothing should be given by mouth, 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. Your dose or dosing schedule of Repaglinide Stada, diet, or exercise may need to be adjusted.

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 to be adjusted.

Other medicines and Repaglinide Stada

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

If prescribed by your doctor, you may take Repaglinide Stada together with metformin, another diabetes medicine. However, you should not take Repaglinide Stada if you are taking gemfibrozil (used to lower blood fat levels).

Your body's response to Repaglinide Stada 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 (to treat high blood fat levels).

• Cyclosporine (to suppress the immune system).

• Deferasirox (to reduce chronic iron overload).

• Clopidogrel (to prevent blood clots).

• Phenytoin, carbamazepine, phenobarbital (for treatment of epilepsy).

• St. John’s wort (herbal remedy).

Use of Repaglinide Stada with food, drinks and alcohol

Take Repaglinide Stada before main meals. Alcohol may interfere with Repaglinide Stada’s ability to lower blood sugar. Be alert for symptoms of hypoglycaemia.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 affected if your blood sugar level is too low or too high. Be aware that you may put yourself or others at risk. Consult your doctor about whether you may drive if:

• You have frequent hypoglycaemic episodes.

• You have few or no 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 Repaglinide Stada

Always follow exactly the instructions given by your doctor or pharmacist when taking this medicine. If in doubt, please consult your doctor or pharmacist again.

Your doctor will determine 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 Repaglinide Stada than your doctor has prescribed.

If you take more Repaglinide Stada than you should

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

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

If you forget to take Repaglinide Stada

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

If you stop taking Repaglinide Stada

Please note that the desired effect will not be achieved if you stop taking Repaglinide 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 experiences 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, breathing difficulties, palpitations, dizziness and sweating which may be symptoms of an anaphylactic reaction). 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)

• 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 the 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines 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 0.5 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 0.5 mg are white, round, biconvex tablets with a thickness of 3.4 mm.

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

Only certain 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 medicinal product is authorized in the European Economic Area member states 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 the most recent review 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/