Eubiocard

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Eubiocard, 150 mg, enteric-coated tablets

Acetylsalicylic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If you do not improve or feel worse, contact your doctor.

Table of contents of the leaflet

• 1. What is Eubiocard and what is it used for
• 2. Important information before taking Eubiocard
• 3. How to take Eubiocard
• 4. Possible side effects
• 5. How to store Eubiocard
• 6. Contents of the pack and other information

1. What is Eubiocard and what is it used for.

Eubiocard contains the active substance acetylsalicylic acid, which inhibits platelet aggregation. The medicine is intended for long-term, preventive use in diseases that threaten the formation of blood clots and emboli in blood vessels. Eubiocard is used:

• to prevent heart attacks in people at high risk,
• to prevent repeated heart attacks,
• in acute myocardial infarction or suspected acute myocardial infarction,
• in unstable angina,
• after surgical or interventional procedures on blood vessels, such as coronary artery bypass grafting or coronary angioplasty,
• to prevent transient ischemic attacks and ischemic strokes, as well as after their occurrence,
• in patients with peripheral arterial disease,
• to prevent coronary thrombosis in patients with multiple risk factors,
• to prevent venous thrombosis and pulmonary embolism in patients who are bedridden for a long time.

2. Important information before taking Eubiocard.

When not to take Eubiocard:

• if the patient is allergic to acetylsalicylic acid, other salicylates, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has an increased tendency to bleeding and coagulation disorders (e.g., hemophilia, thrombocytopenia) and is being treated with anticoagulant medications (e.g., coumarin derivatives, heparin),
• if the patient has gastric or duodenal ulcer disease,
• if the patient has severe renal, hepatic, or cardiac failure,
• if the patient has experienced asthma attacks after taking acetylsalicylic acid or other anti-inflammatory medications (symptoms: shortness of breath, wheezing),
• if the patient is in the third trimester of pregnancy (the last three months of pregnancy),
• if the patient is taking methotrexate (a medication used to treat cancer) in doses of 15 mg per week or higher,
• in children under 12 years of age with viral infections (e.g., flu or chickenpox), due to the risk of liver and brain damage (Reye's syndrome).

Warnings and precautions

Before starting to take Eubiocard, discuss it with your doctor, pharmacist, or nurse:

• if the patient is allergic to anti-inflammatory and anti-rheumatic medications (e.g., naproxen) or other allergenic substances,
• if the patient has asthma, chronic respiratory diseases, or nasal polyps,
• if the patient has had gastric or intestinal ulcer disease,
• if the patient has kidney or liver function disorders, as there is a risk of increased side effects of the medicine,
• do not take Eubiocard for at least 5 days before a planned surgical procedure (including minor procedures, e.g., tooth extraction),
• if the patient is taking oral anti-diabetic medications from the sulfonylurea group, due to the risk of increased hypoglycemic effect (reducing blood glucose levels), and if the patient is taking anti-hypertensive medications,
• if the patient is taking ibuprofen,
• in patients with juvenile rheumatoid arthritis and (or) systemic lupus erythematosus, and with impaired liver function, as the toxicity of salicylates increases; in these patients, liver function should be monitored,
• if there are menstrual bleeding disorders, excessive menstrual bleeding, during the use of an intrauterine contraceptive device, with hypertension, heart failure,
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (a rare hereditary disease),
• in the first and second trimester of pregnancy,
• during breastfeeding.

Children and adolescents

Eubiocard should not be used in children under 12 years of age.

Eubiocard and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. Do not take Eubiocard at the same time as:

• methotrexate in doses of 15 mg per week or higher,

Taking Eubiocard after prior consultation with a doctor with the medications listed below requires special caution:

• with other non-steroidal anti-inflammatory medications, including salicylates,
• with ibuprofen,
• with anticoagulant medications (heparin, coumarin derivatives).
• with medications used to treat gout (e.g., probenecid, benzbromarone),
• with oral anti-diabetic medications (e.g., tolbutamide, glibenclamide) and insulin,
• with medications that inhibit platelet aggregation (e.g., ticlopidine),
• with medications used to treat depression and anxiety (e.g., fluoxetine, paroxetine),
• with diuretics (e.g., furosemide),
• with systemic glucocorticosteroids,
• with anti-hypertensive medications (e.g., enalapril, captopril),
• with valproic acid (an anti-epileptic medication),
• with methotrexate in doses less than 15 mg per week,
• with digoxin (a heart medication),
• with thrombolytic medications (e.g., streptokinase and alteplase),
• with metamizole, as it may reduce the effect of acetylsalicylic acid on platelet aggregation,
• with acetazolamide.

In case of need to use a dose of 75 mg, you should take a different medicinal product containing 75 mg of acetylsalicylic acid.

Using Eubiocard in patients with liver and (or) kidney function disorders

In patients with liver and (or) kidney function disorders, there is a risk of increased side effects of the medicine, so it may be necessary to adjust the dose depending on the severity of liver and (or) kidney failure. The medicine is contraindicated in case of severe liver and (or) kidney failure.

Using Eubiocard in elderly patients

In elderly patients (over 65 years), Eubiocard should be used with special caution, under the supervision of a doctor, due to the increased risk of side effects in this age group.

Using Eubiocard with food, drink, and alcohol

The medicine should be taken during or after a meal. Alcohol may increase the risk of side effects related to the gastrointestinal tract.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Pregnancy Eubiocard can be used in the first 6 months of pregnancy only after consulting a doctor. Do not take Eubiocard in the last trimester of pregnancy, as it may cause complications during the perinatal period, both in the mother and the newborn. Breastfeeding Acetylsalicylic acid passes into breast milk in small amounts. Before taking the medicine, consult your doctor. Short-term use of the medicine by a breastfeeding woman does not pose a significant risk to the breastfed child. However, it is not recommended to breastfeed during long-term use of high doses of acetylsalicylic acid. Fertility This medicine belongs to a group of medicines that may adversely affect fertility in women. This effect is temporary and disappears after the end of treatment.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

Eubiocard contains lactose.

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Eubiocard contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose (1 tablet), which means the medicine is considered "sodium-free".

3. How to take Eubiocard

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse. Eubiocard is available in a dose of 150 mg. Your doctor will prescribe the dose of the medicine suitable for you and determine the duration of treatment. The medicine should be taken orally, preferably during or after a meal, with a glass of water. The recommended dose is: 1 tablet of 150 mg per day. In acute myocardial infarction or in patients with suspected acute myocardial infarction, the initial loading dose is: 300 mg (2 tablets of 150 mg) of acetylsalicylic acid to achieve rapid inhibition of platelet aggregation. The tablets should be chewed very thoroughly to accelerate absorption!

Taking a higher dose of Eubiocard than recommended

If you have taken a higher dose of the medicine than recommended, consult your doctor or pharmacist immediately, and in case of severe poisoning, take the patient to the hospital emergency department immediately. Overdose in elderly patients and young children (taking higher doses than recommended or accidental poisoning) requires special attention, as it can lead to death in these patient groups. After an overdose of acetylsalicylic acid, the following symptoms may occur: nausea, vomiting, rapid breathing, tinnitus. Other symptoms, such as hearing loss, vision disturbances, headaches, motor agitation, drowsiness, and coma, seizures, hyperthermia (body temperature above normal values), have also been observed. In severe poisonings, metabolic acidosis and water-electrolyte disturbances (metabolic acidosis and dehydration) occur.

Missing a dose of Eubiocard

If you miss a dose, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Eubiocard can cause side effects, although not everybody gets them. Stop taking the medicine and contact your doctor immediately if you experience the first symptoms of hypersensitivity (e.g., facial swelling, lip swelling, tongue swelling, throat swelling, causing difficulty breathing or swallowing) or if you experience bleeding, e.g., gastrointestinal bleeding (symptoms: black stools), or hemorrhages. The doctor will assess the severity of the symptoms and decide on further action. After taking acetylsalicylic acid, the following side effects have been reported: Common (in 1 to 10 out of 100 people):

• -gastrointestinal disorders (heartburn, nausea, vomiting) and abdominal pain.

Uncommon (in 1 to 10 out of 10,000 people):

• inflammatory conditions of the stomach and intestines, gastric ulcer disease, and (or) duodenal ulcer disease;
• transient liver function disorders.

Rare or very rare:

• severe bleeding, such as gastrointestinal bleeding (symptoms: black stools), cerebral hemorrhage (especially in patients with uncontrolled hypertension and (or) during concomitant administration of medications that inhibit bleeding).

Bleeding can lead to acute or chronic anemia due to blood loss and (or) iron deficiency anemia (symptoms: weakness, pallor). Very rare (less than 1 in 10,000 people):

• severe allergic reactions, including anaphylactic shock (symptoms: facial swelling, eyelid swelling, tongue swelling, throat swelling, significant decrease in blood pressure, and disturbances in heart rhythm and breathing);
• kidney function disorders;
• decreased blood glucose levels.

Additionally, the following side effects have been reported:

• dizziness and tinnitus (symptoms of overdose);
• hypersensitivity reactions: rash, urticaria, edema, itching, heart and respiratory disorders (including asthma);
• increased risk of bleeding, prolonged bleeding time;
• peroperative bleeding, hematomas, bleeding (from the nose, from the genitourinary tract, from the gums). If any of the side effects get worse or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eubiocard

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the carton and blister after: "Expiry date (EXP)". "Expiry date" means the last day of the month stated. "Lot" means the batch number. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Eubiocard contains

• The active substance of the medicine is acetylsalicylic acid. One tablet contains 150 mg of acetylsalicylic acid.
• The other ingredients are: microcrystalline cellulose; cellulose powder; starch glycolate; stearic acid; hypromellose; lactose monohydrate; macrogol 3350; titanium dioxide (E 171); triacetin; methacrylic acid copolymer type C; talc; silica colloidal anhydrous; sodium bicarbonate; sodium lauryl sulfate.

What Eubiocard looks like and contents of the pack

Eubiocard 150 mg enteric-coated tablets are round, white to cream-colored tablets. The pack contains 15, 30, 60, 90, or 120 enteric-coated tablets in PVC/PVDC/Aluminum blisters in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Eubioco1 Sp. z o.o. ul. Franciszka Klimczaka 1 02-797 Warsaw tel. +48 89 648 00 78

Manufacturer

Laboratorium Galenowe Olsztyn Sp. z o.o. ul. Spółdzielcza 25 A 11-001 Dywity (logo of the marketing authorization holder)Eubioco1 Sp. z o.o. Date of last revision of the leaflet:May 2023
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Information intended for healthcare professionals only

Instructions for overdose:

The patient should be taken to the hospital emergency department. There is no specific antidote. Treatment of overdose:

• Induce vomiting or perform gastric lavage (to reduce absorption of the medicine). Such treatment is effective within 3-4 hours after taking the medicine, and in case of poisoning with a very large dose of the medicinal product, even up to 10 hours.
• Administer activated charcoal in the form of a water suspension (in a dose of 50,000-100,000 mg in adults and 30,000-60,000 mg in children) to reduce the absorption of acetylsalicylic acid.
• In case of hyperthermia, reduce the body temperature by maintaining a low environmental temperature and applying cool compresses.
• Closely monitor water-electrolyte disturbances and correct them quickly.
• To accelerate the excretion of acetylsalicylic acid by the kidneys and to treat acidosis, administer sodium bicarbonate intravenously. Maintain a urine pH of 7.0-7.5.
• In very severe poisonings, when it is not possible to correct water-electrolyte disturbances with conservative treatment, and in cases of concurrent kidney failure, use hemodialysis or peritoneal dialysis. Dialysis effectively removes acetylsalicylic acid from the body and facilitates the correction of water-electrolyte and acid-base disturbances.
• In cases of prolonged prothrombin time, administer vitamin K.
• Do not use medications that act inhibitingly on the central nervous system, such as barbiturates, due to the risk of respiratory acidosis and coma.
• Patients with respiratory disorders should be provided with fresh air, and oxygen should be administered. If necessary, perform endotracheal intubation and use assisted ventilation.
• In case of shock, use standard anti-shock treatment.