Eubiocard

Package leaflet: Information for the patient

Eubiocard, 150 mg, enteric-coated tablets
Acetylsalicylic acid
Please read this 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 the doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If your condition does not improve or worsens, contact your doctor.

Table of contents

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

Eubiocard contains the active substance acetylsalicylic acid, which inhibits the aggregation (clumping) of blood platelets. This medicine is intended for long-term, prophylactic use in diseases associated with the risk of thrombus and embolus formation in blood vessels. Eubiocard is used:

• for the prevention of myocardial infarction in individuals at high risk,
• for the prevention of recurrent myocardial infarction,
• in acute myocardial infarction or suspected acute myocardial infarction,
• in unstable angina,
• after surgical or interventional procedures on blood vessels, e.g. coronary artery bypass grafting, coronary angioplasty,
• for the prevention of transient ischaemic attacks and ischaemic stroke, as well as after such events,
• in patients with atherosclerotic peripheral arterial disease,
• for the prevention of coronary thrombosis in patients with multiple risk factors,
• for the prevention of venous thrombosis and pulmonary embolism in patients who are immobilized for prolonged periods.

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 bleed or has blood clotting disorders (e.g. haemophilia, thrombocytopenia), or if the patient is being treated simultaneously with anticoagulant medicines (e.g. coumarin derivatives, heparin),
• if the patient has peptic ulcer disease of the stomach and/or duodenum,
• if the patient has severe renal, hepatic or cardiac insufficiency,
• if the patient has previously experienced asthma attacks after taking acetylsalicylic acid or other anti-inflammatory drugs (symptoms: shortness of breath, wheezing),
• if the patient is in the third trimester of pregnancy (last three months of pregnancy),
• if the patient is taking methotrexate (a medicine used in cancer treatment) at doses of 15 mg per week or higher,
• in children under 12 years of age with viral infections (e.g. influenza or chickenpox), due to the risk of liver and brain damage (Reye's syndrome).

Warnings and precautions
Before starting treatment with Eubiocard, consult a doctor, pharmacist, or nurse:

• if the patient is allergic to anti-inflammatory and anti-rheumatic medicines (e.g. naproxen) or other allergenic substances,
• if the patient suffers from asthma, chronic respiratory diseases, or has nasal polyps,
• if the patient has a history of peptic ulcer disease of the stomach or intestines,
• if the patient has impaired kidney and/or liver function, as there is a risk of increased adverse effects of the medicine,
• do not use Eubiocard for at least 5 days before any planned surgical procedure (including minor procedures, e.g. tooth extraction),
• if the patient is taking oral antidiabetic sulfonylurea drugs, due to the risk of enhanced hypoglycaemic effect (reduced blood glucose concentration), and if the patient is taking antihypertensive medicines,
• if the patient is taking ibuprofen simultaneously,
• in patients with juvenile rheumatoid arthritis and/or systemic lupus erythematosus and impaired liver function, as salicylate toxicity may increase; liver function should be monitored in these patients,
• if uterine bleeding or excessive menstrual bleeding occurs, especially when using an intrauterine contraceptive device, or in cases of hypertension or heart failure,
• if the patient has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder),
• during the first and second trimesters of pregnancy,
• during breastfeeding.

Children and adolescents
Eubiocard should not be used in children under 12 years of age.
Eubiocard with other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
Do not take Eubiocard simultaneously with:

• methotrexate at doses of 15 mg per week or higher.

Special caution is required when using Eubiocard, after prior consultation with a doctor, together with the following medicines:

• other non-steroidal anti-inflammatory drugs, including salicylates,
• ibuprofen,
• anticoagulant medicines (heparin, coumarin derivatives),
• medicines used in gout treatment (e.g. probenecid, benzbromarone),
• antidiabetic medicines – oral (e.g. tolbutamide, glibenclamide) and insulin,
• medicines that inhibit platelet aggregation (e.g. ticlopidine),
• medicines used in the treatment of depression and anxiety (e.g. fluoxetine, paroxetine),
• diuretics (e.g. furosemide),
• systemic glucocorticoids,
• antihypertensive medicines (e.g. enalapril, captopril),
• valproic acid (an antiepileptic medicine),
• methotrexate at doses less than 15 mg per week,
• digoxin (a cardiac medicine),
• thrombolytic medicines (e.g. streptokinase, alteplase),
• metamizole, as it may reduce the inhibitory effect of acetylsalicylic acid on platelet aggregation,
• acetazolamide.

If a dose of 75 mg is required, another medicinal product containing 75 mg of acetylsalicylic acid should be used.
Use of Eubiocard in patients with impaired liver and/or kidney function
In patients with impaired liver and/or kidney function, there is an increased risk of adverse effects; therefore, dose adjustment may be necessary depending on the severity of liver and/or kidney insufficiency.
Eubiocard is contraindicated in cases of severe liver and/or kidney insufficiency.
Use of Eubiocard in elderly patients
Particular caution and medical supervision are required in elderly patients (over 65 years of age) due to an increased risk of adverse effects in this age group.
Use of Eubiocard with food, drink and alcohol
Take Eubiocard during or after a meal.
Alcohol may increase the risk of gastrointestinal adverse effects.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Eubiocard may be used during the first 6 months of pregnancy only after consultation with a doctor.
Do not use Eubiocard during the last trimester of pregnancy, as it may cause complications in the perinatal period for both mother and newborn.
Breastfeeding
Acetylsalicylic acid passes into breast milk in small amounts. Consult a doctor before using the medicine.
Short-term use of the medicine by a breastfeeding woman does not pose a major risk to the breastfed infant. However, breastfeeding is not recommended during long-term treatment with high doses of acetylsalicylic acid.
Effect on fertility
This medicine belongs to a group of medicines that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.
Driving and operating machinery
Eubiocard has no influence on the ability to drive or operate machinery.
Eubiocard contains lactose.
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Eubiocard contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose (1 tablet), meaning the medicine is considered "sodium-free".

3. How to take Eubiocard

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

Taking more Eubiocard than recommended
If you take more Eubiocard than recommended, contact your doctor or
pharmacist immediately. In cases of severe poisoning, the patient must be taken immediately to a hospital emergency department.
Overdose in elderly individuals and young children (taking higher than recommended doses or accidental poisoning) requires special attention, as it may lead to death in these patient groups.
After an overdose of acetylsalicylic acid, symptoms may include: nausea, vomiting, rapid breathing, tinnitus.
Other symptoms observed include: hearing loss, visual disturbances, headache, motor agitation, drowsiness and coma, seizures, hyperthermia (body temperature above normal). In severe poisonings, disturbances in acid-base and water-electrolyte balance occur (metabolic acidosis and dehydration).

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 a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment should be discontinued and immediate medical advice sought if the patient develops
first signs of hypersensitivity (e.g. swelling of the face, lips, tongue, or throat causing difficulty in
breathing or swallowing) or if bleeding occurs, such as gastrointestinal bleeding (symptoms: black stools), or haemorrhage. The physician will then assess the severity of symptoms and decide on further management.

The following adverse reactions have been reported after use of acetylsalicylic acid:

Common (in 1 to 10 out of 100 people):

• Dyspeptic symptoms (heartburn, nausea, vomiting) and abdominal pain.

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

• Inflammation of the stomach and intestines, gastric and/or duodenal ulceration;
• Transient disturbances in liver function.

Uncommon or rare:

• Severe bleeding such as gastrointestinal haemorrhage (symptoms: black stools), cerebral haemorrhage (particularly in patients with uncontrolled hypertension and/or when used concomitantly with anticoagulant drugs).

Haemorrhage may lead to acute or chronic anaemia due to blood loss and/or iron deficiency anaemia (symptoms: weakness, pallor).

Rare (less than 1 in 10,000 people):

• Severe allergic reactions, including anaphylactic shock (symptoms: swelling of the face, eyelids, tongue, and larynx, marked decrease in blood pressure, and disturbances in heart rhythm and breathing);
• Impaired kidney function;
• Decreased blood glucose concentration.

In addition, the following have been reported:

• Dizziness and tinnitus (symptoms of overdose);
• Hypersensitivity reactions: rash, urticaria, angioedema, pruritus, cardiac and respiratory disorders (including asthma);
• Increased risk of bleeding, prolonged bleeding time;
• Perioperative haemorrhage, bruising, bleeding (from nose, genitourinary tract, gums).

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, the patient should inform their doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Eubiocard
Keep the medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister pack after:
"Expiry date (EXP)". The "Expiry date" refers to the last day of the stated month. "Lot" refers to the batch number.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Eubiocard contains

• The active substance is acetylsalicylic acid. Each tablet contains 150 mg of acetylsalicylic acid.
• The other ingredients are: microcrystalline cellulose; powdered cellulose; pregelatinized starch; stearic acid; hypromellose; lactose monohydrate; macrogol 3350; titanium dioxide (E 171); triacetin; methacrylic acid copolymer type C; talc; colloidal anhydrous silica; 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-coloured tablets.
The pack contains 15, 30, 60, 90 or 120 enteric-coated tablets in PVC/PVDC/Aluminium blisters within a cardboard carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorisation holder) Eubioco1 Sp. z o.o.

Information intended exclusively for medical professionals

Instructions for management of overdose:
The patient should be transported to a hospital emergency department.
There is no specific antidote.
Treatment of overdose:

• Induce vomiting or perform gastric lavage (to reduce drug absorption). This procedure is effective within 3–4 hours after drug ingestion, and in cases of poisoning with a very large dose, even up to 10 hours.
• Administer activated charcoal as an aqueous suspension (dose: 50000–100000 mg in adults, and 30000–60000 mg in children) to reduce absorption of acetylsalicylic acid.
• In case of hyperthermia, reduce body temperature by maintaining a low ambient temperature and applying cool compresses.
• Closely monitor disturbances in water-electrolyte balance and correct them promptly.
• To accelerate renal excretion of acetylsalicylic acid and in the treatment of acidosis, administer sodium bicarbonate intravenously. Urine pH should be maintained at 7.0–7.5.
• In very severe poisonings, when acid-base disturbances cannot be corrected by conservative treatment, and in cases of concomitant renal failure, hemodialysis or peritoneal dialysis should be performed. Dialysis effectively removes acetylsalicylic acid from the body and facilitates correction of acid-base and water-electrolyte imbalances.
• In cases of prolonged prothrombin time, administer vitamin K.
• Do not use drugs that depress the central nervous system, such as barbiturates, due to the risk of respiratory acidosis and coma.
• Patients with respiratory disturbances should be provided with fresh air and oxygen. If necessary, perform endotracheal intubation and apply assisted ventilation.
• In case of shock, apply standard anti-shock measures.