Eupirin Cardio

Leaflet attached to the packaging: patient information

Eupirin Cardio, 75 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Eupirin Cardio and what is it used for

Eupirin Cardio 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. Eupirin Cardio is used:

• to prevent heart attacks in people at high risk,
• to prevent recurrent heart attacks,
• in acute myocardial infarction or suspected acute myocardial infarction,
• in unstable angina pectoris,
• 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 they have occurred,
• 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 immobilized for a long time.

2. Important information before taking Eupirin Cardio

When not to take Eupirin Cardio:

• 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 kidney, liver, or heart failure,
• if the patient has had asthma attacks after taking acetylsalicylic acid or other anti-inflammatory medications (symptoms: shortness of breath, wheezing),
• if the patient is in the last three months of pregnancy, doses greater than 100 mg per day should not be used (see section "Pregnancy and breastfeeding"),
• 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 Eupirin Cardio, the patient should discuss it with their doctor or pharmacist:

• if the patient is allergic to anti-inflammatory and anti-rheumatic medications (e.g., naproxen) or other allergens,
• 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,
• the medicine should not be taken for at least 5 days before a planned surgical procedure (including minor procedures, e.g., tooth extraction), especially ophthalmic and otologic procedures,
• 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, as well as 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, in 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,
• if the patient is taking metamizole, as it may reduce the effect of acetylsalicylic acid on platelet aggregation.

Children and adolescents

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

Eupirin Cardio and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

The patient should not take Eupirin Cardio at the same time as:

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

The use of Eupirin Cardio 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,
• with acetazolamide.

Using Eupirin Cardio 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 cases of severe liver and (or) kidney failure.

Using Eupirin Cardio in elderly patients

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

Using Eupirin Cardio with food, drink, and alcohol

The medicine should be taken during or after a meal.

Alcohol may increase the risk of gastrointestinal side effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

In the case of continued or initiated treatment with Eupirin Cardio during pregnancy, the medicine should always be used in accordance with the doctor's recommendations and not in higher doses than recommended.

Pregnancy - third trimester

Acetylsalicylic acid should not be taken in doses greater than 100 mg per day during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. The use of Eupirin Cardio may cause kidney and heart disorders in the unborn child. It may affect the patient's and their child's tendency to bleed and cause delayed or prolonged labor.

In the case of taking acetylsalicylic acid in lower doses (up to 100 mg per day), close obstetric monitoring is necessary in accordance with the doctor's recommendations.

Pregnancy - first and second trimester

Acetylsalicylic acid should not be used in the first six months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If acetylsalicylic acid is used by women trying to conceive or in the first and second trimester of pregnancy, the lowest possible dose should be used for the shortest possible time. The use of acetylsalicylic acid for a period longer than a few days from the 20th week of pregnancy may cause kidney disorders in the unborn child, which can lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct in the child's heart. In the case of necessary treatment for a period longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding

Acetylsalicylic acid passes into breast milk in small amounts. Before taking the medicine, the patient should consult their 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.

Driving and operating machinery

The medicine does not affect the ability to drive and operate machinery.

Eupirin Cardio contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose (2 tablets), which means the medicine is considered "sodium-free".

3. How to take Eupirin Cardio

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Eupirin Cardio is available in a dose of 75 mg. The doctor will recommend the dose of the medicine suitable for the patient and determine the duration of treatment.

The medicine should be taken orally, preferably during or after a meal, with water.

The recommended dose is: 1-2 tablets of 75 mg per day.

In acute myocardial infarction or in patients with suspected acute myocardial infarction, the initial loading dose is:

A single dose of 300 mg (4 tablets of 75 mg) of acetylsalicylic acid to quickly inhibit platelet aggregation. The tablets should be chewed very thoroughly to accelerate absorption!

Taking a higher dose of Eupirin Cardio than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist, and in case of severe poisoning, the patient should be taken 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 have also been observed, such as: hearing loss, vision disorders, headache, restlessness, drowsiness, and coma, seizures, hyperthermia (body temperature above normal values). In severe poisonings, there are disorders of acid-base and water-electrolyte balance (metabolic acidosis and dehydration).

Missing a dose of Eupirin Cardio

In case of missing a dose, the patient should take the next dose at the scheduled time. The patient should not take a double dose to make up for the missed dose.

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Eupirin Cardio can cause side effects, although not everybody gets them.

The patient should stop taking the medicine and contact their doctor immediately if they experience the first symptoms of hypersensitivity (e.g., facial swelling, lip swelling, tongue swelling, throat swelling, causing difficulty breathing or swallowing) or bleeding, e.g., gastrointestinal bleeding (symptoms: black stools), or hemorrhages. The doctor will then assess the severity of the symptoms and decide on further action.

After taking acetylsalicylic acid, the following have been reported:

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

• -symptoms of indigestion (heartburn, nausea, vomiting) and abdominal pain.

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

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

Rarely or very rarely:

• 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 rarely (less than 1 in 10,000 people):

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

The following have also 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;
• perioperative bleeding, hematomas, bleeding (from the nose, genitourinary tract, gums).

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

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their 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.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Eupirin Cardio

The medicine should be stored out of 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 pack after:

"Expiry date (EXP)". "Expiry date" means the last day of the given month. "Lot" means batch number.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Eupirin Cardio contains

• The active substance of the medicine is acetylsalicylic acid. One tablet contains 75 mg of acetylsalicylic acid.
• The other ingredients are: microcrystalline cellulose; cellulose powder; pregelatinized starch; stearic acid; hypromellose; lactose monohydrate; macrogol 3350; triacetin; methacrylic acid and ethyl acrylate copolymer type A; talc; triethyl citrate; sodium bicarbonate; colloidal anhydrous silica; sodium lauryl sulfate.

What Eupirin Cardio looks like and what the pack contains

Eupirin Cardio 75 mg enteric-coated tablets are round, biconvex tablets, white to cream-colored, with a diameter of 6 mm.

The packaging contains 15, 30, 60, 90, or 120 enteric-coated tablets in PVC/PVDC/Aluminum blisters in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Promedo Pharma Products GmbH

Anklamer Straße 28,

10115 Berlin,

Germany,

[email protected], +48 22 329 65 00

Manufacturer

Laboratorium Galenowe Olsztyn Sp. z o.o.

ul. Spółdzielcza 25 A,

11-001 Dywity

Date of last revision of the leaflet:

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Information intended for healthcare professionals only

Instructions for action in case of 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 action 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, the body temperature should be lowered by maintaining a low ambient temperature and using cool compresses.
• Any water-electrolyte disorders should be closely monitored and quickly corrected.
• To accelerate the excretion of acetylsalicylic acid by the kidneys and to treat acidosis, sodium bicarbonate should be administered intravenously. The pH of the urine should be maintained at 7.0-7.5.
• In very severe poisonings, when it is not possible to correct water-electrolyte disorders with conservative treatment, and in cases of concurrent kidney failure, hemodialysis or peritoneal dialysis should be used. Dialysis effectively removes acetylsalicylic acid from the body and facilitates the correction of water-electrolyte and acid-base disorders.
• In cases of prolonged prothrombin time, vitamin K should be administered.
• Medications that depress the central nervous system, such as barbiturates, should not be used 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, endotracheal intubation and assisted ventilation should be performed.
• In case of shock, standard anti-shock treatment should be used.