Package leaflet: Information for the patient

Eupirin Cardio, 75 mg, enteric-coated tablets
Acidum acetylsalicylicum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor, pharmacist or nurse.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
If you do not get better or if you feel worse, contact your doctor.

Contents of the leaflet

What Eupirin Cardio is and what it is used for
Important information before taking Eupirin Cardio
How to take Eupirin Cardio
Possible side effects
How to store Eupirin Cardio
Contents of the package and other information

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

Eupirin Cardio contains the active substance acetylsalicylic acid, which inhibits the aggregation (clumping) of blood platelets. The medicine is intended for long-term, prophylactic use in diseases associated with an increased risk of thrombus formation and embolism in blood vessels. Eupirin Cardio 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 pectoris,
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 symptomatic 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 immobilised for prolonged periods.

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 or 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 a peptic ulcer 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 last three months of pregnancy, use of doses higher than 100 mg per day is not allowed (see section "Pregnancy and breastfeeding"),
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 to take Eupirin Cardio, discuss this with your doctor or pharmacist:

if the patient is allergic to anti-inflammatory and anti-rheumatic drugs (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 ulcers 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 Eupirin Cardio for at least 5 days before any planned surgical procedure (including minor procedures, e.g. tooth extraction), especially ophthalmological or otological surgeries,
if the patient is taking oral antidiabetic sulfonylurea drugs, due to the risk of enhanced hypoglycaemic effect (reduced blood glucose concentration), or if the patient is taking analgesics,
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,
in cases of uterine bleeding, excessive menstrual bleeding, during use of an intrauterine contraceptive device, in arterial 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,
if the patient is taking metamizole simultaneously, as it may reduce the platelet aggregation-inhibiting effect of acetylsalicylic acid.

Children and adolescents
Eupirin Cardio must not be used in children under 12 years of age.
Eupirin Cardio and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take Eupirin Cardio simultaneously with:

methotrexate at doses of 15 mg per week or higher.

Special caution is required when taking Eupirin Cardio together with the following medicines, after prior consultation with a doctor:

other non-steroidal anti-inflammatory drugs, including salicylates,
ibuprofen,
anticoagulant medicines (heparin, coumarin derivatives),
medicines used in gout (e.g. probenecid, benzbromarone),
oral antidiabetic medicines (e.g. tolbutamide, glibenclamide) and insulin,
medicines that inhibit platelet aggregation (e.g. ticlopidine),
medicines used to treat 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 lower than 15 mg per week,
digoxin (a cardiac medicine),
thrombolytic medicines (e.g. streptokinase and alteplase),
metamizole,
acetazolamide.

Use of Eupirin Cardio in patients with impaired liver and/or kidney function
In patients with impaired liver and/or kidney function, there is a risk of increased adverse effects of the medicine; therefore, dose adjustment may be necessary depending on the severity of hepatic and/or renal insufficiency.
The medicine is contraindicated in cases of severe liver and/or kidney insufficiency.
Use of Eupirin Cardio in elderly patients
Particular caution should be exercised in elderly patients (over 65 years of age), under medical supervision, due to the increased risk of adverse effects in this age group.
Use of Eupirin Cardio with food, drink, and alcohol
The medicine should be taken during or after a meal.
Alcohol may increase the risk of gastrointestinal adverse effects.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
If treatment with Eupirin Cardio is continued or initiated during pregnancy, the medicine should always be used according to the doctor's recommendations, and doses higher than recommended should not be used.
Pregnancy – third trimester
Acetylsalicylic acid should not be taken in doses exceeding 100 mg per day during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of Eupirin Cardio may cause kidney and heart problems in the unborn child. It may affect bleeding tendency in both the mother and the child and may delay or prolong labour.
If acetylsalicylic acid is taken in lower doses (up to 100 mg per day inclusive), close obstetric monitoring is required as recommended by the doctor.
Pregnancy – first and second trimesters
Acetylsalicylic acid should not be used during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If acetylsalicylic acid is used by women attempting to conceive or during the first and second trimesters of pregnancy, the lowest possible dose should be used for the shortest possible duration. Use of acetylsalicylic acid for longer than a few days beyond the 20th week of pregnancy may cause kidney problems in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of the ductus arteriosus in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Acetylsalicylic acid passes into breast milk in small amounts. Consult your 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 use of high doses of acetylsalicylic acid.
Driving and operating machinery
The medicine has no effect on the ability to drive or operate machinery.
Eupirin Cardio contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium in the recommended dose (2 tablets), meaning 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 your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Eupirin Cardio is available in a dosage of 75 mg. Your doctor will recommend the appropriate dose for you 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 achieve rapid inhibition of platelet aggregation. The tablets should be thoroughly chewed to accelerate absorption!

Taking more Eupirin Cardio than recommended
If you take more than the recommended dose, contact your doctor or pharmacist immediately. In case 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 such as nausea, vomiting, hyperventilation, and tinnitus may occur.
Other observed symptoms include: hearing loss, visual disturbances, headache, motor agitation, drowsiness and coma, seizures, and hyperthermia (body temperature above normal). In severe poisoning, disturbances in acid-base balance and water-electrolyte metabolism occur (metabolic acidosis and dehydration).

Missing a dose of Eupirin Cardio
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 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 must be discontinued and immediate contact with a doctor is required if the patient
experiences first signs of hypersensitivity (e.g. swelling of the face, lips, tongue, throat, causing
difficulty in breathing or swallowing) or if bleeding occurs, e.g. gastrointestinal bleeding (symptoms: black stools), or haemorrhage. The doctor will then assess the severity of
the symptoms and decide on further management.
Adverse reactions reported with acetylsalicylic acid include:
Common (in 1 to 10 out of 100 people):

gastrointestinal discomfort (dyspepsia, nausea, vomiting) and abdominal pain.

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

inflammation of the stomach and intestines, peptic ulcer of the stomach and/or duodenum;
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).
Very rare (less than 1 in 10,000 people):

severe allergic reactions, including anaphylactic shock (symptoms: swelling of the face, eyelids, tongue and larynx, marked drop in blood pressure, and disturbances in heart rhythm and breathing);
impaired kidney function;
decreased blood glucose concentration.

Additionally 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, urinary or genital tract, gums).

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions 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 Warszawa
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Eupirin Cardio

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 after:
"Expiry date (EXP)". The "Expiry date" refers to the last day of the stated month. "Lot"
indicates the batch number.
Medicines must 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 Eupirin Cardio contains

The active substance is acetylsalicylic acid. Each tablet contains 75 mg of acetylsalicylic acid.
The other ingredients are: microcrystalline cellulose; powdered cellulose; pregelatinized starch; stearic acid; hypromellose; lactose monohydrate; macrogol 3350; methacrylic acid and ethyl acrylate copolymer type A; talc; triethyl citrate; sodium hydrogen carbonate; colloidal anhydrous silica; sodium lauryl sulfate.

What Eupirin Cardio looks like and contents of the pack
Eupirin Cardio 75 mg enteric-coated tablets are round, biconvex tablets,
white to cream in colour, 6 mm in diameter.
The pack contains 15, 30, 60, 90 or 120 enteric-coated tablets in PVC/PVDC/Aluminium blisters
in a cardboard carton. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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.
Spółdzielcza 25 A,
11-001 Dywity

Information intended exclusively for healthcare professionals

Instructions for management of overdose:
The patient should be transferred 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 of 50,000–100,000 mg in adults and 30,000–60,000 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 and electrolyte balance and promptly correct them.
To accelerate renal excretion of acetylsalicylic acid and treat acidosis, administer intravenous sodium bicarbonate. Maintain urine pH between 7.0 and 7.5.
In very severe poisonings, when acid-base disturbances cannot be corrected by conservative treatment, or 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 with central nervous system depressant effects, 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.