Aspirin Cardio

Leaflet accompanying the packaging: information for the user

ASPIRIN CARDIO, 100 mg, enteric-coated tablets

Acetylsalicylic acid

Table of contents of the leaflet

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

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

Acetylsalicylic acid, the active substance contained in Aspirin Cardio, when administered in small doses, long-term, inhibits platelet aggregation. This plays an important role in preventing the formation of blood clots.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Aspirin Cardio is indicated for use in adults in the following cardiovascular diseases:

• in unstable angina,
• in recent myocardial infarction or suspected recent myocardial infarction,
• to prevent a repeat myocardial infarction,
• to prevent thromboembolic complications after surgical or interventional procedures on vessels [e.g., percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass grafting (CABG), carotid endarterectomy, arteriovenous shunt],
• to prevent transient ischemic attacks (TIA) and ischemic stroke in patients with TIA,
• to prevent the first myocardial infarction in patients with multiple risk factors,
• to prevent deep vein thrombosis and pulmonary embolism in patients who are bedridden for a long time, e.g., after major surgery, as a supplement to other prophylactic methods.

2. Important information before using Aspirin Cardio

When not to use Aspirin Cardio

• if the patient is hypersensitive (allergic) to the active substance - acetylsalicylic acid, other salicylates, or any of the other ingredients of the medicine (listed in section 6),
• if the patient has a bleeding disorder,
• if the patient has acute gastric or duodenal ulcer,
• if the patient has severe renal impairment,
• if the patient has severe hepatic impairment,
• if the patient has severe heart failure,
• if the patient has had asthma attacks in the past, triggered by the administration of salicylates or substances with similar effects, especially non-steroidal anti-inflammatory drugs,
• concomitantly with methotrexate at doses of 15 mg per week or higher (see "Aspirin Cardio and other medicines"),
• if the patient is in the last three months of pregnancy, doses above 100 mg per day should not be taken (see "Pregnancy, breastfeeding, and fertility"),
• in children under 12 years of age with viral infections due to the risk of developing Reye's syndrome - a rare but serious disease that causes liver and brain damage.

Warnings and precautions

Aspirin Cardio should be used with caution:

• in the first and second trimester of pregnancy,
• during breastfeeding,
• in case of hypersensitivity to non-steroidal anti-inflammatory and anti-rheumatic drugs (e.g., ibuprofen, indomethacin) or other allergenic substances,
• when using anticoagulant medications, such as coumarin derivatives, heparin,
• in patients with renal or circulatory disorders,
• when using non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen (anti-inflammatory, antipyretic, or analgesic) (see "Aspirin Cardio and other medicines"),
• in patients with impaired liver function,
• in patients who have had gastric or duodenal ulcers or gastrointestinal bleeding,
• in patients with glucose-6-phosphate dehydrogenase deficiency.

Acetylsalicylic acid may cause bronchospasm and trigger asthma attacks or other hypersensitivity reactions. Patients with asthma, chronic respiratory diseases, hay fever, nasal polyps, and those showing allergic reactions (e.g., skin reactions, itching, hives) to other substances are particularly at risk.

Prior to surgery, patients should inform their doctor about taking Aspirin Cardio.

Acetylsalicylic acid, even in small doses, reduces the excretion of uric acid from the body.

In patients with a tendency to reduced uric acid excretion, the medicine may cause a gout attack.

Aspirin Cardio and other medicines

Please tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Acetylsalicylic acid enhances:

• the toxic effect of methotrexate on the bone marrow; acetylsalicylic acid should not be used concomitantly with methotrexate at doses of 15 mg per week or higher; concomitant use of methotrexate at doses below 15 mg per week requires special caution;
• the effect of anticoagulant medications (e.g., coumarin derivatives, heparin), thrombolytic medications (e.g., streptokinase, urokinase), and platelet aggregation inhibitors (e.g., ticlopidine), which may increase the risk of prolonged bleeding time and bleeding;

Acetylsalicylic acid may increase the risk of gastric ulcer and gastrointestinal bleeding when used concomitantly with corticosteroids, other non-steroidal anti-inflammatory drugs, or alcohol.

• the effect of digoxin, as it increases its serum concentration;
• the effect of antidiabetic medications, such as insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid, which in turn enhances the anti-aggregatory effect of acetylsalicylic acid.
• Acetylsalicylic acid reduces the effect of:
• uricosuric medications used to treat gout, which increase uric acid excretion from the body (e.g., benzbromarone, probenecid), which may worsen gout symptoms;
• diuretics;
• certain antihypertensive medications (from the group of so-called angiotensin-converting enzyme inhibitors, e.g., captopril, enalapril).

Some non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, may reduce the inhibitory effect of Aspirin Cardio on platelet aggregation and thrombus formation.

This may reduce the protective effect of Aspirin Cardio against myocardial infarction and stroke.

Metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation when these medications are used concomitantly.

Therefore, caution should be exercised when using metamizole in patients receiving acetylsalicylic acid.

Concomitant use of selective serotonin reuptake inhibitors (a group of antidepressant medications) increases the risk of gastrointestinal bleeding.

Aspirin Cardio can be used concomitantly with the above-mentioned medications (except for methotrexate at doses of 15 mg per week or higher, when the use of Aspirin Cardio is contraindicated) only after consulting a doctor.

Systemic corticosteroids (corticosteroids/steroids taken orally or by injection), with the exception of hydrocortisone used as replacement therapy in Addison's disease, used concomitantly with acetylsalicylic acid: there is a risk of acetylsalicylic acid overdose after the end of corticosteroid treatment, as well as an increased risk of gastric ulcers and gastrointestinal bleeding caused by concomitant use of Aspirin Cardio and systemic corticosteroids.

The treatment effect may be influenced by concomitant use of Aspirin Cardio with medications used in the following conditions:

• organ rejection after transplants (cyclosporine, tacrolimus);
• pain and inflammatory conditions (e.g., steroids and anti-inflammatory medications).

Alcohol may increase the risk of gastrointestinal side effects.

Using Aspirin Cardio with food and drink

Enteric-coated tablets should be taken orally, preferably at least 30 minutes before a meal, with a large amount of water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you become pregnant or are planning to become pregnant while using Aspirin Cardio, you should use Aspirin Cardio according to your doctor's recommendations and not exceed the recommended dose.

Pregnancy

Last trimester of pregnancy

Do not take Aspirin Cardio in doses above 100 mg per day during the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery.

The medicine may cause kidney and heart problems in the unborn baby.

It may also affect the patient's and the baby's tendency to bleed and cause delayed or prolonged labor.

If you are taking Aspirin Cardio in low doses (up to 100 mg per day), you should be under close obstetric supervision according to your doctor's recommendations.

First and second trimester of pregnancy

Do not use Aspirin Cardio during the first six months of pregnancy unless it is absolutely necessary and has been recommended by your doctor.

If you require treatment during this period or are trying to become pregnant, you should use the lowest possible dose for the shortest possible time.

If Aspirin Cardio is taken for more than a few days from the 20th week of pregnancy, it may cause kidney problems in the unborn baby, leading to a decrease in the amount of amniotic fluid surrounding the fetus (oligohydramnios) or narrowing of the arterial duct in the baby's heart.

If treatment is necessary for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Acetylsalicylic acid passes into breast milk in small amounts.

Driving and using machines

Aspirin Cardio does not affect the ability to drive and use machines.

Aspirin Cardio contains sodium

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

3. How to use Aspirin Cardio

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

• in unstable angina: 1 enteric-coated tablet per day;
• in recent myocardial infarction or suspected recent myocardial infarction: 2 to 3 enteric-coated tablets per day, with the tablets crushed to ensure rapid absorption;
• to prevent a repeat myocardial infarction: 1 enteric-coated tablet per day;
• to prevent thromboembolic complications after surgical or interventional procedures on vessels (e.g., percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass grafting (CABG), carotid endarterectomy, arteriovenous shunt): 1 enteric-coated tablet per day;
• to prevent transient ischemic attacks (TIA) and ischemic stroke in patients with TIA: 1 enteric-coated tablet per day;
• to prevent the first myocardial infarction in patients with multiple risk factors: 1 enteric-coated tablet per day;
• to prevent deep vein thrombosis and pulmonary embolism in patients who are bedridden for a long time, e.g., after major surgery, as a supplement to other prophylactic methods: 1 to 2 enteric-coated tablets per day.

Enteric-coated tablets should be taken orally, whole, preferably at least 30 minutes before a meal, with a large amount of water.

During treatment for myocardial infarction, the enteric-coated tablet should be crushed or chewed and swallowed.

If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Aspirin Cardio than recommended

Overdose in elderly people and small children (taking higher doses than recommended or accidental poisoning) requires special attention, as it can lead to death in these patient groups.

Symptoms of mild poisoning are: dizziness (including vertigo), tinnitus, hearing loss, excessive sweating, nausea, and vomiting, headache, disorientation.

In the case of severe poisoning, the following may occur: initially, hyperventilation, then shallow breathing and difficulty breathing, up to respiratory failure, fever, ketonuria, respiratory alkalosis, metabolic acidosis, coma, cardiogenic shock, significant decrease in blood glucose levels, presence of blood in the urine, seizures, hallucinations, ketonuria (presence of ketone bodies in the urine), proteinuria (presence of protein in the urine), hypokalemia (decreased potassium levels in the blood).

In case of overdose, you should immediately consult a doctor or pharmacist, and in case of severe poisoning, the patient should be taken to the hospital immediately.

Treatment of poisoning involves gastric lavage, administration of activated charcoal, and use of alkaline diuresis.

In severe cases of poisoning, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be necessary.

Missing a dose of Aspirin Cardio

If you miss a dose of the medicine, you should take the next dose of Aspirin Cardio.

Do not take a double dose to make up for the missed dose.

Stopping the use of Aspirin Cardio

If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

Common side effects(occurring in 1 to 10 out of 100 patients):

• indigestion (heartburn, nausea, vomiting),
• abdominal pain,
• inflammatory conditions in the stomach and intestines;
• rash,
• itching,
• nasal congestion,
• dizziness (especially in children and the elderly, usually symptoms of overdose),
• tinnitus (especially in children and the elderly, usually symptoms of overdose),
• nasal bleeding,
• bleeding from the urinary and reproductive tracts,
• gastrointestinal bleeding, with corresponding laboratory and clinical symptoms,
• overdose.

Uncommon side effects(occurring in 1 to 10 out of 1,000 patients):

• gastric or duodenal ulcer,
• hypersensitivity reaction, e.g., edema, hives, skin reactions,
• nasal congestion,
• gum bleeding,
• hematoma,
• cerebral hemorrhage (especially in patients with uncontrolled hypertension and/or concomitant use of bleeding-inhibiting medications), which can be life-threatening in individual cases,
• iron deficiency anemia,
• liver function disorders.

Rare side effects(occurring in 1 to 10 out of 10,000 patients)

• perforation of the gastrointestinal tract in gastric ulcer, with corresponding laboratory and clinical symptoms,
• hypersensitivity reaction, e.g., skin reactions
• bleeding,
• anemia (as a result of bleeding),
• transient liver function disorders with increased aminotransferase activity,
• kidney function disorders and kidney failure.

Frequency not known(side effects observed only after the product was placed on the market, for which the frequency of occurrence could not be determined):

• enteropathy with intestinal stenosis (chronic intestinal obstruction),
• anaphylactic shock,
• cardiovascular disorders,
• perisurgical bleeding,
• hemolysis or hemolytic anemia (in patients with glucose-6-phosphate dehydrogenase deficiency (G6PD)).

Due to the effect of acetylsalicylic acid on platelet aggregation during the use of Aspirin Cardio, the risk of bleeding and prolonged bleeding time increases, as well as the risk of prolonged prothrombin time; thrombocytopenia may also occur.

Severe bleeding, such as hemorrhage, can lead to acute or chronic anemia and/or iron deficiency anemia (e.g., due to occult microbleeding) with corresponding laboratory and clinical symptoms, such as asthenia (fatigue), pallor, hypoperfusion (decreased blood flow).

A symptom of a severe hypersensitivity reaction may be: facial and eyelid edema, tongue and laryngeal edema with narrowing of the airways, difficulty breathing, shortness of breath up to asthma attacks, increased heart rate, sudden decrease in blood pressure up to life-threatening shock.

In case of any of the above symptoms, immediate medical attention should be sought.

These reactions can occur even after the first administration of the medicine.

Prolonged use of medications containing acetylsalicylic acid may cause headache, which increases with subsequent doses.

There have been reports of renal papillary necrosis and interstitial nephritis.

If any of the side effects worsen or if you experience any side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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.

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 Aspirin Cardio

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton.

The expiry date refers to the last day of the month stated.

Store in a temperature below 25°C.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Contents of the pack and other information

What Aspirin Cardio contains

• The active substance of the medicine is acetylsalicylic acid (Acidum acetylsalicylicum). 1 enteric-coated tablet contains 100 mg of the active substance.
• The other ingredients are: powdered cellulose, cornstarch, methacrylic acid copolymer, polysorbate 80, sodium lauryl sulfate, talc, triethyl citrate.

What Aspirin Cardio looks like and contents of the pack

The pack contains 28, 30, 50, 56, 60, 90, or 98 enteric-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bayer Sp. z o.o.

Al. Jerozolimskie 158

02-326 Warsaw

Manufacturer

Bayer Bitterfeld GmbH

Ortsteil Greppin

Salegaster Chaussee 1

06803 Bitterfeld-Wolfen

Germany

To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:

Bayer Sp. z o.o.

Aleje Jerozolimskie 158

02-326 Warsaw

Phone/fax number: +48 22 572 35 00

Date of last revision of the leaflet: August 2024