Aspirin Cardio

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Aspirin Cardio (Adiro)

100 mg, enteric-coated tablets

Acidum actylsalicylicum
Aspirin Cardio and Adiro are different trade names for the same medicine.

C o n t e n t s

• 1. What is Aspirin Cardio and what is it used for
• 2. Important information before taking Aspirin Cardio
• 3. How to take Aspirin Cardio
• 4. Possible side effects
• 5. How to store Aspirin Cardio
• 6. Package contents 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 a significant role in preventing the formation of blood clots.
Aspirin Cardio is indicated for use in adults in the following cardiovascular diseases:

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

2. Important information before taking Aspirin Cardio

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 leaflet for the patient or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including all side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

When not to take 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, caused 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 higher than 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 Reye's syndrome - a rare but serious disease that causes liver and brain damage.

Warnings and precautions

Aspirin Cardio should be used with caution:

• during 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 taking anticoagulant medications, e.g. coumarin derivatives, heparin,
• in patients with renal or circulatory disorders,
• when taking 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 gastrointestinal bleeding in the past,
• 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 (including minor procedures, e.g. tooth extraction), patients should inform their doctor about taking Aspirin Cardio.
Acetylsalicylic acid, even in small doses, reduces uric acid excretion 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Acetylsalicylic acid enhances:

• the toxic effect of methotrexate on the bone marrow; acetylsalicylic acid should not be taken concomitantly with methotrexate at doses of 15 mg per week or higher; concomitant use of methotrexate at doses less than 15 mg per week requires special caution;
• the effect of anticoagulant medications (e.g. coumarin derivatives, heparin), thrombolytic medications (dissolving blood clots, e.g. streptokinase, urokinase) and platelet aggregation inhibitors (e.g. ticlopidine), which may increase the risk of prolonged bleeding time and bleeding;
• the risk of gastric ulcer and gastrointestinal bleeding when taken concomitantly with corticosteroids, other non-steroidal anti-inflammatory drugs, including other salicylates in high doses, or when alcohol is consumed during treatment; after discontinuation of systemic corticosteroids (except for hydrocortisone used as replacement therapy in Addison's disease), the risk of salicylate overdose increases;
• the effect of digoxin, as it increases its serum concentration;
• the effect of antidiabetic medications, e.g. 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:

• anti-gout 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).

Certain non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, may reduce the inhibitory effect of Aspirin Cardio on platelet aggregation (thrombocyte aggregation) and thrombus formation (blood clotting). 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 (platelet aggregation), if these medicines are taken concomitantly. Therefore, caution should be exercised when taking 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 taken concomitantly with the above-mentioned medicines (except for methotrexate at doses of 15 mg per week or higher, when Aspirin Cardio is contraindicated) only after consulting a doctor.
Systemic corticosteroids (corticosteroids/corticosteroids/steroids taken orally or by injection), except for hydrocortisone used as replacement therapy in Addison's disease, taken concomitantly with acetylsalicylic acid: there is a risk of acetylsalicylic acid overdose after discontinuation of corticosteroid therapy, and an increased risk of gastric ulcer and gastrointestinal bleeding due to 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.

Taking 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
If the patient will continue or start treatment with Aspirin Cardio during pregnancy, as advised by a doctor, they should take Aspirin Cardio as directed by the doctor and not take a dose higher than recommended.
Pregnancy
Last trimester of pregnancy
Aspirin Cardio should not be taken in doses higher 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 medicine may cause renal and cardiac disorders in the unborn child. It may also affect the patient's and child's tendency to bleed and cause delayed or prolonged delivery.
If the patient takes Aspirin Cardio in low doses (up to 100 mg per day), they should be under close obstetric supervision as directed by the doctor.
First and second trimester of pregnancy
Aspirin Cardio should not be taken during the first six months of pregnancy, unless it is absolutely necessary and has been prescribed by a doctor. If the patient requires treatment during this period or is trying to become pregnant, they should take 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 renal disorders in the unborn child, leading to a decrease in the amount of amniotic fluid surrounding the fetus (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is necessary for more than a few days, the 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 or use machines.

Aspirin Cardio contains sodium

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

3. How to take Aspirin Cardio

This medicine should always be taken exactly as described in this leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
The recommended dose is:

• in unstable coronary artery disease: 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 or chewed to achieve rapid absorption;
• for the prevention of recurrent myocardial infarction: 1 enteric-coated tablet per day;
• to prevent thromboembolic complications after surgical or interventional procedures on blood 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 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 immobilized 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 a 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 the event of an overdose, a doctor or pharmacist should be consulted immediately, and in the case of severe poisoning, the patient should be taken to the hospital immediately.
Treatment of poisoning involves gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be necessary.

Missing a dose of Aspirin Cardio

In the event of a missed dose, the next dose of Aspirin Cardio should be taken.
A double dose should not be taken to make up for a missed dose.

Stopping treatment with Aspirin Cardio

In case of any further doubts about taking this medicine, a doctor or pharmacist should be consulted.

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 in 100 patients):

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

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

• gastric and duodenal ulcer,
• hypersensitivity reaction, e.g. edema, urticaria, 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 in 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):
• intestinal stricture (chronic intestinal obstruction),
• anaphylactic shock,
• cardio-respiratory disorders,
• peroperative bleeding,
• hemolysis or hemolytic anemia (in patients with glucose-6-phosphate dehydrogenase deficiency (G6PD)).

Due to the effect of acetylsalicylic acid on platelet aggregation, the risk of bleeding and prolonged bleeding time increases during treatment with Aspirin Cardio, as does the risk of thrombocytopenia. 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. The above reactions can occur even after the first administration of the medicine.
• Prolonged use of medications containing acetylsalicylic acid may cause headache, which increases with each subsequent dose.
• Renal papillary necrosis and interstitial nephritis have been reported. If any side effect worsens or any side effect not listed in the leaflet occurs, a doctor or pharmacist should be consulted.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, a doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 .
By reporting side effects, more information can be collected 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 packaging.
The expiry date refers to the last day of the month.
PP/Al blisters: Store in a temperature below 25°C, in the original packaging.
PVC/Al blisters: Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Aspirin Cardio contains

• The active substance of the medicine is acetylsalicylic acid (Acidum acetylsalicylicum). One enteric-coated tablet contains 100 mg of the active substance.
• The other ingredients are: cellulose, powder, corn starch, coating:methacrylic acid copolymer (type C), polysorbate 80, sodium lauryl sulfate, talc, triethyl citrate.

What Aspirin Cardio looks like and what the package contains

The package contains 30, 50, 60, or 90 white, round enteric-coated tablets in PP/Al or PVC/Al blisters in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Spain, the country of export:

Bayer Hispania, S.L., Av. Baix Llobregat 3-5, 08970 – Sant Joan Despí – Barcelona, Spain

Manufacturer:

Bayer HealthCare Manufacturing S.r.l., Via delle Groane, 126, 20024 Garbagnate Milanese, Italy
Bayer AG, Kaiser-Wilhelm-Allee, 1, 51373 Leverkusen, Germany
Bayer Bitterfeld GmbH, OT Greppin, Salegaster Chaussee, 1, 06803 – Bitterfeld-Wolfen, Germany

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Spain, the country of export:723798.3

• 841288.4
• 841296.9 Parallel import authorization number:318/15

Date of leaflet approval: 27.05.2025

[Information about the trademark]