Aspirin Cardio

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Aspirin Cardio(Adiro)

100 mg, enteric-coated tablets

Acetylsalicylic acid
Aspirin Cardio and Adiro are different trade names for the same medicine.

You should carefully read the contents of the leaflet 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 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 the patient experiences any side effects, including all side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 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. 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 (clumping). This plays an essential role in preventing the formation of blood clots.
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,
• 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

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,
• if the patient is taking 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, should not take doses higher than 100 mg per day (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:

• 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 taking anticoagulant medications, e.g., coumarin derivatives, heparin,
• in patients with renal impairment 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.
Patients undergoing surgery (including minor procedures, e.g., tooth extraction) 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

You should 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; it should not be taken simultaneously with methotrexate at doses of 15 mg per week or higher; simultaneous administration of methotrexate at doses lower 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 simultaneously 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 weakens 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 clumping) 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 (clumping of blood cells and thrombus formation) if these medications are taken simultaneously. 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 with the above-mentioned medications (except for methotrexate at doses of 15 mg per week or higher, when taking Aspirin Cardio is contraindicated) only after consulting a doctor.
Systemic corticosteroids (corticosteroids/steroids taken orally or by injection), except for hydrocortisone used as replacement therapy in Addison's disease, taken simultaneously with acetylsalicylic acid: there is a risk of acetylsalicylic acid overdose after discontinuation of corticosteroid treatment, 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 administration 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
If you will continue or start treatment with Aspirin Cardio during pregnancy, as advised by your doctor, you should take Aspirin Cardio as directed by your doctor and not take a dose higher than recommended.
Pregnancy
Last trimester of pregnancy
You should not take Aspirin Cardio at doses above 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 you are taking Aspirin Cardio at low doses (up to 100 mg per day), you should be under close obstetric supervision, as directed by your doctor.
First and second trimester of pregnancy
You should not take Aspirin Cardio during the first six months of pregnancy, unless it is absolutely necessary and has been prescribed by your doctor. If you require treatment during this period or are trying to become pregnant, you 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 reduced amniotic fluid (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child'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 the medicine is considered "sodium-free".

3. How to take Aspirin Cardio

This medicine should always be taken exactly as described in this patient leaflet or as directed by 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 chewed to achieve rapid absorption;
• in the prevention of recurrent myocardial infarction: 1 enteric-coated tablet per day;
• 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): 1 enteric-coated tablet per day;

in the prevention of transient ischemic attacks (TIA) and ischemic stroke in patients with TIA: 1 enteric-coated tablet per day;

• in the prevention of first myocardial infarction in patients with multiple risk factors: 1 enteric-coated tablet per day;
• 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: 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 chewed or crushed 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 the event of taking a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist, 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

If you miss a dose of the medicine, you should take the next dose of Aspirin Cardio.
You should not take a double dose to make up for the missed dose.

Stopping treatment with Aspirin Cardio

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

4. Possible side effects

Like all medicines, this medicine 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 genital tracts,
• gastrointestinal bleeding, with corresponding laboratory and clinical symptoms,
• overdose. Uncommon side effects(occurring in 1 to 10 out of 1,000 patients):
• gastric and 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,
• renal function disorders and renal 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,
• cardio-respiratory disorders,
• perioperative bleeding,
• hemolysis or hemolytic anemia (in patients with glucose-6-phosphate dehydrogenase deficiency). 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 well as a possible decrease in platelet count. 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. If any of these symptoms occur, you should immediately seek medical attention. These reactions can occur even after the first administration of the medicine.
• Prolonged use of medications containing acetylsalicylic acid may cause headache, which worsens with subsequent doses.
• Renal papillary necrosis and interstitial nephritis have been reported.

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, you can help provide 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.
You should not take this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Store at a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. You should 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 type C, polysorbate 80, sodium lauryl sulfate, talc, triethyl citrate.

What Aspirin Cardio looks like and contents of the pack

The pack contains 30 or 60 enteric-coated tablets.
For more detailed information, you should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

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

Manufacturer:

Bayer Bitterfeld GmbH
OT Greppin Salegaster Chaussee, 1

• 06803- Bitterfeld-Wolfen Germany

Bayer HealthCare Manufacturing S.r.l.
Via delle Groane, 126
20024 Garbagnate Milanese
Italy
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Spain, the country of export: 723798.3

Parallel import authorization number: 252/22

Date of leaflet approval: 21.07.2025

[Information about the trademark]