Aspirin Cardio

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! The leaflet should be kept. Information on the immediate packaging 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.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including all side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 packaging and other information

1. WHAT IS ASPIRIN CARDIO AND WHAT IS IT USED FOR

Acetylsalicylic acid, the active substance 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 angina pectoris,
• 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 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, induced 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"),
• in the third trimester of pregnancy,
• 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 patients with hypersensitivity to non-steroidal anti-inflammatory drugs and anti-rheumatic drugs (e.g., ibuprofen, indomethacin) or other allergenic substances,
• when taking anticoagulant medications, such as coumarin derivatives, heparin,
• in patients with impaired renal function 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 peptic ulcer disease or gastrointestinal bleeding in the past,
• in patients with glucose-6-phosphate dehydrogenase deficiency.

Acetylsalicylic acid may cause bronchospasm and induce 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 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 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 taken at the same time as 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 bleeding and prolonged bleeding time;

the risk of developing peptic ulcer disease 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 (thrombocytes) and thrombus formation, thereby reducing 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 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 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), 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 treatment and an increased risk of developing peptic ulcers 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

Tablets should be taken orally, preferably at least 30 minutes before a meal, with a large amount of water.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Aspirin Cardio is contraindicated in the third trimester of pregnancy, as it may cause complications during the perinatal period, both in the mother and the newborn.
In the first and second trimester of pregnancy, Aspirin Cardio should be used only when absolutely necessary. Women planning a pregnancy or who are in the first or second trimester of pregnancy should use Aspirin Cardio in the lowest possible dose and for the shortest possible time.
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 patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
The recommended dose is:

• in unstable angina pectoris: 1 tablet once a day;
• in recent myocardial infarction or suspected recent myocardial infarction: 2 to 3 tablets once a day, with the tablets chewed to ensure rapid absorption;
• in the prevention of recurrent myocardial infarction: 1 tablet once a day;
• in the prevention of 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 tablet once a day;
• in the prevention of transient ischemic attacks (TIA) and ischemic stroke in patients with TIA: 1 tablet once a day;
• in the prevention of first myocardial infarction in patients with multiple risk factors: 1 tablet once a 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 tablets once a day.

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

Stopping treatment with Aspirin Cardio

In case of any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Gastrointestinal disorders, such as symptoms of dyspepsia (heartburn, nausea, vomiting), abdominal pain, rarely inflammatory conditions in the stomach and intestines; gastric and duodenal ulcer disease, very rarely leading to bleeding and perforation with corresponding laboratory and clinical symptoms. In rare cases, transient liver function disorders with increased aminotransferase activity have been reported.
Hypersensitivity reactions, e.g., in the form of skin reactions, hives, rash, itching, cardiovascular and respiratory disorders, asthma attacks, swelling, rhinitis, nasal congestion.
Dizziness and tinnitus, especially in children and the elderly, are usually symptoms of overdose.
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 the risk of thrombocytopenia. Bleeding such as postoperative bleeding, hematomas, nosebleeds, bleeding from the urinary and reproductive tracts has been observed. Rarely or very rarely, serious bleeding such as gastrointestinal bleeding, cerebral hemorrhage (especially in patients with uncontrolled hypertension and/or concomitant use of bleeding-inhibiting medications), which in individual cases may be life-threatening, have been reported.
Bleeding may 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 may occur even after the first administration of the medicine.
• Prolonged use of medications containing acetylsalicylic acid may cause headache, which worsens with subsequent doses.
• Severe kidney function disorders and kidney failure, renal papillary necrosis, interstitial nephritis have been reported.
• In patients with glucose-6-phosphate dehydrogenase deficiency, hemolysis or hemolytic anemia has been reported.
• Enteropathy with intestinal stricture (chronic intestinal obstruction).

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

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 this 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. 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 PACKAGING 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, cornstarch, methacrylic acid copolymer (type C), polysorbate 80, sodium lauryl sulfate, talc, triethyl citrate.

What Aspirin Cardio looks like and contents of the packaging

The packaging contains 30 or 60 enteric-coated tablets.
For more detailed information, you should contact the marketing authorization holder or the 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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spanish export authorization number: 841288.4

• 723798.3

Parallel import authorization number: 12/16

Date of leaflet approval:23.06.2022
[Information about the trademark]