Aspirin cardio

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet; information on the immediate packaging is in a foreign language!
Aspirin Cardio (Adiro)
100 mg, enteric-coated tablets
Acidum acetylsalicylicum
Aspirin Cardio and Adiro are different trade names for the same medicine.
Please read this leaflet carefully before taking 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 a doctor or pharmacist.

• 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

Acetylsalicylic acid, the active substance in Aspirin Cardio, when administered in low doses over a long period, inhibits platelet aggregation (clumping). Thus, it plays an important role in preventing blood clots.
Aspirin Cardio is indicated for use in adults for the following cardiovascular conditions:

• unstable angina pectoris,
• acute myocardial infarction or suspected acute myocardial infarction,
• prevention of recurrent myocardial infarction,
• prevention of thromboembolic complications following surgical or interventional procedures on blood vessels [e.g. percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass grafting (CABG), carotid endarterectomy, arterial-venous shunt (fistula)],
• prevention of transient ischaemic attacks (TIA) and ischaemic stroke in patients with TIA,
• prevention of first myocardial infarction in patients with multiple risk factors,
• prevention of deep vein thrombosis and pulmonary embolism in patients who are immobilised for prolonged periods, e.g. after major surgical procedures, as an adjunct to other prophylactic methods.

2. Important information before using Aspirin Cardio

When not to use Aspirin Cardio

• if the patient is allergic (hypersensitive) 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 tendency,
• if the patient has acute peptic ulcer of the stomach and/or duodenum,
• if the patient has severe renal insufficiency,
• if the patient has severe hepatic insufficiency,
• if the patient has severe heart failure,
• if the patient previously experienced asthma attacks induced by salicylates or substances with similar effects, particularly non-steroidal anti-inflammatory drugs (NSAIDs),
• concurrently 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 during viral infections due to the risk of Reye's syndrome – a rare but serious condition causing liver and brain damage.

Warnings and precautions
Aspirin Cardio should be used with caution:

• during the first and second trimesters 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 used concomitantly with anticoagulant drugs, e.g. coumarin derivatives, heparin,
• in patients with impaired kidney function or circulatory disorders,
• when used concomitantly with non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen (anti-inflammatory, antipyretic or analgesic medicines) (see "Aspirin Cardio and other medicines"),
• in patients with impaired liver function,
• in patients who previously had peptic ulcer disease 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 particularly at risk include those with bronchial asthma, chronic respiratory diseases, hay fever, nasal polyps, or those who have allergic reactions (e.g. skin reactions, itching, urticaria) to other substances.
Patients scheduled for surgical procedures (including minor procedures such as tooth extraction) should inform their doctor about taking Aspirin Cardio.
Acetylsalicylic acid, even in low doses, reduces the excretion of uric acid from the body. In patients predisposed to reduced uric acid excretion, the medicine may trigger an attack of gout.

Aspirin Cardio and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines you plan to take.
Acetylsalicylic acid enhances:

• the toxic effect of methotrexate on bone marrow; acetylsalicylic acid should not be used concurrently with methotrexate at doses of 15 mg per week or higher; concurrent use of methotrexate at doses lower than 15 mg per week requires special caution.
• the effect of anticoagulant drugs (e.g. coumarin derivatives, heparin), thrombolytic drugs (fibrinolytics, e.g. streptokinase, urokinase), and antiplatelet agents (e.g. ticlopidine), which may increase the risk of prolonged bleeding time and hemorrhage.
• the risk of peptic ulcer disease and gastrointestinal bleeding when used concomitantly with corticosteroids, other non-steroidal anti-inflammatory drugs (including other salicylates at high doses), or when alcohol is consumed during treatment; after discontinuation of systemic glucocorticoids (except hydrocortisone used as replacement therapy in Addison's disease), the risk of salicylate overdose increases;
• the effect of digoxin by increasing its plasma concentration;
• the effect of antidiabetic drugs, e.g. insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid, which in turn enhances the antiplatelet effect of acetylsalicylic acid.

Acetylsalicylic acid reduces the effectiveness of:

• antigout medicines that increase uric acid excretion (e.g. benzbromarone, probenecid), which may exacerbate symptoms of gout;
• diuretic medicines;
• certain antihypertensive medicines (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. Consequently, they may diminish the protective effect of Aspirin Cardio against heart attack and stroke.
Metamizole (a substance with analgesic and antipyretic properties) may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and clot formation) when both medicines are used simultaneously. Therefore, caution is advised when using metamizole in patients receiving acetylsalicylic acid.
Concomitant use of selective serotonin reuptake inhibitors (SSRIs, a group of antidepressants) increases the risk of upper gastrointestinal bleeding.
Aspirin Cardio may be used concomitantly with the above-mentioned medicines (except methotrexate at doses of 15 mg per week or higher, when use of Aspirin Cardio is contraindicated) only after consultation with a doctor.
Systemic glucocorticoids (corticosteroids/steroids taken orally or by injection), except hydrocortisone used as replacement therapy in Addison's disease, used concomitantly with acetylsalicylic acid: there is a risk of acetylsalicylic acid overdose after discontinuation of glucocorticoid therapy, and an increased risk of peptic ulcers and gastrointestinal bleeding due to concomitant use of Aspirin Cardio and systemic glucocorticoids.
The effect of treatment may be influenced by concomitant use of Aspirin Cardio with medicines used in the following conditions:

• organ transplant rejection (cyclosporine, tacrolimus);
• pain and inflammatory conditions (e.g. steroids and anti-inflammatory drugs).

Alcohol may increase the risk of gastrointestinal adverse effects.

Taking Aspirin Cardio with food and drink
Enteric-coated tablets should be taken orally, preferably at least 30 minutes before meals, with a large amount of water.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
If the patient continues or starts treatment with Aspirin Cardio during pregnancy, as advised by a doctor, she should use Aspirin Cardio according to the doctor's instructions and should not exceed the recommended dose.

Pregnancy
Third trimester
Aspirin Cardio 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. The medicine may cause kidney and heart function disorders in the unborn child. It may also affect the bleeding tendency in both mother and child and may delay or prolong labor.
If the patient takes Aspirin Cardio in low doses (up to 100 mg per day inclusive), she should be under strict obstetric supervision as recommended by the doctor.

First and second trimesters
Aspirin Cardio should not be used during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If the patient requires treatment during this period or is trying to become pregnant, she should use the lowest possible dose for the shortest possible duration. If Aspirin Cardio is taken for longer than a few days beyond the 20th week of pregnancy, it may cause kidney function disorders in the unborn child, leading to reduced amniotic fluid volume (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If prolonged treatment is necessary, the doctor may recommend additional monitoring.

Breastfeeding
Acetylsalicylic acid passes into breast milk in small amounts.

Driving and operating machinery
Aspirin Cardio does not affect the ability to drive or operate machinery.

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

3. How to use Aspirin Cardio

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor.
If in doubt, consult a doctor or pharmacist.
The recommended dose is:

• in unstable angina: 1 enteric-coated tablet once daily;
• in acute myocardial infarction or suspected acute myocardial infarction: 2 to 3 enteric-coated tablets once daily, which should be chewed to ensure rapid absorption;
• for prevention of recurrent myocardial infarction: 1 enteric-coated tablet once daily;
• for prevention of thromboembolic complications following surgical or interventional procedures on blood vessels (e.g. percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), carotid endarterectomy, arterial-venous bypass ("shunt")): 1 enteric-coated tablet once daily;
• for prevention of transient ischaemic attacks (TIA) and ischaemic stroke in patients with TIA: 1 enteric-coated tablet once daily;
• for prevention of first myocardial infarction in patients with multiple risk factors: 1 enteric-coated tablet once daily;
• for prevention of deep vein thrombosis and pulmonary embolism in patients with prolonged immobilisation, e.g. after major surgical procedures, as an adjunct to other prophylactic methods: 1 to 2 enteric-coated tablets once daily.

Enteric-coated tablets should be taken orally, whole, preferably at least 30 minutes before a meal, with a large amount of water. During treatment of myocardial infarction, the enteric-coated tablet should be crushed or chewed and swallowed.

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

Taking more Aspirin Cardio than recommended

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

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

In severe poisoning, symptoms may include: initially hyperventilation, followed by shallow breathing and breathing difficulties progressing to respiratory failure, fever, ketoacidosis, respiratory alkalosis, metabolic acidosis, coma, cardiogenic shock, marked decrease in blood glucose levels, presence of blood in urine, seizures, hallucinations, ketonuria (presence of ketone bodies in urine), proteinuria (presence of protein in urine), hypokalaemia (decreased potassium levels in blood).

If a dose higher than recommended has been taken, seek immediate advice from a doctor or pharmacist. In cases of severe poisoning, the patient must be taken immediately to hospital.

Treatment of poisoning involves gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis or haemodialysis may be necessary.

Missed dose of Aspirin Cardio

If a dose is missed, take the next dose as scheduled.
Do not take a double dose to make up for a missed dose.

Stopping Aspirin Cardio

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.

Common adverse reactions (occur in 1 to 10 out of 100 patients):

• Dyspepsia (heartburn, nausea, vomiting),
• Abdominal pain,
• Inflammation of the stomach and intestines,
• Rash,
• Itching,
• Nasal mucositis,
• Dizziness (particularly in children and elderly patients; usually symptoms of overdose),
• Tinnitus (particularly in children and elderly patients; usually symptoms of overdose),
• Nosebleeds,
• Bleeding from the urinary and genital tract,
• Gastrointestinal bleeding, with corresponding laboratory and clinical symptoms,
• Overdose.

Uncommon adverse reactions (occur in 1 to 10 out of 1,000 patients):

• Gastric and/or duodenal ulcer disease,
• Hypersensitivity reactions, e.g. swelling, urticaria, skin reactions,
• Nasal mucosal congestion,
• Gum bleeding,
• Haematoma,
• Intracranial haemorrhage (particularly in patients with uncontrolled arterial hypertension and/or when administered concomitantly with drugs that inhibit blood clotting), which in isolated cases may potentially be life-threatening,
• Iron deficiency anaemia,
• Liver function disorders.

Rare adverse reactions (occur in 1 to 10 out of 1,000 patients):

• Perforation of the gastrointestinal tract in peptic ulcer disease, with corresponding laboratory and clinical symptoms,
• Hypersensitivity reactions, e.g. skin reactions,
• Haemorrhage,
• Anaemia (as a consequence of haemorrhage),
• Transient liver function disturbances with increased aminotransferase activity,
• Kidney function disorders and renal failure.

Frequency not known (adverse reactions observed only after product release onto the market, for which frequency of occurrence could not be determined):

• Intestinal stenosing enteropathy (chronic intestinal obstruction),
• Anaphylactic shock,
• Cardio-respiratory disorders,
• Perioperative haemorrhage,
• Haemolysis or haemolytic anaemia (in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency).

Due to the effect of acetylsalicylic acid on platelet aggregation during treatment with Aspirin Cardio, the risk of bleeding and prolonged bleeding time and prothrombin time increases; a decrease in platelet count may also occur. Severe bleeding such as haemorrhage may lead to acute or chronic anaemia and/or iron deficiency anaemia (e.g. due to occult microbleeding), with corresponding laboratory and clinical symptoms such as: asthenia (fatigue), pallor, hypoperfusion (reduced blood flow).

A severe hypersensitivity reaction may manifest as: facial and eyelid swelling, swelling of the tongue and larynx with airway constriction, difficulty breathing, shortness of breath up to asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. If any of the above symptoms occur, immediate professional medical care must be provided. The above reactions may occur even after the first dose of the medicine.

Long-term use of medicines containing acetylsalicylic acid may cause headache, which intensifies with each subsequent dose.

Renal papillary necrosis and interstitial nephritis have been reported.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of 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

Reporting adverse reactions allows the collection of further information on the safety of medicine use.

5. How to store Aspirin Cardio

Keep the medicine out of the 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 stated month.
Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the packaging and other information

What Aspirin Cardio contains

• The active substance is acetylsalicylic acid (Acidum acetylsalicylicum). One enteric-coated tablet contains 100 mg of the active substance.
• The other ingredients are: powdered cellulose, corn starch, 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 further detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorisation Number in Spain, the country of export: 723798.3
Parallel Import Licence Number: 252/22