Aspirin cardio

Patient Information Leaflet

Warning! Keep this leaflet! The packaging information in a foreign language.
Aspirin Cardio (Adiro)
100 mg , enteric-coated tablets
Acetylsalicylic acid
Aspirin Cardio and Adiro are different brand 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
your doctor or pharmacist.

• Keep this leaflet, so you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

C ontents of t his l eaflet

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). In this way, it plays an important role in preventing blood clots.
Aspirin Cardio is indicated for use in adults for the following cardiovascular conditions:

• in unstable angina,
• in acute myocardial infarction or suspected acute myocardial infarction,
• in the prevention of recurrent myocardial infarction,
• in the 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 (bypass)],
• in the prevention of transient ischaemic attacks (TIA) and ischaemic 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 immobilised for prolonged periods, e.g. after major surgical procedures, as an addition to other preventive methods.

2. 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 components of the medicine (listed in section 6),
• if the patient has a bleeding tendency,
• if the patient has acute gastric and/or duodenal ulcer,
• if the patient has severe renal failure,
• if the patient has severe hepatic failure,
• if the patient has severe heart failure,
• if the patient has 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 anticoagulants, e.g. coumarin derivatives, heparin,
• in patients with impaired kidney function or circulatory disorders,
• when using non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen (anti-inflammatory, antipyretic or analgesic drugs) (see "Aspirin Cardio and other medicines"),
• in patients with impaired liver function,
• in patients with a history of peptic ulcer 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 showing allergic reactions (e.g. skin reactions, itching, urticaria) to other substances.
Patients undergoing surgical procedures (including minor procedures, e.g. tooth extraction) should inform their doctor about taking Aspirin Cardio.
Acetylsalicilic acid, even in low doses, reduces the excretion of uric acid from the body.
In patients prone to reduced uric acid excretion, the drug may trigger an attack of gout.

Aspirin Cardio and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Acetylsalicylic acid enhances:

• the toxic effect of methotrexate on bone marrow; acetylsalicylic acid should not be used concurrently with methotrexate administered 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 drugs inhibiting platelet aggregation (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 (NSAIDs), including other salicylates in 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 drugs that increase uric acid excretion from the body (e.g. benzbromarone, probenecid), which may exacerbate symptoms of gout;
• diuretic drugs;
• certain antihypertensive drugs (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. Thus, they may diminish the protective effect of Aspirin Cardio against heart attack and stroke.
Metamizole (a drug with analgesic and antipyretic properties) may reduce the effect of acetylsalicylic acid on platelet aggregation when both drugs are used simultaneously. Therefore, caution should be exercised when using metamizole in patients receiving acetylsalicylic acid.
Concurrent use of selective serotonin reuptake inhibitors (SSRIs, a class of antidepressants) increases the risk of upper gastrointestinal bleeding.
Aspirin Cardio may be used concurrently 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, when used concomitantly with acetylsalicylic acid: there is a risk of acetylsalicylic acid overdose after discontinuation of glucocorticoid therapy, as well as 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 a meal, with a large amount of water.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning 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 on medical advice, she should use Aspirin Cardio according to the doctor's instructions and should not take a higher dose than recommended.

Pregnancy
Third trimester of pregnancy
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 drug may cause kidney and heart function disorders in the unborn child. It may also affect the tendency of the mother and child to bleed 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 according to the doctor's recommendations.

First and second trimesters of pregnancy
Aspirin Cardio should not be used during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. 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, which may lead 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 has no influence on the ability to drive vehicles or operate machinery.

Aspirin Cardio contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine 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 your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose:

• 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; the tablets should be chewed to ensure rapid absorption;
• For prevention of recurrent myocardial infarction: 1 enteric-coated tablet once daily;
• To prevent 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.

The 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 Aspirin Cardio is too strong or too weak, consult your doctor or pharmacist.

Use of a higher than recommended dose of Aspirin Cardio

Overdose in elderly individuals and in young children (ingestion of 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 vertigo), tinnitus, deafness, 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, cardiovascular shock, marked decrease in blood glucose concentration, presence of blood in urine, convulsions, hallucinations, ketonuria (presence of ketone bodies in urine), proteinuria (presence of protein in urine), hypokalaemia (decreased blood potassium concentration).

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

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

Missed dose of Aspirin Cardio

If you miss a dose, take the next dose as scheduled. Do not take a double dose to make up for the 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 experiences 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 mucosal inflammation,
• 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 bleeding), 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):

• Gastrointestinal perforation 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 introduction to market, for which frequency cannot be estimated):

• Constrictive enteropathy of the intestine (chronic intestinal obstruction),
• Anaphylactic shock,
• Cardio-respiratory disturbances,
• 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, breathing difficulties, dyspnoea, asthma attacks, increased heart rate, sudden drop in blood pressure up to life-threatening shock. If any of these symptoms occur, immediate medical attention must be sought. 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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 .
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Aspirin Cardio

Keep this medicine 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 stated month.
PP/Al blisters: Store below 25°C in the original packaging.
PVC/Al blisters: Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Aspirin Cardio contains

• The active substance in this medicinal product 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 contents of the pack
The pack contains 30, 50, 60 or 90 white, round enteric-coated tablets in PP/Al or PVC/Al blisters, packed in a cardboard box.
For further detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Spain, 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 in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorisation number in Spain, country of export: 723798.3
841288.4
841296.9
Parallel import authorisation number: 318/15