Aspirin cardio

Package leaflet: Information for the patient

WARNING: Keep the leaflet, information on the immediate packaging 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 medicinal product.
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 the physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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 clot formation.
Aspirin Cardio is indicated for use in adults in the following cardiovascular diseases:

• in unstable angina pectoris,
• 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 coronary angioplasty (PTCA), coronary artery bypass grafting (CABG), carotid endarterectomy, arterial-venous shunt),
• 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 adjunct to other prophylactic methods.

2. Important information before taking Aspirin Cardio

When not to take 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 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 previously experienced bronchial asthma attacks induced by salicylates or substances with similar effects, particularly non-steroidal anti-inflammatory drugs (NSAIDs),
• concomitantly with methotrexate at doses of 15 mg per week or higher (see: “Aspirin Cardio and other medicines”),
• during the third trimester of pregnancy,
• 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 medicines, e.g. coumarin derivatives, heparin,
• in patients with renal dysfunction or circulatory disorders,
• when using 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 with a history of 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 disorders, hay fever, nasal polyps, or those who have allergic reactions (e.g. skin reactions, itching, urticaria) to other substances.
Patients undergoing surgical procedures (including minor procedures such as tooth extraction) should inform their physician 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 provoke 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 bone marrow toxicity of methotrexate; acetylsalicylic acid should not be used concomitantly with methotrexate at doses of 15 mg per week or higher; concomitant use of methotrexate at doses lower than 15 mg per week requires special caution.
• the effect of anticoagulants (e.g. coumarin derivatives, heparin), thrombolytic agents (clot-dissolving agents, e.g. streptokinase, urokinase), and platelet aggregation inhibitors (e.g. ticlopidine), which may increase the risk of prolonged bleeding time and haemorrhage.
• the risk of peptic ulcer disease and gastrointestinal bleeding when used concomitantly with corticosteroids, other non-steroidal anti-inflammatory drugs, including high-dose salicylates, or when alcohol is consumed; after discontinuation of systemic glucocorticosteroids (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 medicines, 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 effect of:

• uricosuric agents used in the treatment of gout that increase uric acid excretion from the body (e.g. benzbromarone, probenecid), which may exacerbate gout symptoms;
• diuretics;
• 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 (clumping of platelets) and clot formation. Thus, they may diminish the protective effect of Aspirin Cardio against myocardial infarction 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 used concomitantly. Therefore, caution should be exercised 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 physician.
Systemic glucocorticosteroids (cortisone/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 glucocorticosteroid therapy, and an increased risk of peptic ulcers and gastrointestinal bleeding due to concomitant use of Aspirin Cardio and systemic glucocorticosteroids.
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 medicines).

Alcohol may increase the risk of gastrointestinal adverse 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, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine. Aspirin Cardio is contraindicated during the third trimester of pregnancy, as it may cause complications in the perinatal period for both mother and newborn. During the first and second trimesters of pregnancy, Aspirin Cardio should only be used when absolutely necessary. Women planning pregnancy or who are in the first or second trimester of pregnancy should use Aspirin Cardio at the lowest possible dose and for the shortest possible duration.
Acetylsalicylic acid passes into breast milk in small amounts.

Driving and operating machinery
Aspirin Cardio has no influence on the ability to drive or operate machinery.

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

The recommended dose is:

• In unstable coronary artery disease: 1 tablet once daily;
• In acute myocardial infarction or suspected acute heart attack – 2 to 3 tablets once daily, which should be chewed to ensure rapid absorption;
• For prevention of recurrent myocardial infarction: 1 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 tablet once daily;
• For prevention of transient ischaemic attacks (TIA) and ischaemic stroke in patients with TIA: 1 tablet once daily;
• For prevention of first myocardial infarction in patients with multiple risk factors: 1 tablet once daily;
• For prevention of deep vein thrombosis and pulmonary embolism in patients with prolonged immobilization, e.g. after major surgical procedures, as an adjunct to other prophylactic methods: 1 to 2 tablets once daily.

The tablets should be taken orally, whole, preferably at least 30 minutes before a meal, with a large amount of water. During treatment of heart attack, the 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.

Overdose of Aspirin Cardio
Overdose in elderly patients and 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 labyrinthine origin), tinnitus, deafness, excessive sweating, nausea and vomiting, headache, disorientation.

In severe poisoning, the following may occur: initially hyperventilation, followed by shallow breathing and breathing difficulties, up to respiratory failure, fever, ketoacidosis, respiratory alkalosis, metabolic acidosis, coma, cardiogenic 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 potassium concentration in blood).

In case of ingestion of a dose higher than recommended, seek immediate medical advice from a doctor or pharmacist. In cases of severe poisoning, the patient must be immediately transported to hospital.

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

Missed dose of Aspirin Cardio
If you miss a dose, take the next dose of Aspirin Cardio as scheduled. Do not take a double dose to make up for the missed dose.

Stopping Aspirin Cardio
If you have any further doubts 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.
Gastrointestinal disorders such as: dyspeptic symptoms (heartburn, nausea, vomiting), abdominal pain; rarely inflammation of the stomach and intestines; gastric and (or) duodenal ulceration very rarely leading to haemorrhage and perforation, with corresponding laboratory and clinical findings. In rare cases transient disturbances of liver function with increased aminotransferase activity have been reported.
Hypersensitivity reactions, e.g. skin reactions, urticaria, rash, pruritus, cardiorespiratory disorders, asthma attacks, oedema, rhinitis, nasal mucosa hyperaemia.
Dizziness and tinnitus, especially in children and elderly patients, are usually symptoms of overdose.
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 is increased; a decrease in platelet count may also occur. Bleeding events such as: perioperative haemorrhage, haematomas, epistaxis, urinary-genital tract bleeding, gingival bleeding have been observed. Serious bleeding events, such as gastrointestinal haemorrhage, cerebral haemorrhage (particularly in patients with uncontrolled hypertension and (or) when administered concomitantly with anticoagulant drugs), have been reported rarely or very rarely, which in isolated cases may potentially be life-threatening.
Haemorrhage may lead to acute or chronic anaemia and (or) iron-deficiency anaemia (e.g. due to occult microbleeding), with corresponding laboratory and clinical signs such as: asthenia (fatigue), pallor, hypoperfusion (reduced blood flow).

• Severe hypersensitivity reactions may include: facial and eyelid oedema, tongue and laryngeal oedema with airway constriction, breathing difficulties, dyspnoea, up to asthma attacks, tachycardia, sudden drop in blood pressure up to life-threatening shock. If any of the above symptoms occur, immediate professional medical care must be provided. These reactions may occur even after the first dose of the medicine.
• Long-term use of medicines containing acetylsalicylic acid may cause headache, which worsens with continued dosing.
• Severe renal function disorders and renal failure, renal papillary necrosis, interstitial nephritis have been reported.
• Haemolysis or haemolytic anaemia have been reported in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• Constrictive intestinal enteropathy (chronic intestinal obstruction).

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 of 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 enables better assessment of the safety of the medicine.

5. How to store Aspirin Cardio

Keep the medicine out of sight and reach of children.
Store in the original packaging at a temperature below 25°C.
Store at a temperature below 30°C.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Following this advice 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: cellulose, 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

PP/Al or PVC/Al blisters in a cardboard box. The pack contains 30 or 60 enteric-coated tablets.

For further information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Spain, the country of export:
Bayer Hispania, S.L., Av. 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:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged in:
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
Chemiczno-Farmaceutyczna Spółdzielnia Pracy „ESPEFA”, ul. Juliusza Lea 208, 30-133 Kraków
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław

Marketing Authorisation number in Spain, the country of export: 841288.4
723798.3

Parallel Import Licence number: 92/20