Aspirin cardio

Package leaflet: Information for the user

Warning! Keep this 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 brand names of 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 for possible future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. 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 clot formation.
Aspirin Cardio is indicated for use in adults in the following cardiovascular conditions:

• unstable angina,
• 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 (bypass)],
• prevention of transient ischemic attacks (TIA) and ischemic stroke in patients with a history of TIA,
• prevention of first myocardial infarction in patients with multiple risk factors,
• prevention of deep vein thrombosis and pulmonary embolism in patients who are immobilized 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 gastric or duodenal ulcer disease,
• if the patient has severe renal insufficiency,
• if the patient has severe hepatic insufficiency,
• 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 anticoagulant drugs, 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 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 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 physician about taking Aspirin Cardio.
Acetylsalicylic 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 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 use.

Acetylsalicylic acid enhances:

• the toxic effect of methotrexate on bone marrow; concomitant use of acetylsalicylic acid with methotrexate at doses of 15 mg per week or higher is not recommended; 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 (clot-dissolving agents, e.g. streptokinase, urokinase), and platelet aggregation inhibitors (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 in high doses), or when alcohol is consumed during treatment; 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 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:

• uricosuric drugs used in the treatment of gout that increase uric acid excretion (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 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 both drugs are used concomitantly. Therefore, caution should be exercised when using metamizole in patients receiving acetylsalicylic acid.
Concomitant use of selective serotonin reuptake inhibitors (a group of antidepressant drugs) increases the risk of upper gastrointestinal bleeding.
Aspirin Cardio may be used concomitantly with the above-mentioned drugs (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 (cortisones/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 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 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 plans to have a child, 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 physician, she should take Aspirin Cardio according to the physician'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 drug may cause kidney and heart dysfunction in the unborn child. It may also affect the bleeding tendency in both the 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), close obstetric monitoring should be maintained as advised by the physician.

First and second trimesters
Aspirin Cardio should not be used during the first six months of pregnancy unless absolutely necessary and specifically recommended by a physician. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration. If Aspirin Cardio is taken for longer than a few days after the 20th week of pregnancy, it may cause kidney dysfunction 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 physician 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 the medicine is considered "sodium-free".

3. HOW TO USE THE MEDICINE 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 angina: 1 enteric-coated tablet once daily;
• in acute myocardial infarction or suspected acute heart attack – 2 to 3 enteric-coated tablets once daily, and the enteric-coated tablets 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 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 who are immobilised for prolonged periods, 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.
Use of a higher than recommended dose of Aspirin Cardio
Overdose in elderly individuals and young children (intake 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 vestibular 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, significant 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 higher than recommended dose of the medicine, seek immediate medical advice from a doctor or pharmacist; in cases of severe poisoning, the patient must be taken immediately to hospital.
Treatment of poisoning consists of gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis or haemodialysis may be required.
Missing a 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 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 mucosal inflammation,
• dizziness (especially in children and elderly patients; usually symptoms of overdose),
• tinnitus (especially 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,
• bruising,
• intracranial hemorrhage (particularly in patients with uncontrolled hypertension and/or when concomitantly administered with drugs that inhibit blood clotting), which in isolated cases may potentially be life-threatening,
• iron-deficiency anemia,
• 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,
• hemorrhage,
• anemia (as a consequence of hemorrhage),
• transient liver function disturbances with increased aminotransferase activity,
• kidney function disorders and renal failure.

Frequency not known (adverse reactions observed only after the product has been marketed, for which frequency cannot be estimated):

• intestinal stenosing enteropathy (chronic intestinal obstruction),
• anaphylactic shock,
• cardiorespiratory disturbances,
• perioperative hemorrhage,
• hemolysis or hemolytic anemia (in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency).

Due to the effect of acetylsalicylic acid on platelet aggregation, during the use of Aspirin Cardio, the risk of bleeding and prolonged bleeding time and prothrombin time is increased; a decrease in platelet count may also occur. Severe bleeding such as hemorrhage 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 (reduced blood flow).

• Symptoms of a severe hypersensitivity reaction may include: facial and eyelid swelling, swelling of the tongue and larynx with airway constriction, difficulty breathing, shortness of breath, asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. If any of the symptoms listed above 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 intensifies with subsequent doses.
• Cases of renal papillary necrosis, 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, pharmacist, or nurse.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 helps to collect more information on the safety of the medicine.

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.
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. Such measures help protect the environment.

6. CONTENTS OF THE PACKAGE 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; 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 more detailed information, please contact the Marketing Authorisation Holder or the 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Spanish Marketing Authorisation Numbers (country of export): 841288.4
723798.3
Parallel Import Licence Number: 12/16