Acard Cor

Leaflet accompanying the packaging: patient information

Acard Cor, 75 mg, enteric-coated tablets

Acetylsalicylic acid

Read the leaflet carefully 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.

• This leaflet should be kept in case you need to read it again.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Acard Cor and what is it used for
• 2. Important information before taking Acard Cor
• 3. How to take Acard Cor
• 4. Possible side effects
• 5. How to store Acard Cor
• 6. Contents of the packaging and other information

1. What is Acard Cor and what is it used for

Acard Cor contains acetylsalicylic acid, which in small doses belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that cause blood clots to form and are involved in the blood clotting process. When a blood clot forms in an artery, blood flow is blocked, and oxygen supply is cut off. If this happens in the heart, it can cause a heart attack or angina pectoris, and in the brain, it can cause a stroke.
Acard Cor is used for coronary heart disease and in all clinical situations where it is desirable to inhibit platelet aggregation:

• to prevent heart attack in people at high risk;
• in recent heart attack or suspected recent heart attack;
• in unstable angina;
• to prevent recurrent heart attack;
• after surgical or interventional procedures on blood vessels, such as coronary artery bypass grafting, coronary angioplasty;
• to prevent transient ischemic attacks and ischemic stroke, as well as after they have occurred;
• in people with atherosclerotic peripheral artery disease;
• to prevent coronary thrombosis in patients with multiple risk factors;
• to prevent venous thrombosis and pulmonary embolism in patients who are immobilized for a long time.

The decision to start treatment and the dose of Acard Cor should be made by a doctor.

2. Important information before taking Acard Cor

When not to take Acard Cor

• if you are allergic to acetylsalicylic acid, other salicylates, anti-inflammatory drugs, or any of the other ingredients of this medicine (listed in section 6),
• if you have an increased tendency to bleeding and blood clotting disorders,
• if you have stomach or duodenal ulcers,
• if you have had an asthma attack after taking salicylates or substances with similar effects, especially non-steroidal anti-inflammatory drugs (NSAIDs),
• if you have severe kidney or liver disease (severe kidney or liver failure),
• if you are in the last three months of pregnancy, you should not take more than 100 mg per day (see section "Pregnancy and breastfeeding"),
• if you are taking methotrexate (a medicine used to treat cancer) in doses of 15 mg per week or higher.

Warnings and precautions

Before starting treatment with Acard Cor, you should discuss it with your doctor or pharmacist:

• if you are allergic to anti-inflammatory and anti-rheumatic drugs or other allergenic substances - see subsection "When not to take Acard Cor",
• if you have asthma, chronic respiratory diseases, nasal polyps, or if you have had asthma attacks after taking acetylsalicylic acid or other anti-inflammatory drugs (symptoms: shortness of breath, wheezing),
• if you have had stomach or intestinal ulcers,
• if you have kidney or liver function disorders, as there is a risk of increased side effects of the medicine,
• if you are planning to undergo surgery (even minor, such as tooth extraction), as acetylsalicylic acid thins the blood and therefore may increase the risk of bleeding,
• if you are pregnant or planning to become pregnant.

You should immediately seek medical attention if your symptoms worsen or if you experience severe or unexpected side effects, such as unusual bleeding symptoms, serious skin reactions, or any other symptoms of a severe allergic reaction (see section "Possible side effects").
Acetylsalicylic acid may cause Reye's syndrome if given to children. Reye's syndrome is a very rare disease that affects the brain and liver and can be life-threatening.
Therefore, Acard Cor should not be given to children under 16 years of age, unless a doctor decides to use it.
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. If you have ever had gout, you should consult your doctor before starting treatment with Acard Cor.
This medicine is not recommended as an anti-inflammatory, analgesic, or antipyretic.

Children and adolescents

Acard Cor should not be given to children and adolescents under 16 years of age, unless a doctor recommends it (see section "Warnings and precautions").

Acard Cor and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Acard Cor at the same time as:

• methotrexate in doses of 15 mg per week or higher.

It is not recommended to take Acard Cor at the same time as:

• medicines used to treat gout (e.g., probenecid, benzbromarone, sulfinpyrazone).

Acard Cor can be taken after consulting a doctor with the following medicines:

• anticoagulant medicines (e.g., coumarin, heparin, warfarin);
• other non-steroidal anti-inflammatory drugs (including ibuprofen);
• antidiabetic medicines (e.g., sulfonylurea derivatives and insulin);
• platelet aggregation inhibitors (e.g., clopidogrel);
• medicines used to treat depression and anxiety (e.g., sertraline, paroxetine);
• diuretics (e.g., acetazolamide);
• systemic glucocorticosteroids;
• antihypertensive medicines;
• valproic acid (an antiepileptic medicine);
• phenytoin (an antiepileptic medicine);
• methotrexate in doses less than 15 mg per week;
• digoxin (a heart medicine);
• deferazirox (a medicine used in chronic iron overload);
• cyclosporine and tacrolimus (medicines that inhibit immune system activity).
• Concomitant use of metamizole with acetylsalicylic acid may reduce the antiplatelet effect of acetylsalicylic acid. Therefore, metamizole should be used with caution in patients taking acetylsalicylic acid in small doses for cardiovascular protective effects.

Taking Acard Cor with alcohol

Alcohol may increase the risk of side effects related to the gastrointestinal tract caused by acetylsalicylic acid, so you should not drink alcohol during treatment with Acard Cor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you continue or start treatment with Acard Cor during pregnancy according to your doctor's recommendations, you should take the medicine as directed and not take more than the recommended dose.
Pregnancy - last trimester
Acetylsalicylic acid should not be taken in doses greater than 100 mg per day in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Taking Acard Cor may cause kidney and heart problems in the unborn baby. This may affect the tendency to bleed in you and your baby and may cause delayed or prolonged labor.
If you are taking acetylsalicylic acid in small doses (up to 100 mg per day), close obstetric monitoring is necessary according to your doctor's recommendations.
Pregnancy - first and second trimester
Acard Cor should not be taken during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If treatment is necessary during this period or during attempted pregnancy, the smallest effective dose of the medicine should be used for the shortest possible time. Acard Cor taken for more than a few days, starting from the 20th week of pregnancy, may cause kidney problems in the unborn baby, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct in the baby's heart. If longer treatment is necessary, your doctor may recommend additional monitoring.
Breastfeeding
Short-term use of the medicine by a breastfeeding woman does not pose a significant risk to the breastfed baby. However, long-term use of Acard Cor is not recommended during breastfeeding.

Driving and using machines

Acard Cor does not affect the ability to drive or use machines.

Acard Cor contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Acard Cor

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 your doctor or pharmacist.

Recommended dosage:

Prevention of heart attack in people at high risk:
The recommended dose is 1 enteric-coated tablet (75 mg) per day.
Unstable angina, secondary prevention in people after a heart attack:
The recommended dose is 1 enteric-coated tablet (75 mg) per day.
Post-coronary artery bypass grafting, coronary angioplasty:
The recommended dose is 1 enteric-coated tablet (75 mg) per day.
Prevention of transient ischemic attacks and ischemic stroke in patients with transient ischemic attacks (TIA):
The recommended dose is 1 enteric-coated tablet (75 mg) per day.
After ischemic stroke in patients with TIA:
The recommended dose is 1 enteric-coated tablet (75 mg) per day.
In people with atherosclerotic peripheral artery disease:
The recommended dose is 1 enteric-coated tablet (75 mg) per day.
Prevention of coronary thrombosis in patients with multiple risk factors:
The recommended daily dose is 1 to 2 enteric-coated tablets (75 mg to 150 mg).
Prevention of venous thrombosis and pulmonary embolism in patients who are immobilized for a long time, e.g., after major surgery, as an adjunct to other preventive measures:
The recommended dose is 1 to 2 enteric-coated tablets (75 mg to 150 mg) per day.
The tablets should be taken during or after a meal - swallowed whole, with a sufficient amount of water (half a glass). The enteric-coated tablet of Acard Cor has a coating and does not dissolve in the stomach, which reduces the irritating effect of acetylsalicylic acid on the stomach mucosa.
Recent heart attack or suspected recent heart attack:
4 enteric-coated tablets (300 mg) at once. In this case, the enteric-coated tablets should be chewed very carefully to achieve rapid absorption!
Note:in acute heart attack or suspected acute heart attack, enteric-coated tablets may be used when acetylsalicylic acid in non-coated tablets is not available.

Use in children and adolescents

Acard Cor should not be given to children and adolescents under 16 years of age, unless a doctor recommends it (see section "Warnings and precautions").

Use in elderly patients

Acard Cor should be used with caution in elderly patients who are more likely to experience side effects. If there is no severe kidney or liver failure, the recommended dose for adults is recommended.

Taking a higher dose of Acard Cor than recommended

Overdose in elderly people and small children (taking higher doses than recommended or accidental poisoning) requires special attention, as it may have a more severe course.
After an overdose of the medicine, the following symptoms may occur: nausea, vomiting, rapid breathing, tinnitus. Other symptoms, such as hearing loss, headache, restlessness, drowsiness, and coma, seizures, fever, sweating, have also been observed. In severe poisonings, there are disorders of acid-base and water-electrolyte balance (metabolic acidosis and dehydration).
If you have taken more than the recommended dose of the medicine, you should immediately consult a doctor, and in case of severe poisoning, the patient should be taken to the hospital immediately. Treatment of poisoning involves gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe poisonings, forced alkaline diuresis or hemodialysis may be necessary.

Missing a dose of Acard Cor

You should not take a double dose to make up for a missed dose, just take the next dose as usual.

Stopping treatment with Acard Cor

If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, you should stop taking Acard Cor and contact your doctor immediately:

• Sudden wheezing, swelling of the face, lips, tongue, or throat, rash, fatigue, or difficulty swallowing (severe allergic reactions).
• Redness of the skin with blisters or peeling, which may be associated with high fever and joint pain. This may be erythema multiforme, Stevens-Johnson syndrome, or Lyell's syndrome.
• Unusual bleeding, such as coughing up blood, vomiting blood, or blood in the urine, or black stools.

Common side effects (may affect up to 1 in 10 people):

• Indigestion;
• Increased tendency to bleeding.

Uncommon side effects (may affect up to 1 in 100 people):

• Hives;
• Runny nose;
• Breathing difficulties.

Rare side effects (may affect up to 1 in 1,000 people):

• Severe bleeding from the stomach or intestines;
• Bleeding in the brain;
• Changes in blood cell count;
• Nausea and vomiting;
• Constriction of the lower airways (bronchi), asthma attack;
• Severe allergic reactions, such as hives, erythema multiforme, Stevens-Johnson syndrome, and Lyell's syndrome.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Hearing disorders, ringing in the ears (tinnitus);
• Headache;
• Dizziness;
• Ulcers of the stomach or duodenum and their perforation, hemorrhages, erosions;
• Instances of bleeding with prolonged bleeding time, such as nosebleeds, bleeding gums;
• Kidney function disorders;
• Liver failure;
• Increased uric acid levels in the blood;
• Hypersensitivity reactions, such as swelling, e.g., of the lips, face, or body, as well as anaphylaxis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Acard Cor

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 Acard Cor contains

• The active substance of the medicine is acetylsalicylic acid. Each enteric-coated tablet contains 75 mg of acetylsalicylic acid.
• Other ingredients are: Tablet core: corn starch, microcrystalline cellulose, stearic acid, sodium carboxymethyl cellulose (type A).

Tablet coating: hypromellose, titanium dioxide (E 171), triacetin, methacrylic acid, and ethyl acrylate copolymer (1:1) type A, colloidal anhydrous silica, talc, sodium bicarbonate, sodium lauryl sulfate, triethyl citrate.

What Acard Cor looks like and what the packaging contains

The enteric-coated tablets are white or almost white, biconvex, with a smooth surface.
The packaging contains 30, 60, 90, or 120 enteric-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer

Medicofarma S.A.
Tarnobrzeska 13, 26-613 Radom

Date of last revision of the leaflet: