Acard cor

Patient Information Leaflet

Acard Cor, 75 mg, enteric-coated tablets
Acetylsalicylic acid
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Always take this medicine exactly as described in this Patient Information Leaflet or as directed by your 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 side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, consult your doctor.

Leaflet Contents

1. What Acard Cor is and what it is 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 pack and other information

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

Acard Cor contains acetylsalicylic acid, which, when used in low doses, belongs to a group of medicines known as antiplatelet drugs. Platelets are small blood cells involved in blood clot formation and the process of thrombosis. When a blood clot forms in an artery, blood flow becomes blocked, cutting off the supply of oxygen. If this occurs in the heart, it may cause a heart attack or angina pectoris; if it occurs in the brain, it may lead to a stroke.

Acard Cor is used in ischaemic heart disease and in all clinical situations where inhibition of platelet aggregation is indicated:

• for prevention of heart attack in individuals at high risk;
• in acute myocardial infarction or suspected acute myocardial infarction;
• in unstable coronary artery disease;
• for prevention of recurrent heart attack;
• after surgical or interventional procedures on blood vessels, e.g. coronary artery bypass grafting, coronary angioplasty;
• for prevention of transient ischaemic attacks (TIAs) and ischaemic stroke, as well as after such events;
• in patients with atherosclerosis of peripheral arteries;
• for prevention of coronary thrombosis in patients with multiple risk factors;
• for prevention of venous thrombosis and pulmonary embolism in patients who are immobilised for prolonged periods.

The decision to initiate treatment with Acard Cor and the dosage used should be made by a physician.

2. Important information before using Acard Cor

When not to use Acard Cor

• if the patient is allergic to acetylsalicylic acid, other salicylates, anti-inflammatory drugs, or any of the other components of this medicine (listed in section 6),
• if the patient has an increased tendency to bleeding or coagulation disorders,
• if the patient has gastric or duodenal ulcer disease,
• if the patient has ever experienced an asthma attack after taking salicylates or substances with similar effects, particularly non-steroidal anti-inflammatory drugs (NSAIDs),
• if the patient has severe kidney or liver disease (severe renal or hepatic insufficiency),
• if the patient is in the last three months of pregnancy, use of doses higher than 100 mg per day is not allowed (see section "Pregnancy and breastfeeding"),
• if the patient is taking methotrexate (a drug used in cancer treatment) at doses of 15 mg per week or higher.

Warnings and precautions
Before starting treatment with Acard Cor, discuss this with your doctor or pharmacist:

• if the patient is allergic to anti-inflammatory and anti-rheumatic drugs or other allergenic substances – see subsection "When not to use Acard Cor",
• if the patient has asthma, chronic respiratory diseases, nasal polyps, or has previously experienced asthma attacks after taking acetylsallylic acid or other anti-inflammatory drugs (symptoms: shortness of breath, wheezing),
• if the patient has a history of gastrointestinal ulcers,
• if the patient has impaired kidney and/or liver function, as there is a risk of increased adverse effects of the drug,
• if the patient is planning to undergo surgery (even minor procedures, such as tooth extraction), because acetylsalicylic acid thins the blood and may increase the risk of bleeding,
• if the patient is pregnant or planning to become pregnant.

Serious allergic reactions, including chest pain and even myocardial infarction (Kounis syndrome), have occurred during treatment with acetylsalicylic acid (see section 4). Immediate medical attention must be sought if chest pain occurs together with allergic reactions (such as skin rash, difficulty breathing).
The patient must seek immediate medical help if symptoms worsen or if severe or unexpected adverse reactions occur, such as unusual bleeding, serious skin reactions, or any other signs of severe allergy (see section "Possible adverse effects").
Acetylsalicylic acid may cause Reye's syndrome when administered to children. Reye's syndrome is a very rare condition affecting the brain and liver, which may be life-threatening. For this reason, Acard Cor must not be given to children and adolescents under 16 years of age, unless specifically prescribed by a doctor.
Acetylsalicylic acid, even at low doses, reduces the excretion of uric acid from the body. In patients predisposed to reduced uric acid excretion, the drug may trigger an attack of gout. If the patient has ever suffered from gout, they should consult their doctor before starting treatment with Acard Cor.
This medicine is not recommended as an anti-inflammatory, analgesic, or antipyretic agent.

Children and adolescents
Acard Cor must not be given to children and adolescents under 16 years of age, except under clear medical advice when the benefits of treatment outweigh the risks (see section "Warnings and precautions").

Acard Cor and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

Do not use Acard Cor simultaneously with:

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

Concomitant use of Acard Cor is not recommended with:

• drugs used in the treatment of gout (e.g. probenecid, benzbromarone, sulfinpyrazone).

Acard Cor may be used together with the following medicines after prior consultation with a doctor:

• anticoagulants (e.g. coumarin, heparin, warfarin);

• other non-steroidal anti-inflammatory drugs (including ibuprofen);

• antidiabetic drugs (e.g. sulfonylurea derivatives and insulin);

• antiplatelet agents (e.g. clopidogrel);

• drugs used to treat depression and anxiety (e.g. sertraline, paroxetine);

• diuretics (e.g. acetazolamide);

• systemic glucocorticoids;

• antihypertensive drugs;

• valproic acid (an antiepileptic drug);

• phenytoin (an antiepileptic drug);

• methotrexate at doses less than 15 mg per week;

• digoxin (a cardiac drug);

• deferiprone (a drug used in chronic iron overload);

• cyclosporine and tacrolimus (immunosuppressive drugs).

• Concomitant use of metamizole with acetylsalicylic acid may reduce the antiplatelet effect of acetylsalicylic acid. Therefore, metamizole should be used cautiously in patients taking low-dose acetylsalicylic acid for cardiovascular protection.

Use of Acard Cor with alcohol
Alcohol may increase the risk of gastrointestinal adverse effects caused by acetylsalicylic acid. Therefore, alcohol consumption should be avoided during treatment with Acard Cor.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
If the patient continues or starts treatment with Acard Cor during pregnancy as advised by her doctor, she should use Acard Cor strictly according to medical instructions and should not exceed the recommended dose.

Pregnancy – third trimester
Acetylsalicylic acid should not be used 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. Use of Acard Cor may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in both the mother and the child and may delay or prolong labor.
If the patient takes acetylsalicylic acid at low doses (up to and including 100 mg per day), close obstetric monitoring is required as advised by the doctor.

Pregnancy – first and second trimester
Acard Cor should not be taken during the first six months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible duration. Use of Acard Cor for longer than a few days from week 20 of pregnancy may cause kidney problems in the unborn child, leading to low levels of amniotic fluid (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If prolonged treatment is required, the doctor may recommend additional monitoring.

Breastfeeding
Short-term use of Acard Cor by a breastfeeding woman does not pose a major risk to the breastfed infant. However, breastfeeding is not recommended during long-term use of Acard Cor.

Driving and operating machinery
Acard Cor has no influence on the ability to drive or operate machinery.

Acard Cor contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use Acard Cor

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual recommended dosage is as follows:
Prevention of heart attack in individuals at high risk:
The recommended dose is 1 enteric-coated tablet (75 mg) daily.
Unstable angina, secondary prevention in patients after myocardial infarction:
The recommended dose is 1 enteric-coated tablet (75 mg) daily.
After coronary artery bypass grafting (CABG), coronary angioplasty:
The recommended dose is 1 enteric-coated tablet (75 mg) daily.
Prevention of transient ischaemic attacks (TIA) and ischaemic stroke in patients with TIA (TIA – transient ischaemic attacks):
The recommended dose is 1 enteric-coated tablet (75 mg) daily.
After ischaemic stroke in patients with TIA:
The recommended dose is 1 enteric-coated tablet (75 mg) daily.
In patients with atherosclerosis of peripheral arteries:
The recommended dose is 1 enteric-coated tablet (75 mg) daily.
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 immobilised for prolonged periods, e.g. after major surgical procedures, as an adjunct to other prophylactic measures:
The recommended dose is 1 to 2 enteric-coated tablets (75 mg to 150 mg) daily.
Enteric-coated tablets should be taken during or after a meal – swallowed whole with sufficient fluid (half a glass of water). The enteric-coated tablet of Acard Cor has a coating and does not disintegrate in the stomach, thus reducing the irritating effect of acetylsalicylic acid on the gastric mucosa.
Acute myocardial infarction or suspected acute myocardial infarction:
Single dose of 4 enteric-coated tablets (300 mg). In this case, the enteric-coated tablets should be chewed thoroughly to ensure rapid absorption!
Note: In acute myocardial infarction or suspected acute myocardial infarction, enteric-coated tablets may be used only when uncoated acetylsalicylic acid tablets are not available.
Use in children and adolescents
Acard Cor must not be given to children and adolescents under 16 years of age unless specifically advised by a doctor (see section "Warnings and precautions").
Use in elderly patients
Acard Cor should be used with caution in elderly patients, who are more prone to adverse effects. If there is no severe renal or hepatic impairment, the dose usually recommended for adult patients is advised.
Taking more Acard Cor than recommended
Overdose in elderly patients and young children (ingestion of doses higher than recommended or accidental poisoning) requires special attention, as it may lead to more severe consequences.
Symptoms of overdose may include nausea, vomiting, hyperventilation, tinnitus. Other observed symptoms include: hearing loss, headache, restlessness, drowsiness and coma, convulsions, fever, sweating. In severe poisoning, disturbances in acid-base and water-electrolyte balance occur (metabolic acidosis and dehydration).
If an overdose is taken, seek medical advice immediately. 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 or hemodialysis may be necessary.
If you forget to take Acard Cor
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Acard Cor
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.
If the patient notices any of the following serious adverse reactions, treatment with Acard Cor should be
discontinued immediately and medical advice should be sought without delay:

• Sudden wheezing, swelling of the lips, face or body, rash, fatigue or difficulty swallowing (severe allergic reactions).
• Red, blistering or peeling skin rash, possibly 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, blood in the urine, or tarry stools.

Common adverse reactions (may occur in up to 1 in 10 patients):

• Indigestion;
• Increased tendency to bleed.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• Urticaria;
• Rhinitis;
• Breathing difficulties.

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

• Severe gastrointestinal bleeding;
• Intracranial bleeding;
• Changes in blood cell counts;
• Nausea and vomiting;
• Bronchoconstriction (bronchospasm), asthma attack;
• Severe allergic reactions such as purpura, erythema multiforme, Stevens-Johnson syndrome and Lyell's syndrome.

Adverse reaction with unknown frequency (frequency cannot be estimated from available data):

• Hearing disturbances, ringing in the ears (tinnitus);
• Acute myocardial ischaemia (heart pain due to insufficient blood supply to the heart), with or without myocardial infarction (heart attack), occurring as part of an allergic reaction (Kounis syndrome);
• Headache;
• Dizziness;
• Gastric or duodenal ulceration and perforation, petechiae, erosions;
• Episodes of prolonged bleeding time such as nosebleeds, bleeding from the gums;
• Impaired kidney function;
• Liver failure;
• Increased blood uric acid levels;
• Hypersensitivity reactions such as swelling, e.g. of lips, face or body, and anaphylactic shock.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Acard Cor

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep 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 indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Acard Cor contains

• The active substance is acetylsalicylic acid. Each enteric-coated tablet contains 75 mg of acetylsalicylic acid.
• The other ingredients are:
  Tablet core: pregelatinized corn starch, microcrystalline cellulose, stearic acid, sodium carboxymethyl starch (type A).
  Tablet coating: hypromellose, titanium dioxide (E 171), triacetin, methacrylic acid and ethyl acrylate copolymer (1:1) type A, anhydrous colloidal silica, talc, sodium bicarbonate, sodium lauryl sulfate, triethyl citrate.

What Acard Cor looks like and contents of the pack
The enteric-coated tablets are white or almost white, biconvex, with a smooth surface.
The pack contains 30, 60, 90 or 120 enteric-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
POLPHARMA Pharmaceutical Works S.A.
Pelplińska 19, 83-200 Starogard Gdanski
tel. + 48 22 364 61 01
Manufacturer
Medicofarma S.A.
Tarnobrzeska 13, 26-613 Radom