Acard

Leaflet attached to the packaging: patient information

ACARD 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 advised by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or feel worse, contact your doctor.

Table of contents of the leaflet

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

1. What is ACARD and what is it used for

ACARD contains acetylsalicylic acid, which inhibits platelet aggregation (clotting).
The medicine is intended for long-term, preventive use in diseases that threaten the formation of blood clots and emboli in blood vessels.
ACARD is used:

• to prevent heart attack in people at high risk;
• in recent myocardial infarction or suspected recent myocardial infarction;
• in unstable angina;
• to prevent repeated heart attack;
• after surgical or interventional procedures on blood vessels, such as coronary artery bypass grafting, coronary angioplasty;
• to prevent transient cerebral ischemia and ischemic stroke, as well as after their occurrence;
• in people with atherosclerosis of peripheral arteries;
• to prevent coronary thrombosis in patients with multiple risk factors;
• to prevent venous thrombosis and pulmonary embolism in patients with prolonged immobilization.

2. Important information before taking ACARD

When not to take ACARD

• if you are allergic to acetylsalicylic acid, other salicylates, 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 gastric or duodenal ulcer disease;
• if you have severe kidney or liver disorders (severe renal or hepatic insufficiency);
• if you have had asthma attacks after taking acetylsalicylic acid or other anti-inflammatory drugs (symptoms: shortness of breath, wheezing);
• if you are in the last three months of pregnancy, do 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;
• in children under 12 years of age with viral infections (e.g., flu or chickenpox), due to the risk of liver and brain damage (Reye's syndrome).

Warnings and precautions

Before starting treatment with ACARD, discuss it with your doctor or pharmacist:

• if you are allergic to anti-inflammatory and anti-rheumatic drugs (e.g., naproxen) or other allergens - see section "When not to take ACARD";
• if you have asthma, chronic respiratory diseases, nasal polyps;
• if you have had gastric or intestinal ulcer disease;
• if you have a congenital deficiency of glucose-6-phosphate dehydrogenase (a rare inherited disease);
• if you have severe heart failure;
• if you have kidney or liver function disorders, as there is a risk of exacerbating the side effects of the medicine.

Do not take ACARD for at least 5 days before a planned surgical procedure (including minor procedures, e.g., tooth extraction).

ACARD and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• Do not take ACARD at the same time:
• with methotrexate in doses of 15 mg per week or higher;
• with ibuprofen.
• You can take ACARD after consulting your doctor with the following medicines:
• anticoagulant medicines (e.g., acenocoumarol, warfarin, heparin);
• other non-steroidal anti-inflammatory drugs, including salicylates;
• medicines used to treat gout (e.g., probenecid, benzbromarone);
• oral anti-diabetic medicines (e.g., tolbutamide, glibenclamide) and insulin;
• medicines that inhibit platelet aggregation (e.g., ticlopidine);
• medicines used to treat depression and anxiety (e.g., fluoxetine, paroxetine);
• diuretics (e.g., furosemide);
• systemic glucocorticosteroids;
• antihypertensive medicines (e.g., enalapril, captopril);
• valproic acid (an antiepileptic medicine);
• methotrexate in doses less than 15 mg per week;
• digoxin (a heart medicine).
• Metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (clotting), if these medicines are taken at the same time. Therefore, caution should be exercised when using metamizole in patients receiving acetylsalicylic acid.
• Alcohol may increase the risk of gastrointestinal side effects caused by acetylsalicylic acid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you continue or start treatment with ACARD during pregnancy according to your doctor's advice, you should take ACARD as advised and not take more than the recommended dose.
Pregnancy - last trimester
Do not take more than 100 mg of acetylsalicylic acid per day in the last 3 months of pregnancy, as this may harm the unborn child or cause complications during delivery. Taking ACARD may cause kidney and heart disorders in the unborn child. This may affect the tendency to bleeding in you and your child and cause delayed or prolonged labor.
If you take acetylsalicylic acid in small doses (up to 100 mg per day), close obstetric monitoring is necessary according to your doctor's advice.
Pregnancy - first and second trimester
Do not take ACARD during the first 6 months of pregnancy, unless it is absolutely necessary and advised by your doctor. If treatment is necessary during this period or when trying to conceive, use the smallest effective dose for the shortest possible time. ACARD taken for more than a few days, starting from the 20th week of pregnancy, may cause kidney disorders in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child'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 child. However, it is not recommended to breastfeed during long-term use of high doses of acetylsalicylic acid.

Driving and using machines

ACARD does not affect the ability to drive or use machines.

ACARD 75 mg 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

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist.
Consult your doctor before starting treatment with ACARD.
ACARD is available in two doses: 75 mg and 150 mg. Your doctor will recommend the appropriate dose for you and determine the duration of treatment.
Take orally.

• Typically, the following dosing is recommended:

1 enteric-coated tablet (75 mg) per day.
Enteric-coated tablets should be taken after a meal - swallow whole, with a small amount of water.
The enteric-coated tablet of ACARD has a coating and does not dissolve in the stomach, which reduces the irritating effect of acetylsalicylic acid on the gastric mucosa.

• In recent myocardial infarction or suspected recent myocardial infarction:

4 enteric-coated tablets (300 mg) at once. The tablets should be chewed very thoroughly to accelerate absorption.
Note:in acute myocardial infarction or suspected acute myocardial infarction, enteric-coated tablets may be used when acetylsalicylic acid in non-coated tablets is not available.

Taking a higher dose of ACARD than recommended

In case of overdose, contact your doctor, and in case of severe poisoning, take the patient to the hospital immediately.
The first symptoms of poisoning are: tinnitus, rapid breathing, fever, nausea, vomiting, vision disturbances, headaches, dizziness, confusion, skin rashes.
In more severe cases, the following may occur: hallucinations, tremors, shortness of breath, excessive sweating, agitation, coma.

Missing a dose of ACARD

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

Stopping treatment with ACARD

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

4. Possible side effects

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

Stop taking the medicine and contact your doctor immediately if you experience the first symptoms of hypersensitivity (e.g., facial, lip, tongue, or throat swelling, causing difficulty breathing or swallowing) or bleeding, e.g., gastrointestinal (symptoms: black stools), or hemorrhages.

Your doctor will assess the severity of the symptoms and decide on further action.
After taking acetylsalicylic acid, the following have been reported:
Common (in 1 to 10 out of 100 people):

• -symptoms of indigestion (heartburn, nausea, vomiting) and abdominal pain.

Uncommon (in 1 to 10 out of 10,000 people):

• inflammatory diseases of the stomach and intestines, gastric or duodenal ulcer disease;
• transient liver function disorders.

Rare or very rare:

• severe bleeding, such as gastrointestinal bleeding (symptoms: black stools), cerebral hemorrhage (especially in patients with uncontrolled hypertension and/or during concomitant use of anticoagulant medicines). Bleeding may lead to acute or chronic anemia due to blood loss and/or iron deficiency anemia (symptoms: weakness, pallor).

Very rare (less than 1 in 10,000 people):

• severe allergic reactions, including anaphylactic shock (symptoms: facial, eyelid, tongue, and throat swelling, significant blood pressure drop, and disturbances in heart rhythm and breathing);
• kidney function disorders;
• decreased blood glucose levels.

Additionally, the following have been reported:

• dizziness and tinnitus (symptoms of overdose);
• hypersensitivity reactions: rash, urticaria, edema, itching, heart and respiratory disorders (including asthma);
• increased risk of bleeding, prolonged bleeding time;
• perioperative bleeding, hematomas, bleeding (from the nose, genitourinary tract, gums).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should 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 pack and other information

What ACARD contains

• The active substance of the medicine is acetylsalicylic acid. Each enteric-coated tablet contains 75 mg of acetylsalicylic acid.
• The other ingredients are: powdered cellulose, cornstarch, sodium carboxymethylcellulose; coating: hypromellose, methacrylic acid copolymer type C, talc, titanium dioxide (E 171), anhydrous colloidal silica, sodium bicarbonate, sodium lauryl sulfate, triethyl citrate, anti-foaming agent.

What ACARD looks like and what the pack contains

ACARD tablets are white or almost white, heart-shaped, biconvex, with a smooth surface.
The packaging contains 30, 60, 90, or 120 enteric-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Date of last revision of the leaflet:February 2025