Acard 150 mg

Package Leaflet: Information for the Patient

ACARD 150 mg, 150 mg, enteric-coated tablets

Acetylsalicylic acid

Read the package 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 package leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or further information, you should speak to your 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 you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Acard 150 mg and what is it used for
• 2. Important information before taking Acard 150 mg
• 3. How to take Acard 150 mg
• 4. Possible side effects
• 5. How to store Acard 150 mg
• 6. Contents of the pack and other information

1. What is Acard 150 mg and what is it used for

Acard 150 mg contains acetylsalicylic acid, which inhibits platelet aggregation (clumping).
The medicine is intended for long-term, preventive use in diseases that threaten the formation of blood clots and emboli in blood vessels.
Acard 150 mg is used:

• to prevent heart attacks in people at high risk;
• in recent myocardial infarction or suspected recent myocardial infarction;
• after an episode of unstable angina;
• to prevent repeated heart attacks;
• after surgical or interventional procedures on blood vessels, such as coronary artery bypass grafting or coronary angioplasty;
• to prevent transient ischemic attacks and ischemic strokes, 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 who are immobilized for a long time.

The decision to start treatment and the dose of the medicine is made by the doctor.

2. Important information before taking Acard 150 mg

When not to take Acard 150 mg

• 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 coagulation disorders;
• if you have gastric or duodenal ulcer disease;
• if you have severe kidney, liver, or heart disease (severe renal, liver, or heart failure);
• 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, you should not take doses higher than 100 mg per day (see section "Pregnancy and breastfeeding");
• if you have gout;
• if you have a congenital deficiency of glucose-6-phosphate dehydrogenase (a rare hereditary disease);
• if you are taking methotrexate (a medicine used to treat cancer) in doses of 15 mg per week or higher;
• in children and adolescents under 16 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 150 mg, you should discuss it with your doctor or pharmacist:

• if you are allergic to anti-inflammatory and anti-rheumatic drugs (e.g., naproxen) or other allergenic substances - see subsection "When not to take Acard 150 mg";
• if you have asthma, chronic respiratory diseases, or nasal polyps;
• if you have had gastric or intestinal ulcer disease;
• if you have kidney or liver function disorders, as there is a risk of exacerbating the medicine's side effects.

You should not take Acard 150 mg for at least 5 days before a planned surgical procedure (including minor procedures, e.g., tooth extraction).

Children and adolescents

Do not use in children and adolescents under 16 years of age.

Acard 150 mg 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 150 mg at the same time as:
• methotrexate in doses of 15 mg per week or higher.
• You can take Acard 150 mg 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);
• diuretic medicines (e.g., furosemide);
• systemic glucocorticosteroids;
• antihypertensive medicines (e.g., enalapril, captopril);
• valproic acid (an antiepileptic medicine);
• cyclosporin and tacrolimus;
• methotrexate in doses less than 15 mg per week;
• ibuprofen;
• digoxin (a heart medicine).
• Metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping) if taken simultaneously. Therefore, caution should be exercised when using metamizole in patients receiving acetylsalicylic acid.

Acard 150 mg with food, drink, and alcohol

The medicine should be taken after a meal - swallowed whole.
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, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you continue or start treatment with Acard 150 mg during pregnancy according to your doctor's recommendations, you should take the medicine as directed and not exceed the recommended dose.
Pregnancy - last trimester
Acetylsalicylic acid should not be taken in doses higher than 100 mg per day in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Taking Acard 150 mg 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 recommendations.
Pregnancy - first and second trimester
Acard 150 mg should not be taken during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by your doctor. If treatment is necessary during this period or when trying to conceive, the smallest effective dose of the medicine should be used for the shortest possible time. Acard 150 mg 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 blood vessel (ductus arteriosus) in the child's heart. If longer treatment is necessary, your doctor may recommend additional monitoring.
Breastfeeding
Acetylsalicylic acid passes into breast milk in small concentrations, so you should not take the medicine while breastfeeding, due to the risk of Reye's syndrome in the child. If you take high doses of acetylsalicylic acid while breastfeeding, it may cause platelet function disorders in the child.

Driving and using machines

Acard 150 mg does not affect the ability to drive or use machines.

Acard 150 mg contains sodium

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

3. How to take Acard 150 mg

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.
You should consult your doctor before starting treatment with Acard 150 mg.
Your doctor will recommend the dose of the medicine suitable for you and determine the duration of treatment.
Oral use.

• Typically, the following dosage is recommended:

1 enteric-coated tablet (150 mg) per day.
The enteric-coated tablets should be taken after a meal - swallowed whole.
The enteric-coated tablet of Acard 150 mg 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:

Initially, 2 enteric-coated tablets (300 mg). 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.

Overdose of Acard 150 mg

In case of overdose, you should contact your doctor, and in case of severe poisoning, the patient should be taken 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.

Missed dose of Acard 150 mg

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 150 mg

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.

You should 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 if bleeding occurs, e.g., from the gastrointestinal tract (symptoms: black stools) or hemorrhages. Your doctor will then assess the severity of the symptoms and decide on further action.

After taking acetylsalicylic acid, the following have been reported:

Frequently (in 1 to 10 out of 100 people):

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

Rarely (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.

Rarely or very rarely:

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

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

• severe allergic reactions, including anaphylactic shock (symptoms: facial, eyelid, tongue, and throat swelling, significant decrease in blood pressure, and disorders of 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;
• postoperative bleeding, hematomas, bleeding (from the nose, urinary and genital tract, gums).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Acard 150 mg

Do not store above 25°C. Store in the original packaging to protect from moisture.
The medicine should be stored out of 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 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 pack and other information

What Acard 150 mg contains

• The active substance of the medicine is acetylsalicylic acid. Each enteric-coated tablet contains 150 mg of acetylsalicylic acid.
• The other ingredients are: cellulose powder, corn starch, sodium carboxymethylcellulose; coating: hypromellose, Acryl Eze-White (methacrylic acid and ethyl acrylate copolymer (1:1)), talc, titanium dioxide (E 171), colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate), triethyl citrate, simethicone emulsion.

What Acard 150 mg looks like and contents of the pack

Acard 150 mg tablets are white or almost white, round, biconvex, with a smooth surface.
Aluminum/PVC/PVDC blister pack in a cardboard box.
The pack 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