Acard Pro

Package Leaflet: Information for the Patient

Acard PRO, 100 mg, enteric-coated tablets

Acetylsalicylic acid

Read the package leaflet carefully before taking the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Acard PRO contains acetylsalicylic acid, which inhibits platelet aggregation.
The medicine is intended for long-term, preventive use in diseases where there is a risk of thrombosis and embolism in blood vessels.
Acard PRO is used:

• to prevent myocardial infarction in people with high risk;
• in acute myocardial infarction or suspected acute myocardial infarction;
• after an episode of unstable angina;
• to prevent recurrent myocardial infarction;
• after surgical or interventional procedures on blood vessels, e.g. 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 who are immobilized for a long time, e.g. after major surgery, as a supplement to other methods of prophylaxis.

The decision to start treatment with acetylsalicylic acid and the dose used should be made by a doctor.

2. Important information before taking Acard PRO

When not to take Acard PRO

• 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, hepatic, 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, do 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 PRO, 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 subsection "When not to take Acard PRO";
• 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 side effects of the medicine.

Do not take Acard PRO for at least 5 days before scheduled surgery (including minor procedures, e.g. tooth extraction).

Children and adolescents

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

Acard PRO 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 PRO at the same time as:
• methotrexate in doses of 15 mg per week or higher.
• You can take Acard PRO 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);
• medicines used to prevent transplant rejection (e.g. cyclosporine and tacrolimus);
• methotrexate in doses less than 15 mg per week (a medicine used to treat cancer or rheumatoid diseases);
• ibuprofen;
• digoxin (a heart medicine).
• Metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (platelet aggregation and clot formation) if these medicines are taken at the same time. Therefore, caution should be exercised when using metamizole in patients receiving acetylsalicylic acid.

Acard PRO with food, drink, and alcohol

Take the medicine after a meal - swallow 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, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you continue or start treatment with Acard PRO during pregnancy in accordance with your doctor's recommendations, you should take Acard PRO as recommended and not take a higher dose than recommended.
Pregnancy - last trimester
Do not take acetylsalicylic acid in a dose 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 PRO 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 delivery.
If you take acetylsalicylic acid in small doses (up to 100 mg per day), close obstetric monitoring is necessary in accordance with your doctor's recommendations.
Pregnancy - first and second trimester
Do not take Acard PRO 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 during attempted pregnancy, the smallest effective dose of the medicine should be used for the shortest possible time. Acard PRO taken for a period longer 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
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 PRO does not affect the ability to drive or use machines.

Acard PRO contains sodium

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

3. How to take Acard PRO

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Oral administration.

• Typically, the following dosage is recommended:

1 enteric-coated tablet (100 mg) per day.
Enteric-coated tablets should be taken after a meal - swallow whole.
The enteric-coated tablet of Acard PRO has a coating and does not disintegrate in the stomach, which reduces the irritating effect of acetylsalicylic acid on the gastric mucosa.

• In acute myocardial infarction or suspected acute myocardial infarction:

Single dose of 3 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.

• Prevention of venous thrombosis and pulmonary embolism in patients who are immobilized for a long time, e.g. after major surgery, as a supplement to other methods of prophylaxis:

From 1 to 2 enteric-coated tablets (from 100 mg to 200 mg) per day.

Overdose of Acard PRO

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 disorders, 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 PRO

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

Stopping treatment with Acard PRO

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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, 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 per 100 people):

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

Rare (in 1 to 10 per 10,000 people):

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

Rare or very rare:

• serious 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 rare (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;
• peroperative 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 Monitoring of Adverse Reactions to 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 the medicine.

5. How to store Acard PRO

Keep the medicine out of the sight and reach of children.
Do not store above 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 stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. 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 PRO contains

• The active substance of the medicine is acetylsalicylic acid. Each enteric-coated tablet contains 100 mg of acetylsalicylic acid.
• The other ingredients are: cellulose powder, corn starch, sodium carboxymethylcellulose (type C); 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 PRO looks like and contents of the pack

Acard PRO is a white, oval, enteric-coated tablet.
Aluminium/PVC/PVDC blister pack in a cardboard box.
The pack contains 30, 60, 90, or 120 enteric-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: