Acard

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

ACARD(Акард)

75 mg, enteric-coated tablets

Acetylsalicylic acid
ACARD and Акард are trade names of the same medicine written in Polish and Bulgarian languages.

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.

• You should keep this leaflet, so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their 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. 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 aortocoronary bypass grafting, coronary angioplasty;
• to prevent transient cerebral ischemia and ischemic stroke, as well as after their occurrence;
• in patients 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.

2. Important information before taking ACARD

When not to take ACARD:

• if the patient is allergic to acetylsalicylic acid, other salicylates, or any of the other ingredients of this medicine (listed in section 6.);
• if the patient has an increased tendency to bleeding and coagulation disorders;
• if the patient has gastric or duodenal ulcer disease;
• if the patient has severe kidney or liver problems (severe renal or hepatic insufficiency);
• if the patient has had asthma attacks after taking acetylsalicylic acid or other anti-inflammatory drugs (symptoms: shortness of breath, wheezing);
• if the patient is in the third trimester of pregnancy (the last three months of pregnancy);
• if the patient is 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 to take ACARD, you should discuss it with your doctor or pharmacist:

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

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

ACARD and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as about the medicines you plan to take.

• Do not take ACARD at the same time as:
• methotrexate in doses of 15 mg per week or higher;
• ibuprofen.
• You can take ACARD after prior consultation with 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);
• 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 (platelet aggregation and clot formation) if these medicines are taken at the same time. Therefore, caution should be exercised when taking 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, you should consult your doctor or pharmacist before taking this medicine.
ACARD can be used in the first 6 months of pregnancy only after consultation with a doctor.
Taking the medicine in the last three months of pregnancy is contraindicated, as it may cause complications in the mother and the child.
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 and use machines.

ACARD 75 mg 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

This medicine should always be taken exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. You should consult your doctor before starting to take ACARD.
ACARD is available in two doses: 75 mg and 150 mg. The doctor will prescribe the dose of the medicine suitable for the patient and determine the duration of treatment.
Take orally.

• Usually, the following dosing is recommended:

1 tablet (75 mg) per day.
The 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:

one-time 4 enteric-coated tablets (300 mg). The tablets should be chewed very thoroughly to accelerate absorption.
Warning: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, 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.

Missing a dose of ACARD

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

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. The 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:

• -serious bleeding, such as gastrointestinal bleeding (symptoms: black stools), cerebral hemorrhage (especially in patients with uncontrolled hypertension and/or during concomitant administration of bleeding-inhibiting medicines). Bleeding can 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 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 any side effects not listed in the leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ACARD

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

• The active substance of the medicine is acetylsalicylic acid. Each enteric-coated tablet contains 75 mg of acetylsalicylic acid.
• The other ingredients are: cellulose, powder, corn starch, sodium carboxymethylcellulose (type C); coating: hypromellose, triethyl citrate, simethicone emulsion, Acryl-Eze White: methacrylic acid and ethyl acrylate copolymer (1:1), talc, titanium dioxide (E 171), colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate.

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.

What ACARD looks like and what the pack contains

ACARD tablets are white or almost white, heart-shaped, biconvex, with a smooth surface.
The pack contains 30, 60, 90, or 120 enteric-coated tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Polpharma S.A.
Pelplińska 19
83-200 Starogard Gdański
Poland

Manufacturer:

Polpharma S.A.
Pelplińska 19
83-200 Starogard Gdański
Poland
Polpharma S.A.
Production Plant in Nowa Dęba
Metalowca 2
39-460 Nowa Dęba
Poland

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Bulgaria, the country of export: 20170037
Parallel import authorization number: 198/23

Date of leaflet approval: 18.09.2023

[Information about the trademark]