Acard

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

ACARD (АКАРД)

75 mg, enteric-coated tablets

Acetylsalicylic acid
ACARD and АКАРД are the same trade names of the same drug written in Polish and Bulgarian.

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 as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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 using ACARD
• 3. How to use ACARD
• 4. Possible side effects
• 5. How to store ACARD
• 6. Contents of the packaging 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 attacks in people at high risk;
• in recent myocardial infarction or suspected recent myocardial infarction;
• in unstable angina;
• to prevent repeated heart attacks;
• 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 who are immobilized for a long time.

2. Important information before using ACARD

When not to use 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 use 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 allergens - see "When not to use 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.
• ACARD should not be used 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 medicines you are taking or have recently taken, as well as any medicines you plan to take.

• Do not use ACARD at the same time as:
• methotrexate in doses of 15 mg per week or higher;
• ibuprofen.
• ACARD can be used after prior consultation with a 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 (platelet adhesion and clot formation) if these medicines are used 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
ACARD can be used in the first 6 months of pregnancy only after consultation with a doctor.
Using the medicine in the last three months of pregnancy is contraindicated, as it may cause complications in the mother and child.
Short-term use of the medicine by a breastfeeding woman does not pose a significant risk to the breastfed child. However, breastfeeding is not recommended 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 it is considered "sodium-free".

3. How to use ACARD

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
You should consult your doctor before starting to use ACARD.
ACARD is available in two doses: 75 mg and 150 mg. The doctor will prescribe the appropriate dose for the patient and determine the duration of use.
Take orally.

• •The usual recommended dose is:1 tablet (75 mg) per day. Enteric-coated tablets should be taken after a meal - swallowed 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:

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

Using 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, but take the next dose as usual.

Stopping the use of ACARD

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

4. Possible side effects

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

You should stop using 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.

The doctor will then assess the severity of the symptoms and decide on further action.
After using 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):

• inflammation 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 bleeding-inhibiting medicines). Bleeding can 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 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;
• peroperative 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 inform your doctor, 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
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging 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.

What ACARD looks like and what the packaging 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.
For more detailed information, you should contact the marketing authorization holder or 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:

Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Number of the permit in Bulgaria, the country of export: 20170037

Number of the parallel import permit: 387/22 Date of approval of the leaflet: 24.10.2022

[Information about the trademark]