ACECARDIN 75 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Acecardin, 75 mg, enteric-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Acecardin and what is it used for
4. Important information before taking Acecardin
   1. When not to take Acecardin:
   2. Warnings and precautions
   3. Children and adolescents
   4. Acecardin and other medications
   5. Using Acecardin in patients with liver and (or) kidney function disorders
   6. Using Acecardin in elderly patients
   7. Using Acecardin with food, drink, and alcohol
   8. Pregnancy, breastfeeding, and fertility
   9. Pregnancy
   10. Pregnancy - last trimester
   11. Pregnancy - first and second trimester
   12. Breastfeeding
   13. Fertility
   14. Driving and using machines
   15. Acecardin contains lactose
   16. Acecardin contains sodium
5. How to take Acecardin
   1. Taking a higher dose of Acecardin than recommended
   2. Missing a dose of Acecardin
6. Possible side effects
   1. Reporting side effects
7. How to store Acecardin
8. Contents of the pack and other information
   1. What Acecardin contains
   2. What Acecardin looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. Date of last revision of the leaflet: 03/2025
   7. Information intended for healthcare professionals only
   8. Instructions for overdose:

Leaflet accompanying the packaging: patient information

Acecardin, 75 mg, enteric-coated tablets

Acetylsalicylic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Take this medicine always exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

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

Table of contents of the leaflet

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

1. What is Acecardin and what is it used for

Acecardin contains the active substance 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.

Acecardin is used:

• to prevent heart attack in people at high risk,
• to prevent a second heart attack,
• in recent myocardial infarction or suspected recent myocardial infarction,
• in unstable angina pectoris,
• after surgical or interventional procedures on blood vessels, such as coronary artery bypass grafting or coronary angioplasty,
• to prevent transient cerebral ischemic attacks 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 bedridden for a long time.

2. Important information before taking Acecardin

When not to take Acecardin:

• 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 (e.g., hemophilia, thrombocytopenia) and if you are being treated with anticoagulant medications (e.g., coumarin derivatives, heparin),
• if you have stomach or duodenal ulcer disease,
• if you have severe kidney, liver, or heart failure,
• if you have had asthma attacks after taking acetylsalicylic acid or other anti-inflammatory medications (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, breastfeeding, and fertility"),
• if you are taking methotrexate (a medication 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 Acecardin, discuss it with your doctor or pharmacist:

• if you are allergic to anti-inflammatory and anti-rheumatic medications (e.g., naproxen) or other allergens,
• if you have asthma, chronic respiratory diseases, or nasal polyps,
• if you have had stomach or intestinal ulcers,
• if you have kidney or liver function disorders, as there is a risk of increased side effects of the medicine,
• do not take Acecardin for at least 5 days before scheduled surgery (including minor procedures, e.g., tooth extraction),
• if you are taking oral anti-diabetic medications from the sulfonylurea group, due to the risk of increased hypoglycemic effect (lowering blood glucose levels), and if you are taking anti-hypertensive medications,
• if you are taking ibuprofen,
• in patients with juvenile rheumatoid arthritis and (or) systemic lupus erythematosus, and with impaired liver function, as the toxicity of salicylates increases; in these patients, liver function should be monitored,
• if you experience menstrual bleeding, excessive menstrual bleeding, during the use of an intrauterine contraceptive device, in hypertension, heart failure,
• if you have a deficiency of glucose-6-phosphate dehydrogenase (a rare hereditary disease),
• in the first and second trimester of pregnancy,
• during breastfeeding,
• if you are taking metamizole, as it may reduce the effect of acetylsalicylic acid on platelet aggregation.

Children and adolescents

Acecardin should not be used in children under 12 years of age.

Acecardin and other medications

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

Do not take Acecardin at the same time as:

• methotrexate in doses of 15 mg per week or higher,

Taking Acecardin after consulting a doctor with the medications listed below requires special caution:

• with other non-steroidal anti-inflammatory medications, including salicylates,
• with ibuprofen,
• with anticoagulant medications (heparin, coumarin derivatives),
• with medications used to treat gout (e.g., probenecid, benzbromarone),
• with oral anti-diabetic medications (e.g., tolbutamide, glibenclamide) and insulin,
• with medications that inhibit platelet aggregation (e.g., ticlopidine),
• with medications used to treat depression and anxiety (e.g., fluoxetine, paroxetine),
• with diuretics (e.g., furosemide),
• with systemic glucocorticosteroids,
• with anti-hypertensive medications (e.g., enalapril, captopril),
• with valproic acid (an anti-epileptic medication),
• with methotrexate in doses less than 15 mg per week,
• with digoxin (a heart medication),
• with thrombolytic medications (e.g., streptokinase and alteplase),
• with acetazolamide.

Using Acecardin in patients with liver and (or) kidney function disorders

In patients with liver and (or) kidney function disorders, there is a risk of increased side effects of the medicine, so it may be necessary to adjust the dose depending on the severity of liver and (or) kidney failure.

The medicine is contraindicated in case of severe liver and (or) kidney failure.

Using Acecardin in elderly patients

In elderly patients (over 65 years), Acecardin should be used with caution, under medical supervision, due to the increased risk of side effects in this age group.

Using Acecardin with food, drink, and alcohol

Take the medicine with or after a meal.

Alcohol may increase the risk of gastrointestinal side effects.

Pregnancy, breastfeeding, and fertility

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 Acecardin during pregnancy, according to your doctor's instructions, take the medicine as directed by your doctor and do not exceed the recommended dose.

Pregnancy - last trimester

Do not take more than 100 mg of Acecardin per day if you are in the last three months of pregnancy, as this may harm the unborn child or cause complications during delivery.

Taking Acecardin may cause kidney and heart function 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 are taking Acecardin in small doses (up to 100 mg per day), close obstetric monitoring is necessary, according to your doctor's instructions.

Pregnancy - first and second trimester

Do not take Acecardin during the first six months of pregnancy, unless your doctor considers it absolutely necessary and recommends it.

If treatment is necessary during this period or during attempted pregnancy, use the smallest effective dose of the medicine for the shortest possible time.

Taking Acecardin 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 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 amounts.

Before taking the medicine, consult your doctor.

Short-term use of the medicine by a breastfeeding woman does not pose a significant risk to the breastfed child.

However, long-term use of high doses of acetylsalicylic acid is not recommended during breastfeeding.

Fertility

Information on the effect of this medicine on fertility is limited or not available.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

Acecardin contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

Acecardin contains sodium

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

3. How to take Acecardin

Always take this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

If you are unsure, consult your doctor or pharmacist.

Acecardin is available in a dose of 75 mg.

Your doctor will recommend the dose of the medicine suitable for you and determine the duration of treatment.

Take the medicine orally, preferably with or after a meal, with a glass of water.

The recommended dose is: 1-2 tablets of 75 mg per day.

In recent myocardial infarction or in patients with suspected recent myocardial infarction, the initial loading dose is: 300 mg (4 tablets of 75 mg) of acetylsalicylic acid to quickly inhibit platelet aggregation.

Chew the tablets very thoroughly to speed up absorption!

Taking a higher dose of Acecardin than recommended

If you take more than the recommended dose, consult your doctor or pharmacist immediately, and in case of severe poisoning, take the patient to the hospital emergency department immediately.

Overdose in elderly patients and small children (taking higher doses than recommended or accidental poisoning) requires special attention, as it can lead to death in these patient groups.

After an overdose of acetylsalicylic acid, the following symptoms may occur: nausea, vomiting, rapid breathing, tinnitus.

Other symptoms, such as hearing loss, vision disturbances, headaches, restlessness, drowsiness, and coma, seizures, and hyperthermia (body temperature above normal values), have also been observed.

In severe poisonings, metabolic acidosis and water-electrolyte disorders (metabolic acidosis and dehydration) occur.

Missing a dose of Acecardin

If you miss a dose, take the next dose at the scheduled time.

Do not take a double dose to make up for the missed dose.

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

4. Possible side effects

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

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

After taking acetylsalicylic acid, the following side effects 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, stomach and (or) duodenal ulcers;
• 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 administration of medications that inhibit bleeding).

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 swelling, eyelid swelling, tongue swelling, and laryngeal edema, 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 hemorrhage, hematomas, bleeding (from the nose, from the genitourinary tract, from the gums).

If any of the side effects get worse or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Acecardin

Keep the medicine out of the sight and reach of children.

Store in a temperature below 25°C.

Do not use this medicine after the expiry date stated on the carton and blister after EXP.

The expiry date refers to the last day of the month stated.

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 Acecardin contains

• The active substance of the medicine is acetylsalicylic acid.
• Each tablet contains 75 mg of acetylsalicylic acid.
• The other ingredients are: microcrystalline cellulose; cellulose powder; pregelatinized starch; stearic acid; hypromellose; lactose monohydrate; macrogol 3350; triacetin; methacrylic acid and ethyl acrylate copolymer type A; talc; triethyl citrate; sodium bicarbonate; anhydrous colloidal silica; sodium lauryl sulfate.

What Acecardin looks like and contents of the pack

Acecardin 75 mg is a round, biconvex, enteric-coated tablet, white to cream-colored, with a diameter of 6 mm.

The pack contains 15, 30, 60, 90, or 120 enteric-coated tablets in PVC/PVDC/Aluminum blisters, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Dr. Max Pharma s.r.o.

Na Florenci 2116/15

Nové Město

110 00 Prague 1

Czech Republic

tel.: (+420) 516 770 199

Manufacturer:

Laboratorium Galenowe Olsztyn Sp. z o.o.

ul. Spółdzielcza 25 A

11-001 Dywity

(logo of the marketing authorization holder)Dr. Max Pharma s.r.o.

Date of last revision of the leaflet: 03/2025

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Information intended for healthcare professionals only

Instructions for overdose:

Take the patient to the hospital emergency department.

There is no specific antidote.

Treatment of overdose:

• Induce vomiting or perform gastric lavage (to reduce absorption of the medicine).
• Administer activated charcoal in the form of a water suspension (in a dose of 50-100 g in adults and 30-60 g in children) to reduce absorption of acetylsalicylic acid.
• In case of hyperthermia, reduce body temperature by maintaining a low environmental temperature and applying cool compresses.
• Closely monitor water-electrolyte disorders and correct them promptly.
• To accelerate the elimination of acetylsalicylic acid by the kidneys and to treat acidosis, administer sodium bicarbonate intravenously.
• Maintain a urine pH of 7.0-7.5.
• In very severe poisonings, when it is not possible to correct water-electrolyte disorders with conservative treatment, and in cases of concurrent kidney failure, use hemodialysis or peritoneal dialysis.
• Dialysis effectively removes acetylsalicylic acid from the body and helps correct water-electrolyte and acid-base disorders.
• In cases of prolonged prothrombin time, administer vitamin K.
• Do not use medications that act on the central nervous system, such as barbiturates, due to the risk of respiratory acidosis and coma.
• Ensure a supply of fresh air to patients with respiratory disorders, administer oxygen, and if necessary, perform endotracheal intubation and provide assisted ventilation.
• In case of shock, use standard anti-shock treatment.