BONACARD 150 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Bonacard, 150 mg, Enteric-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Bonacard and what is it used for.
4. Important information before taking Bonacard.
   1. When not to take Bonacard:
   2. Warnings and precautions
   3. Children and adolescents
   4. Bonacard and other medicines
   5. Using Bonacard in patients with liver and (or) kidney function disorders
   6. Using Bonacard in elderly patients
   7. Using Bonacard with food, drink, and alcohol
   8. Pregnancy, breastfeeding, and fertility
   9. Driving and using machines
   10. Bonacard contains lactose.
   11. Bonacard contains sodium.
5. How to take Bonacard
   1. Taking a higher dose of Bonacard than recommended
   2. Missing a dose of Bonacard
6. Possible side effects
   1. Reporting side effects
7. How to store Bonacard
8. Contents of the pack and other information
   1. What Bonacard contains
   2. What Bonacard looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Information intended for healthcare professionals only
   7. Instructions for overdose:

Package Leaflet: Information for the Patient

Bonacard, 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 for the patient or as directed by a doctor, pharmacist, or nurse.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this package 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 Package Leaflet

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

1. What is Bonacard and what is it used for.

Bonacard 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. Bonacard is used:

• to prevent heart attacks in people at high risk,
• to prevent repeat heart attacks,
• in recent heart attacks or suspected recent heart attacks,
• in unstable angina,
• 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 they have occurred,
• in patients with atherosclerotic peripheral artery disease,
• 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 Bonacard.

When not to take Bonacard:

• 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 (e.g., hemophilia, thrombocytopenia) and is being treated with anticoagulant medications (e.g., coumarin derivatives, heparin),
• if the patient has stomach or duodenal ulcers,
• if the patient has severe kidney, liver, or heart failure,
• if the patient has had asthma attacks after taking acetylsalicylic acid or other anti-inflammatory medications (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 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 to take Bonacard, the patient should discuss it with their doctor, pharmacist, or nurse:

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

Children and adolescents

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

Bonacard and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Bonacard should not be taken at the same time as:

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

Taking Bonacard with the following medicines, after prior consultation with a doctor, 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 metamizole,
• with acetazolamide.

In the case of a need to use a dose of 75 mg, the patient should take a different medicinal product containing 75 mg of acetylsalicylic acid.

Using Bonacard 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 cases of severe liver and (or) kidney failure.

Using Bonacard in elderly patients

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

Using Bonacard with food, drink, and alcohol

The medicine should be taken during or after a meal. Alcohol may increase the risk of side effects related to the gastrointestinal tract.

Pregnancy, breastfeeding, and fertility

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 taking this medicine. Pregnancy Bonacard can be used in the first six months of pregnancy only after consulting a doctor. The medicine should not be used in the last trimester of pregnancy, as it may cause complications during the perinatal period, both in the mother and the newborn. Breastfeeding Acetylsalicylic acid passes into breast milk in small amounts. Before taking the medicine, the patient should consult their doctor. 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. Fertility This medicine belongs to a group of medicines that may adversely affect fertility in women. This effect is temporary and disappears after the end of treatment.

Driving and using machines

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

Bonacard contains lactose.

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Bonacard contains sodium.

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

3. How to take Bonacard

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse. Bonacard is available in a dose of 150 mg. The doctor will recommend the dose of the medicine suitable for the individual patient and determine the duration of treatment. The medicine should be taken orally, preferably during or after a meal, with a glass of water. The recommended dose is: 1 tablet of 150 mg per day. In recent heart attacks or in patients with suspected recent heart attacks, the initial loading dose is: 300 mg (2 tablets of 150 mg) of acetylsalicylic acid to quickly inhibit platelet aggregation. The tablets should be chewed very thoroughly to speed up absorption!

Taking a higher dose of Bonacard than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist, and in case of severe poisoning, the patient should be taken to the hospital emergency department immediately. Overdose in elderly people 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, hyperthermia (body temperature above normal values), have also been observed. In severe poisonings, disturbances of acid-base balance and water-electrolyte balance (metabolic acidosis and dehydration) occur.

Missing a dose of Bonacard

In case of missing a dose, the patient should take the next dose at the scheduled time. The patient should not take a double dose to make up for the missed dose. In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bonacard can cause side effects, although not everybody gets them. The patient should stop taking the medicine and contact their doctor immediately if they experience the first symptoms of hypersensitivity (e.g., facial swelling, lip swelling, tongue swelling, 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 assess the severity of the symptoms and decide on further action. After taking acetylsalicylic acid, the following side effects have occurred:

• -gastrointestinal upset (heartburn, nausea, vomiting) and abdominal pain.

Rarely (in 1 to 10 per 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, throat swelling, significant decrease in blood pressure, and disturbances of heart rhythm and breathing);
• kidney function disorders;
• decreased blood glucose levels.

Additionally, the following side effects have occurred:

• 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, from the genitourinary tract, from the gums). If any of the side effects get worse or if the patient experiences any side effects not listed in this package leaflet, they should tell their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor, 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 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. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Bonacard

The medicine should be stored out of 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: "Expiry Date (EXP)". "Expiry Date" means the last day of the month stated. "Lot" means batch number. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Bonacard contains

• The active substance of the medicine is acetylsalicylic acid. 1 tablet contains 150 mg of acetylsalicylic acid.
• The other ingredients are: microcrystalline cellulose; cellulose powder; starch glycolate; stearic acid; hypromellose; lactose monohydrate; macrogol 3350; titanium dioxide (E 171); triacetin; methacrylic acid copolymer type C; talc; silica colloidal anhydrous; sodium bicarbonate; sodium lauryl sulfate.

What Bonacard looks like and contents of the pack

Bonacard 150 mg enteric-coated tablets are round, white to cream-colored tablets. 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

Eubioco1 Sp. z o.o. ul. Franciszka Klimczaka 1 02-797 Warsaw tel. +48 89 648 00 78

Manufacturer

Laboratorium Galenowe Olsztyn Sp. z o.o. ul. Spółdzielcza 25 A 11-001 Dywity (logo of the marketing authorization holder)Eubioco1 Sp. z o.o. Date of last revision of the package leaflet:May 2023
-----------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only

Instructions for overdose:

The patient should be taken 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). This procedure is effective within 3-4 hours after taking the medicine, and in case of poisoning with a very large dose of the medicinal product, even up to 10 hours.
• Administer activated charcoal in the form of a water suspension (in a dose of 50,000-100,000 mg in adults and 30,000-60,000 mg in children) to reduce the absorption of acetylsalicylic acid.
• In case of hyperthermia, the body temperature should be reduced by maintaining a low environmental temperature and using cool compresses.
• Any disturbances of water-electrolyte balance should be closely monitored and quickly corrected.
• To accelerate the excretion of acetylsalicylic acid by the kidneys and to treat acidosis, sodium bicarbonate should be administered intravenously. The pH of the urine should be maintained at 7.0-7.5.
• In very severe poisonings, when it is not possible to correct the disturbances of acid-base balance with conservative treatment, and in cases of concurrent kidney failure, hemodialysis or peritoneal dialysis should be used. Dialysis effectively removes acetylsalicylic acid from the body and facilitates the correction of disturbances of acid-base balance and water-electrolyte balance.
• In cases of prolonged prothrombin time, vitamin K should be administered.
• Medications that act inhibitingly on the central nervous system, such as barbiturates, should not be used due to the possibility of respiratory acidosis and coma.
• Patients with respiratory disorders should be provided with fresh air, and oxygen should be administered. If necessary, tracheal intubation and assisted ventilation should be performed.
• In case of shock, standard anti-shock treatment should be used.