Bonacard

Package leaflet: Information for the patient

Bonacard, 150 mg, enteric-coated tablets
Acetylsalicylic acid
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet, or as directed by
the doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse, contact your doctor.

Table of contents

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

Bonacard contains the active substance acetylsalicylic acid, which inhibits platelet aggregation (clumping). This medicine is intended for long-term, prophylactic use in diseases associated with risk of thrombus and embolus formation in blood vessels.
Bonacard is used:

• to prevent myocardial infarction in individuals at high risk,
• to prevent recurrent myocardial infarction,
• in acute myocardial infarction or suspected acute myocardial infarction,
• in unstable angina pectoris,
• following surgical or interventional procedures on blood vessels, e.g. coronary artery bypass grafting, coronary angioplasty,
• to prevent transient ischaemic attacks and ischaemic stroke, as well as after such events,
• in patients with atherosclerotic peripheral arterial disease,
• to prevent coronary thrombosis in patients with multiple risk factors,
• to prevent venous thrombosis and pulmonary embolism in patients who are immobilised for prolonged periods.

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 bleed or blood clotting disorders (e.g. haemophilia, thrombocytopenia), or if the patient is being treated simultaneously with anticoagulant drugs (e.g. coumarin derivatives, heparin),
• if the patient has peptic ulcer disease of the stomach and/or duodenum,
• if the patient has severe renal, hepatic, or cardiac insufficiency,
• if the patient has previously experienced 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 drug used in cancer treatment) at doses of 15 mg per week or higher,
• in children under 12 years of age with viral infections (e.g. influenza or chickenpox), due to the risk of liver and brain damage (Reye's syndrome).

Warnings and precautions
Before starting treatment with Bonacard, consult a doctor, pharmacist, or nurse:

• if the patient is allergic to anti-inflammatory and anti-rheumatic drugs (e.g. naproxen) or other allergenic substances,
• if the patient suffers from asthma, chronic respiratory diseases, or nasal polyps,
• if the patient has a history of peptic ulcer disease of the stomach or intestines,
• if the patient has impaired kidney and/or liver function, as this may increase the risk of adverse effects of the drug,
• do not use Bonacard for at least 5 days before any planned surgical procedure (including minor procedures such as tooth extraction),
• if the patient is taking oral antidiabetic sulfonylurea drugs, due to the risk of enhanced hypoglycaemic effect (reduced blood glucose concentration), and if the patient is taking antihypertensive drugs,
• if the patient is taking ibuprofen simultaneously,
• in patients with juvenile rheumatoid arthritis and/or systemic lupus erythematosus and impaired liver function, as salicylate toxicity may increase; liver function should be monitored in these patients,
• if uterine bleeding, excessive menstrual bleeding occurs, or when using an intrauterine contraceptive device, in hypertension, heart failure,
• if the patient has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder),
• during the first and second trimesters of pregnancy,
• during breastfeeding,
• if the patient is taking metamizole simultaneously, as it may reduce the inhibitory effect of acetylsalicylic acid on platelet aggregation.

Children and adolescents
Bonacard must not be used in children under 12 years of age.
Bonacard with other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Do not use Bonacard simultaneously with:

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

Use of Bonacard, after prior consultation with a doctor, together with the following medicines requires special caution:

• other non-steroidal anti-inflammatory drugs, including salicylates,
• ibuprofen,
• anticoagulants (heparin, coumarin derivatives),
• drugs used in gout (e.g. probenecid, benzbromarone),
• antidiabetic drugs – oral (e.g. tolbutamide, glibenclamide) and insulin,
• drugs inhibiting platelet aggregation (e.g. ticlopidine),
• drugs used in the treatment of depression and anxiety (e.g. fluoxetine, paroxetine),
• diuretics (e.g. furosemide),
• systemic glucocorticoids,
• antihypertensive drugs (e.g. enalapril, captopril),
• valproic acid (an antiepileptic drug),
• methotrexate at doses less than 15 mg per week,
• digoxin (a cardiac drug),
• thrombolytic drugs (e.g. streptokinase, alteplase),
• metamizole,
• acetazolamide.

If a 75 mg dose is required, another medicinal product containing 75 mg of acetylsalicylic acid should be used.
Use of Bonacard in patients with impaired liver and/or kidney function
In patients with impaired liver and/or kidney function, there is an increased risk of adverse effects; therefore, dose adjustment may be necessary depending on the severity of liver and/or kidney insufficiency.
Bonacard is contraindicated in cases of severe liver and/or kidney failure.
Use of Bonacard in elderly patients
In elderly patients (over 65 years of age), Bonacard should be used with particular caution and under medical supervision due to the increased risk of adverse effects in this age group.
Taking Bonacard with food, drink, and alcohol
The medicine should be taken during or after a meal.
Alcohol may increase the risk of gastrointestinal adverse effects.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to conceive, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Bonacard may be used during the first 6 months of pregnancy only after consultation with a doctor.
The medicine must not be used during the last trimester of pregnancy, as it may cause complications in the perinatal period for both mother and newborn.
Breastfeeding
Acetylsalicylic acid passes into breast milk in small amounts. Consult a doctor before using the medicine.
Short-term use of the medicine by a breastfeeding woman does not pose a significant risk to the breastfed infant. However, breastfeeding is not recommended during long-term treatment with high doses of acetylsalicylic acid.
Effect on fertility
This medicine belongs to a group of drugs that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.
Driving and operating machinery
Bonacard has no influence on the ability to drive or operate machinery.
Bonacard contains lactose.
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Bonacard contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium in the recommended dose (1 tablet), meaning the medicine is considered "sodium-free".

3. How to take Bonacard

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Bonacard is available in a 150 mg strength. Your doctor will determine the appropriate dose for you and how long you should take the medicine.

The medicine should be taken orally, preferably during or after a meal, with water.

The recommended dose is: 1 tablet of 150 mg daily.

In the case of acute myocardial infarction or in patients with suspected acute myocardial infarction, the initial loading dose is:

A single dose of 300 mg (2 tablets of 150 mg) of acetylsalicylic acid to achieve rapid inhibition of platelet aggregation. The tablets should be thoroughly chewed to accelerate absorption!

Taking more Bonacard than recommended

If you take more medicine than recommended, contact your doctor or pharmacist immediately. In cases of severe poisoning, the patient should be taken immediately to a hospital emergency department.

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

After an overdose of acetylsalicylic acid, symptoms may include nausea, vomiting, rapid breathing, and tinnitus (ringing in the ears).

Other observed symptoms include: hearing loss, visual disturbances, headache, motor agitation, drowsiness and coma, seizures, and hyperthermia (body temperature above normal).

In severe poisoning, disturbances in acid-base and water-electrolyte balance may occur (metabolic acidosis and dehydration).

If you forget to take Bonacard

If you miss a dose, take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Treatment should be discontinued and immediate contact with a physician must be established if the patient
experiences first signs of hypersensitivity (e.g. swelling of the face, lips, tongue, throat, causing
difficulty in breathing or swallowing) or if bleeding occurs, such as gastrointestinal bleeding
(symptoms: black stools), or haemorrhage. The physician will then assess the severity of symptoms and decide
on further management.

Following administration of acetylsalicylic acid, the following adverse effects have been observed:

Common (in 1 to 10 out of 100 people):

• Gastrointestinal discomfort (dyspepsia, nausea, vomiting) and abdominal pain.

Uncommon (in 1 to 10 out of 10,000 people):

• Inflammation of the stomach and intestines, gastric and/or duodenal ulceration;
• Transient disturbances in liver function.

Uncommon or rare:

• Severe bleeding such as gastrointestinal haemorrhage (symptoms: black stools), cerebral haemorrhage (particularly in patients with uncontrolled arterial hypertension and/or when administered concomitantly with drugs inhibiting blood coagulation).

Haemorrhage may lead to acute or chronic anaemia due to blood loss and/or iron deficiency anaemia (symptoms: weakness, pallor).

Rare (less than 1 in 10,000 people):

• Severe allergic reactions, including anaphylactic shock (symptoms: swelling of the face, eyelids, tongue and larynx, significant drop in blood pressure, and disturbances in heart rhythm and respiration);
• Impaired kidney function;
• Decreased blood glucose concentration.

Other reported adverse effects include:

• Dizziness and tinnitus (symptoms of overdose);
• Hypersensitivity reactions: rash, urticaria, angioedema, pruritus, cardiac and respiratory disorders (including asthma);
• Increased risk of bleeding, prolonged bleeding time;
• Perioperative haemorrhage, bruising, bleeding (from nose, urinary and genital tract, gums).

If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Effects of Medicinal Products, Medical Devices and Biological 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Bonacard

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
"Expiry date (EXP)". The "Expiry date" refers to the last day of the stated month. "Lot" indicates the batch number.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Bonacard contains

• The active substance is acetylsalicylic acid. Each tablet contains 150 mg of acetylsalicylic acid.
• Other ingredients are: microcrystalline cellulose; cellulose, powder; pregelatinized starch; stearic acid; hypromellose; lactose monohydrate; macrogol 3350; titanium dioxide (E 171); triacetin; methacrylic acid copolymer type C; talc; colloidal anhydrous silica; 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-coloured tablets.
The pack contains 15, 30, 60, 90 or 120 enteric-coated tablets in PVC/PVDC/Aluminium blisters in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorisation holder) Eubioco1 Sp. z o.o.

Information intended exclusively for healthcare professionals

Instructions for management in case of overdose:
The patient should be transported to a hospital emergency department.
There is no specific antidote.
Treatment of overdose:

• Induce vomiting or perform gastric lavage (to reduce drug absorption). This procedure is effective within 3–4 hours after drug intake, and in cases of poisoning with a very large dose, even up to 10 hours.
• Administer activated charcoal as an aqueous suspension (dose: 50,000–100,000 mg in adults, and 30,000–60,000 mg in children) to reduce absorption of acetylsalicylic acid.
• In case of hyperthermia, reduce body temperature by maintaining a low ambient temperature and applying cool compresses.
• Closely monitor water-electrolyte imbalances and correct them promptly.
• To accelerate renal excretion of acetylsalicylic acid and in the treatment of acidosis, administer intravenous sodium bicarbonate. Maintain urine pH at 7.0–7.5.
• In very severe poisonings, when acid-base disturbances cannot be corrected by conservative treatment, or in cases of concomitant renal failure, hemodialysis or peritoneal dialysis should be performed. Dialysis effectively removes acetylsalicylic acid from the body and facilitates correction of acid-base and water-electrolyte imbalances.
• In cases of prolonged prothrombin time, administer vitamin K.
• Do not use central nervous system depressants, such as barbiturates, due to the risk of respiratory acidosis and coma.
• Patients with respiratory disturbances should be provided with fresh air and oxygen. If necessary, perform endotracheal intubation and apply assisted ventilation.
• In case of shock, apply standard anti-shock measures.