BONAPIRYNA 300 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Bonapiryna 300 mg tablets
   1. Read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Bonapiryna and what is it used for
4. Important information before taking Bonapiryna
   1. Warnings and precautions
   2. Using the medicine in patients with liver and (or) kidney impairment:
   3. Using the medicine in elderly patients:
   4. Bonapiryna and other medicines:
   5. Using Bonapiryna with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Pregnancy
   8. Breastfeeding
   9. Fertility
   10. Driving and using machines
5. How to take Bonapiryna
   1. Prevention of myocardial infarction:
   2. Using the medicine in children and adolescents under 16 years of age
   3. Taking a higher dose of Bonapiryna than recommended
   4. Treating an overdose
   5. Missing a dose of Bonapiryna
6. Possible side effects
   1. Blood and lymphatic system disorders
   2. Immune system disorders
   3. Nervous system disorders
   4. Cardiac disorders
   5. Vascular disorders
   6. Gastrointestinal disorders
   7. Hepatobiliary disorders
   8. Renal and urinary disorders
   9. Reporting side effects
7. How to store Bonapiryna
8. Contents of the packaging and other information
   1. What Bonapiryna contains
   2. What Bonapiryna looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Bonapiryna 300 mg tablets

Acetylsalicylic acid

Read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Bonapiryna and what is it used for

Bonapiryna contains acetylsalicylic acid, which has analgesic, anti-inflammatory, and antipyretic effects.
Indications for use:

• pain of various origins with mild and moderate severity, including: headaches, toothaches, muscle pains, joint pains.
• symptoms accompanying colds and flu with fever.
• conditions requiring long-term use of acetylsalicylic acid in high doses, such as rheumatoid arthritis (only on a doctor's prescription).
• myocardial infarction.
• prevention of myocardial infarction.

2. Important information before taking Bonapiryna

When not to take Bonapiryna:

• if the patient is allergic to acetylsalicylic acid or any other component of this medicine (listed in section 6). Hypersensitivity to acetylsalicylic acid occurs in 0.3% of the population, including 20% of patients with asthma or chronic urticaria. Symptoms of hypersensitivity: urticaria, and even anaphylaxis may occur within 3 hours of taking acetylsalicylic acid;
• if the patient is allergic to other nonsteroidal anti-inflammatory drugs, with symptoms such as bronchospasm, nasal congestion, anaphylaxis;
• if the patient has asthma, chronic respiratory diseases, hay fever, or nasal polyps, as patients with these conditions may react to nonsteroidal anti-inflammatory drugs with asthma attacks, skin rash, or urticaria;

nonsteroidal anti-inflammatory drugs may cause bronchospasm, nasal congestion, or urticaria in patients with these conditions;

• if the patient has active gastric or duodenal ulcers, as well as inflammatory or bleeding conditions of the gastrointestinal tract (may lead to gastrointestinal bleeding or exacerbation of ulcers);
• if the patient has severe liver, kidney, or heart failure;
• if the patient has blood coagulation disorders (e.g., hemophilia, thrombocytopenia) and
• if the patient is being treated with anticoagulant agents (e.g., coumarin derivatives, heparin);
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (a rare hereditary disease);
• if the patient is taking methotrexate in doses of 15 mg per week or higher, due to its toxic effect on the bone marrow;
• in children and adolescents under 16 years of age;
• if the patient is in the last three months of pregnancy, doses of acetylsalicylic acid greater than 100 mg per day should not be used (see section "Pregnancy, breastfeeding, and fertility");
• during breastfeeding.

Warnings and precautions

Before starting Bonapiryna, the patient should discuss the following situations with their doctor:

• in patients with renal impairment and chronic renal failure;
• if the patient is taking oral antidiabetic drugs from the sulfonylurea group, due to the risk of enhancing the hypoglycemic effect (reducing blood glucose levels), and if the patient is taking antihypertensive drugs;
• in patients with juvenile rheumatoid arthritis and (or) systemic lupus erythematosus, as well as impaired liver function, as the toxicity of salicylates may increase. In these patients, liver function should be monitored;
• in cases of menstrual bleeding, excessive menstrual bleeding, use of an intrauterine contraceptive device, hypertension, heart failure;
• when taking methotrexate in doses less than 15 mg per week, due to the risk of enhancing the toxic effect of methotrexate on the bone marrow. Concurrent use with methotrexate in doses greater than 15 mg per week is contraindicated.
• in the first and second trimester of pregnancy;
• before scheduled surgery. Due to the risk of prolonged bleeding time, both during and after surgery, the medicine should be discontinued 5 to 7 days before the scheduled surgery;
• acetylsalicylic acid may cause bronchospasm and trigger asthma attacks or other hypersensitivity reactions. Patients with asthma, chronic respiratory diseases, hay fever, or nasal polyps are particularly at risk.

In the course of some viral infections, especially in cases of influenza A or B virus infection, or chickenpox, mainly in children and adolescents, there is a risk of developing Reye's syndrome - a rare but life-threatening disease. The occurrence of persistent vomiting during infection may indicate the development of Reye's syndrome, which requires immediate medical attention. The risk of developing Reye's syndrome during viral infections may increase if acetylsalicylic acid is administered concurrently, although a causal relationship has not been proven.
For these reasons, in children under 12 years of age, products containing acetylsalicylic acid should not be used, and in adolescents over 12 years of age, products containing acetylsalicylic acid can only be used on a doctor's prescription.

Using the medicine in patients with liver and (or) kidney impairment:

In patients with liver and (or) kidney impairment, there is a risk of enhancing the adverse effects of the medicine, so it may be necessary to adjust the doses depending on the severity of liver and (or) kidney failure.
The medicine is contraindicated in cases of severe liver and (or) kidney failure.

Using the medicine in elderly patients:

In elderly patients (over 65 years), the medicine should be used in smaller doses and at longer intervals, due to the increased risk of adverse effects in this group of patients.

Bonapiryna and other medicines:

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Medicines contraindicated for concurrent use with acetylsalicylic acid:

• methotrexate in doses of 15 mg per week or higher, due to its toxic effect on the bone marrow.

Caution should be exercised when using concurrently with:

• methotrexate in doses less than 15 mg per week, due to its toxic effect on the bone marrow;
• anticoagulant agents, such as coumarin derivatives, heparin, and thrombolytic agents, such as streptokinase and alteplase, or other medicines that inhibit platelet aggregation, such as ticlopidine. Concurrent use of acetylsalicylic acid with anticoagulant agents may enhance the anticoagulant effect, increasing the risk of bleeding;
• other nonsteroidal anti-inflammatory drugs, as there is an increased risk of adverse effects on the gastrointestinal tract;
• selective serotonin reuptake inhibitors (SSRIs), due to the increased risk of bleeding from the upper gastrointestinal tract due to the synergistic effect of these medicines;
• medicines that increase the excretion of uric acid in the urine, such as benzbromarone, probenecid, as salicylates weaken the effect of these medicines. Acetylsalicylic acid should not be used concurrently with these medicines;
• digoxin, as acetylsalicylic acid may enhance its effect;
• antidiabetic medicines, such as insulin, sulfonylurea derivatives, as acetylsalicylic acid enhances the hypoglycemic effect (reducing blood glucose levels) of antidiabetic medicines;
• diuretics, as acetylsalicylic acid may reduce their effectiveness and enhance the ototoxic (hearing-impairing) effect of furosemide;
• glucocorticosteroids administered systemically, except for hydrocortisone used as replacement therapy in Addison's disease, as they increase the risk of developing gastric ulcers and gastrointestinal bleeding when used concurrently with salicylates, and reduce the salicylate levels in the blood during treatment, and increase the risk of salicylate overdose after treatment;
• angiotensin-converting enzyme inhibitors (ACE inhibitors) used concurrently with acetylsalicylic acid in high doses (e.g., enalapril, captopril), as acetylsalicylic acid reduces the antihypertensive effect of these medicines;
• valproic acid, as it enhances the anti-aggregatory effect of acetylsalicylic acid due to the synergistic anti-aggregatory effect of both medicines;
• acetazolamide, as acetylsalicylic acid may significantly increase its concentration and toxicity.
• metamizole, as it may reduce the anti-platelet effect of acetylsalicylic acid.

Omeprazole and ascorbic acid (vitamin C) do not affect the absorption of acetylsalicylic acid.

Using Bonapiryna with food, drink, and alcohol

The medicine should be taken during or after a meal.
During treatment with acetylsalicylic acid, alcohol should not be consumed, due to the increased risk of damaging the gastrointestinal mucosa.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Pregnancy

First and second trimester of pregnancy
Do not take Bonapiryna during the first 6 months of pregnancy, unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible time.
Taking Bonapiryna for more than a few days from the 20th week of pregnancy may cause renal function disorders in the unborn child, which can lead to low amniotic fluid levels (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment lasts longer than a few days, the doctor may recommend additional monitoring.
Third trimester of pregnancy
Do not take acetylsalicylic acid in doses greater than 100 mg per day in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Taking Bonapiryna may cause renal and heart function disorders in the unborn child. It may affect the patient's and child's tendency to bleed and cause delayed or prolonged labor. If the patient takes acetylsalicylic acid in small doses (up to 100 mg per day), close obstetric monitoring is necessary, according to the doctor's instructions.

Breastfeeding

The medicine is contraindicated during breastfeeding.

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.

3. How to take Bonapiryna

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.
In case of doubt, the patient should consult their doctor, pharmacist, or nurse.
The tablet can be divided into equal doses.
The medicine should be taken orally, preferably during or after a meal, with a large amount of liquid. The tablet can also be dissolved in 1 glass of water or milk before use.
Symptomatic treatment without medical advice should not be continued for more than 3 days.
The smallest effective dose of the medicine should be used.
Recommended dose:
For pain relief and antipyretic:

• Adults: 300 mg to 600 mg (1 to 2 tablets) every 4 hours. Do not take more than 3 g (10 tablets) of the medicine per day.
• Adolescents over 16 years: 600 mg to 900 mg (2 to 3 tablets) per day.

In rheumatic diseases, only on a doctor's prescription:

• in rheumatic fever: 900 mg (3 tablets) 4 times a day;
• in rheumatoid arthritis: 600 mg (2 tablets) 3 to 4 times a day.

Myocardial infarction:

• 150 mg to 300 mg (half to 1 tablet) per day.

Prevention of myocardial infarction:

• 150 mg (half a tablet) per day.

Using the medicine in children and adolescents under 16 years of age

The medicine is contraindicated in children and adolescents under 16 years of age (see section "When not to take Bonapiryna").

Taking a higher dose of Bonapiryna than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.
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.
Mild or moderate symptoms of toxic effects occur after taking acetylsalicylic acid in doses of 150-300 mg/kg body weight. Severe symptoms of poisoning occur after taking doses of 300-500 mg/kg body weight. The potentially fatal dose of acetylsalicylic acid is greater than 500 mg/kg body weight.

Treating an overdose

There is no specific antidote for acetylsalicylic acid. The patient should be taken to the hospital.
Procedure in case of acetylsalicylic acid poisoning:

• induce vomiting and rinse the stomach (to reduce the absorption of the medicine). Such treatment is effective within 3-4 hours after taking the medicine, and in case of poisoning with a very large dose of the medicine, even up to 10 hours;
• 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 the absorption of acetylsalicylic acid;
• in case of hyperthermia, the body temperature should be lowered by maintaining a low ambient temperature and using cool compresses.

In severe poisonings, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be necessary.

Missing a dose of Bonapiryna

In case of missing a dose, the patient should take the next dose at the scheduled time. A double dose should not be taken 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, Bonapiryna can cause side effects, although not everybody gets them.
After taking acetylsalicylic acid, the following side effects may occur:

Blood and lymphatic system disorders

thrombocytopenia, anemia due to microbleeding from the gastrointestinal tract, hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency, leukopenia, agranulocytosis, eosinopenia, increased risk of bleeding, prolonged bleeding time, prolonged prothrombin time.

Immune system disorders

hypersensitivity reactions: rash, urticaria, angioedema, bronchospasm, anaphylaxis.

Nervous system disorders

tinnitus (usually as a symptom of overdose), hearing disturbances, dizziness.

Cardiac disorders

heart failure.

Vascular disorders

hypertension.

Gastrointestinal disorders

dyspepsia, heartburn, feeling of fullness in the upper abdomen, nausea, vomiting, loss of appetite, abdominal pain, gastrointestinal bleeding, gastric mucosa damage, exacerbation of ulcers, perforations.
Gastric ulcers occur in 15% of patients taking acetylsalicylic acid long-term.

Hepatobiliary disorders

focal liver cell necrosis, liver tenderness and enlargement, especially in patients with juvenile rheumatoid arthritis, systemic lupus erythematosus, rheumatic fever, or liver disease in their medical history, transient increase in serum aminotransferase activity, alkaline phosphatase, and bilirubin levels.

Renal and urinary disorders

proteinuria, presence of leukocytes and erythrocytes in the urine, renal papillary necrosis, interstitial nephritis.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient 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
Phone: +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, more information can be collected on the safety of the medicine.

5. How to store Bonapiryna

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging and blister pack after:
Expiry date (EXP). The expiry date refers to the last day of the month. Batch 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 packaging and other information

What Bonapiryna contains

• The active substance of Bonapiryna is acetylsalicylic acid. Each tablet contains 300 mg of acetylsalicylic acid.
• The other ingredients of the medicine are: microcrystalline cellulose; cellulose powder; corn starch; stearic acid.

What Bonapiryna looks like and contents of the pack

Tablets, round, flat with a dividing line, white to cream-colored.
The packaging contains 10 or 20 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:
Eubioco1 Sp. z o.o.
ul. Franciszka Klimczaka 1
02-797 Warsaw
phone: +48 89 648 00 78

Date of last revision of the leaflet: