Bonapiryna

Package leaflet: Information for the patient

Bonapiryna 300 mg tablets
Acetylsalicylic acid
Please read all of this leaflet carefully before taking this medicine, because 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 or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3 days, consult your doctor.

Contents of the leaflet

1. What Bonapiryna is and what it is 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 pack and other information

1. What Bonapiryna is and what it is used for

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

• Mild to moderate pain of various origins, including: headache, toothache, muscle pain, joint pain.
• Symptoms associated with colds and flu accompanied by fever.
• Conditions requiring long-term use of high-dose acetylsalicylic acid, such as rheumatoid arthritis (only on prescription).
• Myocardial infarction.
• Prevention of myocardial infarction.

2. Important information before using the medicine Bonapiryna

When not to use Bonapiryna:

• if the patient is allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity to acetylsalicylic acid occurs in 0.3% of the population, including 20% of patients with bronchial asthma or chronic urticaria. Symptoms of hypersensitivity: urticaria, and even shock, may occur within 3 hours after taking acetylsalicylic acid;

• if the patient is allergic to other non-steroidal anti-inflammatory drugs (NSAIDs), with symptoms such as bronchospasm, nasal mucosal inflammation, or shock;

• if the patient has bronchial asthma, chronic respiratory diseases, hay fever, or nasal mucosal swelling, because patients with these conditions may react to non-steroidal anti-inflammatory drugs with asthma attacks, limited skin and mucosal swelling (angioedema), or urticaria more frequently than other patients;

• if the patient has active peptic ulcer disease of the stomach and/or duodenum, or inflammatory conditions or bleeding from the gastrointestinal tract (this may lead to gastrointestinal bleeding or exacerbation of peptic ulcer disease);

• if the patient has severe liver, kidney, or heart failure;

• if the patient has blood clotting disorders (e.g. haemophilia, thrombocytopenia) or

• is being treated simultaneously with anticoagulants (e.g. coumarin derivatives, heparin);

• if the patient has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder);

• if the patient is simultaneously receiving methotrexate at doses of 15 mg per week or higher, due to harmful effects on 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 exceeding 100 mg per day must not be used (see section "Pregnancy, breastfeeding and effects on fertility");

• during breastfeeding.

Warnings and precautions
Before starting to take Bonapiryna, consult a doctor in the following situations:

• in patients with impaired kidney function or chronic kidney failure;
• if the patient is taking oral antidiabetic drugs of the sulfonylurea group, due to the risk of enhanced hypoglycaemic (reducing blood glucose concentration) effect, and if the patient is taking diuretics;
• in patients with juvenile rheumatoid arthritis and/or systemic lupus erythematosus and impaired liver function, as the toxicity of salicylates increases. In these patients, liver function should be monitored;
• in cases of uterine bleeding, excessive menstrual bleeding, use of intrauterine contraceptive devices, arterial hypertension, or heart failure;
• when used concomitantly with methotrexate at doses lower than 15 mg per week, due to increased risk of methotrexate-induced bone marrow toxicity. Concurrent use with methotrexate at doses higher than 15 mg per week is contraindicated.
• during the first and second trimesters of pregnancy;
• before planned surgical procedures. Due to the risk of prolonged bleeding time both during and after surgery, the medicine should be discontinued 5 to 7 days before the planned surgical procedure;
• acetylsalicylic acid may cause bronchospasm and trigger asthma attacks or other hypersensitivity reactions. Patients with bronchial asthma, chronic respiratory diseases, hay fever, nasal polyps, or those showing allergic reactions (e.g. skin reactions, itching, urticaria) to other substances are particularly susceptible to such reactions.

During certain viral infections, particularly influenza virus A, influenza virus B, or varicella infection, especially in children and adolescents, there is a risk of Reye's syndrome – a rare but life-threatening condition. Persistent vomiting during an infection may indicate the onset of Reye's syndrome, requiring immediate medical attention. The risk of 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, products containing acetylsalicylic acid should not be used in children under 12 years of age, and in adolescents over 12 years of age, products containing acetylsalicylic acid should be used only on a doctor's advice.

Use 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 drug reactions; therefore, dose adjustment may be necessary depending on the severity of liver and/or kidney impairment.
The medicine is contraindicated in cases of severe liver and/or kidney failure.

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

Bonapiryna and other medicines:
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.

Medicines contraindicated for concomitant use with acetylsalicylic acid:

• methotrexate at doses of 15 mg per week or higher, due to its toxic effects on bone marrow.

Use with caution when taken simultaneously with:

• methotrexate at doses lower than 15 mg per week, due to its toxic effects on bone marrow;
• anticoagulants, e.g. coumarin derivatives, heparin, and thrombolytic agents, e.g. streptokinase and alteplase, or other drugs inhibiting platelet aggregation, e.g. ticlopidine. Concomitant use of acetylsalicylic acid with anticoagulants may enhance the anticoagulant effect, thereby increasing the risk of bleeding;
• other non-steroidal anti-inflammatory drugs, as there is an increased risk of gastrointestinal adverse effects;
• selective serotonin reuptake inhibitors (SSRIs), due to an increased risk of upper gastrointestinal bleeding resulting from the synergistic action of these drugs;
• drugs increasing urinary excretion of uric acid, e.g. benzbromarone, probenecid, as salicylates reduce the effectiveness of these drugs. Concomitant use of acetylsalicylic acid with these drugs is not recommended;
• digoxin, as acetylsalicylic acid may enhance the effect of this drug;
• antidiabetic drugs, e.g. insulin, sulfonylurea derivatives, as acetylsalicylic acid enhances the hypoglycaemic (reducing blood glucose concentration) effect of antidiabetic drugs;
• diuretics, as acetylsalicylic acid may reduce the effectiveness of these drugs and enhance the ototoxic (hearing-damaging) effects of furosemide;
• systemically administered glucocorticoids, except hydrocortisone used as replacement therapy in Addison's disease, as their concomitant use with salicylates increases the risk of peptic ulcer disease and gastrointestinal bleeding, reduces salicylate plasma concentrations during treatment, and increases the risk of salicylate overdose after treatment discontinuation;
• angiotensin-converting enzyme (ACE) inhibitors used concomitantly with acetylsalicylic acid at high doses (e.g. enalapril, captopril), as acetylsalicylic acid reduces the antihypertensive effect of these drugs;
• valproic acid, as it enhances the antiplatelet effect of acetylsalicylic acid due to synergistic antiplatelet action of both drugs;
• acetazolamide, as acetylsalicylic acid may significantly increase the concentration and thus the toxicity of acetazolamide;
• metamizole, as it may reduce the platelet aggregation-inhibiting effect of acetylsalicylic acid.

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

Use of Bonapiryna with food, drink, and alcohol
The medicine should be taken during or after a meal.
Alcohol should not be consumed during treatment with acetylsalicylic acid due to the increased risk of gastrointestinal mucosal damage.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
First and second trimesters
Bonapiryna should not be taken during the first 6 months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration.
Bonapiryna taken for longer than a few days after the 20th week of pregnancy may cause impaired kidney function in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment lasts longer than a few days, the doctor may recommend additional monitoring.

Third trimester
Acetylsalicylic acid in doses exceeding 100 mg per day should not be taken during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of Bonapiryna may cause impaired kidney and heart function in the unborn child. It may affect bleeding tendency in both the mother and her baby and may cause delay or prolongation of labour. If the patient takes acetylsalicylic acid in low doses (up to 100 mg per day inclusive), strict obstetric monitoring according to the doctor's recommendations is required.

Breastfeeding
The medicine is contraindicated during breastfeeding.

Effects on fertility
This medicine belongs to a group of medicines that may adversely affect fertility in women. This effect is reversible and disappears after discontinuation of treatment.

Driving and operating machinery
The medicine has no influence on the ability to drive or operate machinery.

3. How to use Bonapiryna

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
The tablet may 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 may also be dissolved in a glass of water or milk before use.
Symptomatic treatment without medical advice should not last longer than 3 days.
The lowest effective dose should be used.

Recommended dose:
For pain relief and fever reduction:
Adults: 300 mg to 600 mg (1 to 2 tablets) every 4 hours. Do not exceed 3 g (10 tablets) of the medicine per day.
Adolescents over 16 years of age: 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 daily;
• In rheumatoid arthritis: 600 mg (2 tablets) 3 to 4 times daily.

Myocardial infarction:

• 150 mg to 300 mg (½ to 1 tablet) per day.

Prevention of myocardial infarction:

• 150 mg (½ tablet) per day.

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

Taking more Bonapiryna than recommended
If you take more than the recommended dose, contact your doctor or pharmacist immediately.
After an overdose of acetylsalicylic acid, the following symptoms may occur: nausea, vomiting, rapid breathing, tinnitus.
Other symptoms observed include: hearing loss, visual disturbances, headache, motor restlessness, drowsiness and coma, seizures, hyperthermia (body temperature above normal). In severe poisoning, acid-base and water-electrolyte imbalances occur (metabolic acidosis and dehydration).
Mild or moderately severe toxic effects occur after acetylsalicylic acid intake at doses of 150–300 mg/kg body weight. Severe poisoning symptoms occur after ingestion of 300–500 mg/kg body weight. A potentially lethal dose of acetylsalicylic acid is greater than 500 mg/kg body weight.

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

• Induce vomiting and perform gastric lavage (to reduce drug absorption). This procedure is effective within 3–4 hours after taking the medicine, and even up to 10 hours in cases of very large overdoses;
• Administer activated charcoal as an aqueous suspension (50–100 g in adults, 30–60 g in children) to reduce absorption of acetylsalicylic acid;
• In case of hyperthermia, reduce body temperature by maintaining a low ambient temperature and applying cold compresses.

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

Missed dose of Bonapiryna
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 doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
After administration of acetylsalicylic acid, the following adverse reactions may occur:

Blood and lymphatic system disorders
Thrombocytopenia, anaemia due to microbleeding from the gastrointestinal tract, haemolytic anaemia 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, shock.

Nervous system disorders
Tinnitus (usually a sign of overdose), hearing disturbances, dizziness.

Cardiac disorders
Heart failure.

Vascular disorders
Hypertension.

Gastrointestinal disorders
Dyspepsia, heartburn, feeling of fullness in the epigastrium, nausea, vomiting, loss of appetite, abdominal pain, gastrointestinal bleeding, gastric mucosal damage, exacerbation of peptic ulcer disease, perforations.
Gastric ulceration occurs in 15% of patients on long-term acetylsalicylic acid therapy.

Hepatic and biliary disorders
Focal hepatic necrosis, tenderness and enlargement of the liver, particularly in patients with juvenile rheumatoid arthritis, systemic lupus erythematosus, rheumatic fever, or history of liver disease; transient increases in serum aminotransferase, alkaline phosphatase, and bilirubin levels.

Renal and urinary disorders
Proteinuria, presence of leukocytes and erythrocytes in urine, renal papillary necrosis, interstitial nephritis.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 helps provide more information on the safety of this medicine.

5. How to store Bonapiryna

Keep the medicine out of 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 after:
EXP. The expiry date refers to the last day of the stated month. Lot is the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bonapiryna contains

• The active substance in Bonapiryna is acetylsalicylic acid. Each tablet contains 300 mg of acetylsalicylic acid.
• Other components of the medicine are: microcrystalline cellulose; powdered cellulose; pregelatinized starch, maize; stearic acid.

What Bonapiryna looks like and contents of the pack
Tablets, round, flat, with a dividing line, white to creamy in colour.
The pack contains 10 or 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eubioco1 Sp. z o.o.
ul. Franciszka Klimczaka 1
02-797 Warszawa
tel. +48 89 648 00 78

Manufacturer
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity

For further information about this medicine, please contact the marketing authorisation holder:
Eubioco1 Sp. z o.o.
ul. Franciszka Klimczaka 1
02-797 Warszawa
tel. +48 89 648 00 78