Eupirin

Leaflet attached to the packaging: patient information

Eupirin, 300 mg, tablets

Acetylsalicylic acid

Read the 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 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 after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Eupirin and what is it used for

Eupirin 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 aches, joint aches,
• 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.

If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Eupirin

When not to take Eupirin:

such as: bronchospasm, nasal mucosa inflammation, anaphylaxis;

• in children and adolescents under 16 years of age;
• during breastfeeding.

Warnings and precautions

Before starting to take Eupirin, the patient should discuss it with their doctor in the following situations:

• in patients with kidney function disorders and chronic kidney failure;
• 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;
• in case 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 increased toxic effect of methotrexate on the bone marrow. Concurrent use with methotrexate in doses higher than 15 mg per week is contraindicated.
• during the first and second trimesters of pregnancy;
• before a planned surgical procedure. Due to the risk of prolonged bleeding time, both during and after the procedure, 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 asthma, chronic respiratory diseases, hay fever, or nasal polyps, as well as those with allergic reactions (e.g., skin reactions, itching, urticaria) to other substances, are particularly at risk.

In the course of some viral diseases, especially in the case 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 the 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, products containing acetylsalicylic acid should not be used in children under 12 years of age, and in adolescents over 12 years of age, they can be used only on a doctor's prescription.

Using Eupirin 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 doses depending on the severity of liver and (or) kidney failure.
The medicine is contraindicated in case of severe liver and (or) kidney failure.

Using Eupirin 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 side effects in this group of patients.

Eupirin 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 that are 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 medications, such as coumarin derivatives, heparin, and thrombolytic agents, such as streptokinase and alteplase, or other medications that inhibit platelet aggregation, such as ticlopidine. Concurrent use of acetylsalicylic acid with anticoagulant medications may lead to increased anticoagulant effect, thereby increasing the risk of bleeding;
• other nonsteroidal anti-inflammatory drugs, as there is an increased risk of side effects from the gastrointestinal tract;
• selective serotonin reuptake inhibitors (SSRIs), due to the increased risk of gastrointestinal bleeding as a result of the synergistic effect of these medications;
• medications that increase uric acid excretion in the urine, such as benzbromarone, probenecid, as salicylates weaken the effect of these medications. Acetylsalicylic acid should not be used concurrently with these medications;
• digoxin, as acetylsalicylic acid may increase the effect of this medication;
• antidiabetic medications, such as insulin, sulfonylurea derivatives, as acetylsalicylic acid increases the hypoglycemic effect (reducing blood glucose levels) of antidiabetic medications;
• diuretic medications, as acetylsalicylic acid may reduce their effectiveness and increase the ototoxic (harmful to hearing) effect of furosemide;
• glucocorticosteroids administered systemically, except for hydrocortisone used as replacement therapy in Addison's disease, as they increase the risk of gastrointestinal ulcers and bleeding when used concurrently with salicylates, and reduce salicylate levels in serum during treatment, and increase the risk of salicylate overdose after treatment;
• angiotensin-converting enzyme (ACE) inhibitors used concurrently with acetylsalicylic acid in high doses (e.g., enalapril, captopril), as acetylsalicylic acid reduces the antihypertensive effect of these medications;
• valproic acid, as it increases the anti-aggregatory effect of acetylsalicylic acid due to the synergistic anti-aggregatory effect of both medications;
• acetazolamide, as acetylsalicylic acid may significantly increase the level and toxicity of acetazolamide;
• 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 Eupirin with food, drinks, 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 gastrointestinal mucosa damage.

Pregnancy and breastfeeding

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.
In case of continuation or initiation of treatment with Eupirin during pregnancy, the medicine should always be used according to the doctor's recommendations and not in higher doses than recommended.
Pregnancy - third trimester
Acetylsalicylic acid should not be taken in doses higher than 100 mg per day during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. The use of Eupirin may cause kidney and heart disorders in the unborn child. It may affect the bleeding tendency in the patient and their child and cause a delay or prolongation of the delivery period.
In case of taking acetylsalicylic acid in lower doses (up to 100 mg per day), close obstetric monitoring is necessary according to the doctor's recommendations.
Pregnancy - first and second trimesters
Acetylsalicylic acid should not be used during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If acetylsalicylic acid is used by women trying to conceive or during the first and second trimesters of pregnancy, the lowest possible dose should be used for the shortest possible time. The use of acetylsalicylic acid for a period longer than a few days from the 20th week of pregnancy may cause kidney disorders in the unborn child, which can lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct in the child's heart. In case of necessity to treat for a period longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
The medicine is contraindicated during breastfeeding.
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

Eupirin does not affect the ability to drive and use machines.

3. How to take Eupirin

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
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 1/2 glass of water or milk before use.
Symptomatic treatment without medical consultation can be carried out for no longer than 3 days.
The lowest effective dose of the medicine should be used.

Recommended dose

For analgesic and antipyretic use:
Adults: from 300 mg to 600 mg (from 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 of age: from 600 mg to 900 mg (from 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:

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

Prevention of myocardial infarction:

• 150 mg (half a tablet) per day.

Using Eupirin in children and adolescents under 16 years of age:

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

Taking a higher dose of Eupirin 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, headache, restlessness, drowsiness, and coma, seizures, hyperthermia (body temperature above normal values), have also been observed. In severe poisonings, there are disorders of acid-base balance and water-electrolyte balance (metabolic acidosis and dehydration).
Mild or moderate symptoms of toxic action occur after taking acetylsalicylic acid in a dose of 150-300 mg/kg body weight. Severe symptoms of poisoning occur after taking a dose of 300-500 mg/kg body weight. A potentially fatal dose of acetylsalicylic acid is higher than 500 mg/kg body weight.

Treatment of 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;
• give 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, reduce the body temperature by maintaining a low ambient temperature and using cold compresses.

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

Missing a dose of Eupirin

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

4. Possible side effects

Like all medicines, this medicine 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 ulcer occurs in 15% of patients taking acetylsalicylic acid for a long time.

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 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:
Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181 C
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 Eupirin

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 carton and blister pack after:
Expiry date (EXP). The expiry date refers to the last day of the month. 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 Eupirin contains

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

What Eupirin looks like and contents of the pack

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

Marketing authorization holder

Promedo Pharma Products GmbH
Anklamer Straße 28
10115 Berlin
Germany

Manufacturer

Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25 A
11-001 Dywity
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:
Promedo Pharma Products GmbH
Anklamer Straße 28
10115 Berlin
Germany
[email protected], +48 22 329 65 00

Date of last revision of the leaflet: