Eupirin

Package leaflet: Information for the patient

Eupirin, 300 mg, tablets
Acidum acetylsalicylicum
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 after 3 days or if the patient feels worse, consult a doctor.

Contents of the leaflet

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

1. What Eupirin is and what it is used for

Eupirin contains acetylsalicylic acid, which has analgesic, anti-inflammatory,
and antipyretic properties.
Indications:

• Mild to moderate pain of various origins, including: headache, toothache, muscle pain, joint pain,
• Symptoms associated with cold 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.

If there is no improvement after 3 days or if the patient feels worse, consult a doctor.

2. Important information before using Eupirin

When not to use Eupirin:

• 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 (such as urticaria or 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, rhinitis, 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 hepatic, renal, or cardiac insufficiency;
• if the patient has bleeding disorders (e.g. haemophilia, thrombocytopenia), or is being treated concomitantly with anticoagulants (e.g. coumarin derivatives, heparin);
• if the patient has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder);
• if the patient is concurrently receiving methotrexate at doses of 15 mg per week or higher, due to its harmful effect on bone marrow;
• in children and adolescents under 16 years of age;
• if the patient is in the last three months of pregnancy, doses higher than 100 mg per day must not be used (see section "Pregnancy and breastfeeding");
• during breastfeeding.

Warnings and precautions
Before starting treatment with Eupirin, consult a doctor in the following situations:

• in patients with impaired renal function or chronic renal failure;
• if the patient is taking oral antidiabetic sulfonylurea drugs, due to the risk of enhanced hypoglycaemic (blood glucose-lowering) 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. Liver function should be monitored in these patients;
• in cases of uterine bleeding, excessive menstrual bleeding, use of intrauterine contraceptive devices, hypertension, or heart failure;
• when used concomitantly with methotrexate at doses less than 15 mg per week, due to increased risk of methotrexate-induced bone marrow toxicity. Concurrent use with methotrexate at doses greater 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, Eupirin should be discontinued 5 to 7 days prior to any planned surgery;
• 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 who exhibit allergic reactions (e.g. skin reactions, itching, urticaria) to other substances are particularly at risk.

In some viral infections, particularly influenza A or B virus or varicella virus infections, mainly in children and adolescents, there is a risk of Reye's syndrome—a rare but life-threatening condition. Persistent vomiting during infection may indicate Reye's syndrome and requires 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, acetylsalicylic acid-containing products should not be used in children under 12 years of age, and in adolescents over 12 years of age, such products should only be used under medical supervision.

Use of Eupirin 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, so dose adjustment may be necessary depending on the severity of hepatic and/or renal impairment.
Eupirin is contraindicated in cases of severe hepatic and/or renal insufficiency.

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

Eupirin and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.

Medicines contraindicated for concomitant use with acetylsalicylic acid:

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

Use with caution when used concomitantly with:

• methotrexate at doses less than 15 mg per week, due to its toxic effect on bone marrow;
• anticoagulants, e.g. coumarin derivatives, heparin, and thrombolytic agents such as 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 (NSAIDs), 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 synergistic effects of these drugs;
• drugs that increase 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 (blood glucose-lowering) effect of antidiabetic drugs;
• diuretics, as acetylsalicylic acid may reduce their effectiveness and enhance the ototoxic (hearing-damaging) effects of furosemide;
• systemic 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 high-dose acetylsalicylic acid (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 its concentration and thus its toxicity;
• 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 Eupirin 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 and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
If treatment with Eupirin is continued or initiated during pregnancy, the medicine should always be used strictly according to medical advice, and doses higher than recommended should not be used.

Pregnancy – third trimester
Acetylsalicylic acid should not be taken in doses exceeding 100 mg per day during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of Eupirin may cause kidney and heart problems in the unborn child. It may affect bleeding tendency in both the mother and the child and may delay or prolong labour.
If lower doses of acetylsalicylic acid (up to and including 100 mg per day) are used, strict obstetric monitoring according to medical advice is required.

Pregnancy – first and second trimesters
Acetylsalicylic acid should not be used during the first six months of pregnancy unless absolutely necessary and prescribed by a doctor. If acetylsalicylic acid is used by women trying to conceive or during the first or second trimester of pregnancy, the lowest possible dose should be used for the shortest possible duration. Use of acetylsalicylic acid for longer than a few days beyond week 20 of pregnancy may cause kidney problems in the unborn child, leading to low levels of amniotic fluid (oligohydramnios) or narrowing of the fetal arterial duct. If prolonged treatment is required, the doctor may recommend additional monitoring.

Breastfeeding
Eupirin is contraindicated during breastfeeding.
This medicine belongs to a group of medicines that may adversely affect female fertility. This effect is reversible and resolves after discontinuation of treatment.

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

3. How to use Eupirin

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
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 fluid.
The tablet may also be dissolved in half 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 take more than 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.

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

Taking more than the recommended dose of Eupirin
If more than the recommended dose is taken, seek immediate medical advice from a doctor or pharmacist.
After an overdose of acetylsalicylic acid, symptoms such as nausea, vomiting, rapid breathing, and tinnitus may occur.
Other symptoms may also be observed, such as hearing loss, visual disturbances, headache, motor agitation, drowsiness and coma, convulsions, and hyperthermia (body temperature above normal).
In severe poisoning, acid-base and water-electrolyte imbalances occur (metabolic acidosis and dehydration).
Mild to moderate toxic effects occur after administration of acetylsalicylic acid at a dose 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 immediately.
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 ingestion, and in cases of very large overdoses, may be effective up to 10 hours;
• Administer activated charcoal as an aqueous suspension (50–100 g in adults and 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 Eupirin
If a dose is missed, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
After administration of acetylsalicylic acid, the following adverse effects 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 as a symptom 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, damage to gastric mucosa, activation of peptic ulcer disease, perforations.
Gastric ulceration occurs in 15% of patients on long-term acetylsalicylic acid therapy.
Hepatobiliary and biliary tract disorders
Focal necrosis of hepatocytes, 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 activity, alkaline phosphatase and bilirubin concentration.
Renal and urinary disorders
Proteinuria, presence of leukocytes and erythrocytes in urine, renal papillary necrosis, interstitial nephritis.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Eupirin

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 following:
Expiry date (EXP). The expiry date refers to the last day of the stated month. Lot stands for
the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Eupirin contains

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

What Eupirin looks like and contents of the pack
Tablets, round, flat, with a break line, white to creamy in colour.
The pack contains 10 or 20 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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
Poland
For further information on this medicine, please contact the marketing authorisation holder:
Promedo Pharma Products GmbH
Anklamer Straße 28
10115 Berlin
Germany
[email protected], +48 22 329 65 00