Aspirin

Package Leaflet: Information for the Patient

ASPIRIN, 500 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 advised by your doctor or pharmacist.

• You should keep this leaflet to be able to read it again if needed.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3-5 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

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

1. What is Aspirin and what is it used for

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

• mild or moderate pain,
• fever.

2. Important information before taking Aspirin

When not to take Aspirin

• in children under 12 years of age.

Warnings and precautions

Before starting Aspirin, you should discuss it with your doctor or pharmacist:

Do not take Aspirin during the first and second trimester of pregnancy, unless it is absolutely necessary.
Acetylsalicylic acid may cause bronchial constriction and trigger asthma attacks or other hypersensitivity reactions. Patients with asthma, chronic respiratory diseases, hay fever, nasal polyps, and those who experience allergic reactions to other substances (e.g., skin reactions, itching, hives) are particularly at risk.
Before surgical procedures (including minor ones, e.g., tooth extraction), patients should inform their doctor about taking Aspirin.
Acetylsalicylic acid, even in small doses, reduces the excretion of uric acid from the body. In patients with a tendency to reduced uric acid excretion, the medicine may cause a gout attack.
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. 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 at the same time, although a causal relationship has not been proven.
For these reasons, in children under 12 years of age, medications containing acetylsalicylic acid should not be used, and in adolescents over 12 years of age, medications containing acetylsalicylic acid can only be used on a doctor's prescription.
Prolonged use of medications containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Prolonged use of painkillers, especially those containing multiple active substances, may lead to severe kidney function disorders and kidney failure.

Aspirin and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Particular caution should be exercised when taking Aspirin with the following medicines, as acetylsalicylic acid enhances:

• the toxic effect of methotrexate on the bone marrow; acetylsalicylic acid should not be taken at the same time as methotrexate at doses of 15 mg per week or higher; concurrent use of methotrexate at doses less than 15 mg per week requires special caution;
• the effect of anticoagulant, thrombolytic (dissolving blood clots), and anti-platelet medications, which may increase the risk of prolonged bleeding and hemorrhages;
• the risk of stomach ulcers and gastrointestinal bleeding if taken concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs, including other salicylates, or if alcohol is consumed during treatment;
• the effect of digoxin (a medicine used for heart conditions), as it increases its concentration in the blood;
• the effect of anti-diabetic medications, e.g., insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid (a medicine used, among others, in epilepsy), which in turn enhances the anti-aggregatory effect of acetylsalicylic acid;
• the effect of selective serotonin reuptake inhibitors (antidepressants). Particular caution should be exercised when taking Aspirin with the following medicines, as acetylsalicylic acid reduces:
• the effect of anti-gout medications used to treat gout, which increase the excretion of uric acid from the body (e.g., benzbromarone, probenecid), which may worsen the symptoms of gout;
• the effect of diuretics;
• the effect of some anti-hypertensive medications (from the group of so-called angiotensin-converting enzyme inhibitors).

Aspirin can be taken with the above-mentioned medicines (except for methotrexate at doses of 15 mg per week or higher) only after consulting a doctor.

Aspirin with food, drink, or alcohol

See section 3 of the leaflet.
Note! Alcohol may increase the risk of adverse reactions from the gastrointestinal tract, such as stomach ulcers or bleeding.

Pregnancy, breastfeeding, and fertility

In pregnancy, during breastfeeding, or if you suspect you are pregnant, or plan to become pregnant, you should consult a doctor or pharmacist before taking the medicine.
Pregnancy
Do not take Aspirin during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medicine may cause kidney and heart function disorders in the unborn child. It may also affect the patient's and child's tendency to bleed and cause delayed or prolonged delivery. Do not take Aspirin during the first 6 months of pregnancy, unless it is absolutely necessary and has been prescribed by a doctor. If the patient requires treatment during this period or is trying to become pregnant, they should use the smallest possible dose for the shortest possible time. If Aspirin is taken for more than a few days from the 20th week of pregnancy, it may cause kidney function disorders in the unborn child, leading to a decrease in the amount of amniotic fluid surrounding the fetus (oligohydramnios) or narrowing of the arterial duct in the child's heart. If treatment is necessary for more than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Acetylsalicylic acid passes into breast milk in small amounts.
Fertility
Aspirin belongs to a group of medicines that may adversely affect female fertility. This effect is temporary and disappears after the end of therapy.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

3. How to take Aspirin

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.
The recommended dose of Aspirin is:

• adults: single dose of 1 to 2 tablets (i.e., 500-1000 mg of acetylsalicylic acid). If necessary, the single dose may be repeated at intervals of no less than 4 to 8 hours. Do not take more than 8 tablets (i.e., 4000 mg of acetylsalicylic acid) per day.
• adolescents over 12 years of age: the medicine may be used in adolescents over 12 years of age only on a doctor's prescription. Take a single dose of 1 tablet (i.e., 500 mg of acetylsalicylic acid). If necessary, the single dose may be repeated at intervals of no less than 4 to 8 hours. Do not take more than 3 tablets (i.e., 1500 mg of acetylsalicylic acid) per day. The medicine should not be used for more than 3-5 days without consulting a doctor.

Tablets should be taken orally, after meals, with a large amount of water.

Taking a higher dose of Aspirin than recommended

Overdose of the active substance of Aspirin may be caused by prolonged use of the medicine (mild overdose) or overdose (severe overdose), which may be life-threatening, e.g., after accidental ingestion by children or the elderly.
Symptoms of mild overdose are: dizziness (including vertigo), tinnitus, deafness, excessive sweating, nausea, and vomiting, headache, confusion (disorders of consciousness with disorientation, thinking, and speech disorders, delusions, hallucinations, anxiety, and psychomotor agitation), rapid breathing, deep breathing, and symptoms of respiratory alkalosis (darkness before the eyes, fainting).
In the case of severe overdose, the following may also occur: high fever, respiratory disorders (up to respiratory arrest and suffocation), heart and blood vessel disorders (from irregular heartbeat, low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration, oliguria [reduced urine output below 400-500 ml per day in adults] to kidney failure), increased or decreased blood glucose levels (especially in children), ketoacidosis, gastrointestinal bleeding, blood coagulation disorders, neurological disorders manifesting as lethargy, confusion, and up to coma and convulsions.
In the event of an overdose, you should immediately consult a doctor or pharmacist, and in the case of severe overdose, the patient should be taken to the hospital immediately. Treatment of overdose involves gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be necessary.

Missing a dose of Aspirin

If you miss a dose and symptoms persist, you should take the next dose of Aspirin. Do not take a double dose to make up for the missed dose.

Stopping Aspirin treatment

If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Aspirin can cause side effects, although not everybody gets them.
Note!

• If you experience coffee ground vomiting or black, tarry stools, you should stop taking the medicine and consult a doctor.
• A symptom of a severe hypersensitivity reaction may be: facial and eyelid edema, tongue and laryngeal edema with narrowing of the airways, difficulty breathing, shortness of breath up to asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. If you experience any of these symptoms, you should seek immediate medical attention. These reactions may occur even after the first administration of the medicine.

Gastrointestinal disorders:
Stomach and abdominal pain, heartburn, nausea, vomiting, indigestion, inflammation of the gastrointestinal tract, potentially life-threatening gastrointestinal bleeding: overt (coffee ground vomiting, black tarry stools) or occult (bleeding occurs more frequently with higher doses); stomach or duodenal ulcers, perforation, enteropathy (especially during prolonged use).
Liver and bile duct disorders:
In rare cases, transient liver function disorders (increased aminotransferase activity) have been reported.
Nervous system disorders:
Dizziness and tinnitus, usually symptoms of overdose.
Blood and lymphatic system disorders:
Increased risk of bleeding, hemorrhages (postoperative, nasal, gingival, genitourinary), hematomas, prolonged bleeding time, prothrombin time, thrombocytopenia.
As a result of bleeding, iron deficiency anemia or post-hemorrhagic anemia may occur, manifesting as asthenia, pallor, hypoperfusion, and abnormal laboratory test results.
Hemolysis and hemolytic anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.
Vascular disorders:
Brain hemorrhage (especially in patients with uncontrolled hypertension and/or concurrent use of other anticoagulant medications) potentially life-threatening.
Renal and urinary disorders:
Renal function disorders and severe kidney damage.
Immune system disorders:
Hypersensitivity reactions with clinical symptoms and abnormal laboratory test results, such as respiratory disease, which worsens after taking acetylsalicylic acid, mild to moderate reactions involving the skin, respiratory system, cardiovascular system with symptoms such as rash, urticaria, edema (including angioedema), respiratory and cardiac disorders, rhinitis, nasal congestion, and very rarely severe reactions, including anaphylactic shock.
Respiratory disorders:
Asthma.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, 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 will help gather more information on the safety of the medicine.

5. How to store Aspirin

Store in a temperature below 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP:". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Aspirin contains

The active substance of Aspirin is acetylsalicylic acid (Acidum acetylsalicylicum).
The other ingredients of the medicine are: cellulose, cornstarch.

What Aspirin looks like and contents of the pack

White, round tablets packaged in blisters of 10 tablets. The pack contains 10, 20, or 100 tablets.

Marketing authorization holder:

Bayer Sp. z o.o.
Aleje Jerozolimskie 158
02-326 Warsaw
Tel.: +48 22 572 35 00
Fax: +48 22 572 35 55

Manufacturer

Bayer Bitterfeld GmbH
OT Greppin
Salegaster Chaussee 1
06803 Bitterfeld-Wolfen
Germany
Date of last revision of the leaflet:08/2023