Aspirin

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Aspirin, 500 mg, tablets
Acetylsalicylic acid

The contents of the leaflet should be carefully read before taking 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 or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 3-5 days, they should contact their 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 packaging 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, the patient should discuss it with their doctor or pharmacist:

Medicines containing acetylsalicylic acid should not be used in women during the first and second trimester of pregnancy, unless it is absolutely necessary.
Acetylsalicylic acid may cause bronchospasm 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.
Patients undergoing surgical procedures (including minor procedures, e.g., tooth extraction) 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 link has not been proven.
For these reasons, in children under 12 years of age, medicines containing acetylsalicylic acid should not be used, and in adolescents over 12 years of age, medicines containing acetylsalicylic acid can only be used on a doctor's prescription.
Long-term use of medicines containing acetylsalicylic acid may cause headaches that worsen during subsequent doses.
Long-term use of painkillers, especially those containing multiple active substances, may lead to severe kidney function disorders and kidney failure.

Aspirin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Special 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 used 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;

and

• the effect of anticoagulant medications, thrombolytic medications (dissolving blood clots), and platelet aggregation inhibitors, which may increase the risk of prolonged bleeding time and bleeding;
• the risk of stomach ulcers and gastrointestinal bleeding if used concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs, including other salicylates, or if alcohol is consumed during treatment;
• the effect of digoxin (a heart medication), as it increases its concentration in the blood;
• the effect of antidiabetic medications, such as insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid (a medication used in epilepsy), which in turn enhances the anti-aggregatory effect of acetylsalicylic acid;
• the effect of selective serotonin reuptake inhibitors (antidepressants). Special caution should be exercised when taking Aspirin with the following medicines, as acetylsalicylic acid weakens:
• the effect of uricosuric medications used to treat gout (e.g., benzbromarone, probenecid), which may worsen gout symptoms;
• the effect of diuretics;
• the effect of some antihypertensive medications (from the group of so-called angiotensin-converting enzyme inhibitors).

Aspirin can be used 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.
Warning! 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 pregnancy is suspected, or if the patient is planning to become pregnant, they should consult their doctor or pharmacist before taking the medicine.
Pregnancy
Aspirin should not be taken 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 labor. Aspirin should not be used 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 or use machines.

3. How to take Aspirin

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose of Aspirin is:

• adults: 1-2 tablets (i.e., 500-1000 mg of acetylsalicylic acid) at a time. If necessary, the single dose may be repeated at intervals of no less than 4 to 8 hours. No more than 8 tablets (i.e., 4000 mg of acetylsalicylic acid) should be taken 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. The patient should take 1 tablet (i.e., 500 mg of acetylsalicylic acid) at a time. If necessary, the single dose may be repeated at intervals of no less than 4 to 8 hours. No more than 3 tablets (i.e., 1500 mg of acetylsalicylic acid) should be taken 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

Poisoning with the active substance of Aspirin can be caused by long-term use of the medicine (mild poisoning) or overdose (severe poisoning), which can be life-threatening, e.g., after accidental ingestion by children or the elderly.
Symptoms of mild poisoning 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 (spots before the eyes, fainting).
In the case of severe poisoning, the following may also occur: high fever, respiratory disorders (up to respiratory arrest and suffocation), cardiac and vascular 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 seizures.
In the event of an overdose, the patient should immediately consult a doctor or pharmacist, and in the case of severe poisoning, the patient should be taken to the hospital immediately.
Treatment of poisoning 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 a dose is missed and symptoms persist, the next dose of Aspirin should be taken. A double dose should not be taken to make up for the missed dose.

Stopping Aspirin treatment

In case of further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

• If vomiting with blood or black, tarry stools occurs, the medicine should be discontinued, and a doctor should be consulted.
• 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 any of these symptoms occur, immediate medical attention should be sought. These reactions can occur even after the first administration of the medicine.

Gastrointestinal disorders:
stomach and abdominal pain, heartburn, nausea, vomiting, indigestion, gastrointestinal inflammation, potentially life-threatening gastrointestinal bleeding: overt (vomiting with blood, black, tarry stools) or occult (bleeding occurs more frequently with higher doses); stomach or duodenal ulcers, perforation, enteropathy (especially during long-term use).
Liver and biliary 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, bleeding (postoperative, from the nose, from the gums, from the urogenital tract), hematomas, prolonged bleeding time, prothrombin time, thrombocytopenia.
Consequences of bleeding may include iron deficiency anemia or post-hemorrhagic anemia, manifesting as asthenia, pallor, hypoperfusion, as well as 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 concomitant use of other anticoagulant medications) potentially life-threatening.
Renal and urinary disorders:
Kidney 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 any side effects occur, including those not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Aspirin

Do not store above 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 packaging.
The expiry date refers to the last day of the month.
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 Aspirin contains

The active substance of Aspirin is acetylsalicylic acid (Acidum acetylsalicylicum). One tablet contains 500 mg of acetylsalicylic acid.
The other ingredients of the medicine are: cellulose, powder, corn starch.

What Aspirin looks like and what the packaging contains

White, round tablets packaged in blisters of 10 tablets. The packaging contains 10, 20, or 100 tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, country of export:

UAB Bayer, Sporto 18, LT-09238 Vilnius, Lithuania

Manufacturer:

Bayer Bitterfeld GmbH, Ortsteil Greppin, Salegaster Chaussee 1, 06803 Bitterfeld-Wolfen, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Lithuania, country of export:
LT/1/94/0846/001
LT/1/94/0846/002

Parallel import authorization number: 95/19

Date of leaflet approval: 23.02.2024

[Information about the trademark]