Aspirin

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

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 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 any side effects not listed in this leaflet, they should inform their doctor or 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

• if the patient is allergic to the active substance - acetylsalicylic acid, other salicylates, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has a bleeding disorder,
• if the patient has acute stomach or duodenal ulcer,
• if the patient has severe heart failure or severe liver or kidney failure,
• if the patient has ever had asthma attacks caused by taking salicylates or substances with similar effects, especially non-steroidal anti-inflammatory drugs,
• if the patient is taking methotrexate (used in cancer treatment) at doses of 15 mg per week or higher,
• if the patient is in the third trimester of pregnancy,
• in children under 12 years of age.

Warnings and precautions

Before starting Aspirin, the patient should discuss it with their doctor or pharmacist:

• if the patient is hypersensitive to non-steroidal anti-inflammatory and anti-rheumatic drugs or other allergenic substances,
• if the patient is taking anticoagulant drugs,
• if the patient has impaired liver function,
• if the patient has impaired kidney function or circulatory disorders (e.g., kidney vessel disease, congestive heart failure, reduced blood volume, extensive surgery, sepsis, severe bleeding), as acetylsalicylic acid may further increase the risk of kidney function disorders and severe kidney failure,
• if the patient has had a history of (chronic or recurrent) stomach ulcers or gastrointestinal bleeding,
• if the patient has a genetic disorder involving a deficiency of the enzyme - glucose-6-phosphate dehydrogenase, as acetylsalicylic acid may cause hemolysis or hemolytic anemia,
• if the patient is breastfeeding.

Drugs 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 with 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 drug 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, drugs containing acetylsalicylic acid should not be used, and in adolescents over 12 years of age, drugs containing acetylsalicylic acid can only be used on a doctor's prescription.
Long-term use of drugs 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 using Aspirin with the following medicines, as acetylsalicylic acid enhances:

• the toxic effect of methotrexate on the bone marrow; acetylsalicylic acid should not be used simultaneously with methotrexate at doses of 15 mg per week or higher;

concomitant use of methotrexate at doses less than 15 mg per week requires special caution;

• the effect of anticoagulant drugs, thrombolytic drugs (dissolving blood clots), and antiplatelet agents, which may increase the risk of prolonged bleeding time and bleeding;
• the risk of stomach ulcers and gastrointestinal bleeding if used concomitantly 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 drugs, e.g., 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 using Aspirin with the following medicines, as acetylsalicylic acid weakens:
• the effect of anti-gout drugs used to treat gout, which increase uric acid excretion from the body (e.g., benzbromarone, probenecid), which may worsen gout symptoms;
• the effect of diuretics;
• the effect of certain antihypertensive drugs (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 gastrointestinal side effects, such as stomach ulcers or bleeding.

Pregnancy, breastfeeding, and fertility

In pregnancy, breastfeeding, or if pregnancy is suspected, or if pregnancy is planned, the patient should consult their doctor or pharmacist before taking the medicine.
Aspirin is contraindicated in the third trimester of pregnancy, as it may cause complications during the perinatal period, both in the mother and the newborn. Drugs containing acetylsalicylic acid should not be used in women during the first and second trimester of pregnancy, unless it is absolutely necessary.
If acetylsalicylic acid needs to be used in women trying to conceive or in the first and second trimester of pregnancy, the patient should take the lowest possible dose for the shortest possible time.
Aspirin belongs to a group of medicines that may adversely affect female fertility. This effect is temporary and disappears after the end of therapy.
Acetylsalicylic acid passes into breast milk in small amounts.

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: 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. The patient should 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 can be life-threatening, e.g., after accidental ingestion by children or the elderly.
Symptoms of mild overdose are: dizziness (including vertigo), tinnitus, hearing loss, 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 overdose, 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 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, the patient 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 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 any 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 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.

In the event of any of the above symptoms, the patient should immediately seek medical attention. The above 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, nasal, gum, urogenital), hematomas, prolonged bleeding time, prothrombin time, thrombocytopenia. The consequence of bleeding may be the development of iron deficiency anemia or post-hemorrhagic anemia, 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:
Cerebral hemorrhage (especially in patients with uncontrolled hypertension and/or concomitantly using other anticoagulant drugs) 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 any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 or parallel importer.
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 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. 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 as the active substance.
The other ingredients of the medicine are: cellulose, powder, cornstarch.

What Aspirin looks like and what the pack contains

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

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:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Marketing authorization number in Lithuania, country of export:LT/1/94/0846/001
LT/1/94/0846/002

Parallel import authorization number: 30/23 Date of leaflet approval: 01.03.2023

[Information about the trademark]