Aspirin

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Aspirin

500 mg, tablets

Acetylsalicylic acid

You should carefully read the contents of the leaflet before taking the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.

• You should keep this leaflet, so that you can read it again if necessary.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3-5 days there is no improvement or the patient feels worse, 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 gastric or duodenal ulcer disease,
• if the patient has severe heart failure or severe liver or kidney failure,
• if the patient has ever had asthma attacks triggered by the administration of 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 to take Aspirin, you should discuss it with your doctor or pharmacist:

• if the patient has hypersensitivity 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, decreased 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) gastric ulcer disease or gastrointestinal bleeding,
• if the patient has a genetic disorder involving a deficiency of the enzyme - glucose-6-phosphate dehydrogenase, as the administration of acetylsalicylic acid may cause the occurrence of hemolysis or hemolytic anemia,
• if the patient is breastfeeding.

Drugs containing acetylsalicylic acid should not be taken by women in 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.
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. The occurrence of 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, drugs containing acetylsalicylic acid should not be taken, and in adolescents over 12 years of age, drugs containing acetylsalicylic acid can only be taken 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

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.
You should exercise special caution 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;

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 antiplatelet drugs, which may increase the risk of prolonged bleeding time and bleeding;
• the risk of developing gastric ulcer disease and gastrointestinal bleeding if taken concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs, including other salicylates in high doses, or if alcohol is consumed during treatment; after stopping systemic corticosteroid therapy (except for hydrocortisone used as replacement therapy in Addison's disease), the risk of salicylate overdose increases;
• 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). You should exercise special caution when taking 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), especially if acetylsalicylic acid is taken in high doses. Aspirin can be taken concurrently 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 you suspect you are pregnant, or plan to become pregnant, you should consult your 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 taken by women in the first and second trimester of pregnancy, unless it is absolutely necessary. If it is necessary to take acetylsalicylic acid in women trying to conceive or in the first and second trimester of pregnancy, the smallest possible dose of the medicine should be taken for the shortest possible time.
Acetylsalicylic acid passes into breast milk in small amounts.
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 has no effect.

3. How to take Aspirin

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubt, you should consult your 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. You should 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 taken by adolescents over 12 years of age only on a doctor's prescription. You 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. You should not take more than 3 tablets (i.e., 1500 mg of acetylsalicylic acid) per day. The tablets should be taken orally, after meals, with a large amount of fluid. The medicine should not be taken for more than 3-5 days without consulting a doctor.

Taking a higher dose of Aspirin than recommended

Poisoning with the active substance of Aspirin can be caused by prolonged use of the medicine (mild poisoning) or overdose (severe poisoning), which can be life-threatening, e.g., after accidental ingestion of the medicine 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), accelerated breathing, too deep breathing, and symptoms of respiratory alkalosis (darkness 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 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 taking a higher dose of Aspirin than recommended, you 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

In the event of missing a dose of Aspirin and the persistence of symptoms, you should take the next dose of Aspirin. You should not take a double dose to make up for the missed dose.

Stopping Aspirin treatment

In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

• If you experience coffee grounds-like vomiting or black, tarry stools, you should stop taking the medicine and consult your 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, accelerated heart rate, sudden drop in blood pressure up to life-threatening shock. In case of any of the above symptoms, you 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 (coffee grounds-like vomiting, black, tarry stools) or occult (bleeding occurs more frequently the higher the dose); gastric or duodenal ulcer disease, perforation.
  Liver and biliary disorders:
  In rare cases, transient liver function disorders (increased aminotransferase activity) have been reported.
  Nervous system disorders:
  Dizziness and tinnitus, which are usually symptoms of overdose.
  Blood and lymphatic system disorders:
  Increased risk of bleeding, bleeding (postoperative, nasal, gingival, urogenital), hematoma, prolonged bleeding time, prothrombin time, thrombocytopenia.
  As a result of bleeding, acute or chronic iron deficiency anemia or acute post-hemorrhagic anemia may occur, 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 concurrent use of other anticoagulant drugs) potentially threatening life.
  Renal and urinary disorders:
  Renal function disorders and severe kidney failure.
  Immune system disorders:
  Hypersensitivity reactions with clinical symptoms and abnormal laboratory test results, such as: asthma, mild to moderate skin reactions, respiratory, cardiovascular, and gastrointestinal 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 any side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration 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
  By reporting side effects, you can 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. 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 packaging and other information

  What Aspirin contains

  The active substance of Aspirin is 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, you should contact the marketing authorization holder or the parallel importer.

  Marketing authorization holder in Lithuania, the 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:

  Medezin Sp. z o.o.
  ul. Zbąszyńska 3
  91-342 Łódź

  Repackaged by:

  Medezin Sp. z o.o.
  ul. Zbąszyńska 3
  91-342 Łódź
  CEFEA Sp. z o.o. Sp. komandytowa
  ul. Działkowa 56
  02-234 Warsaw
  Pharma Innovations Sp. z o.o.
  ul. Jagiellońska 76
  03-301 Warsaw
  SHIRAZ PRODUCTIONS Sp. z o.o.
  ul. Tymiankowa 24/28
  95-054 Ksawerów
  CANPOLAND SPÓŁKA AKCYJNA
  ul. Beskidzka 190
  91-610 Łódź
  Marketing authorization number in Lithuania, the country of export:
  LT/1/94/0846/002
  LT/1/94/0846/001

  Parallel import authorization number: 242/22 Date of leaflet approval: 03.06.2022

  [Information about the trademark]