Aspirin

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Aspirin, 500 mg, tablets
Acidum acetylsalicylicum
Please read this 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
the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• 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, pharmacist or nurse. See section 4.
• If there is no improvement or if you feel worse after 3–5 days, you should consult your doctor.

Contents of the leaflet:

1. What Aspirin is and what it is 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 Aspirin is and what it is used for

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

• mild to moderate pain,
• fever.

2. Important information before using Aspirin

When not to use 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 tendency,
• if the patient has acute gastric or duodenal ulcer,
• if the patient has severe heart failure, severe liver failure, or severe renal failure,
• if the patient has ever experienced bronchial asthma attacks induced by salicylates or substances with similar action, particularly non-steroidal anti-inflammatory drugs (NSAIDs),
• if the patient is concurrently taking methotrexate (used, among others, 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 treatment with Aspirin, consult a 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 concurrently taking anticoagulant medicines,
• if the patient has impaired liver function,
• if the patient has impaired kidney function or circulatory disorders (e.g. renal vascular disease, congestive heart failure, reduced circulating blood volume, sepsis, severe bleeding), as acetylsalicylic acid may additionally increase the risk of kidney function disturbances and severe renal failure,
• if the patient has a history of (chronic or recurrent) peptic ulcer disease or gastrointestinal bleeding,
• if the patient suffers from a genetic disorder involving deficiency of the enzyme glucose-6-phosphate dehydrogenase, as administration of acetylsalicylic acid may trigger hemolysis or hemolytic anemia,
• if the patient is breastfeeding.

Medicines containing acetylsalicylic acid should not be used in women during the first and second trimesters of pregnancy unless absolutely necessary.
Acetylsalicylic acid may cause bronchospasm and provoke asthma attacks or other hypersensitivity reactions. Patients with bronchial asthma, chronic respiratory diseases, hay fever, nasal polyps, or those who experience allergic reactions to other substances (e.g. skin reactions, itching, urticaria) are particularly at risk.
Patients undergoing surgical procedures (including minor procedures such as tooth extraction) should inform their doctor about taking Aspirin.
Acetylsalicylic acid, even at low doses, reduces the excretion of uric acid from the body. In patients predisposed to reduced uric acid excretion, the medicine may trigger an attack of gout.
During certain viral infections, particularly influenza A virus, influenza B virus, or varicella (chickenpox), especially in children and adolescents, there is a risk of Reye's syndrome – a rare but life-threatening condition. Persistent vomiting during an infection may indicate the onset of Reye's syndrome, requiring 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, medicines containing acetylsalicylic acid should not be used in children under 12 years of age, and in adolescents over 12 years of age, such medicines should be used only on a doctor's advice.
Long-term use of medicines containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Prolonged use of analgesic medicines, particularly those containing multiple active substances, may lead to severe kidney function disorders and renal failure.

Aspirin and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines you plan to take.
Particular caution is required when using Aspirin with the following medicines, as acetylsalicylic acid enhances:

• the toxic effect of methotrexate on bone marrow; acetylsalicylic acid should not be used concurrently with methotrexate administered at doses of 15 mg per week or higher; concurrent use of methotrexate at doses lower than 15 mg per week requires

particular caution;

• the effect of anticoagulants, thrombolytics (clot-dissolving agents), and platelet aggregation inhibitors, which may increase the risk of prolonged bleeding time and hemorrhage;
• the risk of peptic ulcer disease and gastrointestinal bleeding if used concomitantly with corticosteroids, other non-steroidal anti-inflammatory drugs, including other salicylates, or if alcohol is consumed during treatment;
• after discontinuation of systemic glucocorticosteroids (except hydrocortisone used as replacement therapy in Addison's disease), the risk of salicylate overdose increases;
• the effect of digoxin (a medicine used in heart diseases), as it increases its plasma concentration;
• the effect of antidiabetic medicines, e.g. insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid (a medicine used, among others, in epilepsy), which in turn enhances the antiplatelet effect of acetylsalicylic acid;
• the effect of selective serotonin reuptake inhibitors (antidepressant medicines).

Particular caution is required when using Aspirin with the following medicines, as acetylsalicylic acid weakens their effect:

• uricosuric agents used in the treatment of gout that increase uric acid excretion from the body (e.g. benzbromarone, probenecid), which may exacerbate symptoms of gout;
• diuretics;
• certain antihypertensive medicines (so-called angiotensin-converting enzyme inhibitors).

Aspirin may be used concurrently with the above-mentioned medicines (except methotrexate administered at doses of 15 mg per week or higher) only after consultation with a doctor.
Aspirin with food, drink, or alcohol
See section 3 of the leaflet.
Warning! Alcohol may increase the risk of adverse effects on the gastrointestinal tract, such as mucosal ulceration or bleeding.
Pregnancy, breastfeeding, and effects on fertility
During pregnancy, breastfeeding, or if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not take Aspirin during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medicine may cause disturbances in kidney and heart function in the unborn child. It may also affect the tendency of both mother and child to bleed and may delay or prolong labour. Do not use Aspirin during the first six months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration. If Aspirin is taken for longer than a few days beyond the 20th week of pregnancy, it may cause disturbances in kidney function in the unborn child, leading to reduced amniotic fluid volume (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If prolonged treatment is necessary, 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 reversible and resolves after discontinuation of therapy.
Driving and operating machinery
Aspirin does not affect the ability to drive or operate machinery.

3. How to use Aspirin

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, 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 no more frequently than every 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: Aspirin may be used in adolescents over 12 years of age only on medical advice. Take 1 tablet (i.e. 500 mg of acetylsalicylic acid) as a single dose. If necessary, the single dose may be repeated no more frequently than every 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 longer than 3–5 days without consulting a doctor.

The tablets should be taken orally, after meals, with plenty of water.
Taking more than the recommended dose of Aspirin
Poisoning with the active substance of Aspirin may result from long-term use (mild poisoning) or overdose (severe poisoning), which may be life-threatening, for example after accidental ingestion by children or elderly individuals.
Symptoms of mild poisoning include: dizziness (including labyrinthine origin), tinnitus, hearing loss, excessive sweating, nausea and vomiting, headache, confusion (mental disturbances with disorientation, impaired thinking and speech, delusions, hallucinations, anxiety, and psychomotor agitation), rapid breathing, deep breathing, and symptoms of respiratory alkalosis (visual disturbances, fainting).
In cases of severe poisoning, additional symptoms may occur: high fever, respiratory disorders (up to respiratory arrest and asphyxia), cardiovascular disorders (from irregular heartbeat and low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration, oliguria [reduced daily urine output below 400–500 ml in adults] up to kidney failure), increased or decreased blood glucose concentration (especially in children), ketosis, gastrointestinal bleeding, blood coagulation disorders, and neurological disturbances manifesting as lethargy, confusion, up to coma and convulsive seizures.
If more than the recommended dose has been taken, seek immediate medical advice from a doctor or pharmacist. In cases of severe poisoning, the patient must be taken immediately to hospital.
Treatment of poisoning includes gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be required.
Missing a dose of Aspirin
If a dose is missed and symptoms persist, take the next dose of Aspirin as scheduled. Do not take a double dose to make up for a missed dose.
Stopping treatment with Aspirin
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 medicinal product may cause adverse reactions, although not everybody will experience them.

Warning!

• If vomiting of coffee-ground material or black, tarry stools occurs, discontinue the medicine and consult a doctor immediately.
• Symptoms of a severe hypersensitivity reaction may include: facial and eyelid swelling, swelling of the tongue and larynx with airway constriction, breathing difficulties, shortness of breath, asthma attacks, rapid heartbeat, sudden drop in blood pressure leading to life-threatening shock. If any of these symptoms occur, immediate professional medical care must be sought. These reactions may occur even after the first dose of the medicine.

Gastrointestinal disorders:
Stomach and abdominal pain, heartburn, nausea, vomiting, dyspepsia, gastrointestinal inflammation,
potentially life-threatening gastrointestinal bleeding: overt (coffee-ground vomiting,
tarry stools) or occult (bleeding occurs more frequently with higher doses); peptic ulcer disease of the stomach or duodenum, perforation, constrictive intestinal enteropathy (particularly during long-term use).

Hepatobiliary disorders:
Rarely, transient disturbances in liver function (increased aminotransferase activity) have been reported.

Nervous system disorders:
Dizziness and tinnitus, typically symptoms of overdose.

Blood and lymphatic system disorders:
Increased risk of bleeding, haemorrhages (postoperative, epistaxis, gingival, genitourinary),
bruising, prolonged bleeding time and prothrombin time, thrombocytopenia.
Bleeding may lead to iron-deficiency anaemia or haemorrhagic anaemia, manifesting as asthenia, pallor, hypoperfusion, and abnormal laboratory test results.
Haemolysis and haemolytic anaemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.

Vascular disorders:
Intracranial haemorrhage (particularly in patients with uncontrolled hypertension and/or those concurrently using other antithrombotic agents), potentially life-threatening.

Renal and urinary disorders:
Renal function impairment and severe kidney damage.

Immune system disorders:
Hypersensitivity reactions with clinical symptoms and abnormal laboratory findings, such as: respiratory disease exacerbated by acetylsalicylic acid intake, mild to moderate reactions affecting the skin, respiratory system, and cardiovascular system, with symptoms including rash, urticaria, angioedema (including vasomotor), respiratory disturbances, cardiac dysfunction, nasal mucosal inflammation, nasal mucosal congestion, and very rarely, severe reactions including anaphylactic shock.

Respiratory system disorders:
Bronchial asthma.

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 the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Aspirin

Do not store at temperatures above 30°C.
Keep the medicine in a place invisible and out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aspirin contains
The active substance is acetylsalicylic acid (Acidum acetylsalicylicum). One tablet contains
500 mg of acetylsalicylic acid.
Other components are: cellulose, powder, corn starch.

What Aspirin looks like and contents of the pack
White, round tablets packed in blisters of 10 tablets. The pack contains 10, 20 or 100
tablets.

For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation 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, Poland

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

Marketing Authorisation numbers in Lithuania, country of export: LT/1/94/0846/001
LT/1/94/0846/002

Parallel import licence number: 95/19