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 carefully all the information in this 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 as directed by
the doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• 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 or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3–5 days, consult your doctor.

Table of 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 properties.
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 asthma attacks induced by salicylates or substances with similar action, particularly nonsteroidal anti-inflammatory drugs,
• 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 nonsteroidal 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 vessel disease, congestive heart failure, reduced circulating blood volume, sepsis, severe bleeding), as acetylsalicylic acid may additionally increase the risk of kidney function disorders and severe renal failure,
• if the patient has had a history of (chronic or recurrent) peptic ulcer 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 mucosal 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 in small doses, reduces the excretion of uric acid from the body. In patients prone to reduced uric acid excretion, the drug may trigger an attack of gout.
During certain viral infections, particularly influenza A, influenza B, 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 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 headache that worsens 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 you are currently taking, have recently taken, or plan to take.
Special 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 at doses of 15 mg per week or higher; concurrent use of methotrexate at doses lower than 15 mg per week requires special caution;
• the effect of anticoagulant medicines, thrombolytic (clot-dissolving) medicines, and medicines that inhibit platelet aggregation (clumping), which may lead to increased risk of prolonged bleeding time and hemorrhage;
• the risk of peptic ulcer disease and gastrointestinal bleeding if used concurrently with corticosteroids, other nonsteroidal 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 anti-aggregatory effect of acetylsalicylic acid;
• the effect of selective serotonin reuptake inhibitors (antidepressant medicines).

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

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

Aspirin may be used concurrently with the above-mentioned medicines (except methotrexate 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 fertility

During pregnancy, breastfeeding, or when pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.
Aspirin is contraindicated during the third trimester of pregnancy, as it may cause complications in the perinatal period, both in the mother and the newborn. Products containing acetylsalicylic acid should not be used in women during the first and second trimesters of pregnancy unless absolutely necessary. If acetylsalicylic acid must be used by women attempting to conceive or during the first or second trimester of pregnancy, the lowest possible dose should be taken for the shortest possible duration.
Aspirin belongs to a group of medicines that may adversely affect female fertility. This effect is reversible and resolves after discontinuation of therapy.
Acetylsalicylic acid passes into breast milk in small amounts.

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 directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

The recommended dose of Aspirin is:

• Adults: 1 to 2 tablets at a time (i.e. 500 - 1000 mg 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 acetylsalicylic acid) per day.

• Adolescents over 12 years of age: This medicine may be used in adolescents over 12 years of age only on a doctor's advice. Take 1 tablet at a time (i.e. 500 mg acetylsalicylic acid). 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 acetylsalicylic acid) per day. The medicine should not be used for longer than 3-5 days without consulting a doctor.

Tablets should be taken orally after meals, with plenty of water.

Overdose of Aspirin

Poisoning with the active substance of Aspirin may result from prolonged use (mild poisoning) or from overdose (severe poisoning), which may be life-threatening, for example after accidental ingestion by children or elderly persons.

Symptoms of mild poisoning include: dizziness (including labyrinthine origin), tinnitus, deafness, excessive sweating, nausea and vomiting, headache, confusion (mental disturbances with disorientation, impaired thinking and speech, hallucinations, illusions, anxiety, and psychomotor agitation), rapid breathing, deep breathing, and symptoms of respiratory alkalosis (visual disturbances, fainting).

In cases of severe poisoning, the following additional symptoms may occur: high fever, respiratory disorders (up to respiratory arrest and suffocation), disturbances in heart and blood vessel function (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 clotting disorders, and neurological disturbances manifesting as lethargy, confusion, progressing to coma and convulsions.

In case of overdose, 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.

Missed dose of Aspirin

If a dose of Aspirin is missed and symptoms persist, take the next dose as scheduled. Do not take a double dose to make up for the missed dose.

Stopping Aspirin

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.

Warning!

• If vomiting of coffee-ground appearance or black, tarry stools occur, discontinue the medicine immediately and consult a doctor.
• Severe hypersensitivity reactions may include: facial and eyelid swelling, swelling of the tongue and larynx with airway constriction, difficulty breathing, shortness of breath, asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. In case any of these symptoms occur, immediate professional medical assistance 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, inflammation of the gastrointestinal tract, potentially life-threatening gastrointestinal bleeding: overt (coffee-ground vomiting, tarry stools) or occult (risk of bleeding increases with higher doses); gastric or duodenal ulceration, perforation, constrictive enteropathy of the intestine (particularly during long-term use).

Hepatic and biliary disorders:
Rarely, transient disturbances in liver function (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, haemorrhages (postoperative, epistaxis, gingival, genitourinary), haematomas, prolonged bleeding time and prothrombin time, thrombocytopenia.
Bleeding may lead to iron deficiency anaemia or haemorrhagic anaemia, manifesting as asthenia, pallor, hypoperfusion, as well as abnormal laboratory test results.
Haemolysis and haemolytic anaemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.

Vascular disorders:
Intracerebral haemorrhage (particularly in patients with uncontrolled hypertension and/or concomitant use of other antithrombotic medicines), 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 aggravated by acetylsalicylic acid intake, mild to moderate reactions affecting skin, respiratory and cardiovascular systems with symptoms such as: rash, urticaria, angioedema (including vasomotor), breathing difficulties, cardiac disturbances, rhinitis, nasal mucosal hyperaemia, and very rarely severe reactions including anaphylactic shock.

Respiratory system disorders:
Bronchial asthma.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to enhance the safety information regarding the use of this medicine.

5. How to store Aspirin

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

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

What Aspirin looks like and contents of the packaging
White, round tablets packed in PP/Al blisters of 10 tablets.
Packaging 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

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

Parallel import licence number: 311/18
[Information about the registered trademark]