Aspirin

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Aspirin
500 mg, tablets
Acetylsalicylic acid
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 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 possible adverse reactions 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. What you need to know 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 for use:

• 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 kidney failure,
• if the patient has previously experienced asthma attacks induced by salicylates or substances with similar effects, particularly nonsteroidal 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 nonsteroidal anti-inflammatory or antirheumatic drugs or other allergenic substances,
• the patient is concurrently taking anticoagulant medicines,
• the patient has impaired liver function,
• 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 further increase the risk of kidney function disturbances and severe kidney failure,
• the patient has a history of (chronic or recurrent) peptic ulcer or gastrointestinal bleeding,
• 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,
• 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 asthma, chronic respiratory diseases, hay fever, nasal polyps, or who have 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 predisposed to reduced uric acid excretion, the medicine may provoke 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 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 under medical supervision.
Long-term use of medicines containing acetylsalicylic acid may cause headache that worsens with continued dosing.
Prolonged use of analgesics, particularly those containing multiple active ingredients, may lead to severe kidney function impairment and kidney failure.

Aspirin and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
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 concomitantly 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 special caution;
• the effect of anticoagulants, thrombolytic drugs (clot-dissolving agents), and antiplatelet agents, which may increase the risk of prolonged bleeding time and hemorrhage;
• the risk of peptic ulcer disease and gastrointestinal bleeding when used concomitantly with corticosteroids, other nonsteroidal anti-inflammatory drugs (including other salicylates at high doses), or when alcohol is consumed during treatment; after discontinuation of systemic glucocorticoids (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 conditions), as it increases its plasma concentration;
• the effect of antidiabetic medicines, e.g. insulin or 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 (e.g. benzbromarone, probenecid), which may exacerbate symptoms of gout;
• diuretics;
• certain antihypertensive medicines (from the group of so-called angiotensin-converting enzyme inhibitors), particularly if acetylsalicylic acid is used in high doses.
  Aspirin may be used concomitantly 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, if pregnancy is suspected, or when planning a pregnancy, consult a doctor or pharmacist before using this medicine.
Aspirin is contraindicated in the third trimester of pregnancy, as it may cause complications in the perinatal period in both mother and newborn. Products containing acetylsalicylic acid should not be used in women during the first and second trimesters of pregnancy unless absolutely necessary. If use of acetylsalicylic acid is required in women attempting to conceive or during the first or second trimester of pregnancy, the lowest possible dose should be used for the shortest possible duration.
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 transient and resolves after discontinuation of therapy.

Driving and operating machinery
The medicine has no effect.

3. How to use Aspirin

This medicine should always be taken exactly as described in the patient leaflet or as directed by your
physician 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 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: Aspirin may be used in adolescents over 12 years of age only on medical advice. Take 1 tablet (i.e. 500 mg 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 acetylsalicylic acid) per day. Tablets should be taken orally, after meals, with plenty of fluid. Do not use this medicine for longer than 3–5 days without consulting a doctor.

Taking more medicine than recommended (overdose)
Poisoning with the active substance in Aspirin may result from long-term 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 (disorders of consciousness with disorientation, disturbances in thinking and speech, hallucinations, illusions, anxiety, and psychomotor agitation), rapid breathing, abnormally deep breathing, and symptoms of respiratory alkalosis (visual disturbances such as flickering before the eyes, fainting).
In case of severe poisoning, the following symptoms may additionally occur: high fever, respiratory disorders (up to respiratory arrest and suffocation), cardiovascular disorders (from irregular heartbeat, low blood pressure up to cardiac arrest), fluid and electrolyte loss (from dehydration, oliguria [reduced daily urine output below 400–500 ml in adults] up to renal failure), increased or decreased blood glucose concentration (especially in children), ketosis, gastrointestinal bleeding, blood coagulation disorders, and neurological disorders manifesting as lethargy, confusion up to coma and convulsive seizures.
If an overdose has been taken, seek immediate medical advice from a doctor or pharmacist; in case of severe poisoning, the patient must be immediately transported 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 necessary.

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 a missed dose.

Stopping Aspirin
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

Warning!

• If vomiting with blood or black, tarry stools occurs, discontinue the medicine and consult a doctor immediately.
• A severe allergic reaction may include: facial and eyelid swelling, swelling of the tongue and larynx with airway constriction, difficulty breathing, shortness of breath, asthma attacks, increased heart rate, sudden drop in blood pressure up to life-threatening shock. In case any of these symptoms occur, immediate professional medical care must be provided. The above reactions may occur even after the first dose of the medicine.

Gastrointestinal disorders:
Stomach and abdominal pain, heartburn, nausea, vomiting, indigestion, inflammation of the gastrointestinal tract, potentially life-threatening gastrointestinal bleeding: overt (vomiting blood, tarry stools) or occult (bleeding occurs more frequently with higher doses); gastric or duodenal ulcer disease, perforation.

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, nosebleeds, gum bleeding, urogenital bleeding), bruising, prolonged bleeding time, prolonged prothrombin time, thrombocytopenia.
As a consequence of bleeding, acute or chronic iron-deficiency anaemia or acute haemorrhagic anaemia may occur, 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:
Intracerebral haemorrhage (especially in patients with uncontrolled hypertension and/or concomitant use of other anticoagulant drugs), potentially life-threatening.

Renal and urinary disorders:
Renal function impairment and severe renal failure.

Immune system disorders:
Hypersensitivity reactions with clinical symptoms and abnormal results of relevant laboratory tests, such as: asthma, mild to moderate skin, respiratory, and cardiovascular system reactions with symptoms such as rash, urticaria, angioedema (including vasomotor type), breathing difficulties, cardiac disturbances, rhinitis, nasal mucosa congestion, 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, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to collect more information on the safety of the medicine.

5. How to store Aspirin

Do not store at temperatures above 30°C.
Keep the medicine in a place invisible and inaccessible to 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 sewage systems or household waste bins. Ask your pharmacist how to dispose of medicines no longer in use. This practice will help protect the environment.

6. Contents of the pack and other information

What Aspirin contains
The active substance is acetylsalicylic acid.
Other ingredients 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 the 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

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

Parallel import authorisation number: 242/22