Aspirin musuiomca

Package Leaflet: Information for the Patient

ASPIRIN effervescent, 500 mg, effervescent tablets
Acidum acetylsalicylicum

Read the package leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in this package leaflet for the patient or as advised by your doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3-5 days, they should consult a doctor.

Package Leaflet Contents:

• 1. What Aspirin effervescent is and what it is used for
• 2. Important information before taking Aspirin effervescent
• 3. How to take Aspirin effervescent
• 4. Possible side effects
• 5. How to store Aspirin effervescent
• 6. Contents of the pack and other information

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

Aspirin effervescent contains acetylsalicylic acid, which acts as a pain reliever, anti-inflammatory, and antipyretic.
Indications for use:

• mild to moderate pain: headaches of various origins (e.g., migraines), toothaches, muscle aches,
• pain and fever in the course of colds and flu.

2. Important information before taking Aspirin effervescent

When not to take Aspirin effervescent

• 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 ulcers,
• 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 effervescent, 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 kidney function disorders 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 a history of (chronic or recurrent) stomach ulcers or gastrointestinal bleeding,
• if the patient has a genetic disorder characterized by a deficiency of the enzyme - glucose-6-phosphate dehydrogenase, as the administration of acetylsalicylic acid may cause 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 bronchospasm 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 effervescent.
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 taken, and in adolescents over 12 years of age, drugs containing acetylsalicylic acid can only be taken on a doctor's prescription.
Long-term administration of drugs containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Long-term administration of painkillers, especially those containing multiple active substances, may lead to severe kidney function disorders and kidney failure.

Aspirin effervescent 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 taking Aspirin effervescent 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; concurrent 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 platelet aggregation inhibitors, which may increase the risk of prolonged bleeding time and bleeding;
• the risk of stomach ulcers and gastrointestinal bleeding if taken concurrently 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 anti-diabetic 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 taking Aspirin effervescent with the following medicines, as acetylsalicylic acid weakens:
• the effect of uricosuric 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 some antihypertensive drugs (from the group of so-called angiotensin-converting enzyme inhibitors).

Aspirin effervescent can be taken with the above-mentioned medicines (except for methotrexate at doses of 15 mg per week or higher) only after consulting a doctor.

Aspirin effervescent with food, drink, and alcohol

See section 3 of the package leaflet.
Warning! Alcohol may increase the risk of adverse reactions from the gastrointestinal tract, i.e., mucosal ulceration or bleeding.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Aspirin effervescent should not be taken during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. The drug may cause kidney and heart function disorders in the unborn child. It may also affect the patient's and child's tendency to bleed and cause delayed or prolonged delivery. Aspirin effervescent should not be taken during the first 6 months of pregnancy, unless it is absolutely necessary and has been prescribed by a doctor. If the patient requires treatment during this period or is trying to conceive, they should take the lowest possible dose for the shortest possible time. If Aspirin effervescent is taken for more than a few days from the 20th week of pregnancy, it may cause kidney function disorders in the unborn child, leading to a decrease in the amount of amniotic fluid surrounding the fetus (oligohydramnios) or narrowing of the arterial duct in the child's heart. If treatment is necessary for more than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Acetylsalicylic acid passes into breast milk in small amounts.
Fertility
Aspirin effervescent 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 does not affect the ability to drive and use machines.

Aspirin effervescent contains sodium

One effervescent tablet contains 543 mg of sodium (the main component of common salt). This corresponds to 27% of the maximum recommended daily dose of sodium in the diet for adults. The maximum daily dose of this product is equivalent to 216% of the WHO-recommended maximum daily intake of sodium. This should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.

3. How to take Aspirin effervescent

This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose of Aspirin effervescent is:

• adults: 1-2 effervescent tablets (i.e., 500-1000 mg of acetylsalicylic acid) at a time. If necessary, the single dose may be repeated at intervals of no less than 4 to 8 hours. Do not take more than 8 effervescent 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. Take 1 effervescent tablet (i.e., 500 mg of acetylsalicylic acid) at a time. If necessary, the single dose may be repeated at intervals of no less than 4 to 8 hours. Do not take more than 3 effervescent tablets (i.e., 1500 mg of acetylsalicylic acid) per day. The medicine should not be taken for more than 3-5 days without consulting a doctor.

The effervescent tablets should be dissolved in a glass of water and the effervescent liquid drunk. Take after meals.

Overdose of Aspirin effervescent

Acetylsalicylic acid poisoning can be caused by prolonged administration of the medicine (mild poisoning) or overdose (severe poisoning), which can be life-threatening, e.g., after accidental ingestion 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), rapid breathing, deep breathing, and symptoms of respiratory alkalosis (spots 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), cardiovascular 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, 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 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.

Missed dose of Aspirin effervescent

In the event of a missed dose and persistence of symptoms, the next dose of Aspirin effervescent should be taken. A double dose should not be taken to make up for the missed dose.

Stopping Aspirin effervescent treatment

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

4. Possible side effects

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

• If coffee grounds-like vomiting or black, tarry stools occur, 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 these symptoms, immediate medical attention should be sought. These 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); stomach or duodenal ulcers, perforation, enteropathy (especially during long-term use).
Liver and bile duct 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, gingival, genitourinary), hematoma, prolonged bleeding time, prothrombin time, thrombocytopenia.
Consequences of bleeding may include iron deficiency anemia or post-hemorrhagic anemia, 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:
Cerebral hemorrhage (especially in patients with uncontrolled hypertension and/or concomitant use of other anticoagulant drugs) potentially life-threatening.
Renal and urinary disorders:
Kidney function disorders and severe kidney damage.
Immune system disorders:
Hypersensitivity reactions with clinical symptoms and abnormal laboratory test results, such as respiratory system 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 those not listed in the package leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Aspirin effervescent

Store in a temperature below 25°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 the term "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 pack and other information

What Aspirin effervescent contains

• The active substance of the medicine is acetylsalicylic acid (Acidum acetylsalicylicum).
• The other ingredients are: sodium citrate, sodium bicarbonate, citric acid, sodium carbonate.

What Aspirin effervescent looks like and contents of the pack

White, round effervescent tablets packaged in sachets. The pack contains 10, 12, or 24 effervescent tablets.
Marketing authorization holder:
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
Tel.: +48 22 572 35 00
Fax: +48 22 572 35 55
Manufacturer:
Bayer Bitterfeld GmbH
OT Greppin
Salegaster Chaussee 1
06803 Bitterfeld-Wolfen
Germany
Date of last revision of the package leaflet:08/2023