Aspirin Effect

Leaflet attached to the packaging: patient information

ASPIRIN EFFECT, 500 mg, granules

Acetylsalicylic acid

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

important information for the patient.
The medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this 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.

Table of contents of the leaflet:

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

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

Aspirin Effect is a pain-relieving, anti-inflammatory, and antipyretic medicine in a convenient granule form for direct application to the tongue.
Indications for use:

• painful conditions, e.g., headache, toothache, muscle pain, joint pain, back pain,
• conditions associated with colds and flu,
• fever.

2. Important information before taking Aspirin Effect

When not to take Aspirin Effect

• if the patient is allergic to 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 ulcer,
• 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 treatment with Aspirin Effect, 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 medications,
• 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, 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 involving 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.

Acetylsalicylic acid should not be used in women during 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 with 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 Effect.
Aspirin Effect should be discontinued 5-7 days before a planned surgical procedure.
Acetylsalicylic acid, even in small doses, reduces the excretion of uric acid.
In patients with a tendency to reduced uric acid excretion, the medicine 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 relationship has not been proven.
For these reasons, in children under 12 years of age, medicines containing acetylsalicylic acid should not be used, and in adolescents over 12 years of age, medicines containing acetylsalicylic acid can only be used on a doctor's prescription.
Prolonged use of medicines containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Prolonged use of painkillers, especially those containing multiple active substances, may lead to severe kidney function disorders and kidney failure.

Aspirin Effect with 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 using Aspirin Effect with the following medicines, as acetylsalicylic acid enhances:

• the toxic effect of methotrexate on the bone marrow; acetylsalicylic acid should not be used simultaneously with 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, thrombolytic (dissolving blood clots), and anti-platelet aggregation medications, which may increase the risk of prolonged bleeding time and bleeding;
• the risk of stomach ulcers and gastrointestinal bleeding if used concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs, including other salicylates, or if alcohol is consumed during treatment;
• the effect of digoxin (a medicine used to treat heart conditions), as it increases its concentration in the blood;
• the effect of anti-diabetic medications, e.g., insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid (a medicine used in epilepsy), which in turn enhances the anti-aggregatory effect of acetylsalicylic acid;
• the effect of selective serotonin reuptake inhibitors (antidepressant medications). Special caution should be exercised when using Aspirin Effect with the following medicines, as acetylsalicylic acid weakens:
• the effect of anti-gout medications 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 anti-hypertensive medications (from the group of so-called angiotensin-converting enzyme inhibitors).

Aspirin Effect with food, drinks, and alcohol

See section 3 of the leaflet.
Warning! Alcohol may increase the risk of gastrointestinal side effects, such as stomach ulcers 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 using this medicine.
Pregnancy
Aspirin Effect should not be taken during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medicine 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 Effect should not be used 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 become pregnant, they should use the smallest possible dose for the shortest possible time. If Aspirin Effect 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 Effect 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 or use machines.

Aspirin Effect contains aspartame

The medicine contains 5 mg of aspartame in each sachet, which corresponds to 5 mg of aspartame in 1 sachet of Aspirin Effect. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Aspirin Effect contains sodium

One sachet of Aspirin Effect contains 19 mg of sodium (the main component of common salt). This corresponds to 1% of the maximum recommended daily dose of sodium in the diet for adults. The maximum daily dose of this product is equivalent to 8% 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 Effect

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of Aspirin Effect is:

• adults - single dose of 1 to 2 sachets (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. Do not take more than 8 sachets (i.e., 4000 mg of acetylsalicylic acid) per day.
• adolescents over 12 years of age - the medicine may be used in adolescents over 12 years of age only on a doctor's prescription. Take a single dose of 1 sachet (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. Do not take more than 3 sachets (i.e., 1500 mg of acetylsalicylic acid) per day. The medicine should not be used for more than 3-5 days without consulting a doctor.

The granules should be placed directly on the tongue and left to dissolve. The dissolved granules should be swallowed, and if necessary, water can be drunk.
The medicine should not be taken on an empty stomach.

Taking a higher dose of Aspirin Effect than recommended

Poisoning with the active substance of Aspirin Effect 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 by children or the elderly.
Symptoms of mild poisoning are: dizziness (including vertigo), tinnitus, hearing loss, 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), heart and blood vessel disorders (from irregular heartbeat, low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration, oliguria [reduced urine output below 400-500 ml per day 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 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.

Missing a dose of Aspirin Effect

If a dose is missed and symptoms persist, the next dose of Aspirin Effect should be taken. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Aspirin Effect

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

4. Possible side effects

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

• If coffee-ground 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. If any of these symptoms occur, 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, inflammation of the gastrointestinal tract, potentially life-threatening gastrointestinal bleeding: overt (coffee-ground vomiting, black tarry stools) or occult (bleeding occurs more frequently with higher doses); stomach or duodenal ulcers, perforation, enteropathy (especially during prolonged 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, from the nose, from the gums, from the urogenital tract), hematomas, 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:
Brain hemorrhage (especially in patients with uncontrolled hypertension and/or concomitantly using other anticoagulant medications) potentially life-threatening.
Kidney and urinary tract 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 system disorders:
Asthma.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 gather more information on the safety of the medicine.

5. How to store Aspirin Effect

Store at 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 "Expiry date (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 packaging and other information

What Aspirin Effect contains

• The active substance of the medicine is acetylsalicylic acid (Acidum acetylsalicylicum).
• The other ingredients are: mannitol, sodium bicarbonate, sodium dihydrogen citrate, ascorbic acid, Cola H& R 290053 flavor, orange flavor 290038 HR SPT, citric acid, aspartame (E951).

What Aspirin Effect looks like and what the packaging contains

White granules in a sachet. The packaging contains 2 or 10 sachets of PETP/Aluminum/LDPE in a cardboard box.
One sachet contains 840 mg of granules.
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 update of the leaflet:08/2023