Aspirin C

Leaflet attached to the packaging: patient information

ASPIRIN C, 400 mg + 240 mg, effervescent tablets

Acetylsalicylic acid + Ascorbic acid

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

important for the patient.
The medicine should always be used exactly as described in this patient leaflet or as directed 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 side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3-5 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Aspirin C contains acetylsalicylic acid, which has analgesic, anti-inflammatory, and antipyretic effects, as well as vitamin C, which is beneficial in the course of colds, during which there is an increased demand for vitamin C.
Indications for use:
Symptomatic treatment of mild to moderate pain (e.g., headaches, toothaches, muscle aches).
Symptomatic treatment of pain and fever in the course of colds and flu.

2. Important information before taking Aspirin C

When not to take Aspirin C:

• if the patient is allergic to the active substances, 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 caused 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 diseases) 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,
• if the patient has a history of kidney stones,
• if the patient has increased oxalate excretion in the urine,
• if the patient has hemochromatosis.

Warnings and precautions

Before starting Aspirin C, 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, decreased 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 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 C.
Acetylsalicylic acid, even in small doses, reduces uric acid excretion from the body.
In patients with a tendency to reduced uric acid excretion, the medicine may cause a gout attack.
In the course of certain 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, medications containing acetylsalicylic acid should not be used, and in adolescents over 12 years of age, medications containing acetylsalicylic acid can only be used on a doctor's prescription.
In patients with calcium oxalate kidney stones or recurrent kidney stones, caution is recommended when consuming ascorbic acid.
Prolonged use of medications 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 C 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 C 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;

Concurrent use of methotrexate at doses less than 15 mg per week requires special caution;

• the effect of anticoagulant medications, thrombolytic medications (dissolving blood clots), and antiplatelet agents, 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; after discontinuing systemic corticosteroids (except for hydrocortisone used as replacement therapy in Addison's disease), the risk of salicylate overdose increases;
• the effect of digoxin (a medication used in heart diseases), as it increases its serum concentration;
• the effect of antidiabetic medications, such as 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 C with the following medicines, as acetylsalicylic acid weakens:
• the effect of uricosuric medications used to treat gout (e.g., benzbromarone, probenecid), which may worsen gout symptoms;
• the effect of diuretics;
• the effect of certain antihypertensive medications (from the group of so-called angiotensin-converting enzyme inhibitors).

Aspirin C can be taken concurrently with the above-mentioned medicines (except for methotrexate at doses of 15 mg per week or higher) only after consulting a doctor.
Concurrent use of deferiprone with ascorbic acid may increase the toxicity of iron in tissues, especially in the heart, leading to its failure.

Aspirin C with food, drink, and alcohol:

See section 3 of the leaflet.
Note! 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 taking this medicine.
Pregnancy
Aspirin C 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 C 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 become pregnant, they should use the smallest possible dose for the shortest possible time. If Aspirin C 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 and vitamin C pass into breast milk in small amounts.
Fertility
Aspirin C 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 vehicles or operate machines.

Aspirin C contains sodium

One effervescent tablet contains 467 mg of sodium (the main component of table salt). This corresponds to 23% of the maximum recommended daily dose of sodium in the diet for adults. The maximum daily dose of this product is equivalent to 187% 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.

Laboratory tests

Vitamin C may interact chemically during laboratory tests, including affecting glucose measurements in urine and blood, leading to false results, although it does not affect blood glucose levels.

3. How to take Aspirin C

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

• adults: 1-2 effervescent tablets (i.e., 400-800 mg of acetylsalicylic acid and 240-480 mg of ascorbic acid) at a time. If necessary, the single dose may be repeated at intervals of not less than 4 to 8 hours. Do not take more than 8 tablets per day (i.e., 3200 mg of acetylsalicylic acid and 1920 mg of ascorbic acid).
• adolescents over 12 years of age, only on a doctor's prescription: 1 tablet (i.e., 400 mg of acetylsalicylic acid and 240 mg of ascorbic acid) at a time. If necessary, the single dose may be repeated at intervals of not less than 4 to 8 hours. Do not take more than 3 tablets per day (i.e., 1200 mg of acetylsalicylic acid and 720 mg of ascorbic acid). 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 should be drunk. Take after meals.

Taking a higher dose of Aspirin C than recommended

Aspirin C poisoning 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, deafness, excessive sweating, nausea, and vomiting, headache, confusion (disorders of consciousness with disorientation, thought disorders, and speech disorders, delusions, hallucinations, anxiety, and psychomotor agitation), rapid breathing, too deep breathing, and symptoms of respiratory alkalosis (darkness 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, 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.
Generally, symptoms of vitamin C overdose may include gastrointestinal disorders, such as diarrhea, nausea, and vomiting. If symptoms of overdose occur, the product should be discontinued and a doctor or pharmacist consulted.
Acute or chronic overdose of vitamin C (>2 g/day in adults) may cause a significant increase in oxalate levels in the urine. In some cases, this leads to hyperoxaluria, calcium oxalate crystallization, kidney stone formation, calcium oxalate deposition, and acute kidney failure.
Vitamin C overdose in people with glucose-6-phosphate dehydrogenase deficiency (>3 g/day in children and >15 g/day in adults) may lead to hemolysis of red blood cells.

Missing a dose of Aspirin C

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

Stopping Aspirin C

If there are any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

• If bloody vomit 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 may occur even after the first administration of the medicine.

Gastrointestinal disorders:
Stomach and abdominal pain, heartburn, diarrhea, nausea, vomiting, indigestion, gastrointestinal inflammation, potentially life-threatening gastrointestinal bleeding: overt (bloody vomit, tarry stools) or occult (bleeding occurs more frequently the higher the dose); stomach or duodenal ulcer, 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 (surgical bleeding, nosebleeds, bleeding from the gums, from the urogenital system), hematomas, prolonged bleeding time, prothrombin time, thrombocytopenia. The consequence of bleeding may be the development of acute or chronic iron deficiency anemia or acute post-hemorrhagic anemia, manifested by asthenia, pallor, hypoperfusion, and 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 concurrent use of 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: exacerbation of respiratory 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 any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 C

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 "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 C contains

• The active substances of the medicine are: acetylsalicylic acid (Acidum acetylsalicylicum)and vitamin C (Acidum ascorbicum).
• The other ingredients are: anhydrous sodium citrate, sodium bicarbonate, citric acid, sodium carbonate.

What Aspirin C looks like and what the pack contains

White, round tablets packaged in sachets.
The packaging contains 10, 20, or 40 effervescent tablets.

Marketing authorization holder

Bayer Sp. z o.o.
Aleje Jerozolimskie 158
02-326 Warsaw
Phone number: +48 22 572 35 00
Fax number: +48 22 572 35 55

Manufacturer

Bayer Bitterfeld GmbH
OT Greppin
Salegaster Chaussee 1
06803 Bitterfeld-Wolfen
Germany
Date of last revision of the leaflet:08/2023