Aspirin C

Leaflet attached to the packaging: patient information

Note: Direct packaging in a foreign language! Keep the leaflet!

ASPIRIN C (АСПИРИН C), 400 mg + 240 mg, effervescent tablets

Acetylsalicylic acid + Ascorbic acid
ASPIRIN C and АСПИРИН C are the same trade names of the same drug written in Polish and Bulgarian.

You should carefully read the contents of the 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 a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3-5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What Aspirin C is and what it is 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 Aspirin C is and what it is 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 need 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, liver, or kidney failure,
• if the patient has ever had asthma attacks triggered by salicylates or substances with similar effects, especially non-steroidal anti-inflammatory drugs,
• if the patient is taking methotrexate (used in cancer, etc.) at doses of 15 mg per week or higher,
• if the patient is in the last 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 to take Aspirin C, you should discuss it with your 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 involving a deficiency of the enzyme - glucose-6-phosphate dehydrogenase, as acetylsalicylic acid may cause hemolysis or hemolytic anemia,
• if the patient is breastfeeding.

Aspirin C 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 drug 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. The occurrence of 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 used, and in adolescents over 12 years of age, drugs containing acetylsalicylic acid can only be used on a doctor's prescription.
In patients with calcium oxalate kidney stones or recurrent kidney stones, special caution is recommended when consuming ascorbic acid.
Long-term use of drugs containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Long-term use of painkillers, especially those containing multiple active substances, may lead to severe kidney function disorders and kidney failure.

Aspirin C and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or 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;
• the effect of anticoagulant, thrombolytic (dissolving blood clots), and antiplatelet drugs, 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 stopping systemic glucocorticoids (except for hydrocortisone used as replacement therapy in Addison's disease), the risk of salicylate overdose increases;
• the effect of digoxin (a heart medication), as it increases its serum concentration;
• the effect of antidiabetic drugs, such as insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid (a medication used in epilepsy, etc.), 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 anti-gout 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 C 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.
Concurrent use of deferoxamine with ascorbic acid may increase tissue toxicity of iron, especially in the heart, leading to its failure.

Aspirin C with food, drink, or 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 you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
You should not take Aspirin C 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. You should not take Aspirin C during the first 6 months of pregnancy, unless it is absolutely necessary and prescribed by a doctor. If you need treatment during this period or are trying to conceive, you should use the smallest possible dose for the shortest possible time. If you take Aspirin C for a longer period 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 a longer period, your 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 and use machines.

Aspirin C contains sodium

One effervescent tablet contains 467 mg of sodium (the main component of common 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, causing false results, although it does not affect blood glucose levels.

3. How to take Aspirin C

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The recommended dose of Aspirin C is:

• adults: 1-2 effervescent tablets at a time (i.e., 400-800 mg of acetylsalicylic acid and 240-480 mg of ascorbic acid). If necessary, the single dose may be repeated at intervals of not less than 4-8 hours. You should 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 at a time (i.e., 400 mg of acetylsalicylic acid and 240 mg of ascorbic acid). If necessary, the single dose may be repeated at intervals of not less than 4-8 hours. You should 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 used 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 long-term 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, thinking, and speech disorders, delusions, hallucinations, anxiety, and psychomotor agitation), rapid breathing, 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 asphyxia), cardiac and vascular 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.
If you have taken more than the recommended dose of Aspirin C, you 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 of Aspirin C 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 the missed dose.

Stopping Aspirin C treatment

If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

• If you experience coffee grounds-like vomiting or black, tarry stools, you should stop taking the medicine and consult a doctor.
• 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, you should immediately seek medical attention. These reactions can occur even after the first dose of the medicine.

Gastrointestinal disorders
Stomach and abdominal pain, heartburn, diarrhea, 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 (surgical bleeding, nosebleeds, bleeding from the gums, genitourinary tract), hematomas, prolonged bleeding time, prothrombin time, thrombocytopenia.
Consequences of bleeding may include acute or chronic iron deficiency anemia or acute post-hemorrhagic anemia, manifesting as 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 drugs) 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 worsening 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 you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of this 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 packaging.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 ascorbic acid (Acidum ascorbicum).
• The other ingredients of the medicine are: sodium citrate, sodium bicarbonate, citric acid, sodium carbonate.

What Aspirin C looks like and contents of the packaging

White, round tablets packaged in sachets.
The packaging contains 10 or 20 effervescent tablets.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Bayer Bulgaria Ltd
5 Rezbarska street
1510 Sofia
Bulgaria

Manufacturer:

Bayer Bitterfeld GmbH
Salegaster Chaussee
06803 Bitterfeld-Wolfen
Germany

Parallel importer:

Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Czeski Cieszyn
Czech Republic

Repackaged by:

Euceryna Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45

• 31-353 Kraków

Medezin Sp. z o.o
ul. Zbąszyńska 3, 91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa

Marketing authorization number in Bulgaria, the country of export: 20000836

Parallel import authorization number: 19/20

Date of leaflet approval: 13.11.2024

[Information about the registered trademark]