Aspirin C

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

ASPIRIN C (АСПИРИН C)

400 mg + 240 mg, effervescent tablets

Acetylsalicylic acid + Ascorbic acid
ASPIRIN C and АСПИРИН С are the same trade names for 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 this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet so that 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 side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 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 triggered by the administration of salicylates or substances with similar effects, particularly 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 currently has or has had kidney stone disease,
• 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 has hypersensitivity 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 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 had 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-containing drugs should not be used in women during the first and second trimesters of pregnancy, unless 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 have 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 some viral diseases, particularly 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, acetylsalicylic acid-containing drugs should not be used, and in adolescents over 12 years of age, acetylsalicylic acid-containing drugs can only be used on a doctor's prescription.
In the case of patients with calcium oxalate kidney stone disease or recurrent kidney stone disease, special caution is recommended when consuming ascorbic acid.
Long-term use of acetylsalicylic acid-containing drugs 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 medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Special caution should be exercised when using Aspirin C 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; simultaneous 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 when used simultaneously with corticosteroids, other non-steroidal anti-inflammatory drugs, including other salicylates, or when alcohol is consumed during treatment; after discontinuing 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 disease drug), as it increases its serum concentration;
• the effect of antidiabetic drugs, e.g., insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid (a drug 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 using 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;
• diuretics;
• certain antihypertensive drugs (from the group of so-called angiotensin-converting enzyme inhibitors).

Aspirin C can be used simultaneously with the above-mentioned medicines (except for methotrexate at doses of 15 mg per week or higher) only after consulting a doctor.
Simultaneous 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, 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, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Aspirin C is contraindicated in the third trimester of pregnancy, as it may cause complications during the perinatal period, both in the mother and the newborn. Acetylsalicylic acid-containing products should not be used in women during the first and second trimesters of pregnancy, unless absolutely necessary. If acetylsalicylic acid needs to be used in women trying to conceive or in the first and second trimesters of pregnancy, the smallest possible dose of the drug should be taken for the shortest possible time.
Aspirin C belongs to a group of drugs that may adversely affect female fertility. This effect is temporary and disappears after the end of therapy.
Acetylsalicylic acid and vitamin C pass into breast milk in small amounts. During pregnancy and breastfeeding, or if pregnancy is suspected, or if pregnancy is planned, before taking this medicine, you should consult a doctor or pharmacist.

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 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, 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 your doctor or pharmacist. In case of doubt, you should consult a 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 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 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 heart rhythm, 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, 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 should be 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

In the event of a missed dose and persistence of symptoms, 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

In case of any further doubts regarding the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

• If bloody vomit or black, tarry stools occur, the medicine should be discontinued and a doctor should be 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 heart rate, 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, diarrhea, nausea, vomiting, indigestion, gastrointestinal inflammation, potentially life-threatening gastrointestinal bleeding: overt (bloody vomit, tarry stools) or hidden (the more frequent the bleeding, 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, from the urogenital system), hematomas, prolonged bleeding time, prothrombin time, thrombocytopenia. As a result of bleeding, acute or chronic iron deficiency anemia or acute post-hemorrhagic anemia may occur, 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 concomitantly using 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: 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, nasal mucosal inflammation, nasal congestion, and very rarely severe reactions, including anaphylactic shock.
Respiratory system disorders:
Asthma.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your 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.
By reporting side effects, you can help provide 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) - vitamin C.1 effervescent tablet contains 400 mg of acetylsalicylic acid and 240 mg of ascorbic acid - vitamin C.
The other ingredients of the medicine are: sodium citrate, sodium bicarbonate, citric acid, sodium carbonate.

What Aspirin C looks like and contents of the pack

White, round tablets packaged in sachets.
The packaging contains 10 or 20 effervescent tablets in a cardboard box.
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 EOOD
Rezbarska street 5
1510 Sofia
Bulgaria

Manufacturer:

Bayer Bitterfeld GmbH
Salegaster Chaussee
06803 Bitterfeld-Wolfen
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Bulgaria, the country of export:20000836
Parallel import authorization number:247/18
Date of leaflet approval: 08.05.2023
[Information about the trademark]