Aspirin C

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

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

ASPIRIN C(АСПИРИН C)

400 mg + 240 mg, effervescent tablets

Acidum acetylsalicylicum + Acidum ascorbicum
ASPIRIN C and АСПИРИН C are the same trade names for the same medicine written in Polish and Bulgarian.

You should carefully read the contents of the leaflet before using 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 your 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 contact a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse.
• 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 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 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 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 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.

Warnings and precautions

Before starting treatment with 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 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. Aspirin C should not be used in women during the first and second trimesters 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.
Prior to surgical procedures (including minor procedures, e.g., tooth extraction), patients should inform their doctor about taking Aspirin C.
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 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, 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.
In the case of patients with calcium oxalate kidney stones or recurrent kidney stones, it is recommended to exercise particular caution when consuming ascorbic acid.
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 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.
Particular 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 used 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 particular caution;
• the effect of anticoagulant, thrombolytic (dissolving blood clots), and antiplatelet (preventing blood clots) drugs, 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 in high doses, or if 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 medicine used in heart diseases), as it increases its concentration in the blood;
• the effect of antidiabetic medicines, 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 medicines). Particular caution should be exercised when taking Aspirin C with the following medicines, as acetylsalicylic acid weakens:
• the effect of uricosuric medicines (used in the treatment of gout), which increase the excretion of uric acid from the body (e.g., benzbromarone, probenecid), which may worsen the symptoms of gout;
• the effect of diuretics;
• the effect of certain antihypertensive medicines (from the group of so-called angiotensin-converting enzyme inhibitors), especially if acetylsalicylic acid is used in high doses.

Aspirin C can be used 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 deferoxamine with ascorbic acid may increase the 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.
Warning! Alcohol may increase the risk of gastrointestinal side effects, such as stomach ulcers or bleeding.

Pregnancy, breastfeeding, and fertility

In pregnancy, breastfeeding, or if you suspect you are pregnant, or plan to become pregnant, you should consult your 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. Products containing acetylsalicylic acid should not be used in women during the first and second trimesters of pregnancy, unless it is absolutely necessary. If acetylsalicylic acid needs to be used in women trying to conceive or in the first and second trimesters of pregnancy, the lowest possible dose should be taken for the shortest possible time.
Acetylsalicylic acid passes into breast milk in small amounts.
In pregnancy, breastfeeding, or if you suspect you are pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before taking this medicine. 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 has no effect.

Aspirin C contains sodium

One effervescent tablet contains 438 mg of sodium (the main component of common salt). This corresponds to 21.9% of the maximum recommended daily intake of sodium in the diet for adults. The maximum daily dose of this product is equivalent to 175% of the WHO's 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 C

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

• adults: 1 to 2 effervescent tablets 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 tablets per day.
• adolescents over 12 years of age, only on a doctor's prescription: 1 tablet 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 tablets per day. Effervescent tablets should be dissolved in a glass of water and the effervescent liquid should be drunk. Take after meals.

The medicine should not be used for more than 3-5 days without consulting a doctor.

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, thought disorders, and speech, delusions, hallucinations, anxiety, and psychomotor agitation), rapid breathing, deep breathing, and symptoms of respiratory alkalosis (blurred vision, fainting).
In the case of severe poisoning, the following may also occur: high fever, respiratory disorders (up to respiratory arrest and suffocation), 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 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 contact 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 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 the missed dose.

Stopping treatment with Aspirin C

If you have any further doubts about the use of this medicine, you should contact your doctor or pharmacist.

4. Possible side effects

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

• If you experience coffee grounds-like vomiting or black, tarry stools, you should stop taking the medicine and contact your 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 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 ulcer, perforation.
Liver and bile duct disorders:
In rare cases, transient liver function disorders (increased aminotransferase activity) have been reported.
Nervous system disorders:
Dizziness and tinnitus, which are usually symptoms of overdose.
Blood and lymphatic system disorders:
Increased risk of bleeding, bleeding (postoperative, from the nose, 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 concurrently using other anticoagulant medicines) potentially life-threatening.
Renal and urinary disorders:
Renal function disorders and severe kidney failure.
Immune system disorders:
Hypersensitivity reactions with clinical symptoms and abnormal laboratory test results, such as: asthma, mild to moderate skin reactions, respiratory, cardiovascular, and gastrointestinal 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, pharmacist, or nurse. Side effects can be reported directly to the Department for 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
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). One effervescent tablet contains 400 mg of acetylsalicylic acid and 240 mg of ascorbic acid (vitamin C).
• The other ingredients are: sodium citrate, sodium bicarbonate, citric acid, sodium carbonate.

What Aspirin C looks like and what the packaging contains

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

Marketing authorization holder in Bulgaria, the country of export:

Bayer Bulgaria EOOD
Rezbarska 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
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
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Bulgaria, the country of export: 20000836

Parallel import authorization number: 186/22 Date of leaflet approval: 28.04.2022

[Information about the trademark]