Aspirin C Forte

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

ASPIRIN C FORTE (ΑСПΙРИН С ФОРТЕ)

800 mg + 480 mg, effervescent tablets

Acetylsalicylic acid + Ascorbic acid
ASPIRIN C FORTE and ΑСПΙРИН С ФОРТЕ are the same trade names for the same medicine, 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 taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept so that it can be read again if necessary.
• If advice or additional information is needed, 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 there is no improvement or the patient feels worse after 4 days, they should contact their doctor.

Table of contents of the leaflet

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

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

Aspirin C Forte contains acetylsalicylic acid, which has analgesic, anti-inflammatory, and antipyretic effects, as well as vitamin C.
Indications for use:
Symptomatic treatment of mild or moderate pain (e.g., headaches, toothaches, muscle aches).
Symptomatic treatment of pain and fever in colds and flu.

2. Important information before taking Aspirin C Forte

When not to take Aspirin C Forte:

• 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 (tendency to bleed);
• if the patient has acute gastric or duodenal ulcer;
• if the patient has severe heart, 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;

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• if the patient is being treated with methotrexate at doses of 15 mg per week or higher (a medicine used to treat certain cancers and rheumatoid arthritis);
• if the patient is in the third trimester of pregnancy;
• in children and adolescents;
• if the patient currently has or has had kidney stones;
• if the patient has increased oxalate excretion in the urine;
• if the patient has hemochromatosis.

Aspirin C Forte is not intended for use in children and adolescents due to the quantitative content of active substances in one effervescent tablet.

Warnings and precautions

Before starting to take Aspirin C Forte, 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 medicines (e.g., coumarin derivatives, heparin), thrombolytic medicines (which dissolve blood clots), or antiplatelet agents (e.g., ticlopidine), due to the increased risk of bleeding;
• if the patient has liver, kidney, 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 dysfunction 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 red blood cell disorder characterized by a deficiency of the enzyme glucose-6-phosphate dehydrogenase, as acetylsalicylic acid may cause hemolysis (destruction of red blood cells) or hemolytic anemia (anemia caused by excessive destruction of red blood cells);
• if the patient is breastfeeding.

Aspirin C Forte should not be taken by women in the first and second trimesters of pregnancy unless absolutely necessary. Aspirin C Forte may affect fertility in women (see section: Pregnancy, breastfeeding, and fertility).
Acetylsalicylic acid may cause bronchial spasms and trigger asthma attacks or other hypersensitivity reactions. Patients with asthma, chronic respiratory diseases, hay fever, nasal polyps, and patients who experience allergic reactions (e.g., skin reactions, itching, hives) to other substances are particularly at risk.
Patients undergoing surgical procedures (including minor procedures, e.g., tooth extraction) should inform their doctor, surgeon, anesthesiologist, or dentist about taking Aspirin C Forte.
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 case of patients with calcium oxalate kidney stones or recurrent kidney stones, it is recommended to exercise caution when consuming vitamin C (ascorbic acid) contained in Aspirin C Forte.
Prolonged use of medicines containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
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Chronic use of painkillers, especially those containing multiple active substances, may lead to severe kidney dysfunction and kidney failure.
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 relationship has not been proven.

Aspirin C Forte 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.
Aspirin C Forte should not be taken:

• with methotrexate at doses of 15 mg per week or higher, due to the toxic effect of methotrexate on the bone marrow.

The patient should discuss with their doctor or pharmacist before starting to take Aspirin C Forte with any of the following medicines:

• methotrexate at doses less than 15 mg per week;
• anticoagulant medicines (e.g., coumarin derivatives, heparin), thrombolytic medicines (which dissolve blood clots), and antiplatelet agents (e.g., ticlopidine), due to the increased risk of bleeding;
• other non-steroidal anti-inflammatory drugs, including other salicylates, as there is a risk of stomach ulcers and gastrointestinal bleeding, as well as kidney damage;
• corticosteroids administered systemically (so-called steroids, used to treat, among other things, rheumatoid arthritis), with the exception of hydrocortisone (used as replacement therapy in Addison's disease), due to the risk of stomach ulcers and gastrointestinal bleeding, as well as decreased salicylate levels in the blood during corticosteroid treatment and increased risk of salicylate overdose after stopping corticosteroid treatment;
• digoxin (a medicine used to treat heart diseases), as acetylsalicylic acid increases its levels in the blood;
• antidiabetic medicines, e.g., insulin, sulfonylurea derivatives;
• valproic acid (a medicine used to treat, among other things, epilepsy);
• selective serotonin reuptake inhibitors (medicines used to treat depression);
• medicines used to treat gout (e.g., benzbromarone, probenecid), as acetylsalicylic acid may reduce their effectiveness, which may worsen gout symptoms;
• diuretics (medicines that increase urine production), as acetylsalicylic acid may reduce their effectiveness;
• certain medicines used to treat high blood pressure (from the group of so-called angiotensin-converting enzyme inhibitors), as acetylsalicylic acid may reduce their effectiveness;
• deferoxamine (a medicine used, among other things, in iron overdose), as it may increase the toxicity of iron in tissues, especially in the heart, leading to its failure, when used together with ascorbic acid (vitamin C) contained in Aspirin C Forte.

Aspirin C Forte can be taken together with the above-mentioned medicines (except for methotrexate at doses of 15 mg per week or higher) only after consulting a doctor.
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Aspirin C Forte with food, drinks, and alcohol

See section 3 of the leaflet.
Aspirin C Forte should not be taken with alcohol, as it may increase the risk of adverse effects on the gastrointestinal tract, 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 Forte 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 problems 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 Forte should not be taken during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If the patient requires treatment during this period or is trying to become pregnant, they should use the lowest possible dose for the shortest possible time. If Aspirin C Forte is taken for more than a few days from the 20th week of pregnancy, it may cause kidney problems in the unborn child, leading to reduced amniotic fluid (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, so it is not recommended to take Aspirin C Forte while breastfeeding.
Fertility
Aspirin C Forte belongs to a group of medicines that may have a negative effect on fertility in women. This effect is temporary and disappears after the end of treatment.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

Aspirin C Forte contains sodium

One effervescent tablet contains 438 mg of sodium (the main component of common salt). This corresponds to 22% of the maximum recommended daily intake of sodium in the diet for adults. The maximum daily dose of this product is equivalent to 66% of the WHO-recommended maximum daily intake of sodium. This should be taken into account in patients with reduced kidney function and in patients who control their sodium intake.
Lab tests
Vitamin C may interact chemically during lab 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 Forte

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.

Recommended dose:

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Adults
Single dose: 1 effervescent tablet (i.e., 800 mg of acetylsalicylic acid and 480 mg of ascorbic acid).
If necessary, the single dose can be repeated every 4 to 8 hours.
No more than 3 effervescent tablets should be taken per day (i.e., 2400 mg of acetylsalicylic acid and 1440 mg of ascorbic acid).
The medicine is for oral use.
The effervescent tablet should be dissolved in a glass of water and the effervescent liquid should be drunk. The medicine should be taken after meals.
The medicine should not be used for more than 4 days without consulting a doctor.

Use in children and adolescents

Aspirin C Forte should not be used in children and adolescents due to the quantitative content of active substances in one effervescent tablet.

Taking a higher dose of Aspirin C Forte than recommended

Overdose of Aspirin C Forte can be caused by prolonged use of the medicine (mild overdose) or overdose (severe overdose), which can be life-threatening, e.g., after accidental ingestion by children or the elderly.
Symptoms of mild overdose 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 overdose, 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, and 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 overdose, the patient should be taken to the hospital immediately.
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 Forte

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Aspirin C Forte

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

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

The patient should immediately inform their doctor or go to the nearest hospital emergency department if they experience:

• gastrointestinal bleeding (vomiting blood or coffee grounds-like material) or black, tarry stools;
• symptoms of severe hypersensitivity reactions, such as: 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. These reactions may occur even after the first administration of the medicine.

The following side effects may occur:

• stomach and abdominal pain, heartburn, diarrhea, nausea, vomiting, indigestion, gastrointestinal inflammation, stomach or duodenal ulcers, perforation (perforation of the stomach or intestine);
• liver function disorders (increased aminotransferase activity);
• dizziness and tinnitus, usually symptoms of overdose;
• increased risk of bleeding, bleeding (surgical bleeding, nosebleeds, bleeding from the gums, bleeding from the urogenital tract), hematomas, prolonged bleeding time, prothrombin time, thrombocytopenia (reduced platelet count), acute or chronic iron deficiency anemia or acute post-hemorrhagic anemia, characterized by general weakness, pallor, hypoperfusion, and abnormal laboratory test results;
• hemolysis and hemolytic anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency (see section: Warnings and precautions);
• intracranial bleeding (especially in patients with uncontrolled hypertension and/or concomitant use of other anticoagulant medicines);
• kidney function disorders and severe kidney damage;
• hypersensitivity reactions, such as: exacerbation of respiratory diseases, which worsen after taking acetylsalicylic acid, rash, urticaria, edema (including angioedema), respiratory and cardiac disorders, nasal mucositis, nasal congestion, and very rarely severe reactions, including anaphylactic shock;
• asthma;
• enteropathy with intestinal stenosis (especially during long-term use).

In connection with the treatment of NSAIDs (non-steroidal anti-inflammatory drugs), reports of edema, hypertension, and heart failure have been made.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Aspirin C Forte

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
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Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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 Forte contains

• The active substances of the medicine are: acetylsalicylic acid (Acidum acetylsalicylicum) and vitamin C (Acidum ascorbicum). One effervescent tablet contains 800 mg of acetylsalicylic acid and 480 mg of ascorbic acid (vitamin C).
• Other ingredients are: modified sodium bicarbonate: sodium bicarbonate and sodium carbonate, citric acid, povidone, anhydrous colloidal silica.

What Aspirin C Forte looks like and what the packaging contains

White or almost white, round tablets with the Bayer company logo (a cross in a circle) on one side of the tablet and no markings on the other side, packaged in sachets, in a cardboard box.
The packaging contains 10 or 20 effervescent tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Bayer Bulgaria EOOD
Blvd. Tsarigradsko Shose N 115 M
1784 Sofia, Bulgaria

Manufacturer:

Bayer Bitterfeld GmbH, Salegaster Chaussee 1, 06803 Bitterfeld-Wolfen, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Bulgarian marketing authorization number: 20170100

Parallel import authorization number: 99/22

Date of leaflet approval: 01.08.2025

Translation of certain entries on the immediate packaging:

отворете тук

• Open here

[Information about the trademark]
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