Aspirin C Forte

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Aspirin C Forte(АСПИРИН C ФОРТЕ)

800 mg + 480 mg, effervescent tablets

Acidum acetylsalicylicum + Acidum ascorbicum
Aspirin C Forte and АСПИРИН C 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.
• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 4 days there is no improvement or you feel worse, you should contact your 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:

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 Forte

When not to take Aspirin C Forte

• if you are allergic to the active substances, other salicylates, or any of the other ingredients of this medicine (listed in section 6);
• if you have a bleeding disorder (tendency to bleed);
• if you have acute stomach or duodenal ulcer;
• if you have severe heart, liver, or kidney failure;
• if you have ever had asthma attacks caused by the administration of salicylates or substances with similar effects, especially non-steroidal anti-inflammatory drugs;
• if you are being treated with methotrexate at doses of 15 mg per week or higher (a medicine used, among other things, to treat certain cancers and rheumatoid arthritis);
• if you are in the last trimester of pregnancy;
• in children and adolescents;
• if you currently have or have had kidney stones;
• if you have increased oxalate excretion in your urine;
• if you have 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, you should discuss it with your doctor or pharmacist:

• if you are hypersensitive to non-steroidal anti-inflammatory and anti-rheumatic drugs or other allergenic substances;
• if you are taking anticoagulant medications (e.g., coumarin derivatives, heparin), thrombolytic medications (dissolving blood clots), and medications that inhibit platelet aggregation (e.g., ticlopidine), due to the increased risk of prolonged bleeding time and bleeding;
• if you have 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 function disorders and severe kidney failure;
• if you have had a history of (chronic or recurrent) stomach ulcers or gastrointestinal bleeding;
• if you have a genetic red blood cell disorder characterized by a deficiency of the enzyme - glucose-6-phosphate dehydrogenase, as the administration of acetylsalicylic acid may cause hemolysis (destruction of red blood cells) or hemolytic anemia (anemia caused by excessive destruction of red blood cells);
• if you are breastfeeding.

Do not take medications containing acetylsalicylic acid during 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 bronchospasm 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 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 case of patients with calcium oxalate kidney stones or recurrent kidney stones, it is recommended to exercise special caution when consuming vitamin C (ascorbic acid)
Long-term use of medications containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Habitual use of painkillers, especially those containing multiple active substances, may lead to severe kidney function disorders 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 the 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.

Aspirin C Forte and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Aspirin C Forte:

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

You should discuss with your doctor or pharmacist before starting to take Aspirin C Forte with any of the following medicines:

• methotrexate taken at doses less than 15 mg per week;
• anticoagulant medications (e.g., coumarin derivatives, heparin), thrombolytic medications (dissolving blood clots), and medications that inhibit platelet aggregation (e.g., ticlopidine), due to the increased risk of prolonged bleeding time and 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, rheumatic disease) 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 discontinuation of corticosteroids;
• digoxin (a medicine used to treat heart diseases), as acetylsalicylic acid increases its levels in the blood;
• antidiabetic medications, 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 weakens their effect, which may worsen the symptoms of gout;
• diuretics (medicines that increase urine production), as acetylsalicylic acid weakens their effect;
• certain medicines used to treat high blood pressure (from the group of so-called angiotensin-converting enzyme inhibitors), as they weaken their effect;
• deferoxamine (a medicine used, among other things, in iron overdose), as it may increase the tissue toxicity of iron, especially in the heart, when used together with ascorbic acid (vitamin C, which is part of Aspirin C Forte), leading to heart failure.

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

Aspirin C Forte with food, drink, and alcohol

See section 3 of the leaflet.
Do not take Aspirin C Forte with alcohol, as it may increase the risk of adverse reactions from the gastrointestinal tract, such as stomach ulcers or bleeding.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not take Aspirin C Forte 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 tendency to bleeding in the mother and child and cause delayed or prolonged labor. Do not use Aspirin C Forte during the first 6 months of pregnancy, unless absolutely necessary and recommended by a doctor. If you require treatment during this period or are trying to become pregnant, you should use the smallest 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 function disorders 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, your 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 during 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 and use machines.

Aspirin C Forte contains sodium

One effervescent tablet contains 473.73 mg of sodium (the main component of table salt). This corresponds to 23.7% of the maximum recommended daily dose of sodium in the diet for adults. The maximum daily dose of this product is equivalent to 71% 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.

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 Forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.

Recommended dose:

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.
Do not take more than 3 effervescent tablets per day (i.e., 2400 mg of acetylsalicylic acid and 1440 mg of ascorbic acid).
The medicine is for oral administration.
The effervescent tablet 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 4 days without consulting a doctor.

Use in children and adolescents

Do not use 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, excessive sweating, nausea, and vomiting, headache, confusion (disorders of consciousness with disorientation, thought, 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 overdose, 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 per day in adults] to kidney failure), increased or decreased blood glucose levels (especially in children), ketoacidosis, gastrointestinal bleeding, coagulation disorders, neurological disorders manifesting as lethargy, confusion, and up to coma and seizures.
In the event of an overdose, you 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 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, tubulointerstitial nephropathy, 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

Do not take a double dose to make up for a missed dose.

Stopping treatment with Aspirin C Forte

If you have any further doubts about 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.

You should immediately inform your doctor or go to the nearest hospital emergency department if you 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 genitourinary system),
• hematomas, prolonged bleeding time, prothrombin time, thrombocytopenia (reduced platelet count), acute or chronic iron deficiency anemia or acute post-hemorrhagic anemia, which may manifest as 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 medications);
• kidney function disorders and severe kidney damage;
• hypersensitivity reactions, such as: exacerbation of respiratory disease, which worsens 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 stricture (especially during long-term use).

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of 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 gather more information 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.
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.
Translation of the text on the immediate packaging:отворете тук – open here

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 soft blisters paper/PE/aluminum/ionomer, in a cardboard box.
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
5, Rezbarska Str.
1510 Sofia
Bulgaria

Manufacturer:

Bayer Bitterfeld GmbH
Salegaster Chaussee 1
06803 Bitterfeld-Wolfen
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20170100
Parallel import authorization number:101/22

Date of leaflet approval: 29.10.2024

[Information about the trademark]