Aspirin C Forte

Package Leaflet: Information for the Patient

ASPIRIN C FORTE, 800 mg + 480 mg, Effervescent Tablets

Acetylsalicylic Acid + Ascorbic Acid

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

Important information for the patient.
This medicine should always be taken exactly as described in this package 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 more information, you should speak to your 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 Package Leaflet

• 1. What Aspirin C Forte is and what it is 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 pack and other information

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

Aspirin C Forte contains acetylsalicylic acid, which acts as a pain reliever, anti-inflammatory, and antipyretic, as well as 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 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 ulcers;
• if you have severe heart, liver, or kidney failure;
• if you have ever had asthma attacks caused by salicylates or substances with similar effects, especially nonsteroidal anti-inflammatory drugs;
• if you are being treated with methotrexate at doses of 15 mg per week or higher (a medicine used 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 the 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 have hypersensitivity to nonsteroidal anti-inflammatory and anti-rheumatic drugs or other allergenic substances;
• if you are taking anticoagulant medicines (e.g., coumarin derivatives, heparin), thrombolytic medicines (dissolving blood clots), or antiplatelet agents (e.g., ticlopidine), due to the increased risk of 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 acetylsalicylic acid may cause hemolysis (red blood cell destruction) or hemolytic anemia (anemia caused by excessive red blood cell destruction);
• if you are breastfeeding.

Do not take medicines containing acetylsalicylic acid during the first and second trimesters of pregnancy, unless absolutely necessary. Aspirin C Forte may affect fertility in women (see section on 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 those who have 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, caution is advised when consuming vitamin C (ascorbic acid) in Aspirin C Forte.
Prolonged use of medicines 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. Persistent vomiting during infection may indicate the onset 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

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

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

You should talk to your 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 (dissolving blood clots), and antiplatelet agents (e.g., ticlopidine), due to the increased risk of bleeding;
• other nonsteroidal 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), except for 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 corticosteroids;
• 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;
• diuretic medicines (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 vitamin C (ascorbic acid) 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.

Aspirin C Forte with food, drink, and alcohol

See section 3 of the package leaflet.
Do not take Aspirin C Forte 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking 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 patient's and child's tendency to bleed and cause delayed or prolonged delivery. Do not use Aspirin C Forte during the first 6 months of pregnancy, unless absolutely necessary and advised 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 adversely affect 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 438 mg of sodium (the main component of common salt). This corresponds to 22% of the maximum recommended daily sodium intake in the diet for adults. The maximum daily dose of this product is equivalent to 66% of the WHO-recommended maximum daily sodium intake. 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, 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 package leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Recommended dose:

Adults
Take one effervescent tablet (i.e., 800 mg of acetylsalicylic acid and 480 mg of ascorbic acid) at a time.
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 use.
Dissolve the effervescent tablet in a glass of water and drink the effervescent liquid. Take after meals.
Do not use the medicine 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, thinking, and speech disorders, delusions, hallucinations, anxiety, and psychomotor agitation), rapid breathing, deep breathing, and symptoms of respiratory alkalosis (dark 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, neurological disorders manifesting as lethargy, confusion, 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 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

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 your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aspirin C Forte 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 down 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 urinary and genital 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 on Warnings and precautions);
• intracranial bleeding (especially in patients with uncontrolled hypertension and/or concomitantly using other anticoagulant medicines);
• kidney function disorders and severe kidney damage;
• hypersensitivity reactions, such as: worsening of respiratory diseases, which worsens after taking acetylsalicylic acid, rash, urticaria, edema (including angioedema), respiratory and cardiac disorders, nasal mucosa inflammation, 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 (nonsteroidal anti-inflammatory drugs), reports of edema, hypertension, and heart failure have been made.

Reporting side effects

If you experience any side effects, including those not listed in the package leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
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 Forte

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton after "EXP:". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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).
• The other ingredients are: sodium bicarbonate (modified): sodium bicarbonate and sodium carbonate, citric acid, povidone, colloidal silica.

What Aspirin C Forte looks like and contents of the pack

White or almost white, round tablets with the Bayer company logo (a cross in a circle) on one side and no markings on the other, packaged in sachets, in a cardboard box.
The pack contains 10 or 20 effervescent tablets.

Marketing authorization holder

Bayer Sp. z o.o.
Aleje Jerozolimskie 158
02-326 Warsaw
Phone: +48 22 572 35 00
Fax: +48 22 572 35 55

Manufacturer

Bayer Bitterfeld GmbH
OT Greppin
Salegaster Chaussee 1
06803 Bitterfeld-Wolfen
Germany
Date of last revision of the package leaflet:08/2023