Aspirin c forte

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Aspirin C Forte (ASPIRIN C FORTE)
800 mg + 480 mg effervescent tablets
Acetylsalicylic acid + Ascorbic acid
Aspirin C Forte and ASPIRIN C FORTE are the same brand names of the same medicinal product written in Polish and Bulgarian.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Always take this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 4 days, or if you feel worse, consult your doctor.

Table of Contents

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 has analgesic, anti-inflammatory and antipyretic properties, as well as vitamin C.
Indications:
Symptomatic treatment of mild to moderate pain (e.g. headache, toothache, muscle pain).
Symptomatic treatment of pain and fever associated with colds and influenza.

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 tendency (hemorrhagic diathesis);
• if the patient has acute gastric or duodenal ulcer;
• if the patient has severe heart, liver, or kidney failure;
• if the patient has previously experienced asthma attacks triggered by salicylates or substances with similar effects, particularly non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient is being treated with methotrexate at doses of 15 mg per week or higher (a drug used, among others, in the treatment of certain cancers and rheumatoid arthritis);
• if the patient is in the last trimester of pregnancy;
• in children and adolescents;
• if the patient currently has or has previously had kidney stones (nephrolithiasis);
• if the patient has increased urinary excretion of oxalates;
• 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, consult a doctor or pharmacist:

• if the patient is hypersensitive to non-steroidal anti-inflammatory or anti-rheumatic drugs, or to other allergenic substances;
• if the patient is concurrently taking anticoagulant drugs (blood thinners, see section: Aspirin C Forte and other medicines);
• if the patient has impaired liver, kidney, or circulatory function (e.g. kidney vessel disease, congestive heart failure, reduced circulating blood volume, 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) peptic ulcer disease or gastrointestinal bleeding;
• if the patient has a genetic red blood cell disorder due to glucose-6-phosphate dehydrogenase deficiency, as acetylsalicylic acid may cause hemolysis (destruction of red blood cells) or hemolytic anemia (anemia caused by excessive breakdown of red blood cells);
• if the patient is breastfeeding.

Do not use medicines containing acetylsalicylic acid in women during the first and second trimesters of pregnancy unless absolutely necessary. Aspirin C Forte may affect fertility in women (see section: Pregnancy, breastfeeding, and effects on fertility).

Acetylsalicylic acid may cause bronchospasm and trigger asthma attacks or other hypersensitivity reactions. Patients with bronchial asthma, chronic respiratory diseases, hay fever, nasal mucosal polyps, or those who experience allergic reactions (e.g. skin reactions, itching, urticaria) to other substances are particularly at risk.

Patients undergoing surgical procedures (including minor procedures such as tooth extraction) should inform their doctor, surgeon, anesthesiologist, or dentist that they are taking Aspirin C Forte.

Acetylsalicylic acid, even at low doses, reduces the excretion of uric acid from the body. In patients predisposed to reduced uric acid excretion, the drug may trigger an attack of gout.

In patients with calcium oxalate kidney stones or recurrent kidney stones, particular caution is advised when taking vitamin C (ascorbic acid).

Long-term use of medicines containing acetylsalicylic acid may cause headaches that worsen with continued dosing.

Chronic use of analgesics, particularly those containing multiple active substances, may lead to severe kidney dysfunction and kidney failure.

During certain viral infections, particularly influenza A, influenza B, or varicella (chickenpox), mainly in children and adolescents, there is a risk of Reye’s syndrome—a rare but life-threatening condition. Persistent vomiting during infection may indicate Reye’s syndrome and requires immediate medical attention. The risk of Reye’s syndrome during viral infections may increase if acetylsalicylic acid is administered concurrently, although a causal relationship has not been proven.

Aspirin C Forte and other medicines

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.

Do not take Aspirin C Forte:

• with methotrexate administered at doses of 15 mg per week or higher, due to methotrexate’s toxic effects on bone marrow.

Talk to your doctor or pharmacist before starting treatment with Aspirin C Forte if you are taking any of the following medicines:

• methotrexate administered at doses less than 15 mg per week;
• anticoagulants (e.g. coumarin derivatives, heparin), thrombolytic agents (clot-dissolving drugs), and antiplatelet agents (e.g. ticlopidine), due to increased risk of prolonged bleeding time and hemorrhage;
• other non-steroidal anti-inflammatory drugs, including other salicylates, due to increased risk of peptic ulcer disease, gastrointestinal bleeding, and kidney damage;
• systemic glucocorticosteroids (known as steroids, used, among others, in the treatment of rheumatic diseases), except hydrocortisone (used as replacement therapy in Addison’s disease), due to increased risk of gastric ulceration and gastrointestinal bleeding, as well as reduced plasma salicylate concentrations during glucocorticoid therapy and increased risk of salicylate overdose after discontinuation of glucocorticoids;
• digoxin (a drug used in heart conditions), as acetylsalicylic acid increases its plasma concentration;
• antidiabetic drugs, e.g. insulin, sulfonylurea derivatives;
• valproic acid (a drug used, among others, in epilepsy treatment);
• selective serotonin reuptake inhibitors (drugs used in depression treatment);
• drugs used in the treatment of gout (e.g. benzbromarone, probenecid), as acetylsalicylic acid reduces their effectiveness, potentially worsening gout symptoms;
• diuretics (drugs that increase urine production), as acetylsalicylic acid reduces their effectiveness;
• certain antihypertensive drugs (e.g. angiotensin-converting enzyme inhibitors), as acetylsalicylic acid reduces their effectiveness;
• deferoxamine (a drug used, among others, in iron overdose), as concomitant use with ascorbic acid (vitamin C contained in Aspirin C Forte) may increase tissue iron toxicity, especially in the heart, leading to cardiac failure.

Aspirin C Forte may be used concomitantly with the above-mentioned medicines (except methotrexate administered at doses of 15 mg per week or higher) only after consultation with 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 effects on the gastrointestinal tract, such as mucosal ulceration or bleeding.

Pregnancy, breastfeeding, and effects on fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

Do not take Aspirin C Forte during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. The drug may cause kidney and heart dysfunction in the unborn child. It may also affect the bleeding tendency in both mother and child and may delay or prolong labor. Do not use Aspirin C Forte during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. If Aspirin C Forte is taken for longer than a few days after the 20th week of pregnancy, it may cause kidney dysfunction in the unborn child, leading to reduced amniotic fluid volume (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the child’s heart. If prolonged treatment is necessary, the doctor may recommend additional monitoring.

Breastfeeding

Acetylsalicylic acid and vitamin C pass into breast milk in small amounts; therefore, taking Aspirin C Forte during breastfeeding is not recommended.

Fertility

Aspirin C Forte belongs to a group of medicines that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery

This medicine does not affect the ability to drive or operate machinery.

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 sodium intake in the adult diet. The maximum daily dose of this product is equivalent to 71% of the WHO-recommended maximum daily sodium intake. This should be taken into account in patients with impaired kidney function and in patients monitoring dietary sodium intake.

Laboratory tests

Vitamin C may interfere chemically during laboratory tests, including blood and urine glucose measurements, potentially causing falsely altered results, although it does not affect actual blood glucose concentration.

3. How to take Aspirin C Forte

This medicine should always be taken exactly as described in the patient leaflet or as advised by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults
One effervescent tablet at a time (i.e. 800 mg acetylsalicylic acid and 480 mg ascorbic acid).
If necessary, the single dose may be repeated every 4 to 8 hours.
Do not take more than 3 effervescent tablets per day (i.e. 2400 mg acetylsalicylic acid and 1440 mg
ascorbic acid).
This medicine is for oral use.
The effervescent tablet should be dissolved in a glass of water and the resulting effervescent solution
drunk. Take after meals.
Do not use this medicine for longer 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.
Accidental overdose of Aspirin C Forte
Poisoning with Aspirin C Forte may result from prolonged use (mild poisoning) or overdose (severe
poisoning), which may be life-threatening, e.g. after accidental ingestion by children or elderly
individuals.
Symptoms of mild poisoning include: dizziness (including labyrinthine origin), tinnitus, hearing loss,
excessive sweating, nausea and vomiting, headache, confusion (mental disturbances with
disorientation, impaired thinking and speech, hallucinations, illusions, anxiety, and psychomotor
agitation), rapid breathing, deep breathing, and symptoms of respiratory alkalosis (visual
disturbances, fainting).
In cases of severe poisoning, additional symptoms may occur: high fever, respiratory disorders (up
to respiratory arrest and suffocation), cardiovascular disturbances (from irregular heartbeat, low
blood pressure up to cardiac arrest), fluid and electrolyte loss (from dehydration, oliguria [reduced
daily urine output below 400–500 ml in adults] up to renal failure), increased or decreased blood
glucose concentration (especially in children), ketosis, gastrointestinal bleeding, coagulation
disorders, and neurological disturbances manifesting as lethargy, confusion up to coma and
convulsive seizures.
In case of overdose, seek immediate medical advice from a doctor or pharmacist; in cases of severe
poisoning, the patient must be immediately transported to hospital.
Generally, symptoms of vitamin C overdose may include gastrointestinal disturbances such as
diarrhea, nausea, and vomiting. If symptoms of overdose occur, discontinue use and consult a doctor
or pharmacist.
Acute or chronic vitamin C overdose (>2 g/day in adults) may cause a significant increase in urinary
oxalate concentration. In some cases, this may lead to hyperoxaluria, calcium oxalate crystallization,
kidney stone formation, calcium oxalate deposition, tubulointerstitial nephropathy, and acute renal
failure.
Vitamin C overdose in individuals with glucose-6-phosphate dehydrogenase deficiency (>3 g/day in
children and >15 g/day in adults) may lead to hemolysis of erythrocytes.
Missed 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should immediately inform your doctor or go to the nearest hospital emergency department if any of the following occur:

• gastrointestinal bleeding (vomiting blood or coffee-ground-like material) or black, tarry stools;
• signs of a severe allergic reaction such as: swelling of the face and eyelids, swelling of the tongue and larynx with airway constriction, difficulty breathing, shortness of breath, asthma attacks, rapid heartbeat, sudden drop in blood pressure leading to life-threatening shock. These reactions may occur even after the first dose of the medicine.

The following adverse reactions may occur

• stomach and abdominal pain, heartburn, diarrhoea, nausea, vomiting, indigestion, gastrointestinal inflammation, gastric or duodenal ulcer, perforation (perforation of the stomach or intestine);
• liver function disorders (increased aminotransferase activity);
• dizziness and tinnitus, usually symptoms of overdose;
• increased risk of bleeding, haemorrhages (surgical bleeding, nosebleeds, gum bleeding, genitourinary bleeding),
• bruising, prolonged bleeding time, prolonged prothrombin time, thrombocytopenia (reduced platelet count), acute or chronic iron-deficiency anaemia or acute haemorrhagic anaemia manifesting as general weakness, pallor, hypoperfusion, and abnormal laboratory test results;
• haemolysis and haemolytic anaemia in patients suffering from severe glucose-6-phosphate dehydrogenase deficiency (see section: Warnings and precautions);
• intracerebral bleeding (especially in patients with uncontrolled hypertension and/or those concurrently using other anticoagulant medicines);
• kidney function disorders and severe kidney damage;
• hypersensitivity reactions such as: worsening of respiratory disease which worsens after taking acetylsalicylic acid, rash, urticaria, oedema (including angioedema), breathing difficulties and cardiac disturbances, nasal mucosal inflammation, nasal mucosal congestion, and very rarely severe reactions, including anaphylactic shock;
• bronchial asthma;
• intestinal stenosing enteropathy (particularly during long-term use).

Due to treatment with NSAIDs (non-steroidal anti-inflammatory drugs), cases of oedema, hypertension and heart failure have been reported.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the 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 packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures 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 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: modified sodium hydrogen carbonate: sodium hydrogen carbonate and sodium carbonate, citric acid, povidone, colloidal anhydrous silica.

What Aspirin C Forte looks like and contents of the pack
White or almost white, round tablets with the Bayer trademark (cross in a circle) on one side of the tablet and no markings on the other side, packed in soft blisters
Paper/PE/Aluminium/ionomer, in a cardboard box.
The pack contains 10 or 20 effervescent tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Bulgaria, 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
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorisation number in Bulgaria, country of export: 20170100
Parallel import authorisation number: 101/22