Aspirin c forte

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
ASPIRIN C FORTE (ΑСПИΡΙΝ С ФОРТЕ)
800 mg + 480 mg, effervescent tablets
Acetylsalicylic acid + Ascorbic acid
ASPIRIN C FORTE and ΑСПИΡΙΝ С ФОРТЕ are the same trade names of the same medicine
written in Polish and Bulgarian.
Please read this leaflet carefully 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
the doctor or pharmacist.

• Keep this leaflet, so that it can be read again if necessary.
• If advice or additional information is needed, consult a pharmacist.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist or nurse. See section 4.
• If there is no improvement or if the patient feels worse after 4 days, consult a doctor.

Table of contents of the 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 has analgesic, anti-inflammatory and antipyretic effects, and 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 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 tendency (predisposition to bleeding);
• if the patient has acute gastric or duodenal ulcer;
• if the patient has been diagnosed with severe heart, liver, or kidney failure;
• if the patient has ever experienced asthma attacks triggered by salicylates or substances with similar effects, particularly non-steroidal anti-inflammatory drugs (NSAIDs);

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• if the patient is being treated with methotrexate at doses of 15 mg per week or higher (a medicine 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 excretion of oxalates in the urine;
• if the patient has haemochromatosis.

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

Warnings and precautions
Before starting to take Aspirin C Forte, discuss this with your doctor or pharmacist:

• if the patient has hypersensitivity to non-steroidal anti-inflammatory or anti-rheumatic drugs or other allergenic substances;
• if the patient is concurrently using anticoagulant drugs (blood thinners, see section: Aspirin C Forte and other medicines);
• if the patient has liver, kidney, or circulatory disorders (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 function disturbances and severe kidney failure;
• if the patient has had a history of (chronic or recurrent) peptic ulcer or gastrointestinal bleeding;
• if the patient has a genetic red blood cell disorder due to glucose-6-phosphate dehydrogenase deficiency, as administration of acetylsalicylic acid may cause haemolysis (destruction of red blood cells) or haemolytic anaemia (anaemia 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 rashes, 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, anaesthesiologist, or dentist that they are taking Aspirin C Forte.

Acetylsalicylic acid, even in small doses, reduces the excretion of uric acid from the body. In patients predisposed to reduced uric acid excretion, the medicine may trigger an attack of gout.

In patients with calcium oxalate kidney stones or recurrent kidney stones, particular caution is advised regarding the intake of vitamin C (ascorbic acid).

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 function disorders and kidney failure.

During certain viral infections, particularly influenza A, influenza B, or varicella (chickenpox), especially in children and adolescents, there is a risk of Reye's syndrome—a rare but life-threatening condition. Persistent vomiting during an 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 planned for future use.

Do not take Aspirin C Forte:

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

Talk to 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;
• anticoagulants (e.g. coumarin derivatives, heparin), thrombolytics (clot-dissolving agents), and platelet aggregation inhibitors (e.g. ticlopidine), due to increased risk of prolonged bleeding time and haemorrhage;
• other non-steroidal anti-inflammatory drugs, including other salicylates, due to the risk of peptic ulcer disease, gastrointestinal bleeding, and kidney damage;
• systemic glucocorticosteroids (steroids used, among others, in rheumatic disease treatment), except hydrocortisone (used as replacement therapy in Addison's disease), due to the risk of gastric ulceration and gastrointestinal bleeding, as well as reduced salicylate plasma concentrations during glucocorticosteroid therapy and increased risk of salicylate overdose after discontinuation of glucocorticosteroids;
• digoxin (a medicine used in heart conditions), as acetylsalicylic acid increases its plasma concentration;
• antidiabetic agents, e.g. insulin, sulfonylurea derivatives;
• valproic acid (a medicine used, among others, in epilepsy treatment);
• selective serotonin reuptake inhibitors (medicines used in depression treatment);
• medicines used in the treatment of gout (e.g. benzbromarone, probenecid), as acetylsalicylic acid weakens their effect, potentially worsening gout symptoms;
• diuretics (medicines that increase urine production), as acetylsalicylic acid reduces their effectiveness;
• certain antihypertensive medicines (angiotensin-converting enzyme inhibitors), as acetylsalicylic acid may reduce their effectiveness;
• deferoxamine (a medicine used, among others, in iron overdose), as concurrent use with ascorbic acid (vitamin C contained in Aspirin C Forte) may increase tissue iron toxicity, particularly in the heart, leading to heart failure.

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

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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 gastrointestinal effects, such as mucosal ulceration or bleeding.

Pregnancy, breastfeeding and effects on fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her 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 medicine may cause kidney and heart function disturbances in the unborn child. It may also affect the tendency of both mother and child to bleed and may delay or prolong labour. 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 duration. If Aspirin C Forte is taken for longer than a few days from the 20th week of pregnancy, it may cause kidney function disturbances 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 438 mg of sodium (the main component of table salt). This corresponds to 22% of the maximum recommended daily sodium intake in the diet of adults. The maximum daily dose of this product equals 66% 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 in laboratory tests, including affecting glucose measurements in urine and blood, leading to falsely altered results, although it does not affect 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 directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose:
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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 administration.
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 a single effervescent tablet.
Accidental overdose of Aspirin C Forte
Poisoning with Aspirin C Forte may result from long-term use (mild poisoning) or from acute 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, deafness, excessive sweating, nausea and vomiting, headache, confusion (mental disturbances with disorientation, impaired thinking and speech, hallucinations, delusions, anxiety, and psychomotor agitation), rapid breathing, abnormally 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 asphyxia), cardiovascular disturbances (from irregular heartbeat and low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration, oliguria [reduced daily urine output below 400–500 ml in adults] to renal failure), increased or decreased blood glucose levels (especially in children), ketosis, gastrointestinal bleeding, coagulation disorders, and neurological disturbances manifesting as lethargy, confusion progressing to coma, and convulsions.
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 a hospital.
Generally, symptoms of vitamin C overdose may include gastrointestinal disturbances such as diarrhoea, nausea, and vomiting. If symptoms of overdose occur, discontinue use and consult a doctor or pharmacist.
Acute or chronic overdose of vitamin C (>2 g/day in adults) may cause a significant increase in urinary oxalate levels. 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 haemolysis 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.
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4. Possible adverse reactions

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

• gastrointestinal bleeding (vomiting blood or material that looks like coffee grounds) 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 narrowing of the airways, breathing difficulties, shortness of breath up to asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. Such 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, inflammation of the gastrointestinal tract, peptic ulcer disease of the stomach or duodenum, 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 haemorrhage, nosebleeds, gum bleeding, urogenital 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 with severe glucose-6-phosphate dehydrogenase deficiency (see section: Warnings and precautions);
• intracerebral bleeding (particularly in patients with uncontrolled hypertension and/or those concurrently using other anticoagulant medicines);
• renal 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, inflammation of the nasal mucosa, nasal mucosal congestion, and very rarely severe reactions including anaphylactic shock;
• bronchial asthma;
• constriction enteropathy of the intestines (particularly during long-term use).

Due to treatment with NSAIDs (non-steroidal anti-inflammatory drugs, painkillers), occurrence of oedema, hypertension and heart failure has been reported.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
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.
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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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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 (a cross in a circle) on one side
of the tablet and no markings on the other side, packed in sachets within a cardboard box.
The pack contains 10 or 20 effervescent tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Bulgaria, the country of export: 20170100
Parallel import authorisation number: 99/22
Translation of some texts appearing on the immediate packaging:
отворете тук - Open here
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