Aspirin c forte

Patient Information Leaflet

ASPIRIN C FORTE, 800 mg + 480 mg, effervescent tablets
Acetylsalicylic acid + Ascorbic acid
Please read this leaflet carefully before taking this 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, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement in symptoms or if your condition worsens after 4 days, 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 (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 previously experienced asthma attacks induced 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 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;
• 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 one 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 to other allergenic substances;
• if the patient is simultaneously taking 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 dysfunction and severe kidney failure;
• if the patient has previously had (chronic or recurrent) peptic ulcer disease or gastrointestinal bleeding;
• if the patient has a genetic red blood cell disorder due to deficiency of the enzyme glucose-6-phosphate dehydrogenase, 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.

Medicines containing acetylsalicylic acid should not be used 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 bronchoconstriction and trigger asthma attacks or other hypersensitivity reactions. Patients with bronchial asthma, chronic respiratory diseases, hay fever, nasal 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, 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 suffering from 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 each subsequent dose.

Habitual use of painkillers, especially those containing multiple active substances, may lead to serious kidney dysfunction and kidney failure.

In 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 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

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or 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 bone marrow.

Talk to your doctor or pharmacist before starting to take Aspirin C Forte together 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 drugs), and drugs that inhibit platelet aggregation (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 the treatment of rheumatic disease), 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 drugs, 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, which may exacerbate gout symptoms;
• diuretics (medicines that increase urine production), as acetylsalicylic acid reduces their effectiveness;
• certain medicines used to treat hypertension (so-called angiotensin-converting enzyme inhibitors), as acetylsalicylic acid reduces their effectiveness;
• deferoxamine (a medicine used, among others, in iron overdose), as its concurrent use with ascorbic acid (vitamin C contained in Aspirin C Forte) may increase tissue toxicity of iron, especially 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.

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 ulceration of the mucosa 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 dysfunction in the unborn child. It may also affect the bleeding tendency in both mother and child and may delay or prolong labour. Aspirin C Forte should not be used 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 for the shortest possible time should be used. 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, the use of Aspirin C Forte is not recommended during breastfeeding.

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

The 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 adult diet. The maximum daily dose of this product is equivalent to 66% of the maximum daily sodium intake recommended by WHO. This should be taken into account in patients with impaired kidney function and in patients controlling dietary sodium intake.

Laboratory tests

Vitamin C may interfere chemically in laboratory tests, including affecting glucose measurements in urine and blood, causing 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 information 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 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 a single effervescent tablet.

Taking more Aspirin C Forte than recommended
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 persons.

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, abnormally deep respiration, and symptoms of respiratory alkalosis (visual disturbances, fainting).

In cases of severe poisoning, additional symptoms may occur: high fever, respiratory disturbances (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, blood coagulation disorders, and neurological disturbances manifesting as lethargy, confusion, up 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 taken immediately to 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 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 haemolysis of erythrocytes.

If you forget to take 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 effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
You should immediately inform your doctor or go to the nearest hospital emergency department if the following occur:

• Gastrointestinal bleeding (vomiting blood or coffee-ground-like material) or black, tarry stools;
• Signs of severe hypersensitivity reaction such as: facial and eyelid swelling, swelling of the tongue and larynx with airway narrowing, breathing difficulties, 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 dose of the medicine.

The following adverse effects may occur:

• Stomach and abdominal pain, heartburn, diarrhoea, nausea, vomiting, indigestion, gastrointestinal inflammation, peptic ulcer 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 bleeding, 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 haemorrhage (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 disease, which worsens after taking acetylsalicylic acid, rash, urticaria, angioedema (including angioedema), breathing and heart function disturbances, nasal mucosa inflammation, nasal mucosa hyperaemia, and very rarely severe reactions, including anaphylactic shock;
• Bronchial asthma;
• Constrictive intestinal enteropathy (particularly during long-term use).

Due to treatment with NSAIDs (non-steroidal anti-inflammatory drugs, painkillers),
the occurrence of oedema, hypertension, and heart failure has been reported.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, you should inform your doctor or pharmacist.
Adverse effects 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aspirin C Forte

Keep this 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 outer packaging following the term "EXP:".
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 required. Such practices 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 components are: 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 effervescent tablets with the Bayer trademark (a cross in a circle) on one side,
unmarked on the reverse side, packed in sachets within a cardboard box.
The pack contains 10 or 20 effervescent tablets.

Marketing Authorisation Holder
Bayer Sp. z o.o.
Aleje Jerozolimskie 158
02-326 Warszawa
Telephone number: +48 22 572 35 00
Fax number: +48 22 572 35 55

Manufacturer
Bayer Bitterfeld GmbH
OT Greppin
Salegaster Chaussee 1
06803 Bitterfeld-Wolfen
Germany