Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
ASPIRIN C (ASPIRIN C)
400 mg + 240 mg, effervescent tablets
Acetylsalicylic acid + Ascorbic acid
ASPIRIN C and ASPIRIN C are the same brand names of the same medicinal product written in
Polish and Bulgarian.
Please read carefully the information in this leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

Keep this leaflet so that it can be read again if necessary.
If advice or further information is needed, consult a pharmacist.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. See section 4.
If there is no improvement after 3–5 days, or if the patient feels worse, contact a doctor.

Table of contents of the leaflet

What Aspirin C is and what it is used for
Important information before using Aspirin C
How to use Aspirin C
Possible side effects
How to store Aspirin C
Contents of the pack and other information

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

Aspirin C contains acetylsalicylic acid, which has analgesic, anti-inflammatory and antipyretic properties, and vitamin C, the addition of which is beneficial during colds, when there is an increased demand for 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 using Aspirin C

When not to use Aspirin C:

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,
if the patient has acute gastric or duodenal ulcer,
if the patient has severe heart failure, severe liver failure, or severe renal failure,
if the patient has ever experienced asthma attacks induced by administration of salicylates or substances with similar action, particularly nonsteroidal anti-inflammatory drugs,
if the patient is concurrently taking methotrexate (used, among others, in neoplastic diseases) at doses of 15 mg per week or higher,
if the patient is in the last trimester of pregnancy,
in children under 12 years of age,
if the patient currently has or has had kidney stones in the past,
if the patient has increased urinary excretion of oxalates,
if the patient has hemochromatosis.

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

if the patient has hypersensitivity to nonsteroidal anti-inflammatory and anti-rheumatic drugs or other allergenic substances,
if the patient is concurrently taking anticoagulant drugs,
if the patient has impaired liver function,
if the patient has impaired kidney function or circulatory disorders (e.g. renal vascular 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 renal failure,
if the patient has had a history of (chronic or recurrent) peptic ulcer disease or gastrointestinal bleeding,
if the patient has a genetic disorder characterized by deficiency of the enzyme glucose-6-phosphate dehydrogenase, as administration of acetylsalicylic acid may trigger hemolysis or hemolytic anemia,
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.
Acetylsalicylic acid may cause bronchoconstriction and provoke asthma attacks or other
hypersensitivity reactions. Patients with bronchial asthma,
chronic respiratory diseases, hay fever, nasal polyps, and those who experience allergic
reactions to other substances (e.g. skin reactions, itching, urticaria) are particularly at risk.
Patients undergoing surgical procedures (including minor procedures such as tooth extraction)
should inform their doctor about taking Aspirin C.
Acetylsalicylic acid, even in small doses, reduces the excretion of uric acid from the
body. In patients prone to reduced excretion of uric acid, the medicine may
trigger an attack of gout.
During certain viral infections, particularly infection with influenza virus type
A, influenza virus type B, or varicella, 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 the onset of Reye's syndrome, requiring
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.
For the above reasons, medicines containing acetylsalicylic acid should not be used in children under 12 years of age, and in adolescents over 12 years of age, acetylsalicylic acid-containing medicines should only be used under medical supervision.
In patients suffering from calcium oxalate kidney stones or recurrent
kidney stones, special caution should be exercised when taking ascorbic acid.
Long-term use of medicines containing acetylsalicylic acid may cause headache, which worsens with subsequent doses.
Long-term use of analgesics, particularly those containing multiple active
ingredients, may lead to severe kidney function impairment and renal failure.
Aspirin C and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Special caution is required when using Aspirin C with the following medicines, as acetylsalicylic acid enhances:

the toxic effect of methotrexate on bone marrow; do not use acetylsalicylic acid concurrently with methotrexate administered at doses of 15 mg per week or higher; concurrent use of methotrexate at doses lower than 15 mg per week requires special caution;
the effect of anticoagulants, thrombolytic drugs (clot-dissolving agents), and platelet aggregation inhibitors, which may increase the risk of prolonged bleeding time and hemorrhage;
the risk of peptic ulcer disease and gastrointestinal bleeding, if used concurrently with corticosteroids, other nonsteroidal anti-inflammatory drugs, including other salicylates, or if alcohol is consumed during treatment; after discontinuation of systemic glucocorticoids (except hydrocortisone used as replacement therapy in Addison's disease), the risk of salicylate overdose increases;
the effect of digoxin (a medicine used in heart diseases), as it increases its plasma concentration;
the effect of antidiabetic medicines, e.g. insulin, sulfonylurea derivatives;
the toxic effect of valproic acid (a medicine used, among others, in epilepsy), which in turn enhances the antiplatelet effect of acetylsalicylic acid;
the effect of selective serotonin reuptake inhibitors (antidepressant medicines). Special caution is required when using Aspirin C with the following medicines, as acetylsalicylic acid reduces the effect of:
uricosuric agents used in the treatment of gout, which increase uric acid excretion from the body (e.g. benzbromarone, probenecid), potentially exacerbating symptoms of gout;
diuretics;
certain antihypertensive medicines (from the group of so-called angiotensin-converting enzyme inhibitors).

Aspirin C may be used concurrently with the above-mentioned medicines (except methotrexate
administered at doses of 15 mg per week or higher) only after consultation with a doctor.
Concurrent use of deferoxamine with ascorbic acid may increase tissue toxicity of iron, especially in the heart, leading to heart failure.
Aspirin C with food, drink, and alcohol:
See section 3 of the leaflet.
Warning! Alcohol 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 or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Aspirin C is contraindicated in the last trimester of pregnancy, as it may cause
complications in the perinatal period, both in the mother and the newborn. Products containing acetylsalicylic acid should not be used in women during the first and second
trimesters of pregnancy unless absolutely necessary. If acetylsalicylic acid must be used by women trying to conceive or during the first and second
trimesters of pregnancy, the lowest possible dose should be taken for the shortest possible duration.
Aspirin C belongs to a group of medicines that may adversely affect female fertility.
This effect is reversible and resolves after discontinuation of therapy.
Acetylsalicylic acid and vitamin C pass into breast milk in small amounts.
During pregnancy and breastfeeding, or if there is suspicion of pregnancy, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
Aspirin C contains sodium
One effervescent tablet contains 467 mg of sodium (main component of table salt). This corresponds to
23% of the maximum recommended daily sodium intake in the diet for adults. The maximum daily dose
of this product is equivalent to 187% of the WHO recommended maximum daily sodium intake. This should be taken into account in patients with impaired kidney function and in
patients monitoring sodium intake in their diet.
Laboratory tests
Vitamin C may chemically interfere with 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 use Aspirin C

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose of Aspirin C is:

Adults: 1 to 2 effervescent tablets at a time (i.e. 400–800 mg acetylsalicylic acid and 240–480 mg ascorbic acid). If necessary, the single dose may be repeated no more frequently than every 4 to 8 hours. Do not take more than 8 tablets per day (i.e. 3200 mg acetylsalicylic acid and 1920 mg ascorbic acid).
Adolescents over 12 years of age only on a doctor's advice: 1 effervescent tablet at a time (i.e. 400 mg acetylsalicylic acid and 240 mg ascorbic acid). If necessary, the single dose may be repeated no more frequently than every 4 to 8 hours. Do not take more than 3 tablets per day (i.e. 1200 mg acetylsalicylic acid and 720 mg ascorbic acid). This medicine should not be used for longer than 3–5 days without consulting a doctor.

Effervescent tablets should be dissolved in a glass of water and the resulting effervescent solution drunk. Take after meals.
Taking more Aspirin C than recommended
Poisoning with Aspirin C may result from long-term use (mild poisoning) or overdose (severe poisoning), which may be life-threatening, for example 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, delusions, anxiety, and psychomotor agitation), rapid breathing, abnormally deep breathing, and symptoms of respiratory alkalosis (visual disturbances such as flickering spots before the eyes, 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 and low blood pressure 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 convulsions.
If an overdose has occurred, seek immediate medical advice from a doctor or pharmacist; in cases of severe poisoning, the patient must be taken to hospital immediately.
Treatment of poisoning includes gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be required.
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 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 haemolysis of erythrocytes.
Missing a dose of Aspirin C
If a dose is missed and symptoms persist, take the next dose of Aspirin C as scheduled. Do not take a double dose to make up for a missed dose.
Stopping Aspirin C
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.
Warning!

If frothy vomiting or black, tarry stools occur, discontinue the medicine and consult a doctor immediately.
Severe hypersensitivity reactions may present as facial and eyelid swelling, swelling of the tongue and larynx with airway narrowing, breathing difficulties, shortness of breath, asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. In case any of these symptoms occur, immediate professional medical care must be provided. Such reactions may occur even after the first dose of the medicine.

Gastrointestinal disorders:
Stomach and abdominal pain, heartburn, diarrhoea, nausea, vomiting, indigestion, inflammation of the gastrointestinal tract, potentially life-threatening gastrointestinal bleeding: overt (frothy vomiting, tarry stools) or occult (bleeding occurs more frequently with higher doses); gastric or duodenal ulceration, perforation, constrictive enteropathy of the intestines (particularly during long-term use).

Liver and biliary disorders:
Rare cases of transient disturbances in liver function (increased aminotransferase activity) have been reported.

Nervous system disorders:
Dizziness and tinnitus, typically symptoms of overdose.

Blood and lymphatic system disorders:
Increased risk of bleeding, haemorrhages (perioperative bleeding, epistaxis, gingival bleeding, urogenital bleeding), bruising, prolonged bleeding time and prothrombin time, thrombocytopenia. Bleeding may lead to acute or chronic iron-deficiency anaemia or acute haemorrhagic anaemia, manifesting as asthenia, pallor, hypoperfusion, and abnormal laboratory test results.
Haemolysis and haemolytic anaemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.

Vascular disorders:
Intracerebral haemorrhage (particularly in patients with uncontrolled hypertension and/or concomitant use of other antithrombotic drugs), potentially life-threatening.

Renal and urinary disorders:
Impaired kidney function and severe kidney damage.

Immune system disorders:
Hypersensitivity reactions with clinical symptoms and abnormal laboratory findings, such as exacerbation of respiratory disease, which worsens after intake of acetylsalicylic acid, mild to moderate reactions affecting the skin, respiratory system, cardiovascular system, with symptoms such as rash, urticaria, angioedema (including angioedema of vascular origin), breathing difficulties and cardiac disturbances, rhinitis, nasal mucosal hyperaemia, and very rarely severe reactions, including anaphylactic shock.

Respiratory system disorders:
Bronchial asthma.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aspirin C

Store below 25°C.
Keep the medicine in a place inaccessible and out of sight of children.
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 required. This will help protect the environment.

6. Contents of the pack and other information

What Aspirin C contains
The active substances in this medicine are: acetylsalicylic acid (Acidum acetylsalicylicum) and ascorbic acid (Acidum ascorbicum) – vitamin C. Each tablet contains 400 mg of acetylsalicylic acid and 240 mg of ascorbic acid (vitamin C).
Other ingredients are: sodium citrate, sodium bicarbonate, citric acid, sodium carbonate.

What Aspirin C looks like and contents of the pack
White, round effervescent tablets packed in sachets.
The pack contains 10 or 20 effervescent tablets in a cardboard box.
For further information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Bulgaria, country of export:
Bayer Bulgaria EOOD
Rezbarska street 5
1510 Sofia
Bulgaria

Manufacturer:
Bayer Bitterfeld GmbH
Salegaster Chaussee
06803 Bitterfeld-Wolfen
Germany

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing Authorisation Number in Bulgaria, country of export: 20000836
Parallel Import Licence Number: 247/18