Aspirin c

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
ASPIRIN C (АСПИРИН С)
400 mg + 240 mg, effervescent tablets
Acidum acetylsalicylicum + Acidum ascorbicum
ASPIRIN C and АСПИРИН С 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.
This medicine should always be used 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 possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse after 3–5 days, you should contact your doctor.

Table of contents

1. What Aspirin C is and what it is used for
2. Important information before taking Aspirin C
3. How to take Aspirin C
4. Possible side effects
5. How to store Aspirin C
6. 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, which is beneficial during colds and similar illnesses, when the body's requirement for vitamin C is increased.
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. 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 components 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 kidney failure,
• if the patient has ever experienced asthma attacks induced by salicylates or substances with similar action, particularly nonsteroidal anti-inflammatory drugs (NSAIDs),
• if the patient is concurrently taking methotrexate (used, among others, in cancer 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 previously had kidney stones (nephrolithiasis),
• if the patient has increased urinary excretion of oxalates,
• if the patient has hemochromatosis.

Warnings and precautions
Before starting treatment with Aspirin C, consult a doctor or pharmacist if:

• the patient has hypersensitivity to nonsteroidal anti-inflammatory or antirheumatic drugs, or to other allergenic substances,
• the patient is concurrently taking anticoagulant drugs,
• the patient has impaired liver function,
• 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 kidney failure,
• the patient has had a history of (chronic or recurrent) peptic ulcer or gastrointestinal bleeding,
• the patient has a genetic disorder involving glucose-6-phosphate dehydrogenase deficiency, as administration of acetylsalicylic acid may trigger hemolysis or hemolytic anemia,
• the patient is breastfeeding.

Acetylsalicylic acid-containing medicines should not be used in women during the first and second trimesters of pregnancy unless absolutely necessary.
Acetylsalicylic acid may cause bronchospasm and provoke asthma attacks or other hypersensitivity reactions. Patients with bronchial asthma, chronic respiratory diseases, hay fever, nasal polyps, or those who experience allergic reactions to other substances (e.g. skin rashes, 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 predisposed to reduced uric acid excretion, the drug may trigger an attack of gout.
During certain viral infections, particularly influenza A or B virus, or varicella (chickenpox), especially in children and adolescents, there is a risk of developing 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.
For these reasons, acetylsalicylic acid-containing medicines should not be used in children under 12 years of age, and in adolescents over 12 years of age, such medicines should only be used under medical supervision.
In patients with calcium oxalate kidney stones or recurrent kidney stones, special caution is advised when taking ascorbic acid.
Prolonged use of medicines containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Long-term use of analgesics, particularly those containing multiple active ingredients, may lead to severe kidney function impairment and kidney failure.

Aspirin C and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Special caution is required when using Aspirin C with the following medicines, as acetylsalicylic acid enhances:

• the toxic effect of methotrexate on bone marrow; acetylsalicylic acid should not be used 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, thrombolytics (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) by increasing 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 weakens their effect:

• uricosuric agents used in the treatment of gout that increase uric acid excretion from the body (e.g. benzbromarone, probenecid), which may exacerbate symptoms of gout;
• diuretic medicines;
• certain antihypertensive medicines (angiotensin-converting enzyme inhibitors, ACE inhibitors).

Aspirin C may be used concurrently with the above medicines (except methotrexate at doses of 15 mg per week or higher) only after consultation with a doctor.
Concurrent use of deferoxamine and ascorbic acid may increase tissue iron toxicity, 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take Aspirin C 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 labor. Aspirin C 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 should be used for the shortest possible duration. If Aspirin C is taken for longer than a few days after 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 the 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.

Fertility
Aspirin C belongs to a group of medicines that may adversely affect female fertility. This effect is reversible and resolves after discontinuation of therapy.

Driving and operating machinery
The 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 of 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 controlling sodium intake in their diet.

Laboratory tests
Vitamin C may interfere chemically during 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 this patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician 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 medical advice: 1 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 physician.

The effervescent tablets must 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
persons.
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, deep breathing, 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, coagulation
disorders, neurological disturbances manifesting as lethargy, confusion up to coma and convulsive
seizures.
In case of overdose, seek immediate medical advice from a physician or pharmacist; in cases of
severe poisoning, the patient must be immediately transported to hospital.
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
diarrhea, nausea, and vomiting. If symptoms of overdose occur, discontinue use and consult a physician
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 hemolysis of erythrocytes.
Missing a dose of Aspirin C
If a dose is missed and symptoms persist, take the next dose of Aspirin C. Do not take a double dose
to make up for a missed dose.
Stopping treatment with Aspirin C
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Warning!

• If frothy vomiting or black, tarry stools occur, discontinue the medicine and consult a doctor immediately.
• Signs of a severe allergic reaction may include: swelling of the face and eyelids, swelling of the tongue and larynx with airway constriction, difficulty breathing, shortness of breath up to asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. If any of these symptoms occur, immediate professional medical care must be provided. These 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); peptic ulcer disease of the stomach or duodenum, perforation, constrictive intestinal enteropathy (especially during long-term use).

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

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

Blood and lymphatic system disorders:
Increased risk of bleeding, haemorrhages (surgical bleeding, nosebleeds, gum bleeding, urogenital bleeding), bruising, prolonged bleeding time, prolonged 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:
Cerebral haemorrhage (particularly in patients with uncontrolled hypertension and/or those concurrently using other anticoagulant medicines), potentially life-threatening.

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

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

Respiratory system disorders:
Bronchial asthma.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse.
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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions 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 out of sight and reach 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 the sewage system 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 contains

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

What Aspirin C looks like and contents of the pack
White, round effervescent tablets packed in soft blisters.
Pack contains 10 or 20 effervescent tablets.
For further information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Bulgaria, country of export:
Bayer Bulgaria EOOD
Blvd. Tsarigradsko Shose № 115 M, ground floor
1784 Sofia
Bulgaria
Manufacturer:
Bayer Bitterfeld GmbH
Salegaster Chaussee 1
06803 Bitterfeld-Wolfen
Germany
Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing Authorisation Number in Bulgaria, country of export: 20000836
Parallel Import Authorisation Number: 43/23