Aspirin c

Package leaflet: Information for the patient

WARNING: Keep the leaflet. The information on the immediate packaging is in a foreign language.
ASPIRIN C (АСПИРИН C),
400 mg + 240 mg, effervescent tablets
Acetylsalicylic acid + Ascorbic acid
ASPIRIN C and АСПИРИН C are the same brand names of the same medicinal product written in
Polish and Bulgarian.
Please read the 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
a physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3–5 days, consult your doctor.

Table of contents of the leaflet:

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 due to increased vitamin C requirements.
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 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 previously experienced asthma attacks induced by salicylates or substances with similar action, particularly nonsteroidal anti-inflammatory drugs,
• if the patient is concurrently taking methotrexate (used, among others, in cancer treatment) at doses of 15 mg per week or higher,
• if the patient is in the third trimester of pregnancy,
• in children under 12 years of age.

Warnings and precautions
Before starting treatment with Aspirin C, discuss the following 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 medicines,
• if the patient has impaired liver function,
• if the patient has kidney dysfunction 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 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 disorder involving deficiency of the enzyme glucose-6-phosphate dehydrogenase, as administration of acetylsalicylic acid may trigger hemolysis or hemolytic anemia,
• if 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 particularly at risk include those with bronchial asthma,
chronic respiratory disorders, hay fever, nasal polyps, and those who experience allergic
reactions to other substances (e.g. skin reactions, itching, urticaria).
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 medicine may trigger an attack of gout.
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 infection may indicate Reye’s syndrome and requires
immediate medical attention. The risk of Reye’s syndrome during viral infections may increase
when acetylsalicylic acid is administered concurrently, although a causal relationship has not been
proven.
Due to the above, 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 be used only on
medical advice.
In patients with calcium oxalate kidney stones or recurrent kidney stones, particular caution is
advised when consuming ascorbic acid.
Long-term use of medicines containing acetylsalicylic acid may cause headache that worsens with
subsequent doses.
Long-term use of analgesics, particularly those containing multiple active substances, may lead to
severe kidney dysfunction and kidney failure.

Aspirin C and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken,
or plan to take.
Particular 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 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 antiplatelet agents, which may increase the risk of prolonged bleeding time and hemorrhage;
• the risk of peptic ulcer disease and gastrointestinal bleeding when used concomitantly with corticosteroids, other nonsteroidal anti-inflammatory drugs, including other salicylates in high doses, or when 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 conditions), 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).

Particular 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;
• diuretics;
• certain antihypertensive medicines (from the group of so-called angiotensin-converting enzyme inhibitors), particularly when acetylsalicylic acid is used in high doses.

Aspirin C 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.
Concurrent use of deferoxamine with ascorbic acid may increase tissue iron toxicity, particularly 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 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.
Aspirin C is contraindicated in the third trimester of pregnancy, as it may cause complications in
the perinatal period in both mother and 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 for the shortest possible duration should be used.
Acetylsalicylic acid passes into breast milk in small amounts.
During pregnancy and breastfeeding, or if there is suspicion of pregnancy or plans for pregnancy,
consultation with a doctor or pharmacist is required before using this medicine. 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 has no effect.

Aspirin C contains sodium
One effervescent tablet contains 467 mg of sodium (the 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 monitoring sodium intake in their diet.

3. How to use Aspirin C

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.
The recommended dose of Aspirin C is:

• Adults: 1 to 2 effervescent tablets at a time. 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.
• Adolescents over 12 years of age, only on medical advice: 1 effervescent tablet at a time. 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.

Effervescent tablets should be dissolved in a glass of water and the resulting effervescent solution should be drunk. Take after meals.
Do not use the medicine for longer than 3–5 days without consulting a doctor.

Taking more Aspirin C than recommended
Poisoning with Aspirin C may result from prolonged use of the medicine (mild poisoning) or overdose (severe poisoning), which may be life-threatening, for example after accidental ingestion by children or elderly people.
Symptoms of mild poisoning include: dizziness (including labyrinthine origin), tinnitus, deafness, excessive sweating, nausea and vomiting, headache, confusion (disturbances of consciousness with disorientation, disturbances of thinking and speech, delusions, hallucinations, anxiety, and psychomotor agitation), rapid breathing, abnormally deep breathing, and symptoms of respiratory alkalosis (visual disturbances such as spots before the eyes, fainting).
In cases of severe poisoning, additional symptoms may occur: high fever, disturbances of the respiratory system (up to respiratory arrest and suffocation), disturbances in heart and blood vessel function (from irregular heartbeat and low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration and oliguria [reduced daily urine output below 400–500 ml in adults] to kidney failure), increased or decreased blood glucose concentration (especially in children), ketosis, gastrointestinal bleeding, blood clotting disorders, and neurological disturbances manifesting as lethargy, confusion, up to coma and convulsive seizures.
If more than the recommended dose has been taken, seek immediate medical advice from a doctor 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 necessary.

Missed dose of Aspirin C
If a dose is missed and symptoms persist, take the next dose of Aspirin C as soon as possible. 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 vomiting of coffee-ground appearance or black, tarry stools occurs, discontinue the medicine and consult a doctor immediately.
• Signs of a severe hypersensitivity reaction may include: facial and eyelid swelling, swelling of the tongue and larynx with airway constriction, breathing difficulties, shortness of breath, asthma attacks, increased heart rate, sudden drop in blood pressure up to life-threatening shock. In case any of these symptoms occur, immediate professional medical care must be provided. The above reactions may occur even after the first dose of the medicine.

Gastrointestinal disorders:
Stomach and abdominal pain, heartburn, nausea, vomiting, dyspepsia, gastrointestinal inflammation,
potentially life-threatening gastrointestinal bleeding: overt (coffee-ground vomiting,
tarry stools) or occult (bleeding occurs more frequently with higher doses); gastric or duodenal ulcer disease, perforation.

Liver and biliary disorders:
In rare cases, transient disturbances in liver function (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 (postoperative, epistaxis, gingival, urogenital),
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 anticoagulant medicines), potentially life-threatening.

Renal and urinary disorders:
Renal function impairment and severe renal failure.

Immune system disorders:
Hypersensitivity reactions with clinical symptoms and abnormal results of relevant laboratory tests, such as: asthma, mild to moderate skin, respiratory, and cardiovascular system reactions 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 effects

If any adverse effects occur, including any not listed in this leaflet, 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
Reporting adverse effects helps to collect further 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Aspirin C contains
The active substances in the medicine are: acetylsalicylic acid (Acidum acetylsalicylicum) and ascorbic acid (Acidum ascorbicum) – vitamin C.
Other components of the medicine are: sodium citrate, sodium bicarbonate, citric acid, sodium carbonate.

What Aspirin C looks like and contents of the packaging
White, round tablets packed in sachets.
The packaging contains 10 or 20 effervescent tablets.

For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in Bulgaria, country of export:
Bayer Bulgaria EOOD, 5 Rezbarska Str., 1510 Sofia, Bulgaria

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

Parallel importer:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged in:
IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 Warszawa
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warszawa
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa
Chemiczno-Farmaceutyczna Spółdzielnia Pracy „ESPEFA”, ul. Juliusza Lea 208, 30-133 Kraków
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław

Marketing authorization number in Bulgaria, country of export: 20000836
Parallel import authorization number: 229/17