Aspirin c

Package leaflet: Information for the user

Warning: The immediate packaging is in a foreign language! Keep the leaflet!
ASPIRIN C (АСПИРИН C), 400 mg + 240 mg, effervescent tablets
Acidum acetylsalicylicum + Acidum ascorbicum
ASPIRIN C and АСПИРИН C are the same brand names of the same medicinal product written in
Polish and Bulgarian, respectively.
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 advised by
the 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 or pharmacist. See section 4.
• If there is no improvement after 3–5 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet:

1. What Aspirin C is and what it is used for
2. What you need to know 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, whose addition is beneficial during colds, 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. 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 an active peptic ulcer of the stomach or duodenum,
• 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 currently taking methotrexate (used, among others, in cancer treatment) 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 a history of kidney stones,
• if the patient has increased excretion of oxalates in urine,
• 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 other allergenic substances,
• the patient is concurrently taking anticoagulant medications,
• the patient has impaired liver function,
• the patient has kidney dysfunction or circulatory disorders (e.g. renal vessel disease, congestive heart failure, reduced circulating blood volume, sepsis, severe bleeding), as acetylsalicylic acid may further increase the risk of kidney function impairment and severe kidney failure,
• the patient has a history of (chronic or recurrent) peptic ulcer disease or gastrointestinal bleeding,
• 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,
• 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.
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 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 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 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, medicines containing acetylsalicylic acid 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 regarding intake of ascorbic acid.
Prolonged use of medicines containing acetylsalicylic acid may cause headache that worsens with continued dosing.
Long-term use of analgesics, particularly those containing multiple active substances, may lead to severe kidney function disorders and kidney failure.

Aspirin C and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you 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, thrombolytic drugs (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), 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 or 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 (e.g. benzbromarone, probenecid), which may exacerbate symptoms of gout;
• diuretic medicines;
• certain antihypertensive medicines (angiotensin-converting enzyme inhibitors).

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.
Concomitant use of deferoxamine with ascorbic acid may increase tissue toxicity of iron, especially in the heart, leading to cardiac failure.

Aspirin C with food, drink, or alcohol:
See section 3 of the leaflet.
Warning! Alcohol may increase the risk of gastrointestinal adverse effects, such as mucosal ulceration or bleeding.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Aspirin C should not be taken 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 disorders 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 six 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 duration should be used. If Aspirin C is taken for longer than a few days after the 20th week of pregnancy, it may cause kidney function disorders 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.

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
This medicine does not affect the ability to drive or operate machinery.

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 adult diet. The maximum daily dose of this product is equivalent to 187% of the maximum daily sodium intake recommended by WHO.
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 blood and urine glucose measurements, leading to falsely altered results, although it does not affect actual blood glucose concentration.

3. How to use Aspirin C

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 of Aspirin C:

• Adults: Single dose of 1 to 2 effervescent tablets (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 doctor’s advice: single dose of 1 tablet (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 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 people.

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, illusions, 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), disturbances in heart and blood vessel function (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 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.

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 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.

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 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 kidney 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 red blood cells.

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 treatment with 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 will experience them.

Warning!

• If coffee-ground vomiting or black, tarry stools occur, discontinue the medicine and consult a doctor immediately.
• Signs of a severe allergic reaction may include: 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. 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, 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 ulceration, perforation, constrictive intestinal enteropathy (especially during long-term use).

Hepatobiliary 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 (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
Intracranial 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 findings, such as: exacerbation of respiratory disease, which worsens after taking acetylsalicylic acid; mild to moderate skin, respiratory, or cardiovascular system reactions with symptoms such as rash, urticaria, angioedema (including vasomotor type), breathing difficulties, cardiac disturbances, nasal mucosal inflammation, 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 those 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 allows the collection of further information on the safety of the medicine.

5. How to store Aspirin C

Store below 25°C.
Keep the medicine out of the 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 properly dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Aspirin C contains

• The active substances are: acetylsalicylic acid (Acidum acetylsalicylicum) and vitamin C (Acidum ascorbicum).
• Other components of the medicine are: sodium citrate, sodium hydrogen carbonate, 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.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Bulgaria, country of export:
Bayer Bulgaria Ltd
5 Rezbarska street
1510 Sofia
Bulgaria
Manufacturer:
Bayer Bitterfeld GmbH
Salegaster Chaussee
06803 Bitterfeld-Wolfen
Germany
Parallel importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Czech Cieszyn
Czech Republic
Repacked in:
Euceryna Pharmaceutical Factory COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Medezin Sp. z o.o
ul. Zbąszyńska 3, 91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Marketing authorisation number in Bulgaria, country of export: 20000836
Parallel import authorisation number: 19/20
[Information about registered trademark]