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 (ASPIRIN C)
400 mg + 240 mg, effervescent tablets
Acidum acetylsalicylicum + Acidum ascorbicum
ASPIRIN C and АСПИРИН C are the same brand names of the same medicine written in
Polish and Bulgarian.
Please read the entire leaflet carefully before using 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 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.
• If there is no improvement or if you feel worse after 3–5 days, you should consult a 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 effects, and vitamin C, which 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 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 kidney failure;
• if the patient has ever experienced asthma attacks induced by salicylates or substances with similar action, particularly non-steroidal anti-inflammatory drugs (NSAIDs);
• 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, consult a doctor or pharmacist:

• if the patient is hypersensitive to non-steroidal 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 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 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.

Medicinal products 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 particularly at risk include those 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).
Patients undergoing surgical procedures (including minor procedures such as tooth extraction) should inform their physician 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, 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 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, medicinal products containing acetylsalicylic acid should not be used in children under 12 years of age, and in adolescents over 12 years of age, such products should only be used under medical supervision.
In patients with calcium oxalate kidney stones or recurrent kidney stones, special caution is advised when consuming ascorbic acid.
Prolonged use of medicinal products containing acetylsalicylic acid may cause headaches that worsen with continued dosing.
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 currently or recently taken, as well as any medicines planned for use.
Particular caution is required when using Aspirin C with the following medicines, as acetylsalicylic acid enhances:

• the bone marrow toxicity of methotrexate; acetylsalicylic acid should not be used concurrently with methotrexate at doses of 15 mg per week or higher; concurrent use of methotrexate at doses below 15 mg per week requires special caution;
• the effects 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 concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs (including other salicylates at 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 toxicity 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 (from the group of so-called angiotensin-converting enzyme inhibitors), particularly when acetylsalicylic acid is used at 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, 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 adverse gastrointestinal effects, such as mucosal ulceration or bleeding.

Pregnancy, breastfeeding, and effects on fertility
During pregnancy and breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
Aspirin C is contraindicated during the third trimester of pregnancy, as it may cause complications in the perinatal period for 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 attempting to conceive or during the first and second trimesters of pregnancy, the lowest possible dose for the shortest possible duration should be administered.
Acetylsalicylic acid passes into breast milk in small amounts.
During pregnancy and breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist 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 438 mg of sodium (the main component of table salt). This corresponds to 21.9% of the maximum recommended daily sodium intake in the diet of adults. The maximum daily dose of this product is equivalent to 175% 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 used exactly as described in the patient information 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. The single dose may be repeated if necessary, 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 a physician's advice: 1 effervescent tablet at a time. The single dose may be repeated if necessary, no more frequently than every 4 to 8 hours. Do not take more than 3 tablets per day.

Effervescent tablets must be dissolved in a glass of water and the resulting effervescent solution should be drunk after meals.

Do not use this medicine for longer than 3–5 days without consulting a physician.

Overdose of Aspirin C

Poisoning with Aspirin C may result from long-term use (mild poisoning) or acute 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, deafness, excessive sweating, nausea and vomiting, headache, confusion (disturbances of consciousness with disorientation, impaired thinking and speech, hallucinations, illusions, 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, the following additional symptoms may occur: high fever, respiratory disturbances (up to respiratory arrest and suffocation), disturbances of heart and blood vessels (from irregular heartbeat and 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, progressing 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 transferred 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.

Missed dose of Aspirin C

If a dose of Aspirin C is missed and symptoms persist, take the next dose as scheduled. Do not take a double dose to make up for the missed dose.

Stopping treatment with Aspirin C

If you have any further questions about using 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 coffee-ground vomiting or black, tarry stools occur, 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 up to 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. These reactions may occur even after the first dose of the medicine.

Gastrointestinal disorders
Stomach and abdominal pain, heartburn, 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.
Liver and biliary tract disorders:
Rarely, 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), haematomas, prolonged bleeding time, prolonged prothrombin time, thrombocytopenia.
Bleeding may result in acute or chronic iron-deficiency anaemia or acute haemorrhagic anaemia, manifesting as asthenia, pallor, hypoperfusion, and abnormal laboratory findings.
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 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 laboratory findings such as: asthma, mild to moderate skin, respiratory, or cardiovascular reactions with symptoms such as: rash, urticaria, angioedema (including vasomotor), respiratory and cardiac disturbances, rhinitis, nasal mucosal 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 your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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
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 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 helps protect the environment.

6. Contents of the pack and other information

What Aspirin C contains

• The active substances in the medicine are: acetylsalicylic acid (Acidum acetylsalicylicum) and ascorbic acid (Acidum ascorbicum). One effervescent 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 aluminium sachets.
Pack contains 10 or 20 effervescent tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Bulgaria, country of export:
Bayer Bulgaria EOOD
Rezbarska 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
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
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorisation Number in Bulgaria, country of export: 20000836
Parallel Import Licence Number: 186/22