Ultrapirina Fast C

Leaflet attached to the packaging: patient information

ULTRAPIRYNA FAST C, 500 mg + 250 mg, effervescent tablets
Acidum acetylsalicylicum + Acidum ascorbicum

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 the patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3-5 days, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Ultrapiryna Fast C and what is it used for
• 2. Important information before taking Ultrapiryna Fast C
• 3. How to take Ultrapiryna Fast C
• 4. Possible side effects
• 5. How to store Ultrapiryna Fast C
• 6. Contents of the packaging and other information

1. What is Ultrapiryna Fast C and what is it used for

Ultrapiryna Fast C contains acetylsalicylic acid, which has analgesic, anti-inflammatory, and antipyretic effects, as well as ascorbic acid (vitamin C). Vitamin C has a positive effect on the functioning of the immune system cells and the protection of the body against free oxygen radicals, which affects the course of the inflammatory process. The addition of ascorbic acid to acetylsalicylic acid may improve the tolerance of the combined preparation compared to acetylsalicylic acid alone.
Indications for use:
Symptomatic treatment of mild to moderate pain (e.g., headaches, toothaches, muscle aches). Symptomatic treatment of pain and fever in colds and flu.
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2. Important information before taking Ultrapiryna Fast C

When not to take Ultrapiryna Fast C:

• if the patient is hypersensitive 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 disorder,
• if the patient has acute gastric or duodenal ulcer,
• if the patient has severe heart failure or severe liver or kidney failure,
• if the patient has ever had asthma attacks, induced by the administration of salicylates or substances with similar effects, especially non-steroidal anti-inflammatory drugs,
• if the patient is taking methotrexate (used in cancer, etc.) 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 Ultrapiryna Fast C, the patient should discuss it with their 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 taking anticoagulant medications,
• if the patient has impaired liver function,
• if the patient has impaired kidney function or circulatory disorders (e.g., kidney vessel disease, congestive heart failure, reduced blood volume, extensive surgery, sepsis, severe bleeding), as acetylsalicylic acid may further increase the risk of kidney function disorders 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 a deficiency of the enzyme - glucose-6-phosphate dehydrogenase, as the administration of acetylsalicylic acid may cause hemolysis or hemolytic anemia,
• if the patient is breastfeeding.

Acetylsalicylic acid should not be used in women during the first and second trimesters of pregnancy, unless it is absolutely necessary.
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Acetylsalicylic acid may cause bronchospasm and trigger asthma attacks or other hypersensitivity reactions. Patients with asthma, chronic respiratory diseases, hay fever, nasal polyps, and those with allergic reactions to other substances (e.g., skin reactions, itching, hives) are particularly at risk.
Patients undergoing surgical procedures (including minor procedures, e.g., tooth extraction) should inform their doctor about taking Ultrapiryna Fast C.
Acetylsalicylic acid, even in small doses, reduces the excretion of uric acid from the body. In patients with a tendency to reduced uric acid excretion, the medicine may cause a gout attack.
In the course of some viral diseases, especially in the case of influenza A or B virus infection or chickenpox, mainly in children and adolescents, there is a risk of developing Reye's syndrome - a rare but life-threatening disease. Persistent vomiting during infection may indicate the development of Reye's syndrome, which requires immediate medical attention. The risk of developing Reye's syndrome during viral infections may increase if acetylsalicylic acid is administered at the same time, although a causal link has not been proven. For these reasons, in children under 12 years of age, medications containing acetylsalicylic acid should not be used, and in adolescents over 12 years of age, medications containing acetylsalicylic acid can only be used on a doctor's prescription.
In patients with calcium oxalate kidney stones or recurrent kidney stones, it is recommended to exercise special caution when consuming ascorbic acid.
Long-term use of medications containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Long-term use of painkillers, especially those containing multiple active substances, may lead to severe kidney function disorders and kidney failure.

Ultrapiryna Fast C and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Special caution should be exercised when taking Ultrapiryna Fast C with the following medicines, as acetylsalicylic acid enhances:

• the toxic effect of methotrexate on the bone marrow; acetylsalicylic acid should not be used at the same time as methotrexate at doses of 15 mg per week or higher; concurrent use of methotrexate at doses less than 15 mg per week requires special caution;
• the effect of anticoagulant, thrombolytic (dissolving blood clots), and antiplatelet medications, which may increase the risk of prolonged bleeding time and bleeding;
• the risk of developing peptic ulcer disease and gastrointestinal bleeding if used concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs, including other salicylates in high doses, or if alcohol is consumed during treatment; after stopping systemic glucocorticoids (except for 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 concentration in the blood;
• the effect of antidiabetic medicines, such as insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid (a medicine used in epilepsy, etc.), which in turn enhances the antiplatelet effect of acetylsalicylic acid;
• the effect of selective serotonin reuptake inhibitors (antidepressant medicines).

Special caution should be exercised when taking Ultrapiryna Fast C with the following medicines, as acetylsalicylic acid weakens:

• the effect of uricosuric medicines used to treat gout (e.g., benzbromarone, probenecid), which may worsen the symptoms of gout;
• the effect of diuretics;
• the effect of certain antihypertensive medicines (from the group of so-called angiotensin-converting enzyme inhibitors), especially if acetylsalicylic acid is used in high doses.

Ultrapiryna Fast C can be used concurrently with the above-mentioned medicines (except for methotrexate at doses of 15 mg per week or higher) only after consulting a doctor.
Concurrent use of deferiprone with ascorbic acid may increase the tissue toxicity of iron, especially in the heart, leading to its failure.
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Ultrapiryna Fast C with food, drink, or alcohol

See section 3 of the leaflet.
Warning! Alcohol may increase the risk of gastrointestinal side effects, such as stomach ulcers or bleeding.

Pregnancy, breastfeeding, and fertility

In pregnancy, breastfeeding, or if pregnancy is suspected, or if the patient is planning to become pregnant, they should consult their doctor or pharmacist before taking the medicine.
Ultrapiryna Fast C is contraindicated in the third trimester of pregnancy, as it may cause complications during the perinatal period, both for the mother and the newborn. Products containing acetylsalicylic acid should not be used in women during the first and second trimesters of pregnancy, unless it is absolutely necessary. If acetylsalicylic acid needs to be used in women trying to conceive or in the first and second trimesters of pregnancy, the lowest possible dose should be taken for the shortest possible time.
Acetylsalicylic acid passes into breast milk in small amounts.
In pregnancy, breastfeeding, or if pregnancy is suspected, or if the patient is planning to become pregnant, they should consult their doctor or pharmacist before taking this medicine. Ultrapiryna Fast C belongs to a group of medicines that may have a negative impact on female fertility. This effect is temporary and disappears after the end of therapy.

Driving and using machines

The medicine has no effect.

Ultrapiryna Fast C contains sodium and sorbitol, as well as glucose

The medicine contains 381 mg of sodium, the main component of table salt, in each tablet. This corresponds to 19.4% of the maximum recommended daily intake of sodium in the diet of adults.
The medicine contains 0.52 mg of sorbitol in each unit dose.
If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Ultrapiryna Fast C

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

• adults: 1-2 effervescent tablets at a time. If necessary, the single dose may be repeated at intervals of no less than 4 to 8 hours. No more than 8 tablets should be taken per day.
• adolescents over 12 years of age, only on a doctor's prescription: 1 tablet at a time. If necessary, the single dose may be repeated at intervals of no less than 4 to 8 hours. No more than 3 tablets should be taken per day. Method of administration Oral. Effervescent tablets should be dissolved in a glass of water and the effervescent liquid should be drunk. The medicine should be taken after meals. The tablets should not be divided. Duration of use The medicine should not be used for more than 3-5 days without consulting a doctor.

Taking a higher dose of Ultrapiryna Fast C than recommended

Overdose of Ultrapiryna Fast C can be caused by prolonged use of the medicine (mild overdose) or overdose (severe overdose), which can be life-threatening, e.g., after accidental ingestion by children or the elderly.
Symptoms of mild overdose are: dizziness (including vertigo), tinnitus, deafness, excessive sweating, nausea, and vomiting, headache, confusion (disorders of consciousness with disorientation, thinking, and speech disorders, delusions, hallucinations, anxiety, and psychomotor agitation), rapid breathing, too deep breathing, and symptoms of respiratory alkalosis (blurred vision, fainting).
In the case of severe overdose, the following may also occur: high fever, respiratory disorders (up to respiratory arrest and asphyxia), cardiac and vascular disorders (from irregular heartbeat, low blood pressure to cardiac arrest), fluid and electrolyte disturbances (from dehydration, oliguria [reduced urine output below 400-500 ml in adults] to kidney failure), increased or decreased blood glucose levels (especially in children), ketoacidosis, gastrointestinal bleeding, blood coagulation disorders, neurological disorders manifesting as lethargy, confusion, and up to coma and convulsions.
In the event of an overdose, the patient should immediately consult a doctor or pharmacist, and in the case of severe overdose, the patient should be taken to the hospital immediately. Treatment of overdose involves gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be necessary.
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Missing a dose of Ultrapiryna Fast C

If a dose is missed and symptoms persist, the next dose of Ultrapiryna Fast C should be taken. A double dose should not be taken to make up for a missed dose.

Stopping Ultrapiryna Fast C

If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ultrapiryna Fast C can cause side effects, although not everybody gets them.
Warning!

• If vomiting with blood or black, tarry stools occurs, the medicine should be stopped and a doctor should be consulted.
• A symptom of a severe hypersensitivity reaction may be: facial and eyelid edema, tongue and laryngeal edema with narrowing of the airways, difficulty breathing, shortness of breath up to asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock.

In the event of any of the above symptoms, the patient should immediately seek medical attention. These reactions can occur even after the first administration of the medicine.
Gastrointestinal disorders
Stomach and abdominal pain, heartburn, nausea, vomiting, indigestion, inflammation of the gastrointestinal tract, potentially life-threatening gastrointestinal bleeding: overt (vomiting with blood, black stools) or occult (bleeding occurs more frequently the higher the dose); gastric or duodenal ulcer, perforation.
Liver and bile duct disorders:
In rare cases, transient liver function disorders (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, bleeding (postoperative, from the nose, from the gums, from the urogenital system), hematomas, prolonged bleeding time, prothrombin time, thrombocytopenia.
As a result of bleeding, acute or chronic iron deficiency anemia or acute post-hemorrhagic anemia may occur, manifesting as asthenia, pallor, hypoperfusion, as well as abnormal laboratory test results. Hemolysis and hemolytic anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.
Vascular disorders:
Brain hemorrhage (especially in patients with uncontrolled hypertension and/or concurrent use of other anticoagulant medicines) potentially life-threatening.
Renal and urinary disorders:
Renal function disorders and severe kidney failure.
Immune system disorders:
Hypersensitivity reactions with clinical symptoms and abnormal laboratory test results, such as: asthma, mild to moderate skin reactions, respiratory, cardiovascular, and gastrointestinal symptoms, such as: rash, urticaria, angioedema (including angioedema), respiratory and cardiac disorders, rhinitis, nasal congestion, and very rarely severe reactions, including anaphylactic shock.
Respiratory disorders:
Asthma.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ultrapiryna Fast C

Store in a temperature below 30°C. Store in the original packaging to protect from moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP:". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.
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6. Contents of the packaging and other information

What Ultrapiryna Fast C contains

• The active substances of the medicine are: acetylsalicylic acid (Acidum acetylsalicylicum)and vitamin C (Acidum ascorbicum).
• The other ingredients of the medicine are: citric acid, sodium bicarbonate, sodium carbonate, sodium dihydrogen citrate, sodium citrate, povidone K 30, mannitol (E 421), sodium docusate, simethicone, sodium cyclamate, sodium saccharin, lemon flavor "KS", code 145 (natural flavor preparations, natural flavoring substances, flavoring substances, mannitol (E 421), gluconolactone (E 575), sorbitol (E 420), maltodextrin, acacia (E 414), anhydrous colloidal silica (E 551)).

What Ultrapiryna Fast C looks like and what the packaging contains

Round, white tablet with a notch.
A polypropylene container with a polyethylene lid containing a desiccant.
The packaging contains 10 or 20 effervescent tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

Manufacturer:

HERMES PHARMA GmbH
Hans-Urmiller-Ring 52
82515 Wolfratshausen
Germany
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35, 02-822 Warszawa
tel.: +48 (22) 543 60 00

Date of last revision of the leaflet: July 2021

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