Ultrapiryna fast c

Package leaflet: Information for the patient

ULTRAPIRYNA FAST C, 500 mg + 250 mg, effervescent tablets
Acetylsalicylic acid + Ascorbic acid
Please read carefully all of this leaflet before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed 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.

Contents of the leaflet:

1. What Ultrapiryna Fast C is and what it is 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 pack and other information

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

Ultrapiryna Fast C contains acetylsalicylic acid, which has analgesic, anti-inflammatory and antipyretic properties, as well as ascorbic acid (vitamin C). Vitamin C has a positive effect on immune system cell function and protects the body against oxygen free radicals, thereby influencing the course of inflammatory processes. The addition of ascorbic acid to acetylsalicylic acid may improve the tolerability of the combination preparation compared to acetylsalicylic acid alone.
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.
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2. Important information before using Ultrapiryna Fast C

When not to use Ultrapiryna Fast 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 bronchial asthma attacks induced by salicylates or substances with similar action, particularly non-steroidal 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 Ultrapiryna Fast C, consult a doctor or pharmacist:

• if the patient has hypersensitivity 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 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 disorders 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.

Do not use medicines containing acetylsalicylic acid in women during the first and second
trimesters of pregnancy unless absolutely necessary.
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Acetylsalicylic acid may cause bronchoconstriction and provoke asthma attacks or other
hypersensitivity reactions. Patients particularly at risk include those with bronchial asthma, chronic
respiratory diseases, hay fever, nasal polyps, or those with 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 Ultrapiryna Fast 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 virus, influenza B virus, or varicella virus,
mainly 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 the onset of Reye's syndrome, which
requires immediate medical attention. The risk of Reye's syndrome during viral infections may
increase if acetylsalicylic acid is administered concomitantly, 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 be
used only on a doctor's advice.
In patients suffering from calcium oxalate kidney stones or recurrent kidney stones, special
caution is advised when consuming ascorbic acid.
Long-term use of medicines containing acetylsalicylic acid may cause headache, which worsens
with each subsequent dose.
Prolonged use of analgesic medicines, particularly those containing multiple active substances, may lead to severe kidney function disorders and kidney failure.
Ultrapiryna Fast C and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any
medicines planned for future use.
Special caution is required when using Ultrapiryna Fast C with the following medicines, as
acetylsalicylic acid may enhance:
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• the toxic effects of methotrexate on bone marrow; do not use acetylsalicylic acid 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 effects of anticoagulants, thrombolytic drugs (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 when used concomitantly with corticosteroids, other non-steroidal 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 drug used in heart conditions), as it increases its plasma concentration;
• the effect of antidiabetic drugs, e.g. insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid (a drug used, among others, in epilepsy), which in turn enhances the antiplatelet effect of acetylsalicylic acid;
• the effect of selective serotonin reuptake inhibitors (antidepressant drugs).

Special caution is required when using Ultrapiryna Fast C with the following medicines, as
acetylsalicylic acid may reduce the effect of:

• uricosuric drugs 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 drugs;
• certain antihypertensive drugs (so-called angiotensin-converting enzyme inhibitors), particularly if acetylsalicylic acid is used in high doses.

Ultrapiryna Fast 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 heart failure.
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Ultrapiryna Fast C with food and drink or 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
During pregnancy and breastfeeding, or if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.
Ultrapiryna Fast 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 should be taken for the shortest possible duration.
Acetylsalicylic acid passes into breast milk in small amounts.
During pregnancy and breastfeeding, or if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine. Ultrapiryna
Fast 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.
Ultrapiryna Fast C contains sodium, sorbitol, and 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 dietary sodium intake for adults.
The medicine contains 0.52 mg of sorbitol in each dosage unit.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking the medicine.

3. How to use Ultrapiryna Fast C

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

• Adults: single dose of 1 to 2 effervescent tablets. 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: single dose of 1 tablet. 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.

Method of administration
For oral use. Effervescent tablets must be dissolved in a glass of water and the resulting effervescent solution should be drunk. Take after meals. Do not divide the tablets.

Duration of treatment
Do not use the medicine for longer than 3–5 days without consulting a doctor.

Taking more Ultrapiryna Fast C than recommended
Poisoning with Ultrapiryna Fast 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 (disturbances of consciousness with disorientation, disturbances in thinking and speech, hallucinations, illusions, anxiety, and psychomotor agitation), rapid breathing, abnormally 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 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 levels (especially in children), ketosis, gastrointestinal bleeding, blood coagulation disorders, 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 required.

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

Stopping Ultrapiryna Fast C
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• If vomiting with blood 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 the symptoms listed above 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 (haematemesis, tarry stools) or occult (bleeding occurs more frequently with higher doses); gastric or duodenal ulcer disease, perforation.

Liver and biliary system 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, nosebleeds, gum 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 concomitant use of other anticoagulant medicines), potentially life-threatening.

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

Immune system disorders:
Hypersensitivity reactions with clinical symptoms and abnormal laboratory test results such as asthma, mild to moderate skin, respiratory, and cardiovascular reactions with symptoms such as rash, urticaria, oedema (including angioedema), breathing difficulties, cardiac disturbances, nasal mucosal inflammation, nasal mucosal congestion, and very rarely severe reactions, including anaphylactic shock.

Respiratory system disorders:
Bronchial asthma.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ultrapiryna Fast C

Store below 30°C. Keep 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
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6. Contents of the pack and other information

What Ultrapiryna Fast C contains

• The active substances are: acetylsalicylic acid (Acidum acetylsalicylicum) and vitamin C (Acidum ascorbicum).
• Other components are: citric acid, sodium hydrogen carbonate, sodium carbonate, sodium dihydrogen citrate, trisodium citrate, povidone K 30, mannitol (E 421), sodium lauryl sulfate, simethicone, sodium cyclamate, sodium saccharin, lemon flavour "KS", code 145 (natural flavourings, natural aromatic substances, aromatic substances, mannitol (E 421), gluconolactone (E 575), sorbitol (E 420), maltodextrin, acacia (E 414), colloidal anhydrous silica (E 551)).

What Ultrapiryna Fast C looks like and contents of the pack
Round, white effervescent tablet with a score line.
Polypropylene container with a polyethylene cap containing a desiccant.
The pack contains 10 or 20 effervescent tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.
Ziębicka 40 Street
50-507 Wrocław
Poland

Manufacturer:
HERMES PHARMA GmbH
Hans-Urmiller-Ring 52
82515 Wolfratshausen
Germany

For further information, please contact the local representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
Poleczki 35, 02-822 Warsaw
Phone: +48 (22) 543 60 00

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