Package leaflet: Information for the patient

ULTRAPIRYNA FAST, 500 mg, effervescent tablets
Acidum acetylsalicylicum
Please read carefully the entire leaflet 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 according to the instructions given 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 contact your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse after 3–5 days, you should consult your doctor.

Table of contents:

What Ultrapiryna Fast is and what it is used for
Important information before taking Ultrapiryna Fast
How to take Ultrapiryna Fast
Possible side effects
How to store Ultrapiryna Fast
Contents of the pack and other information

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

Ultrapiryna Fast contains acetylsalicylic acid, which has analgesic, antipyretic, and anti-inflammatory properties.
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

When not to use Ultrapiryna Fast:

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 previously experienced asthma attacks induced by salicylates or substances with similar effects, 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 has severe heart failure, severe liver failure, or severe renal failure,
if the woman is in the third trimester of pregnancy,
in children under 12 years of age.

Warnings and precautions
Before starting treatment with Ultrapiryna Fast, discuss with your 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 renal failure,
if the patient has previously had (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 induce hemolysis or hemolytic anemia,
if the patient is breastfeeding.

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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, e.g. tooth extraction) should inform their doctor about taking Ultrapiryna Fast.
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 infection, 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 the onset of Reye's syndrome, requiring 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, medications containing acetylsalicylic acid should not be used in children under 12 years of age, and in adolescents over 12 years of age, such medications should be used only under medical supervision.
Long-term use of medications 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 function disorders and renal failure.

Ultrapiryna Fast and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Exercise particular caution when using Ultrapiryna Fast with the following medicines, as acetylsalicylic acid intensifies:

the toxic effect 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 effect 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 concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs, including other salicylates at high doses, or if 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 anti-aggregatory effect of acetylsalicylic acid;
the effect of selective serotonin reuptake inhibitors (antidepressant drugs).

Exercise particular caution when using Ultrapiryna Fast with the following medicines, as acetylsalicylic acid weakens:

uricosuric drugs used in the treatment of gout, which increase uric acid excretion from the body (e.g. benzbromarone, probenecid), potentially exacerbating symptoms of gout;
diuretic drugs;
certain antihypertensive drugs (from the group of so-called angiotensin-converting enzyme inhibitors), particularly if acetylsalicylic acid is used in high doses. Ultrapiryna Fast may be used concurrently with the above-mentioned drugs (except methotrexate at doses of 15 mg per week or higher) only after consultation with a doctor.

Ultrapiryna Fast 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 and breastfeeding and effect on fertility
During pregnancy and breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
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Ultrapiryna Fast is contraindicated during the last, 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 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.
Ultrapiryna Fast 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 contains sodium
The medicine contains 276 mg of sodium—the main component of table salt—in each tablet. This corresponds to 14% of the maximum recommended daily sodium intake in the diet of adults.

3. How to use Ultrapiryna Fast

This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist. The recommended
dose of Ultrapiryna Fast 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 the age of 12 years, only on a physician's advice: 1 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.

Method of administration
For oral use. The effervescent tablets must be dissolved in a glass of water and the resulting effervescent solution should be drunk. Take after meals.

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

Taking more Ultrapiryna Fast than recommended
Poisoning with Ultrapiryna Fast may result from prolonged use (mild poisoning) or overdose (severe
poisoning), which may be life-threatening, e.g. after accidental ingestion by children or elderly persons.
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Symptoms of mild poisoning include: dizziness (including labyrinthine origin), tinnitus,
deafness, excessive sweating, nausea and vomiting, headache, confusion (mental disturbances with
disorientation, disturbances in thinking and speech, hallucinations, delusions, anxiety, and psychomotor agitation),
rapid breathing, abnormally deep breathing, and symptoms of respiratory alkalosis
(blurred vision, 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, 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 kidney failure), increased or decreased blood glucose concentration (especially in children), ketosis, gastrointestinal bleeding, coagulation disorders, neurological disturbances manifesting as lethargy, confusion, up to coma and convulsions.
In case of overdose, seek immediate medical advice from a physician or pharmacist. In cases of severe poisoning, the patient must be immediately transported to hospital.
Treatment of poisoning consists of 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 Ultrapiryna Fast:
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
If you have any further questions about the use of 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.
If the patient notices any of the following severe adverse reactions, use of Ultrapiryna Fast should be discontinued immediately and medical advice should be sought without delay:

Coffee-ground vomiting or black, tarry stools; severe hypersensitivity reactions: 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;
Skin redness with blistering or peeling, which may be associated with high fever and joint pain. Such symptoms may indicate the occurrence of the life-threatening Stevens-Johnson syndrome (characterized by transient presence of blisters on the mucous membranes of the oral cavity rapidly progressing to erosions and ulcerations) and toxic epidermal necrolysis.

Common adverse reactions (not more frequent than 1 in 10 people)

Dyspepsia;
Increased tendency to bleeding;

Uncommon (not more frequent than 1 in 100 people)

Nasal mucositis;

Rare (not more frequent than 1 in 1,000 people)

Potentially life-threatening gastrointestinal bleeding: overt (coffee-ground vomiting, tarry stools) or occult (bleeding occurs more frequently with higher doses);
Nausea, vomiting;
Intracerebral hemorrhage (particularly in patients with uncontrolled hypertension and/or concurrently using other anticoagulant drugs), potentially life-threatening;
Bronchoconstriction, bronchial asthma;
Severe skin reactions, such as life-threatening Stevens-Johnson syndrome (characterized by transient presence of blisters on the mucous membranes of the oral cavity rapidly progressing to erosions and ulcerations) and toxic epidermal necrolysis.

Frequency not known (frequency cannot be estimated from available data)

Peptic ulcer disease of the stomach or duodenum and perforation;
Stomach and abdominal pain, heartburn, gastrointestinal inflammation;
Transient liver function abnormalities (increased aminotransferase activity);
Dizziness and tinnitus, usually symptoms of overdose;
Increased risk of bleeding, hemorrhages (postoperative, epistaxis, gingival, urogenital), ecchymoses, prolonged bleeding time and prothrombin time, thrombocytopenia. Bleeding may lead to acute or chronic iron-deficiency anemia or acute hemorrhagic anemia, manifesting as asthenia, pallor, hypoperfusion, and abnormal laboratory findings. Hemolysis and hemolytic anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency;
Renal function disorders and severe renal failure;
Hypersensitivity reactions, angioedema, allergic edema, anaphylactic reactions including anaphylactic shock;
High levels of uric acid in the blood.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring 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
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

Store in the original packaging to protect from moisture.
Keep the medicine out of the 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.
Expiry after first opening – 18 months.
Medicines must 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.

6. Contents of the pack and other information

What Ultrapiryna Fast contains
The active substance is acetylsalicylic acid (Acidum acetylsalicylicum).
The other ingredients are: citric acid, sodium hydrogen carbonate, sodium carbonate, disodium hydrogen citrate, sodium citrate, povidone K 30, mannitol (E421), sodium lauryl sulfate, simethicone.

What Ultrapiryna Fast looks like and contents of the pack
Round, white effervescent tablet with a notch.
Polypropylene container with a polyethylene cap containing a moisture-absorbing agent.
The pack contains 10 or 20 effervescent tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.
Ziębicka Street 40
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50-507 Wrocław
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 Street 35, 02-822 Warsaw
Tel.: +48 (22) 543 60 00
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