ULTRAPIRYNA 500 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains
   2. Table of contents of the leaflet:
2. What is Ultrapiryna Fast and what is it used for
3. Important information before taking Ultrapiryna Fast
   1. When not to take Ultrapiryna Fast:
   2. Warnings and precautions
   3. Before starting Ultrapiryna Fast, the patient should discuss it with their doctor or pharmacist:
   4. Ultrapiryna Fast and other medicines
   5. Ultrapiryna Fast with food, drink, or alcohol:
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Ultrapiryna Fast contains sodium
4. How to take Ultrapiryna Fast
   1. Taking a higher dose of Ultrapiryna Fast than recommended
   2. Missing a dose of Ultrapiryna Fast
   3. Stopping Ultrapiryna Fast treatment
5. Possible side effects
   1. Frequent side effects (occurring in no more than 1 in 10 people)
   2. Uncommon side effects (occurring in no more than 1 in 100 people)
   3. Rare side effects (occurring in no more than 1 in 1,000 people)
   4. Frequency not known (frequency cannot be estimated from available data)
   5. Reporting side effects
6. How to store Ultrapiryna Fast
7. Contents of the packaging and other information
   1. What Ultrapiryna Fast contains
   2. What Ultrapiryna Fast looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. Date of last revision of the leaflet: July 2021

Leaflet attached to the packaging: patient information

ULTRAPIRYNA FAST, 500 mg, effervescent tablets
Acetylsalicylic acid

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as advised by
a doctor or pharmacist.

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

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

Ultrapiryna Fast contains acetylsalicylic acid with analgesic, antipyretic, and anti-inflammatory effects.
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

When not to take 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 disorder,
• if the patient has acute stomach or duodenal ulcer,
• if the patient has ever had asthma attacks caused 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 treatment) at doses of 15 mg per week or higher,
• if the patient has severe heart failure or severe liver or kidney failure,
• if the patient is in the third trimester of pregnancy,
• in children under 12 years of age.

Warnings and precautions

Before starting Ultrapiryna Fast, 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 kidney function disorders 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 a history of (chronic or recurrent) stomach ulcers 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.

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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 who experience allergic reactions to other substances (e.g., skin reactions, itching, hives) are particularly at risk of such reactions.
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 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 relationship has not been proven.
Therefore, 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 should only be used on a doctor's prescription.
Prolonged use of medications containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Prolonged use of painkillers, especially those containing multiple active substances, may lead to severe kidney function disorders and kidney failure.

Ultrapiryna Fast 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 with the following medicines, as acetylsalicylic acid enhances:

• the toxic effects of methotrexate on the bone marrow; acetylsalicylic acid should not be taken 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;

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• the effects of anticoagulant medications, thrombolytic medications (dissolving blood clots), and antiplatelet agents, which may increase the risk of prolonged bleeding time and bleeding;
• the risk of stomach ulcers and gastrointestinal bleeding if taken concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs, including other salicylates in high doses, or if alcohol is consumed during treatment; after discontinuing systemic corticosteroids (except for hydrocortisone used as replacement therapy in Addison's disease), the risk of salicylate overdose increases;
• the effect of digoxin (a heart medication), as it increases its serum concentration;
• the effect of antidiabetic medications, e.g., insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid (a medication used in epilepsy), which in turn enhances the antiplatelet effect of acetylsalicylic acid;
• the effect of selective serotonin reuptake inhibitors (antidepressants).

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

• the effect of uricosuric medications used to treat gout, which increase uric acid excretion from the body (e.g., benzbromarone, probenecid), which may worsen gout symptoms;
• the effect of diuretics;
• the effect of certain antihypertensive medications (from the group of so-called angiotensin-converting enzyme inhibitors), especially if acetylsalicylic acid is taken in high doses. Ultrapiryna Fast can be taken concurrently with the above-mentioned medications (except for methotrexate at doses of 15 mg per week or higher) only after consulting a doctor.

Ultrapiryna Fast with food, drink, or alcohol:

See section 3 of the leaflet.
Note! Alcohol may increase the risk of adverse reactions from the gastrointestinal tract, 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.
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Ultrapiryna Fast is contraindicated in the third trimester of pregnancy, as it may cause complications during the perinatal period, both in the mother and the newborn. Products containing acetylsalicylic acid should not be used in women in the first and second trimesters of pregnancy, unless absolutely necessary. If acetylsalicylic acid needs to be taken by 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.
Ultrapiryna Fast belongs to a group of medicines that may adversely affect female fertility.
This effect is temporary and disappears after the end of therapy.

Driving and using machines

The medicine has no effect.

Ultrapiryna Fast contains sodium

The medicine contains 276 mg of sodium, a major component of common salt, in each effervescent tablet. This corresponds to 14% of the maximum recommended daily intake of sodium in the diet of adults.

3. How to take Ultrapiryna Fast

This medicine should always be taken exactly as described in the patient leaflet or as advised by
a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The recommended dose of Ultrapiryna Fast is:

• adults: 1-2 effervescent tablets at a time. If necessary, the single dose may be repeated at intervals of not 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 not less than 4 to 8 hours. No more than 3 tablets should be taken per day. Method of administration Oral administration. Effervescent tablets should be dissolved in a glass of water and the effervescent liquid should be drunk. The medicine should be taken after meals. Duration of treatment The medicine should not be taken for more than 3-5 days without consulting a doctor.

Taking a higher dose of Ultrapiryna Fast than recommended

Ultrapiryna Fast poisoning may be caused by prolonged use of the medicine (mild poisoning) or overdose (severe poisoning), which can be life-threatening, e.g., after accidental ingestion by children or the elderly.
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Symptoms of mild poisoning are: dizziness (including vertigo), tinnitus, hearing loss, excessive sweating, nausea, and vomiting, headache, confusion (disorders of consciousness with disorientation, thinking and speech disorders, delusions, hallucinations, anxiety, and psychomotor agitation), rapid breathing, deep breathing, and symptoms of respiratory alkalosis (dark spots before the eyes, fainting).
In the case of severe poisoning, the following may also occur: high fever, respiratory disorders (up to respiratory arrest and suffocation), heart and blood vessel disorders (from irregular heartbeat, low blood pressure to cardiac arrest), fluid and electrolyte loss (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 seizures.
In the event of an overdose, the patient should immediately consult their doctor or pharmacist, and in the case of severe poisoning, the patient should be taken to the hospital immediately.
Treatment of poisoning involves gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be necessary.

Missing a dose of Ultrapiryna Fast

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

Stopping Ultrapiryna Fast treatment

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 can cause side effects, although not everybody gets them.
If the patient notices any of the following serious side effects, they should stop taking Ultrapiryna Fast and contact their doctor immediately:

• coffee grounds vomiting or black, tarry stools; severe hypersensitivity reactions: 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;
• skin redness with blisters or peeling, which may be associated with high fever and joint pain. Such symptoms may indicate the development of life-threatening Stevens-Johnson syndrome (characterized by short-term presence of blisters on the mucous membranes of the mouth, quickly turning into erosions and ulcers) and toxic epidermal necrolysis.

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These symptoms may indicate the development of life-threatening Stevens-Johnson syndrome (characterized by short-term presence of blisters on the mucous membranes of the mouth, quickly turning into erosions and ulcers) and toxic epidermal necrolysis.

Frequent side effects (occurring in no more than 1 in 10 people)

• indigestion;
• increased tendency to bleeding;

Uncommon side effects (occurring in no more than 1 in 100 people)

• nasal congestion;

Rare side effects (occurring in no more than 1 in 1,000 people)

• potentially life-threatening gastrointestinal bleeding: overt (coffee grounds vomiting, black, tarry stools) or occult (bleeding occurs more frequently the higher the dose);
• nausea, vomiting;
• brain hemorrhage (especially in patients with uncontrolled hypertension and/or concurrent use of other anticoagulant medications) potentially life-threatening;
• lower airway spasm, asthma;
• severe skin reactions, such as: life-threatening Stevens-Johnson syndrome (characterized by short-term presence of blisters on the mucous membranes of the mouth, quickly turning into erosions and ulcers) and toxic epidermal necrolysis.

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

• stomach or duodenal ulcer and perforation;
• stomach and abdominal pain, heartburn, gastrointestinal inflammation;
• transient liver function disorders (increased aminotransferase activity);
• dizziness and tinnitus, usually symptoms of overdose;
• increased risk of bleeding, bleeding (postoperative, nasal, gingival, genitourinary), hematomas, prolonged bleeding time, prothrombin time, thrombocytopenia. The consequence of bleeding may be the development of acute or chronic iron deficiency anemia or acute post-hemorrhagic anemia, 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;
• kidney function disorders and severe kidney failure;
• hypersensitivity reactions, angioedema, allergic edema, anaphylactic reactions, including shock;
• high uric acid levels in the blood.

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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 Adverse Reactions to 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Ultrapiryna Fast

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 the term "EXP:". The expiry date refers to the last day of the month.
Shelf life after first opening - 18 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ultrapiryna Fast contains

The active substance of the medicine is acetylsalicylic acid (Acidum acetylsalicylicum).
The other ingredients of the medicine are: citric acid, sodium bicarbonate, sodium carbonate, sodium dihydrogen citrate, sodium citrate, povidone K 30, mannitol (E421), sodium docusate, simethicone.

What Ultrapiryna Fast looks like and what the packaging contains

Round, white tablet with a notch.
A polypropylene container with a polyethylene cap 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
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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 Warsaw
tel.: +48 (22) 543 60 00

Date of last revision of the leaflet: July 2021

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