Ultrapirina

Leaflet attached to the packaging: patient information

ULTRAPIRYNA, 325 mg, enteric-coated 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 directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3-5 days there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet

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

1. What is Ultrapiryna and what is it used for

Acetylsalicylic acid in Ultrapiryna has analgesic, antipyretic, and anti-inflammatory effects.

Indications for use

The main use of Ultrapiryna is:

• cold, flu, feverish conditions;
• chronic treatment of pain and inflammation, for example in rheumatoid arthritis, juvenile arthritis, systemic lupus erythematosus, degenerative joint disease, Reiter's syndrome (conjunctivitis, mucocutaneous lesions, arthritis) and periarticular changes;
• mild and moderately severe toothache, headache, menstrual pain.

2. Important information before taking Ultrapiryna

When not to take Ultrapiryna:

• if the patient is hypersensitive to acetylsalicylic acid, other salicylates, or any of the other ingredients of this medicine (listed in section 6);
• in cases of diseases where bleeding occurs or may occur, such as:
• hemophilia,
• gastric or duodenal ulcer disease;
• during pregnancy (in the last trimester of pregnancy);
• in patients with severe liver and kidney failure;
• in patients with a history of asthma, especially those induced by salicylates or substances with similar effects, particularly non-steroidal anti-inflammatory drugs (NSAIDs);
• in children and adolescents under 16 years of age, unless a doctor recommends otherwise, due to the risk of Reye's syndrome, a rare but serious disease that causes liver and brain damage(see also "Warnings and precautions", below);
• concomitantly with methotrexate at doses of 15 mg per week or higher.

Warnings and precautions

Before starting treatment with Ultrapiryna, discuss it with your doctor or pharmacist:

• in case of pregnancy: first and second trimester;
• if the patient is breastfeeding;
• in case of hypersensitivity to other anti-inflammatory and anti-rheumatic drugs or other allergenic substances;
• in case of severe liver or kidney disease;
• if the patient taking Ultrapiryna is also taking anticoagulant medications, such as: heparin, coumarin;
• if the patient has a history of gastric or duodenal ulcer disease;
• if the patient has a tendency to bleeding (hemophilia, vitamin K deficiency);
• in patients with glucose-6-phosphate dehydrogenase deficiency;
• during concomitant use of ibuprofen;
• if the patient has asthma, chronic respiratory diseases, hay fever, or nasal polyps, they may be more likely to react to NSAIDs, including acetylsalicylic acid, with asthma attacks, angioedema, or urticaria;
• in case the patient is on a salt-free diet;
• in patients with reduced uric acid excretion, the medicine may cause a gout attack;
• in patients with glucose-6-phosphate dehydrogenase deficiency.

Consult a doctor even if the above warnings refer to past situations.
Long-term use of medicines containing acetylsalicylic acid may cause headache, which worsens during subsequent doses.
Long-term use of painkillers, especially those containing several active substances, may lead to severe kidney dysfunction and kidney failure.
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 Reye's syndrome - a rare but life-threatening disease (see "When not to take Ultrapiryna", above). The occurrence of persistent vomiting during 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 concurrently, although a causal relationship has not been proven.
Do not use for at least 5 days before a planned surgical procedure due to the possibility of increased bleeding.
Ultrapiryna may cause increased liver enzyme activity, urea, and creatinine in the blood, hyperkalemia (increased potassium in the blood), proteinuria, and prolonged bleeding time.

Children and adolescents

Ultrapiryna should not be given to children and adolescents under 16 years of age(see "When not to take Ultrapiryna" and "Warnings and precautions", above).

Ultrapiryna and other medicines

Inform your doctor about all medicines taken recently, even those available without a prescription.
Ultrapiryna may:

• weaken the effect of certain medicines used in hypertension;
• increase the effect of anticoagulant medications with the possibility of bleeding;
• increase or change the effect of medicines used in epilepsy;
• increase the effect of methotrexate and its toxic effect;
• increase the effect of oral diabetes medications;
• weaken the effect of medicines used in gout;
• weaken the effect of spironolactone;
• increase the risk of gastric ulcer and bleeding from the gastrointestinal tract, as well as kidney damage during concomitant use of non-steroidal anti-inflammatory drugs and glucocorticosteroids;
• increase digoxin levels in the blood;
• increase valproic acid levels in the blood and cause its toxic effect;
• show reduced efficacy during concomitant use of ibuprofen.
• Metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (clotting of blood cells and clot formation) if these medicines are taken concurrently. Therefore, caution should be exercised when using metamizole in patients receiving acetylsalicylic acid.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Taking Ultrapiryna in early pregnancy increases the risk of miscarriage, congenital heart defects. Ultrapiryna should not be taken by women in the first and second trimester of pregnancy.
In the third trimester of pregnancy, the medicine may have a negative effect on the circulatory and respiratory systems, as well as disrupt kidney function. At the end of pregnancy, taking Ultrapiryna may lead to prolonged bleeding time, even with small doses, and inhibit uterine contractions leading to delayed delivery or prolonged labor.
Therefore, Ultrapiryna should not be taken in the third trimester of pregnancy.
Particular caution should be exercised when taking Ultrapiryna in breastfeeding women.
Ultrapiryna, at a dose of 500 mg of acetylsalicylic acid or more per day, belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may have a negative effect on female fertility. This effect is temporary and disappears after the end of therapy.

Driving and operating machinery

Ultrapiryna does not affect the ability to drive vehicles and operate machinery.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Ultrapiryna

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Tablets should be taken orally, preferably after meals, with a large amount of liquid. If the doctor does not recommend otherwise, the following doses are used: for analgesic and antipyretic purposes - 1 tablet every 4 hours or 1 to 2 tablets every 6 hours.
In adolescents over 16 years of age, do not take more than 1500 mg of acetylsalicylic acid per day.
Do not take in children and adolescents under 16 years of age(see "When not to take Ultrapiryna" and "Warnings and precautions" in section 2).
If you feel that the effect of Ultrapiryna is too strong or too weak, consult a doctor.

Taking a higher dose of Ultrapiryna than recommended

In case of taking a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately.
Symptoms of overdose include ringing in the ears, headaches and dizziness, nausea and vomiting, confusion, hallucinations, tremors, shortness of breath, excessive sweating, fever.
If you experience any of the above symptoms, consult a doctor.

Missing a dose of Ultrapiryna

Do not take a double dose to make up for a missed dose.

Stopping treatment with Ultrapiryna

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Ultrapiryna can cause side effects, although not everybody gets them.
Common side effects (occurring in 1 to 10 people out of 100) are: symptoms of indigestion (heartburn, nausea, vomiting) and abdominal pain.
Rarely (occurring in 1 to 10 people out of 10,000) there were cases of inflammation of the stomach and intestines, gastric and duodenal ulcer disease, very rarely leading to bleeding and perforation, as well as transient liver function disorders with increased aminotransferase activity.
Rarely or very rarely, serious bleeding occurred, such as gastrointestinal bleeding, cerebral hemorrhage, which can lead to anemia, and in individual cases may be life-threatening.
Very rarely (less than 1 in 10,000 patients) severe allergic reactions occurred, including anaphylactic shock, as well as kidney function disorders, hypoglycemia.
Frequency not known: increased risk of bleeding, prolonged bleeding time, bleeding such as postoperative bleeding, hematomas, nosebleeds, bleeding from the genitourinary tract, gum bleeding, hypersensitivity reactions (e.g., shortness of breath or skin reactions), dizziness, tinnitus, especially in children and the elderly, usually being symptoms of overdose.
Long-term use of medicines containing acetylsalicylic acid may cause headache, which worsens during subsequent doses, and may lead to severe kidney dysfunction and kidney failure (especially when taking several medicines).
Reporting side effects
If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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, you can help provide more information on the safety of the medicine.

5. How to store Ultrapiryna

Keep the medicine out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. Ask your 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 contains

• The active substance of the medicine is acetylsalicylic acid. Each tablet contains 325 mg of acetylsalicylic acid.
• Other ingredients are: tablet core: pre-gelatinized starch, microcrystalline cellulose, talc, sodium carboxymethylcellulose (type A); tablet coating: Opadry YS-1-7027 coating: hypromellose, titanium dioxide (E171), triacetin; ACRYL-EZE 93A18597 coating: methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide (E171), colloidal silica, anhydrous sodium bicarbonate, sodium lauryl sulfate; triethyl citrate.

What Ultrapiryna looks like and what the packaging contains

A polyethylene tablet container with a polyethylene cap containing a desiccant, in a cardboard box. The container contains 30 or 100 enteric-coated tablets.
PVC/PVDC/Aluminum blister, in a cardboard box. One blister contains 4 or 6 tablets. The packaging contains 4, 6, 12, or 18 enteric-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

Manufacturer:

Medicofarma S.A.
Tarnobrzeska 13, 26-613 Radom
To obtain more detailed information, please contact the local representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
Poleczki 35, 02-822 Warsaw
phone: +48 (22) 543 60 00

Date of last update of the leaflet: