ULTRAPIRYNA 500 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. ULTRAPIRYNA FORTE, 500 mg, enteric-coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet:
3. What is ULTRAPIRYNA FORTE and what is it used for
4. Important information before taking ULTRAPIRYNA FORTE
   1. When not to take ULTRAPIRYNA FORTE:
   2. Warnings and precautions
   3. ULTRAPIRYNA FORTE and other medicines
   4. ULTRAPIRYNA FORTE and alcohol
   5. Pregnancy and breastfeeding
   6. Driving and operating machinery
5. How to take ULTRAPIRYNA FORTE
   1. Adults and adolescents over 12 years of age:
   2. Taking a higher dose of ULTRAPIRYNA FORTE than recommended
   3. Missing a dose of ULTRAPIRYNA FORTE
6. Possible side effects
   1. Reporting side effects
7. How to store ULTRAPIRYNA FORTE
8. Contents of the package and other information
   1. What ULTRAPIRYNA FORTE contains
   2. What ULTRAPIRYNA FORTE looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. Date of last revision of the package leaflet: January 2020

Package Leaflet: Information for the User

ULTRAPIRYNA FORTE, 500 mg, enteric-coated tablets

Acetylsalicylic acid

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• The package 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 package leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 10 days (in the case of pain) or 3 days (in the case of fever) there is no improvement or the patient feels worse, a doctor should be consulted.

Table of Contents of the Package Leaflet:

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

1. What is ULTRAPIRYNA FORTE and what is it used for

Acetylsalicylic acid is a non-steroidal anti-inflammatory drug with analgesic and antipyretic effects. It acts antipyretically by dilating peripheral blood vessels and increasing blood flow, and analgesically and anti-inflammatory by inhibiting the release and biosynthesis of prostaglandins that contribute to the development of the inflammatory response. The pharmaceutical form of the drug - enteric-coated tablet - protects the gastric mucosa from the irritating effect of acetylsalicylic acid. ULTRAPIRYNA FORTE is indicated for use in the following cases:

• pain of mild and moderate intensity, such as toothache, joint pain, muscle pain, headache;
• menstrual cramps;
• pain and inflammation in rheumatic diseases;
• fever.

2. Important information before taking ULTRAPIRYNA FORTE

When not to take ULTRAPIRYNA FORTE:

• if the patient is hypersensitive to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypersensitivity to salicylates or other non-steroidal anti-inflammatory drugs, with a history of bronchial asthma, nasal polyps;
• if the patient has active peptic ulcer disease;
• if the patient has bleeding disorders;
• in the third trimester of pregnancy and during breastfeeding;
• in the case of viral infections (especially flu and chickenpox) in children under 12 years of age;
• if the patient has severe heart failure.

Warnings and precautions

Particular caution should be exercised when taking ULTRAPIRYNA FORTE in the following cases: allergic diseases (bronchial asthma, hay fever), menstrual bleeding, excessive menstrual bleeding, pregnancy and breastfeeding (see "Pregnancy and breastfeeding"), before surgical procedures (do not take acetylsalicylic acid at least 5 days before), gout, history of peptic ulcer disease, and after gastrointestinal bleeding; concomitant treatment with anticoagulant medications (oral antivitamins K, heparin, low molecular weight heparins, antiplatelet agents - ticlopidine, indobufen), renal and hepatic impairment, use of an intrauterine contraceptive device, hypertension, anemia, heart failure, glucose-6-phosphate dehydrogenase deficiency (congenital lack of a certain enzyme in the blood). Taking acetylsalicylic acid in children under 12 years of age with viral infections such as chickenpox or flu may cause Reye's syndrome, a rare but serious disease that causes liver and brain damage. Taking such medications as ULTRAPIRYNA FORTE may be associated with a slight increase in the risk of heart attack or stroke. This risk increases with long-term use of high doses of the medicine. Do not take higher doses or longer treatment than recommended (see section 3). In case of heart disorders, previous stroke or suspected risk of such disorders (e.g. high blood pressure, diabetes, high cholesterol, smoking), the treatment method should be discussed with a doctor or pharmacist. This medicine belongs to a group of medicines that may adversely affect female fertility. This effect is temporary and disappears after the end of therapy.

ULTRAPIRYNA FORTE and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken by the patient, as well as any medicines that the patient plans to take. Acetylsalicylic acid increases the hypoglycemic effect (lowering blood sugar levels) of oral antidiabetic agents from the sulfonylurea group (e.g. tolbutamide, chlorpropamide, glimepiride, glipizide), increases the anticoagulant effect of coumarin derivatives (e.g. warfarin, dicumarol, acenocoumarol), and increases the effect of methotrexate. It increases the risk of gastrointestinal bleeding when taken with other non-steroidal anti-inflammatory drugs and alcohol, and increases the effect and side effects caused by non-steroidal anti-inflammatory drugs. When taken with vancomycin, it increases the risk of temporary hearing loss. Probenecid increases the effect of acetylsalicylic acid. Long-term use of high doses of the medicine may cause increased excretion of ascorbic acid (vitamin C). Acetylsalicylic acid increases the serum concentration of digoxin, barbiturates, lithium compounds, and increases the effect of sulfonamides and their combinations, and increases the effect of valproic acid. It reduces the effect of aldosterone antagonists and loop diuretics, antihypertensive agents, and uricosuric agents (sulfinpyrazone, probenecid). Metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (clotting of blood cells and formation of a blood clot) if these medicines are taken together. Therefore, caution should be exercised when taking metamizole in patients receiving acetylsalicylic acid.

ULTRAPIRYNA FORTE and alcohol

Drinking alcohol during treatment with acetylsalicylic acid may increase the irritating effect on the gastrointestinal tract.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine. The medicine may be used in the 1st and 2nd trimester of pregnancy only in cases where the benefit to the mother outweighs the potential risk to the fetus. The medicine should not be used in the 3rd trimester of pregnancy, as it may cause fetal malformations and complications during delivery. Acetylsalicylic acid passes into breast milk, so the medicine should be avoided during breastfeeding.

Driving and operating machinery

The medicine taken as directed does not impair psychophysical abilities.

3. How to take ULTRAPIRYNA FORTE

Adults and adolescents over 12 years of age:

for analgesic and antipyretic purposes: orally, 1 tablet (500 mg) every 3-4 hours. The maximum daily dose is 4 g. If pain persists after 10 days, and fever after 3 days of taking the medicine, a doctor should be consulted. in rheumatic diseases (anti-inflammatory): orally, 3.5 to 5.5 g per day in divided doses, usually initially 1 or 2 tablets 4 times a day, during meals and before bedtime. The dose is then increased until maximum efficacy is achieved. The dose should not be increased if tinnitus or ringing in the ears occurs. The average daily dose is 4.5 g per day in divided doses. In acute rheumatic fever, up to 7-8 g per day in divided doses.

Taking a higher dose of ULTRAPIRYNA FORTE than recommended

Symptoms of overdose are: headache and dizziness, ringing in the ears, blurred vision, rapid breathing, restlessness, balance disorders, drowsiness, elevated body temperature. If these symptoms occur, the medicine should be discontinued and fluids, mainly fruit juices, should be drunk. If the symptoms worsen and/or cardiac arrhythmias, auditory (ringing in the ears) or visual hallucinations, hearing loss, excessive sweating, nosebleeds, and gastrointestinal bleeding occur, a doctor should be consulted immediately.

Missing a dose of ULTRAPIRYNA FORTE

In case of a missed dose, a double dose should not be taken to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The occurrence of side effects depends on the size of the doses used and the individual patient's reaction. Blood and lymphatic system disorders:thrombocytopenia (thrombocytopenia, platelet deficiency), hypoprothrombinemia (prothrombin deficiency in the blood - a factor responsible for blood clotting). Immune system disorders:hypersensitivity reactions with corresponding laboratory and clinical symptoms, including bronchial asthma, skin changes in the form of flushing or urticaria. Nervous system disorders:dizziness and ringing in the head. Eye disorders:vision disturbances. Ear and labyrinth disorders:hearing disturbances. Cardiac disorders:heart failure, increased risk of arterial thrombosis (e.g. heart attack or stroke). Respiratory, thoracic, and mediastinal disorders:rapid breathing, bronchial asthma. Gastrointestinal disorders:dyspeptic disorders (nausea, vomiting), exacerbation of peptic ulcer disease, gastric mucosal erosion, sometimes with bleeding. Skin and subcutaneous tissue disorders:excessive sweating. Renal and urinary disorders:kidney stones, acid-base balance disorders. With the use of non-steroidal anti-inflammatory drugs (NSAIDs), edema, hypertension, and heart failure have been reported. Taking such medications as ULTRAPIRYNA FORTE may be associated with a slight increase in the risk of heart attack (heart attack or stroke).

Reporting side effects

If any side effects occur, including any possible side effects not listed in the package leaflet, the doctor or pharmacist should be informed. 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: Al. Jerozolimskie 181C 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]. 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 FORTE

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Store at a temperature below 25°C. Store in the original packaging to protect from moisture. Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What ULTRAPIRYNA FORTE contains

The active substance of the medicine is acetylsalicylic acid. One enteric-coated tablet contains 500 mg of acetylsalicylic acid. The other ingredients are: tablet core: corn starch, microcrystalline cellulose, talc. Coating: methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate, povidone, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What ULTRAPIRYNA FORTE looks like and what the package contains

The medicine is in the form of yellow, enteric-coated tablets with a smooth surface, convex on both sides. The package contains 10, 20, or 50 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

Manufacturer:

Polfarmex S.A., ul. Józefów 9, 99-300 Kutno, SUN-FARM Sp. z o.o., Człekówka 75, 05-340 Kołbiel

Date of last revision of the package leaflet: January 2020