Pireox

Package Leaflet: Information for the User

Pyreox, 500 mg, coated tablets

Metamizole sodium monohydrate
Pyreox may cause a severely decreased number of white blood cells (agranulocytosis), which can lead to severe and life-threatening infections (see section 4).
You should stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms: fever, chills, sore throat, painful mouth ulcers, nose, throat, or genital and anal areas.
If the patient has ever had agranulocytosis while taking metamizole or similar medicines, they should never take this medicine again (see section 2).

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• You should keep this leaflet to be able to read it again if needed.
• If you need advice or additional information, you should contact your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If after 3-5 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is Pyreox and what is it used for

Pyreox is a medicinal product with analgesic (pain-relieving), antipyretic (fever-reducing), and spasmolytic (smooth muscle-relaxing) effects.
Pyreox is indicated for use in the following cases:

• severe acute or chronic (long-term) pain;
• high fever that does not respond to other measures.

This medicine is indicated for use in adults and adolescents from 15 years of age.
If after 3-5 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Pyreox

When not to take Pyreox

• if the patient has a history of a significant decrease in the number of white blood cells called granulocytes caused by metamizole or other similar medicines called pyrazolones or pyrazolidines;
• if the patient has disorders of bone marrow function or a disease that affects the production or function of blood cells;
• if the patient is allergic to metamizole, other pyrazolones or pyrazolidines (e.g., phenazone or propyphenazone, phenylbutazone, oxyphenbutazone) or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has had a reaction after taking these active substances;
• if the patient has asthma associated with the use of painkillers or other forms of intolerance to painkillers, i.e., bronchospasm (sudden narrowing of the airways) or other allergic reactions, such as hives, rhinitis, angioedema (swelling of various parts of the body, most often the face and throat), in response to painkillers such as salicylates, paracetamol, or other non-opioid painkillers, including non-steroidal anti-inflammatory drugs such as diclofenac, ibuprofen, indomethacin, or naproxen;
• if the patient has acute intermittent porphyria (a hereditary disease characterized by disturbances in hemoglobin synthesis);
• if the patient has a congenital deficiency of an enzyme called glucose-6-phosphate dehydrogenase;
• if the patient is in the last three months of pregnancy.

Warnings and precautions

Before starting to take Pyreox, you should discuss it with your doctor or pharmacist:

• if the patient has low systolic blood pressure (below 100 mmHg), heart disease, and circulatory disorders (e.g., heart attack, coronary heart disease, or multi-organ damage), narrowing of the arteries supplying blood to the brain, decreased blood volume, or dehydration, as metamizole may lower blood pressure;
• if the patient has a high fever;
• if the patient has kidney or liver function disorders;
• if the patient has bronchial asthma, especially with concurrent rhinitis and sinusitis;
• if the patient is at increased risk of reactions similar to allergies, including atopic reactions and chronic urticaria;
• if the patient has intolerance to certain dyes (e.g., tartrazine) or preservatives (e.g., benzoates);
• if the patient has alcohol intolerance characterized by sneezing, tearing, and intense flushing of the face in response to even small amounts of alcohol; this may indicate previously undiagnosed analgesic-induced asthma.

Agranulocytosis (severely decreased number of white blood cells)

Pyreox may cause agranulocytosis, a severely decreased number of a certain type of white blood cell called granulocytes, which play an important role in fighting infections (see section 4). You should stop taking metamizole and contact your doctor immediately if you experience any of the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful mouth ulcers, especially in the mouth, nose, and throat or in the genital and anal areas. Your doctor will order a blood test to check your blood cell count.
If metamizole is taken for fever, some symptoms of developing agranulocytosis may remain unnoticed. Similarly, symptoms may also be masked if the patient is taking antibiotics.
Agranulocytosis can develop at any time during Pyreox use and even for a short time after stopping metamizole.
Agranulocytosis can occur even if metamizole was previously taken without complications.

Liver problems

In patients taking metamizole, cases of liver inflammation have been reported, with symptoms developing over several days to several months after starting treatment.
You should stop taking Pyreox and contact your doctor if you experience symptoms of liver problems, such as nausea (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or eyes, itching, rash, or abdominal pain. Your doctor will check your liver function.
You should not take Pyreox if you have previously taken a medicine containing metamizole and had liver problems.

Severe skin reactions

Severe skin reactions have been reported with metamizole, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). If you experience any symptoms of these severe skin reactions, you should stop taking metamizole and seek medical help immediately.
If you have ever had a severe skin reaction, you should never take this medicine again (see section 4).

Effect on laboratory tests

In patients treated with metamizole, abnormal laboratory and diagnostic test results have been observed, based on the Trinder reaction or similar reactions (e.g., creatinine, triglycerides, HDL cholesterol, or uric acid in serum).

Pyreox and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. You should especially inform your doctor about taking the following medicines:

• cyclosporine and tacrolimus: medicines used to prevent organ rejection in patients after organ transplantation;
• sertraline: a medicine used to treat depression;
• bupropion: a medicine used to treat depression or to help quit smoking;
• methotrexate: a medicine used to treat cancer or certain rheumatic diseases;
• efavirenz: a medicine used to treat HIV/AIDS;
• methadone: a medicine used to treat opioid dependence;
• valproate: a medicine used to treat epilepsy or bipolar disorder;
• acetylsalicylic acid. Metamizole may reduce its effect on platelets. When taking low doses of acetylsalicylic acid as a cardioprotective agent, caution should be exercised when taking Pyreox.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Available data on the use of metamizole during the first three months of pregnancy are limited but do not indicate a harmful effect on the fetus. In selected cases, if there are no other treatment options, after consulting your doctor or pharmacist, you may take single doses of metamizole in the first and second trimester, after careful consideration of the benefits and risks associated with taking the medicine. However, metamizole is not recommended during the first and second trimester of pregnancy.
You should not take Pyreox during the last three months of pregnancy due to the increased risk of complications in the mother and child (bleeding, premature closure of the fetal ductus arteriosus, a vital blood vessel that normally closes after birth).
Breastfeeding
Metamizole metabolites pass into breast milk in significant amounts, and a risk to the breastfed child cannot be excluded. Therefore, you should especially avoid repeated use of metamizole during breastfeeding. If you take a single dose of metamizole, you should be advised to discard breast milk for 48 hours after taking the medicine.
Fertility
There is no information on this.

Driving and using machines

Pyreox at recommended doses does not have a negative effect on the ability to drive vehicles and operate machines. However, when taking higher doses, the medicine may affect the ability to drive vehicles and concentrate. In such cases, you should not drive vehicles or operate machines.

Pyreox contains sodium

This medicine contains 32.73 mg of sodium (the main component of common salt) per tablet. This corresponds to 1.64% of the recommended maximum daily sodium intake in the diet for an adult.

3. How to take Pyreox

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should contact your doctor or pharmacist.
The dose depends on the severity of pain or fever and individual patient response to Pyreox.
You should always choose the smallest dose necessary to control pain and fever.
The onset of action can be expected within 30 to 60 minutes after oral administration.
The medicine should be taken orally, with a sufficient amount of liquid (e.g., a glass of water). The medicine can be taken with or without food.
Adults and adolescents 15 years and older
Adults and adolescents over 15 years (with a body weight over 53 kg) can take one to two tablets (500 mg to 1000 mg of metamizole) no more than four times a day, at intervals of 6-8 hours, corresponding to a maximum daily dose of 4000 mg.
Duration of treatment
Pyreox should not be taken for more than 3 to 5 days. If symptoms persist or worsen after this period, you should consult your doctor immediately.
Children and adolescents under 15 years
Pyreox should not be used in children and adolescents under 15 years. Other forms and doses of this medicine are available for younger children; you should ask your doctor or pharmacist about them.
Elderly patients and patients with poor general health and (or) kidney function disorders
In elderly patients, weakened patients, and patients with reduced kidney function, the dose should be reduced, as the elimination of metamizole metabolites from the body may be delayed.
Patients with kidney or liver function disorders
Due to the reduced elimination rate from the body in patients with kidney or liver function disorders, you should avoid repeated administration of high doses of the medicine. In the case of short-term use, dose reduction is not required. There is no data on long-term use.

Overdose of Pyreox

Accidental overdose may lead to nausea, vomiting, abdominal pain, kidney function disorders and (or) kidney failure, nervous system disorders (dizziness, drowsiness, coma, convulsions), low blood pressure, and heart rhythm disorders. Administration of higher doses of metamizole may cause harmless red discoloration of urine.

Missed dose of Pyreox

You should not take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, you should contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pyreox can cause side effects, although not everybody gets them.

The following side effects may have serious consequences; if they occur, you should stop taking Pyreox and contact your doctor immediately:

• severe allergic reactions, severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis. In such cases, you should not take Pyreox again without medical supervision. Early discontinuation of treatment may be crucial for recovery.

In case of symptoms of agranulocytosis (very rare), you should stop taking Pyreox immediately. The treating doctor must monitor the blood cell count results. You should not delay stopping treatment until laboratory test results are available.
You should also not take Pyreox again if you experience any of the following symptoms, which may indicate agranulocytosis:

• unexpected deterioration of general well-being (e.g., fever, chills, sore throat, swallowing disorders);
• fever that does not subside or recurs;
• painful changes on mucous membranes, mainly in the mouth, nose, throat, or genital and anal areas. See also section 2 Warnings and precautions.

You should stop taking Pyreox and contact your doctor immediately if you experience any of the following symptoms:

• nausea (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or eyes, itching, rash, or abdominal pain. These may be symptoms of liver damage. See also section 2 Warnings and precautions.

Possible side effects

Common(may affect up to 1 in 10 people)

• drowsiness;
• headache;
• dizziness, vertigo;
• low blood pressure, occurring mainly during intravenous administration (hypotension);
• rash, itching, urticaria.

Uncommon(may affect up to 1 in 100 people)

• decrease in the number of white blood cells in the blood (leukopenia).

Rare side effects(may affect up to 1 in 1,000 people)

• allergic reactions (anaphylactoid or anaphylactic reactions). Milder reactions usually have the form of irritated eyes, cough, rhinitis, sneezing, chest tightness, facial flushing, urticaria, and facial edema, and in rarer cases also nausea and stomach cramps. Specific warning signs include a burning sensation, itching, and a feeling of heat on the tongue/under the tongue, especially on the palms and soles of the feet.
• Such mild reactions can progress to more severe reactions characterized by severe urticaria, severe angioedema (including laryngeal edema), severe bronchospasm (narrowing of the airways), tachycardia (sometimes also bradycardia), arrhythmias, low blood pressure (sometimes preceded by high blood pressure), loss of consciousness, and shock. These reactions can also occur after repeated administration of the medicine without complications and can be severe and life-threatening, even fatal. In patients with analgesic-induced asthma, intolerance to the medicine usually occurs in the form of asthma attacks (see section 2).
  Very rare side effects(may affect up to 1 in 10,000 people)
  • significant decrease in the number of certain white blood cells, which can be fatal (agranulocytosis).

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

  • myocardial infarction as a symptom of an allergic reaction (Kounis syndrome);
  • anemia with concurrent bone marrow dysfunction (aplastic anemia), decrease in the number of white blood cells (granulocytopenia), and platelets (thrombocytopenia);
  • dyspnea;
  • nausea (nausea);
  • transient increase in liver transaminase activity (ALT, AST) and bilirubin levels due to abnormal liver function;
  • acute worsening of kidney function, in some cases with decreased urine output or absence of urine (oliguria or anuria), proteinuria, or progression to acute kidney failure; kidney inflammation (acute interstitial nephritis);
  • skin rashes (e.g., morbilliform);
  • widespread blisters on the skin and separation of the upper skin layer (Stevens-Johnson syndrome or toxic epidermal necrolysis);
  • purple to dark red skin rash, partially blistering (persistent erythema);
  • severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS).

  Reporting side effects

  If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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: 22 49 21 301
  Fax: 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 this medicine.

  5. How to store Pyreox

  The medicine should be stored out of sight and reach of children.
  There are no special storage instructions for the medicine.
  Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
  Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

  6. Contents of the pack and other information

  What Pyreox contains

  • The active substance of the medicine is metamizole sodium monohydrate. Each coated tablet contains 500 mg of metamizole sodium monohydrate.
  • The other ingredients are: tablet core: macrogol 4000, magnesium stearate; tablet coating: Opadry 03F280040 White [containing hypromellose (6 mPas), titanium dioxide (E 171), macrogol 8000, talc].

  What Pyreox looks like and contents of the pack

  White to light yellow coated tablets, oblong, biconvex with a score line on one side and smooth on the other.
  Packaging:
  6 or 12 coated tablets (1 or 2 blisters of 6) and 10 or 20 coated tablets (1 or 2 blisters of 10).
  Not all pack sizes may be marketed.

  Marketing authorization holder

  Bausch Health Ireland Limited
  3013 Lake Drive
  Citywest Business Campus
  Dublin 24, D24 PPT3
  Ireland
  Phone: +48 17 865 51 00

  Manufacturer

  ICN Polfa Rzeszów S.A.
  Przemysłowa 2
  35-105 Rzeszów
  Poland

  This medicine is authorized in the Member States of the European Economic Area under the following names:

  Croatia:
  Metamizolnatrij hidrat Bausch Health 500 mg filmom obložene tablete
  Poland:
  Pyreox
  Czech Republic:
  Emitazem 500 mg
  Slovakia:
  Emitazem 500 mg
  Date of last revision of the leaflet:May 2025