Piralgin

Leaflet attached to the packaging: patient information

Pyralgin, 500 mg/ml, oral drops, solution

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

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

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Pyralgin and what is it used for
• 2. Important information before taking Pyralgin
• 3. How to take Pyralgin
• 4. Possible side effects
• 5. How to store Pyralgin
• 6. Package contents and other information

1. What is Pyralgin and what is it used for

Pyralgin contains the active substance metamizole sodium monohydrate and is a pain reliever and antipyretic belonging to the group of pyrazolones.
Pyralgin is indicated in adults and children for:
severe pain after injuries or operations;
colic abdominal pain;
cancer pain;
other severe acute or chronic pain when the use of other medications is contraindicated;
high fever that does not respond to other agents.

2. Important information before taking Pyralgin

When not to take Pyralgin:

• 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 drugs called pyrazolones or pyrazolidines;
• if the patient has bone marrow disorders or a disease that affects the production or function of blood cells,
• if the patient is allergic to metamizole or other pyrazolones (e.g., phenazone, propyphenazone) or pyrazolidines (e.g., phenylbutazone, oxyphenbutazone), or any of the other ingredients of this drug (listed in section 6),

if the patient has a known intolerance to painkillers (aspirin asthma syndrome or intolerance to painkillers manifested by urticaria and/or angioedema). This applies to patients who, after exposure to painkillers such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, or naproxen, experience bronchospasm (sudden narrowing of the lower airways) or other symptoms of hypersensitivity, such as itching, runny nose, and swelling (urticaria, rhinitis, angioedema).

• if the patient has a genetically determined deficiency of glucose-6-phosphate dehydrogenase (a congenital defect associated with the risk of red blood cell breakdown),
• if the patient has acute hepatic porphyria (a hereditary disease associated with disturbances in hemoglobin synthesis),
• if the patient is in the last three months of pregnancy.

Warnings and precautions

Before starting treatment with Pyralgin, you should discuss it with your doctor or pharmacist.
Pyralgin contains a pyrazolone derivative, metamizole, the use of which is associated with a life-threatening risk of:

• sudden cardiac arrest;
• agranulocytosis.

Agranulocytosis
Pyralgin may cause agranulocytosis, a very low 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 takingmetamizole and immediately contact your doctorif you experience any of the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful ulcers of the mucous membrane, especially in the mouth, nose, and throat, or in the genital or anal area.
Your doctor will order a blood test to check the patient's blood 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 treatment with Pyralgin, and even for a short time after stopping metamizole.
Agranulocytosis can occur even if metamizole was previously administered without complications.
Pyralgin should be discontinued immediately and medical help soughtif symptoms of pancytopenia (such as general malaise, signs of infection, persistent fever, bruising, bleeding, and pallor) or thrombocytopenia (such as increased bleeding tendency and small red spots on the skin and mucous membranes due to bleeding) occur (see section 4).

Your doctor may regularly check your blood count and may stop treatment if certain changes occur.
Patients who have had hypersensitivity reactions (anaphylactic reactions) to Pyralgin are also at risk of a similar reaction to other painkillers.
Patients who have had an allergic reaction or other immunological reaction to Pyralgin are also at risk of a similar reaction to other pyrazolones and pyrazolidines (chemically similar substances), such as painkillers: phenazone, propyphenazone, phenylbutazone, and oxyphenbutazone.
If a patient has had an allergic reaction or other immunological reaction to other pyrazolones, pyrazolidines, or other painkillers, there is also a high risk of a reaction to Pyralgin in the same way.
Severe hypersensitivity reactions
If a patient has any of the following disorders or intolerances, the risk of severe hypersensitivity reactions to Pyralgin may be significantly increased:

• allergy to painkillers and anti-rheumatic drugs, with symptoms such as itching and swelling (urticaria, angioedema). In such cases, Pyralgin should not be used. For more information, see section 2. "When not to take Pyralgin";
• asthmatic attacks caused by bronchial constriction (asthma), especially if accompanied by nasal and sinus inflammation (sinusitis) and nasal polyps;
• chronic urticaria;
• hypersensitivity to dyes (e.g., tartrazine) or preservatives (e.g., benzoates);
• alcohol intolerance, manifested by sneezing, tearing, and severe flushing of the face in response to even small amounts of alcohol; this may indicate previously undiagnosed intolerance to painkillers (see section 2. "When not to take Pyralgin").

In patients with an increased risk of hypersensitivity reactions, Pyralgin should only be administered after careful consideration of the benefit-risk ratio (see also section 2. "When not to take Pyralgin").
If Pyralgin is administered in such cases, the patient must be under close medical supervision, with easy access to rescue equipment.
Patient with allergy may experience anaphylactic reaction (see section 4. "Possible side effects"). Therefore, patients with asthma or showing a tendency to hypersensitivity (atopy) should be particularly cautious.
Severe skin reactions
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS syndrome), have been reported with metamizole treatment. If a patient experiences any of these severe skin reactions, they should stop taking metamizole and seek medical attention immediately.
If a patient has ever experienced severe skin reactions during metamizole treatment, they should never take Pyralgin or other metamizole-containing drugs again (see section 4. "Possible side effects").
Liver disorders
There have been cases of liver inflammation in patients taking metamizole, with symptoms appearing within a few days to several months after starting treatment.
You should stop taking Pyralgin and contact your doctor if you experience any liver disorders, such as: malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, light-colored stools, yellowing of the skin or whites of the eyes, itching, rash, or pain in the upper abdomen. Your doctor will check the patient's liver function.
A patient should not take Pyralgin if they have previously taken metamizole-containing drugs and had liver disorders.
Low blood pressure
During treatment with Pyralgin, a decrease in blood pressure may occur (see section 4. "Possible side effects"). The risk of such reactions is increased:

• if the patient has low blood pressure (pre-existing hypotension), severe dehydration, or poor blood circulation, or in the early stages of circulatory failure (e.g., after a heart attack or severe injuries),
• if the patient has a high fever.

Therefore, to minimize the risk of any drop in blood pressure, your doctor will consider and closely monitor the use of preventive measures (correction of circulatory disorders).
In patients who must avoid a decrease in blood pressure (e.g., in severe coronary heart disease or significant cerebral vessel narrowing), Pyralgin may only be used under close circulatory monitoring.
Patient with kidney or liver disorders
In cases of kidney or liver disorders, Pyralgin should only be used after careful consideration of the benefit-risk ratio and with appropriate precautions (see section 3, subsection "Patients with kidney or liver disorders").

Pyralgin and other drugs

You should tell your doctor about all the drugs you are currently taking or have recently taken, as well as any drugs you plan to take.
You should inform your doctor about taking any of the following drugs, as they may decrease the level of Pyralgin in the blood and reduce its effectiveness:

• bupropion (a drug used to treat depression or to help quit smoking),
• efavirenz (a drug used to treat HIV infection (AIDS)),
• methadone (a drug used to treat opioid addiction),
• valproate (a drug used to treat epilepsy or bipolar disorder),
• cyclosporine (a drug used to weaken the immune system),
• tacrolimus (a drug used to prevent organ rejection in patients after transplantation),
• sertraline (a drug used to treat depression). Your doctor should monitor the effectiveness and/or blood level of the drug.

You should inform your doctor about taking any of the following drugs, which may interact with Pyralgin:

• methotrexate (a drug used to treat cancer or rheumatic diseases). Concomitant use may increase the potential risk of blood cell damage by methotrexate, especially in elderly patients. Therefore, concomitant use of these two drugs should be avoided.
• acetylsalicylic acid, used in small doses to prevent heart disease. Concomitant use may reduce the effect of acetylsalicylic acid on platelets.
• chlorpromazine (a drug used to treat mental illnesses). Concomitant use may cause a significant drop in body temperature.

With regard to pyrazolone derivatives, to which Pyralgin belongs, interactions may occur with:

• blood thinners (oral anticoagulants),
• captopril (a drug used to lower high blood pressure and in certain heart diseases),
• lithium (a drug used to treat mental illnesses),
• diuretics (e.g., triamterene),
• drugs used to lower high blood pressure (antihypertensive drugs). The potential impact of Pyralgin on these interactions is unknown.

Effect on laboratory tests
Before performing laboratory tests, you should inform your doctor about taking Pyralgin, as metamizole may affect the results of some tests (e.g., determination of creatinine, lipids, HDL cholesterol, or uric acid levels).

Pyralgin and alcohol

If possible, you should not drink alcohol while taking Pyralgin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this drug.
Pregnancy
Available data on the use of metamizole during the first 3 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 a doctor or pharmacist, a woman may take a single dose of metamizole in the first and second trimester, provided that the benefits and risks associated with taking the drug are carefully weighed. As a rule, the administration of metamizole in the first and second trimester is not recommended.
You should not take Pyralgin during the last three months of pregnancy due to the increased risk of complications in the mother and child (bleeding, premature closure of the ductus arteriosus, a vital blood vessel in the fetus that normally closes after birth).

Driving and using machines

Within the recommended dosage range, Pyralgin does not affect or has a negligible effect on the ability to drive and use machines. However, as a precaution, especially when taking higher doses, particularly in combination with alcohol, you should consider the possibility of impaired ability and refrain from operating machinery, driving vehicles, or performing activities that involve risk.

Pyralgin contains sodium

The drug contains 1.67 mg of sodium (the main component of table salt) per ml (20 drops). This corresponds to 0.084% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Pyralgin

This drug should always be taken as directed by your doctor. If you have any doubts, you should consult your doctor. This will help you get the best results from the treatment and reduce the risk of side effects.
The dose depends on the severity of the pain or fever and the individual's response to Pyralgin.
You should always choose the smallest dose necessary to control the pain and/or fever. Your attending doctor will tell you how to take Pyralgin.
The following table shows the recommended single doses and maximum daily doses depending on body weight or age:

Single doses can be administered no more than four times a day, depending on the maximum daily dose.
A noticeable effect can be expected within 30 to 60 minutes after oral administration.
Use in children and adolescents
In the treatment of pain in children and adolescents up to 14 years of age, Pyralgin can be administered in a single dose of 8 to 16 mg per kilogram of body weight (see table above).
In the case of fever in children, a dose of Pyralgin usually sufficient is 10 mg per kilogram of body weight:

Elderly patients and patients in poor general health or with renal impairment
In elderly patients, weakened patients, and patients with impaired renal function, the dose should be reduced due to the possibility of prolonged elimination of metamizole metabolites.
Patient with kidney or liver disorders
Due to the reduced elimination rate in patients with kidney or liver disorders, large doses should be avoided. In the case of short-term use, dose reduction is not required. There is a lack of experience with long-term use.
Method of administration
Oral administration.
It is recommended to take the drops with water (about half a glass of water).
To open the bottle, you should press the cap down and turn it in the direction indicated by the arrow.
After use, the bottle should be tightly closed by screwing the cap to protect it from children.
The bottle should be held upright, and if necessary, you can gently tap the bottom of the bottle to release the drops.
Duration of treatment
The duration of treatment depends on the type and severity of the symptoms and is determined by the doctor.
If the doctor (or dentist) does not recommend otherwise, the drug should not be used for more than 3-5 days.

Using a higher dose of Pyralgin than recommended

In case of overdose, you should immediately consult a doctor. It may be necessary to take appropriate measures.
Symptoms of overdose:

• nausea,
• vomiting,
• abdominal pain,
• kidney function disorders, and even acute kidney failure (e.g., with symptoms of interstitial nephritis),
• dizziness,
• drowsiness,
• disorders of consciousness,
• seizures,
• decreased blood pressure, up to circulatory shock (shock),
• heart rhythm disorders (tachycardia).

Note: After taking very large doses, the excretion of a harmless metabolite (rubazonic acid) may cause red discoloration of the urine.

Missing a dose of Pyralgin

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

4. Possible side effects

Like all drugs, Pyralgin can cause side effects, although not everybody gets them.

You should stop taking the drug and consult your doctor if you experience any of the following side effects; they may have serious consequences.

If any of these side effects occur suddenly or worsen rapidly, you should immediately inform your doctor, as some reactions to the drug (e.g., severe hypersensitivity reactions, agranulocytosis, pancytopenia) can be life-threatening.
In such cases, you should not take Pyralgin without medical supervision. Immediate discontinuation of treatment is crucial for recovery.
If symptoms of agranulocytosis, pancytopenia, or thrombocytopenia occur (see below), you should stop taking Pyralgin immediately, and your doctor will order a blood count test (including a blood smear). You should not wait for the laboratory test results to discontinue treatment.

You should stop taking Pyralgin and seek medical attention immediately if you experience any of the following symptoms:

• malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, light-colored stools, yellowing of the skin or whites of the eyes, itching, rash, or pain in the upper abdomen. These may be symptoms of liver damage. See also section 2 "Warnings and precautions".

Severe skin reactions

You should stop taking metamizole and seek medical attention immediately if you experience any of the following severe side effects:

• red, flat patches on the torso in a target shape or round, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other side effects

Uncommon side effects (occurring in less than 1 in 100 people)

• purple to dark red skin rash, sometimes with blisters (drug rash),
• excessive decrease in blood pressure (isolated hypotensive reaction), probably caused by the direct action of the drug and not accompanied by other symptoms of hypersensitivity.

This reaction causes a significant drop in blood pressure only in rare cases. The risk of decreased blood pressure may be increased in patients with very high fever (hyperpyrexia).
Typical symptoms of severe decreased blood pressure include: increased heart rate, pallor, trembling, dizziness, nausea, and loss of consciousness.

Rare (occurring in less than 1 in 1,000 people)

• allergic reactions (anaphylactoid or anaphylactic reactions). Typical symptoms of mild reactions may include: burning eyes, cough, nasal symptoms, nasal congestion, chest pain, flushing of the skin (especially the face and head), urticaria, and facial swelling, and - rarely - nausea and abdominal cramps. The most important symptoms are a feeling of heat on and under the tongue and, especially, on the palms and soles. Such mild reactions can progress to more severe forms, with generalized urticaria, severe angioedema (also in the larynx), severe bronchospasm (constrictive narrowing of the lower airways), increased heart rate (sometimes decreased), arrhythmias, decreased blood pressure (sometimes preceded by an increase), loss of consciousness, and circulatory shock. These reactions can occur even if the drug was previously taken without complications and can be life-threatening, sometimes leading to death. In patients with aspirin asthma syndrome, allergic reactions are manifested by asthma attacks (see section 2. "When not to take Pyralgin");
• decrease in the number of white blood cells (leukopenia),
• skin rash (e.g., maculopapular rash).

Very rare (occurring in less than 1 in 10,000 people)

significant decrease in the number of certain white blood cells (agranulocytosis), including cases with a fatal outcome (see section 2 "Warnings and precautions"), or decrease in the number of platelets (thrombocytopenia). These reactions are probably immunological. They can also occur when metamizole was previously administered without complications. Symptoms of agranulocytosis: fever, chills, sore throat, and difficulty swallowing, as well as inflammatory conditions of the mouth, nose, throat, and genital or anal area. However, in patients taking antibiotics (drugs used to treat bacterial infections), these symptoms may be less severe. The erythrocyte sedimentation rate is significantly increased, while the lymph nodes are only slightly or not at all enlarged.
Symptoms of thrombocytopenia include increased bleeding tendency and petechiae (small red spots on the skin and mucous membranes due to bleeding).

• asthma attacks (shortness of breath caused by bronchial constriction),
• formation of large blisters and skin changes (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• worsening of kidney function, in some cases with reduced or absent urine output (oliguria or anuria), proteinuria, or acute kidney failure; kidney inflammation (acute interstitial nephritis).

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

• anaphylactic shock,
• myocardial infarction in the course of an allergic reaction (Kounis syndrome),
• decrease in blood volume with accompanying bone marrow dysfunction (aplastic anemia), decrease in the number of white and red blood cells and platelets (pancytopenia), including cases with a fatal outcome. Symptoms of pancytopenia and aplastic anemia include: general malaise, signs of infection, persistent fever, bruising, bleeding, and pallor of the skin.
• reports of gastrointestinal bleeding,
• liver inflammation, yellowing of the skin and whites of the eyes, increased liver enzyme activity in the blood,
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Excretion of a harmless metabolite (rubazonic acid) may cause red discoloration of the urine.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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 this drug.

5. How to store Pyralgin

The drug should be stored out of sight and reach of children.
Do not use this drug after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Do not store in the refrigerator or freeze.
After opening the bottle, do not use for more than 6 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Pyralgin contains

• The active substance of Pyralgin is metamizole sodium monohydrate. Each ml (20 drops) contains 500 mg of metamizole sodium monohydrate. 1 drop contains 25 mg of metamizole sodium monohydrate.
• The other ingredients are: sodium dihydrogen phosphate dihydrate, disodium phosphate, sucralose, sodium saccharin, raspberry flavor (natural flavorings and flavor enhancers, flavorings and flavor enhancers, flavor preparations; 1,2-propylene glycol (E 1520), glycerol triacetate (E 1518), maltol), purified water.

Pyralgin, oral drops, solution is a clear, yellow solution with a raspberry flavor, in a bottle with a dropper (with a child-resistant closure), in a cardboard box.
Pyralgin is available in 10 ml, 20 ml, 50 ml, and 100 ml packages.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

SOFARIMEX Indústria Química e Farmacêutica, S.A.
Avenida das Indústrias, Alto do Colaride, Agualva
2735–213 Cacém
Portugal
Date of last revision of the leaflet:February 2025