Piralgina

Leaflet attached to the packaging: patient information

Pyralgina, 500 mg, tablets

Metamizole sodium
The Pyralgina medicine 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 medicine 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 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 so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. 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 Pyralgina and what is it used for
• 2. Important information before taking Pyralgina
• 3. How to take Pyralgina
• 4. Possible side effects
• 5. How to store Pyralgina
• 6. Contents of the packaging and other information

1. What is Pyralgina and what is it used for

Pyralgina belongs to non-opioid analgesics from the pyrazolone derivative group with analgesic and antipyretic effects.
It also has a spasmolytic effect on smooth muscles.
Pyralgina is indicated for the treatment of:

• pain of various origins with high intensity and fever, when the use of other agents is contraindicated or ineffective.

2. Important information before taking Pyralgina

When not to take Pyralgina:

• if the patient has a history of significantly reduced white blood cell count caused by metamizole or other similar medicines 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, other pyrazolone derivatives, and pyrazolidines (e.g., propyphenazone, phenazone, or phenylbutazone) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has analgetic asthma syndrome or known intolerance to painkillers manifesting as urticaria, angioedema (swelling of the face, lips, and/or throat), i.e., patients who react with bronchospasm or other anaphylactoid reactions to salicylates, paracetamol, or other non-opioid analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, ibuprofen, indomethacin, or naproxen;
• if the patient has acute renal or hepatic failure, acute porphyria;
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase (a rare hereditary disease);
• if the patient is taking a medicine from the pyrazolone and pyrazolidine derivative group (e.g., phenylbutazone, propyphenazone);
• if the patient is in the last three months of pregnancy.

Warnings and precautions

Before starting Pyralgina, you should discuss it with your doctor or pharmacist:

• if the patient has a systolic blood pressure below 100 mmHg or heart disease and circulatory disorders (e.g., heart attack, coronary artery disease, or multiple organ injuries), cerebral vessel constriction, reduced blood volume, as well as in dehydrated patients, as the medicine may cause a decrease in blood pressure;
• if the patient has a high fever;
• if the patient has renal or hepatic impairment;
• if the patient has gastric or duodenal ulcer disease;
• if the patient has bronchial asthma, especially if it is accompanied by nasal and sinus polypous inflammation;
• if the patient has allergic diseases, including atopic, chronic urticaria;
• if the patient has intolerance to certain dyes (e.g., tartrazine) or preservatives (e.g., benzoates);
• in patients with alcohol intolerance manifesting as sneezing, tearing, and severe facial flushing in response to even small amounts of alcohol; this may indicate previously undiagnosed analgetic asthma.

Due to the life-threatening risk, the medicine should be discontinued immediately and medical help sought in case of:

• facial, lip, tongue, and/or throat swelling, which may cause difficulty swallowing or breathing;
• severe bronchospasm,
• skin and mucous membrane changes, such as itching, burning, redness, urticaria;
• anaphylactic shock (life-threatening decrease in blood pressure, weakness, fainting). Patients who have had an allergic reaction or other immunological reaction to metamizole are also at risk of a similar reaction to other pyrazolones and pyrazolidines and other non-opioid analgesics. In patients with allergies, anaphylactic shock may occur. Therefore, during the use of the medicine, special caution is recommended in patients with asthma or atopy (e.g., atopic dermatitis or mucous membrane inflammation, hay fever, allergic asthma). Patients with an increased risk of reactions similar to severe allergic reactions to metamizole should only be given the medicine after careful consideration of the benefit-to-risk ratio. If necessary, it should be administered under close medical supervision, with the possibility of providing emergency care.

The medicine should be discontinued immediately and medical help sought in case of:

• thrombocytopenia, e.g., petechiae on the skin and mucous membranes, ecchymoses, recurrent bleeding from the gums, nose, gastrointestinal tract;
• pancytopenia (significant reduction in the number of all blood cells: red and white blood cells and platelets), e.g., general malaise, fever, signs of infection, ecchymoses, bleeding, pallor;

Abnormally low white blood cell count (agranulocytosis)
Pyralgina may cause agranulocytosis, i.e., a very low number of a certain type of white blood cells 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 ulcers of the mucous membrane, especially in the mouth, nose, and throat or in the genital or anal area.
Your doctor will order a laboratory 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 may develop at any time during Pyralgina treatment and even for a short time after stopping metamizole.
Agranulocytosis may occur even if metamizole was previously taken without complications.
Severe skin reactions
Severe skin reactions have been reported with metamizole, including Stevens-Johnson syndrome: blisters and ulcers on the skin, in the mouth, eyes, and genitals, fever, and joint pain, toxic epidermal necrolysis: large blisters, extensive ulcers on the skin, shedding of large skin patches, and fever, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). If you experience any of these symptoms of severe skin reactions mentioned in section 4, you should stop taking metamizole and seek medical attention immediately.
If you have ever had severe skin reactions while taking metamizole, you should never take Pyralgina or other medicines containing metamizole again (see section 4).
Liver problems
There have been cases of liver inflammation in patients taking metamizole, with symptoms appearing within a few days to a few months after starting treatment.
You should stop taking Pyralgina and contact your doctor if you experience any liver problems, such as: malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or whites of the eyes, itching, rash, or pain in the upper abdomen. Your doctor will check your liver function.
You should not take Pyralgina if you have previously taken medicines containing metamizole and had liver problems.

Pyralgina and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of Pyralgina is contraindicated:

• with medicines from the pyrazolone and pyrazolidine derivative group (phenylbutazone, propyphenazone).

You should inform your doctor about the use of:

• anticoagulant medicines (e.g., warfarin);
• oral antidiabetic medicines;
• phenytoin (an antiepileptic medicine);
• sulfonamides (antibacterial medicines);
• cyclosporine, tacrolimus (immunosuppressive medicines used, among other things, to prevent transplant rejection);
• barbiturates (e.g., phenobarbital - a medicine used, among other things, in epilepsy);
• monoamine oxidase inhibitors (e.g., selegiline, moclobemide - medicines used, among other things, in depression);
• chlorpromazine (a medicine used, among other things, in the treatment of schizophrenia);
• lithium, sertraline (antidepressant medicines);
• bupropion (a medicine used in the treatment of depression or as an aid to smoking cessation);
• medicines that lower blood pressure (e.g., captopril);
• diuretic medicines (e.g., triamterene);
• methotrexate (a medicine used in the treatment of cancer);
• efavirenz (a medicine used in the treatment of HIV infection (AIDS));
• methadone (a medicine used in the treatment of opioid dependence);
• valproate (a medicine used in the treatment of epilepsy or bipolar disorder).

Metamizole may reduce the effect of acetylsalicylic acid on platelets.
Care should be taken when concomitantly administering acetylsalicylic acid used to prevent heart disease.

Pyralgina with food, drink, and alcohol

See section 3. Alcohol may affect the efficacy of the medicine.

Pregnancy, breastfeeding, and fertility

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 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 a doctor or pharmacist, the patient may take single doses of metamizole in the first and second trimester, provided that the benefits and risks associated with taking the medicine are carefully weighed. As a rule, administering metamizole in the first and second trimester is not recommended.
You should not take Pyralgina in 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).
Breastfeeding
Metamizole metabolites pass into breast milk in significant amounts, and the risk to the breastfed infant cannot be excluded. Therefore, you should avoid repeated use of metamizole during breastfeeding.
In the case of single administration of metamizole, mothers should be advised to discard and discard breast milk for 48 hours after administration of the medicine.

Driving and using machines

Within the recommended dosage range, no impairment of concentration and reaction time has been observed. However, when using higher doses, caution should be exercised, and you should refrain from operating machines, driving vehicles, or performing activities that involve risk.

Pyralgina contains sodium

The medicine contains 34.5 mg of sodium (the main component of common salt) per tablet.
This corresponds to 1.7% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Pyralgina

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
The dose depends on the severity of the pain or fever and the individual's response to Pyralgina.
You should always choose the smallest dose necessary to control the pain and/or fever.
Adults and adolescents over 15 years old (with a body weight over 53 kg) can take a maximum of 1000 mg of metamizole in a single dose (2 tablets) no more than 4 times a day at 6-8 hour intervals. The maximum daily dose is 4000 mg (equivalent to 8 tablets).
A noticeable effect can be expected within 30 to 60 minutes after oral administration.
Pyralgina should not be used in children under 15 years old. For younger children, other forms and strengths of this medicine are available; you should ask your doctor or pharmacist about this.
Tablets should be taken with a sufficient amount of liquid (e.g., a glass of water).
The medicine should be taken during or immediately after meals.
The medicine should not be taken for more than 3-5 dayswithout consulting a doctor or seek medical attention immediately if symptoms worsen despite taking the medicine.
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.
Patients with renal or hepatic impairment
Due to reduced elimination in patients with renal or hepatic impairment, you should avoid repeated administration of high doses. In the case of short-term use, dose reduction is not required. There is a lack of experience with long-term use.

Overdose of Pyralgina:

In case of overdose, you should immediately consult a doctor or pharmacist.
During overdose, dizziness, tinnitus, hearing disorders, psychomotor agitation, impaired consciousness, coma, tonic-clonic seizures, or decreased blood pressure, cardiac arrhythmias (tachycardia) may occur. Metamizole overdose may also cause abdominal pain, vomiting, gastric and duodenal ulcers, bleeding, perforation, liver cell damage, interstitial nephritis, and anaphylactic bronchospasm. Cases of rash, urticaria, edema, exfoliative dermatitis, and toxic epidermal necrolysis have been reported.
After taking very high doses, the excretion of rubazonic acid may cause red discoloration of the urine.
There have also been reports of blood morphology disorders, such as bone marrow damage with a decrease in the number of white blood cells (leukopenia or agranulocytosis), platelets (thrombocytopenia), or aplastic anemia.
There is no antidote for metamizole.
In case of overdose, you should immediately consult a doctor. Symptomatic and supportive treatment may be necessary.

4. Possible side effects

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

Due to the life-threatening risk, the medicine should be discontinued immediately and medical help sought if you experience any of the following severe side effects:

• severe allergic reactions (anaphylactic):
• rarely occurring facial, lip, tongue, and/or throat swelling, which may cause difficulty swallowing or breathing;
• very rarely occurring severe bronchospasm;
• skin and mucous membrane changes, such as itching, burning, redness, urticaria;
• anaphylactic shock (life-threatening decrease in blood pressure, weakness, fainting) - frequency not known;
• severe skin reactions:
• 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 serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

You should stop taking the medicine and consult your doctor immediately if you experience any of the following severe side effects:

• pancytopenia (significant reduction in the number of all blood cells: red and white blood cells and platelets), manifesting as general malaise, fever, signs of infection, ecchymoses, bleeding, pallor;
• agranulocytosis (total or almost total disappearance of granulocytes from the blood), including cases of death, manifesting as:
• fever, chills;
• sore throat, difficulty swallowing, and inflammation of the mucous membrane of the mouth, nose, throat, genitals, and anus;
• elevated erythrocyte sedimentation rate;
• not always normal hemoglobin, erythrocyte, and platelet values, although they are usually within normal limits;
• slightly enlarged lymph nodes and spleen, although they are usually unchanged (see also section 2 "Warnings and precautions");
• malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale 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".

Other side effects:

You should consult your doctor if you experience any of the following side effects:
Uncommon (less than 1 in 100 patients) side effects include:

• drug rash (transient rash of various types: papular, macular, pustular, erythematous);
• excessive decrease in blood pressure.

Rare (less than 1 in 1,000 patients) side effects include:

• maculopapular skin changes;
• leukopenia (decrease in white blood cell count).

Very rare (less than 1 in 10,000 patients) side effects include:

• analgetic asthma (see "When not to take Pyralgina" in section 2), asthma attacks;
• agranulocytosis (total or almost total disappearance of granulocytes from the blood), including cases of death (see above "You should stop taking the medicine and consult your doctor immediately if you experience any of the following severe side effects");
• thrombocytopenia (petechiae, bleeding);
• sudden worsening of renal function with proteinuria, oliguria, or anuria;
• acute renal failure;
• interstitial nephritis.

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

• nausea, vomiting, abdominal pain, gastric irritation, diarrhea, dry mouth;
• liver damage;
• hepatitis, jaundice, increased liver enzyme activity in the blood;
• headache, dizziness;
• hemolytic anemia, aplastic anemia, bone marrow damage, sometimes fatal. In patients with glucose-6-phosphate dehydrogenase deficiency, the medicine causes hemolysis of red blood cells;
• red discoloration of the urine (after administration of very high doses of metamizole).

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 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 medicine.

5. How to store Pyralgina

The medicine should be stored out of sight and reach of children.
Store in the original packaging.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date stated on the packaging refers to the last day of the given month.
The inscription on the blister after the abbreviation EXP means the expiry date, and after the abbreviation LOT means the batch number.
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 packaging and other information

What Pyralgina contains

• The active substance of the medicine is metamizole sodium monohydrate. Each tablet contains 500 mg of metamizole sodium monohydrate.
• The other ingredients are: potato starch, gelatin, magnesium stearate.

What Pyralgina looks like and contents of the packaging

White or almost white tablets, oblong, biconvex.
The packaging contains 2, 6, 12, 18, 20, 24, or 50 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01
Date of last revision of the leaflet:April 2025