Piralgin

Leaflet accompanying the packaging: patient information

Pyralgin, 0.5 g/ml, solution for injection

Metamizole sodium
The Pyralgin medicine may cause a seriously 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, 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 in the future (see section 2).

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

• You should keep this leaflet so that you can read it again if necessary.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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. Contents of the packaging and other information

1. What is Pyralgin and what is it used for

Pyralgin contains metamizole, which is a pyrazolone derivative with analgesic, antipyretic, and spasmolytic effects.
Indications for use:
Pain of various origins with high intensity.
Fever, when other treatment methods are ineffective.
Pyralgin in the form of a solution for injection should only be used when oral administration is not indicated.

2. Important information before taking Pyralgin

When not to use Pyralgin:

• if the patient has a history of significantly reduced white blood cell count (granulocytopenia) 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, manifested by urticaria, angioedema (swelling of the face, lips, and/or tongue), or 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 group of pyrazolone and pyrazolidine derivatives (e.g., phenylbutazone, propyphenazone);
• if the patient has low blood pressure and circulatory disorders;
• if the patient is in the last three months of pregnancy.

Warnings and precautions

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

• if you have a history of low blood pressure, heart disease, and circulatory disorders (e.g., heart attack, coronary artery disease, or multiple organ injuries), cerebral vessel constriction, reduced blood volume, and dehydration, as the medicine may cause a decrease in blood pressure;
• if you have a high fever;
• if you have renal or hepatic impairment;
• if you have stomach or duodenal ulcers;
• if you have bronchial asthma, especially if it is accompanied by polyposis of the nasal mucosa and sinuses;
• if you have allergic diseases, including atopic diseases, chronic urticaria;
• if you have intolerance to certain dyes (e.g., tartrazine) or preservatives (e.g., benzoates);
• if you have alcohol intolerance, manifested by 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 should be sought if the patient experiences any of the following symptoms of an allergic reaction (anaphylaxis), such as:

• swelling of the face, lips, tongue, and/or throat, 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) - frequency not known;

Metamizole may reduce the effect of acetylsalicylic acid on platelets.
You should exercise caution when taking acetylsalicylic acid for the prevention of heart disease.

Pyralgin 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.
The use of Pyralgin is contraindicated:

• with medicines from the group of pyrazolone and pyrazolidine derivatives (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).

Pyralgin and alcohol

You should not drink alcohol while taking 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 3 months of pregnancy are limited, but they 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 pregnant woman may take a single dose 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, 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, which normally closes after birth).
Breastfeeding
Metamizole metabolites pass into breast milk in significant amounts, and the risk to the breastfed child cannot be excluded. Therefore, you should avoid repeated use of metamizole during breastfeeding.
In the case of a single dose of metamizole, you should recommend that mothers discard and dispose of breast milk for 48 hours after taking the medicine.
Fertility
There is no data on the effect of metamizole on fertility.

Driving and using machines

Within the recommended dose range, the medicine does not affect the ability to drive and use machines.
In the case of doses higher than recommended, especially in combination with alcohol, you should not drive or operate machines, as your reaction and concentration abilities may be impaired.

Pyralgin contains sodium

The medicine contains 34.5 mg of sodium in 1 ml. This corresponds to 1.7% of the maximum recommended daily intake of sodium in the diet for adults.
The medicine can be mixed with the following solutions: 5% glucose solution, 0.9% sodium chloride solution, Ringer's solution. The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the medicine. To obtain accurate information about the sodium content in the solution used to dilute the medicine, you should consult the leaflet of the diluent used.

3. How to take Pyralgin

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult your doctor.
Detailed dosage and administration instructions are provided at the end of the leaflet, in the section "Information intended exclusively for healthcare professionals".

Using a higher dose of Pyralgin than recommended

If you suspect that you have taken too much Pyralgin, you should tell your doctor as soon as possible.
In the case of an overdose, the following symptoms may occur: dizziness, ringing in the ears, hearing disorders, psychomotor agitation, impaired consciousness, coma, tonic-clonic seizures, or decreased blood pressure, cardiac arrhythmias (tachycardia). Overdose of metamizole may also cause abdominal pain, vomiting, ulcers in the mucous membrane of the stomach and duodenum, bleeding, perforation, liver cell damage, interstitial nephritis, and anaphylactic bronchospasm. Cases of rash, urticaria, angioedema, exfoliative dermatitis, and toxic epidermal necrolysis (Lyell's syndrome) have been reported. After taking very high doses, the excretion of rubazonic acid may cause red discoloration of the urine.
There is no antidote for metamizole.
In the case of an overdose, you should immediately consult a doctor. Symptomatic and supportive treatment may be necessary.

4. Possible side effects

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

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

• severe allergic reactions (anaphylaxis):
• rarely occurring swelling of the face, lips, tongue, and/or throat, 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 discontinue the medicine and consult a 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), manifested by general malaise, fever, signs of infection, bruising, bleeding, pallor;
• agranulocytosis (complete or almost complete disappearance of granulocytes from the blood), including fatal cases, manifested by:
• fever, chills;
• sore throat, difficulty swallowing, and inflammation of the mucous membrane of the mouth, nose, throat, genitals, and anus;
• increased OB;
• not always normal hemoglobin, erythrocyte, and platelet values, although they are usually normal;
• 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, 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".

Other side effects:

You should consult your doctor if you experience any of the following side effects:

• drug rash (transient rash of various types: papular, macular, pustular, erythematous);
• excessive decrease in blood pressure (rapid intravenous injection increases the risk of hypotension).

Rarely (less than 1 in 1,000 patients) the following side effects may occur:

• skin changes with papules;
• leukopenia (reduced white blood cell count).

Very rarely (less than 1 in 10,000 patients) the following side effects may occur:

• analgetic asthma (see "When not to use Pyralgin" in section 2), asthma attacks;
• agranulocytosis (complete or almost complete disappearance of granulocytes from the blood), including fatal cases (see above "You should discontinue the medicine and consult a doctor immediately if you experience any of the following severe side effects");
• thrombocytopenia (bruising, bleeding);
• sudden worsening of kidney 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, stomach upset, 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 taking very high doses of metamizole);
• after intramuscular injection, pain at the injection site and local reactions may occur, and in very rare cases, phlebitis.

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 the medicine.

5. How to store Pyralgin

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date stated on the packaging is the last day of the stated month.
The inscription on the packaging after the abbreviation "EXP" indicates the expiry date, and after the abbreviation "Lot" indicates 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 Pyralgin contains

• The active substance of the medicine is metamizole sodium. Each 1 ml of the solution for injection contains 0.5 g of metamizole (in the form of metamizole sodium monohydrate). Each 2 ml ampoule contains 1 g of metamizole sodium (in the form of metamizole sodium monohydrate). Each 5 ml ampoule contains 2.5 g of metamizole sodium (in the form of metamizole sodium monohydrate).
• The other ingredient is water for injection.

What Pyralgin looks like and contents of the packaging

The immediate packaging of the solution for injection Pyralgin is colorless glass ampoules with a capacity of 2 ml and 5 ml. The medicine is packaged in a cardboard box containing 5 ampoules and a leaflet.

Marketing authorization holder and manufacturer

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

Date of the last update of the leaflet: ---------------------------------------------------------------------------------------------------------------------------

Information intended exclusively for healthcare professionals:

The dose is determined by the severity of the pain or fever and the individual response to Pyralgin. The choice of the smallest dose that allows pain and/or fever control is crucial.
In children and adolescents up to 14 years of age, metamizole can be administered in a single dose of 8-16 mg per kilogram of body weight. In the case of fever in children, a dose of metamizole of 10 mg per kilogram of body weight is usually sufficient. Adults and adolescents over 15 years of age (>53 kg) can be given a maximum of 1,000 mg in a single dose.
Depending on the maximum daily dose, a single dose can be taken no more than 4 times a day at intervals of 6-8 hours.
A noticeable effect can be expected within 30 minutes of parenteral administration.
To minimize the risk of hypotensive reactions, intravenous injections must be administered very slowly.
The medicine can be diluted:

• 5% glucose solution,
• 0.9% sodium chloride solution
• Ringer's solution. Since the stability of such mixtures is limited, they should be administered immediately after preparation. After dilution, a change and/or deepening of the color towards yellow may occur, without changing the properties of the medicine. Metamizole should not be mixed with other medicines, except for injection solutions containing tramadol 50 mg/ml.

Mixing with tramadol
It has been shown that Pyralgin, 0.5 g/ml, solution for injection can be mixed with injection solutions containing tramadol 50 mg/ml (composition: tramadol hydrochloride, sodium acetate trihydrate, water for injection).
The mixture of tramadol and metamizole is administered in a prepared ratio of 1:10, after dilution in the above-mentioned solutions, e.g., 2 ml of the medicine containing tramadol 50 mg/ml (100 mg of tramadol hydrochloride) and 2 ml of Pyralgin (1,000 mg of metamizole sodium) diluted in 20 ml of 0.9% sodium chloride solution or Ringer's solution, or 5% glucose solution.
The prepared mixture of metamizole and tramadol may have a yellowish color.
For microbiological reasons, the prepared mixture should be used immediately. If the mixture is not used immediately, the user is responsible for the storage time and conditions before use.
Shelf life after first opening
Pyralgin should be used immediately after opening.
Shelf life after dilution
Pyralgin should be used immediately after dilution.
Duration of treatment
The duration of treatment depends on the type and severity of the disease.