Piralgina Max

Leaflet accompanying the packaging: patient information

Pyralgina MAX, 1000 mg, coated tablets

Metamizole sodium monohydrate
The Pyralgina MAX 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 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.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• 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 or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Pyralgina MAX and what is it used for

Pyralgina MAX contains the active substance metamizole sodium monohydrate, which belongs to a group of medicines called pyrazolone derivatives, with analgesic and antipyretic effects.
Pyralgina MAX is indicated for use in adolescents from 15 years of age and adults for the treatment of:
severe pain after injuries or operations;
spasmodic abdominal pain (colic);
cancer pain;

• other severe acute or chronic pain, when the use of other medicines is contraindicated; high fever that does not respond to other medicines.

2. Important information before taking Pyralgina MAX

When not to take Pyralgina MAX

• 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 or other pyrazolone derivatives (e.g. phenazone, propyphenazone) or pyrazolidine derivatives (e.g. phenylbutazone, oxyphenbutazone);
• if the patient is allergic to any of the other ingredients of this medicine (listed in section 6);
• if the patient has intolerance to painkillers (aspirin asthma syndrome or urticaria and/or angioedema). This applies to patients who experience bronchospasm (sudden narrowing of the airways) or other hypersensitivity reactions, such as itching, runny nose, and swelling (urticaria, rhinitis, angioedema) after taking painkillers, such as salicylates and paracetamol or diclofenac, ibuprofen, indomethacin, naproxen;
• if the patient has ever had an allergic reaction to metamizole, such as severe skin reactions (see section 4. "Possible side effects");
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase (a hereditary disease associated with the risk of red blood cell breakdown);
• if the patient has acute intermittent porphyria (a hereditary disease associated with hemoglobin production disorders);
• during the last three months of pregnancy.

Warnings and precautions

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

• sudden collapse (cardiac arrest);
• agranulocytosis.

A low number of white blood cells (agranulocytosis)
Pyralgina MAX 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 mouth ulcers, especially in the mouth, nose, and throat or in the genital and anal areas.
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 can develop at any time during treatment with Pyralgina MAX, and even for a short time after stopping metamizole.
Agranulocytosis can occur even if metamizole was previously administered without complications.
You should stop taking Pyralgina MAX immediately and consult a doctorif you experience 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) (see section 4. "Possible side effects"). Your doctor will order a blood morphology test and may discontinue treatment if certain changes occur.

• 4. "Possible side effects").

Severe hypersensitivity reactions

• Patient with hypersensitivity reactions (anaphylactic reactions) to Pyralgina MAX are also particularly at risk of experiencing similar reactions to other painkillers.
• Patient with allergic reactions or other immunological reactions (e.g. agranulocytosis) to Pyralgina MAX are also particularly at risk of experiencing similar reactions to other pyrazolones and pyrazolidines (chemically similar substances) (painkillers, such as phenazone, propyphenazone, phenylbutazone, oxyphenbutazone).

The risk of severe hypersensitivity reactions to Pyralgina MAX may be significantly increased if the patient has any of the following disorders and/or intolerances:

• allergy to non-steroidal anti-inflammatory drugs (used to treat pain and rheumatism), with symptoms such as itching and swelling (urticaria, angioedema). In such cases, the use of Pyralgina MAX is contraindicated (see section 2 "When not to take Pyralgina MAX");
• asthma attacks caused by bronchial constriction (asthma), especially if there is also 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 even with small amounts of alcohol; this may indicate previously undiagnosed intolerance to painkillers (see section 2. "When not to take Pyralgina MAX").

In patients with an increased risk of hypersensitivity reactions, Pyralgina MAX may only be used after careful consideration of the benefit-risk ratio.
If Pyralgina MAX is administered in such cases, the patient must be under close medical supervision, with easy access to rescue equipment.
In particularly sensitive patients, anaphylactic reactions may occur. Therefore, patients with asthma or a tendency to hypersensitivity (atopy) should be particularly cautious.

Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), have been reported in association with metamizole treatment.
If the patient experiences any of these symptoms of severe skin reactions listed in section 4, they should stop taking metamizole and seek medical attention immediately.
If the patient has ever experienced severe skin reactions during metamizole treatment, they should never take Pyralgina MAX again (see section 4).

Decreased blood pressure (hypotensive reaction)

During treatment with Pyralgina MAX, a decrease in blood pressure (hypotensive reactions, see section 4. "Possible side effects") may occur.
This risk 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. The doctor will carefully consider the use of the medicine and closely monitor the patient's condition. If necessary, preventive measures (correction of circulatory disorders) can be taken to reduce the risk of potential blood pressure drop.

In patients in whom a decrease in blood pressure must be avoided at all costs (e.g. in severe coronary heart disease or significant stenosis of blood vessels supplying blood to the brain), Pyralgina MAX may only be used under close monitoring of circulatory parameters.

Liver disorders

In patients taking metamizole, cases of liver inflammation have been reported, with symptoms appearing within a few days to several months after starting treatment.
You should stop taking Pyralgina MAX and contact your doctor if you experience any liver disorders, 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.

Patient with kidney or liver disorders

In cases of kidney or liver disorders, Pyralgina MAX 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").

Children and adolescents

Do not use this medicine in children and adolescents under 15 years of age.

Pyralgina MAX 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.
You should inform your doctor about the use of:

• methotrexate (a medicine used to treat cancer or certain rheumatic diseases). Concomitant use of metamizole and methotrexate may increase the potential risk of blood cell damage by methotrexate, especially in elderly patients. Concomitant use of these two medicines should be avoided.
• chlorpromazine (a medicine used to treat symptoms of mental illnesses). Taking Pyralgina MAX with chlorpromazine may cause excessive lowering of body temperature.
• cyclosporin (a medicine used to weaken the immune system);
• acetylsalicylic acid. Metamizole may reduce the effect of acetylsalicylic acid on blood platelets. Caution is advised when using Pyralgina MAX and acetylsalicylic acid in low doses and used to prevent heart disease.
• bupropion (a medicine used to treat depression or to help quit smoking);
• efavirenz (a medicine used to treat HIV infection (AIDS));
• methadone (a medicine used to treat opioid dependence);
• valproate (a medicine used to treat epilepsy or bipolar disorder);
• tacrolimus (a medicine used to prevent organ rejection in patients who have undergone a transplant);
• sertraline (an antidepressant).

Active substances from the pyrazolone group (to which metamizole also belongs) may interact with:

• medicines that prevent blood clotting (oral anticoagulants);
• medicines used to lower high blood pressure and in some heart diseases (captopril);
• medicines used to treat mental illnesses (lithium);
• diuretics (e.g. triamterene),
• medicines used to lower high blood pressure (medicines used to treat hypertension).

Effect on laboratory test results

Before performing any laboratory tests, you should tell your doctor that you are taking Pyralgina MAX, as metamizole may affect the results of some tests (such as creatinine, triglycerides, HDL cholesterol, or uric acid levels in the blood).

Pyralgina MAX and alcohol

Do not drink alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 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, the patient may take a single dose of metamizole in the first and second trimester, provided that the benefit-risk ratio is carefully considered. As a rule, the administration of metamizole in the first and second trimester is not recommended.
Do not take Pyralgina MAX 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 in the unborn child, which normally closes only after birth).

Breastfeeding

Metamizole metabolites pass into breast milk in significant amounts, and the risk to the breastfed child cannot be ruled out. Therefore, metamizole should be avoided during breastfeeding, especially if repeated administration is necessary. If a single dose of metamizole is administered, mothers should be advised to express and discard breast milk for 48 hours after taking the medicine.

Driving and using machines

Within the recommended dose range, no adverse effects are known to affect concentration and reaction. However, as a precaution, you should consider the possibility of such adverse effects - especially when using higher doses - and refrain from operating machinery, driving vehicles, or performing activities that involve risk.
This applies particularly to individuals who consume alcohol.

Pyralgina MAX contains sodium

The medicine contains 71.3 mg of sodium (the main component of common salt) per tablet.
This corresponds to 3.56% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Pyralgina MAX

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The dose depends on the severity of the pain or fever and the individual's response to the medicine.
You should always choose the smallest dose necessary to control the pain and/or fever.
Your doctor will inform you how to take Pyralgina MAX.
Adults and adolescents from 15 years of age (with a body weight over 53 kg) can be given a maximum of 1000 mg of metamizole in a single dose (1 tablet of 1000 mg) no more than 4 times a day, at intervals of 6-8 hours. The maximum daily dose is 4000 mg (corresponding to 4 tablets of 1000 mg).
A noticeable effect can be expected within 30 to 60 minutes of oral administration.
Elderly patients and patients in poor general health or with impaired renal function
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 kidney or liver disorders
Due to the reduced elimination rate in patients with kidney or liver disorders, high doses should be avoided. In the case of short-term use, dose reduction is not necessary. There is a lack of experience with long-term use.

Use in children and adolescents

• Adolescents from 15 years of age (body weight over 53 kg): see dosing as for adults.
• Pyralgina MAX should not be used in children and adolescents under 15 years of age. Other forms and strengths of this medicine are available for younger children; you should consult your doctor or pharmacist.

Method of administration

Oral administration.
Do not chew the tablets. The tablets should be taken with a sufficient amount of liquid (e.g. a glass of water). The tablet can be divided into equal doses.

Overdose of Pyralgina MAX

If you experience any of the following overdose symptoms, you should immediately consult a doctor or go to the nearest hospital emergency department:

• nausea, vomiting, abdominal pain,
• kidney function disorders, and in some cases, a lack of or insufficient urine production (oliguria or anuria), increased protein excretion in the urine (proteinuria), or acute kidney failure; interstitial nephritis (acute interstitial nephritis).
• dizziness, drowsiness, impaired consciousness,
• seizures,
• decreased blood pressure, up to circulatory shock (shock),
• heart rhythm disorders (tachycardia).

In the event of an overdose, you should immediately consult a doctor. It may be necessary to implement appropriate corrective measures.
After taking very high doses, the excretion of a harmless metabolite (rubazonic acid) may cause the urine to turn red.

Missed dose of Pyralgina MAX

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

4. Possible side effects

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

You should stop taking the medicine and consult a 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 medicine (e.g. severe hypersensitivity reactions, severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, agranulocytosis, pancytopenia) can be life-threatening.
In such cases, you should not take Pyralgina MAX without medical supervision.
Immediate discontinuation of the medicine is crucial for recovery.
You should stop taking Pyralgina MAX and seek medical attention immediately if you experience any of the following symptoms:

• 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".
• severe allergic reactions(anaphylactoid or anaphylactic reactions) - uncommon(occurring in less than 1 in 100 people). Typical symptoms of mild reactions may include: burning eyes, cough, runny nose, sneezing, chest tightness, facial flushing, and urticaria, as well as - less frequently - nausea and abdominal cramps. Particularly important symptoms are burning, itching, and flushing on and under the tongue and, especially, on the palms and soles. Mild reactions can progress to more severe forms, with generalized urticaria, severe angioedema (including laryngeal edema), severe bronchospasm (bronchial constriction), increased heart rate, arrhythmias, decreased blood pressure (sometimes preceded by an increase), loss of consciousness, and circulatory shock. These reactions can occur even if metamizole was previously administered without complications and can be severe or life-threatening, and sometimes even fatal.
• red, flat patches on the torso in a target shape or round, often with blisters in the center, peeling skin, mouth ulcers, throat, nose, genital and anal areas, and eyes. The occurrence of such serious skin rashes may be preceded by fever and flu-like symptoms ( Stevens-Johnson syndrome, toxic epidermal necrolysis) - rare(occurring in less than 1 in 1000 people).
• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome) - frequency not known(frequency cannot be estimated from the available data).
• significant decrease in the number of certain white blood cells (agranulocytosis), including cases with a fatal outcome (see section 2 "Warnings and precautions"), or a decrease in platelet count (thrombocytopenia) - rare(occurring in less than 1 in 10,000 people). These reactions are likely to be immunological. They may also occur if metamizole was previously administered without complications. Symptoms of thrombocytopenia include, for example, increased bleeding tendency and petechiae (pinpoint bleeding in the skin and mucous membranes). If symptoms of agranulocytosis, pancytopenia (see below), or thrombocytopenia occur, you should immediately stop taking Pyralgina MAX, and your doctor will order a blood morphology test (including a blood smear). Do not wait until the laboratory test results are available to discontinue treatment.
• 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 - frequency not known(frequency cannot be estimated from the available data). Symptoms of pancytopenia and aplastic anemia include: general malaise, infection, persistent fever, bruising, bleeding, and pallor.

Other possible side effects

Uncommon(occurring in less than 1 in 100 people):

• purple to dark red skin rash, sometimes with blisters ( drug rash),
• decreased blood pressure(isolated hypotensive reaction), probably caused by the direct action of the medicine and not accompanied by other hypersensitivity symptoms. Such a 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 1000 people):

• decrease in white blood cell count ( leukopenia),
• skin rash(e.g. maculopapular rash).

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

• asthma attacks(shortness of breath caused by bronchial constriction),
• acute kidney function deterioration, in some cases with a lack of or insufficient urine production (oliguria or anuria), increased protein excretion in the urine (proteinuria), or acute kidney failure; interstitial nephritis (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),
• liver inflammation, yellowing of the skin and whites of the eyes, increased liver enzyme activity in the blood,
• gastrointestinal bleeding.

The excretion of a harmless metabolite (rubazonic acid) may cause the urine to turn red.

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 MAX

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 and blister after EXP.
The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
There are no special precautions for storing the medicine.
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 MAX contains

• The active substance of the medicine is metamizole sodium monohydrate. Each tablet contains 1000 mg of metamizole sodium monohydrate.
• The other ingredients are: sodium croscarmellose, magnesium stearate, hypromellose 2910 (6±2 mPa∙s), titanium dioxide (E 171), macrogol 8000, and talc.

What Pyralgina MAX looks like and contents of the pack

White or almost white, biconvex, oblong tablets with a dividing line on one side. The tablet can be divided into equal doses.
Pyralgina MAX is packaged in non-transparent, perforated or non-perforated blisters made of PVC/Aluminum or PVC/PE/PVDC/Aluminum and cardboard boxes.
The packaging contains 6 coated tablets.

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

Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larissa Industrial Area
41500 Larissa
Greece

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

Poland: Pyralgina MAX
Hungary: Pyralgina

Date of last revision of the leaflet: