PIXALZINA 500 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Pixalzina, 500 mg, coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Pixalzina and what is it used for
4. Important information before taking Pixalzina
   1. When not to take Pixalzina
   2. Warnings and precautions
   3. Children and adolescents
   4. Pixalzina and other medicines
   5. Pixalzina and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Pixalzina contains lactose and sodium
5. How to take Pixalzina
   1. Recommended dose
   2. Use in children and adolescents
   3. Elderly patients, patients in poor general condition, or with renal impairment
   4. Patients with renal or hepatic impairment
   5. Overdose of Pixalzina
   6. Missed dose of Pixalzina
6. Possible side effects
   1. The following side effects may be serious; you should stop taking Pixalzina and immediately contact your doctor:
   2. if you experience any of the following:
   3. Other side effects
   4. Reporting side effects
7. How to store Pixalzina
8. Contents of the pack and other information
   1. What Pixalzina contains
   2. What Pixalzina looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   8. For further information on this medicine, you should contact the representative of the marketing authorization holder in Poland:

Leaflet attached to the packaging: patient information

Pixalzina, 500 mg, coated tablets

Metamizole sodium monohydrate
Pixalzina 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 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 the 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 consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or feel worse after 3-5 days, you should contact your doctor.

Table of contents of the leaflet:

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

1. What is Pixalzina and what is it used for

Pixalzina is a pain reliever and contains metamizole sodium monohydrate, which belongs to a group of medicines called pyrazolones. In addition to its pain-relieving effect, Pixalzina has antispasmodic (anticonvulsant) and antipyretic (fever-reducing) effects.
It is used to treat acute, severe, or chronic pain (such as headache, migraine, toothache, muscle and joint pain, post-traumatic and post-operative pain, pain caused by kidney or biliary colic, or cancer pain) and high fever when other treatments are ineffective.
This medicine is intended for adults and adolescents over 15 years of age.

2. Important information before taking Pixalzina

When not to take Pixalzina

• if you are allergic to metamizole or other pyrazolones (e.g., phenazone, propyphenazone), or pyrazolidines (e.g., phenylbutazone, oxyphenbutazone) or any of the other ingredients of this medicine (listed in section 6).
• if you have had a significant decrease in the number of white blood cells called granulocytes, caused by metamizole or other similar medicines called pyrazolones or pyrazolidines.
• if you have bone marrow disorders or diseases that affect the production or function of blood cells.
• if you have blood disorders (hematological disorders).
• if you have a proven intolerance to pain relievers (aspirin-induced asthma syndrome or pain reliever intolerance manifested by urticaria and/or angioedema). This applies to patients who experience bronchospasm (sudden narrowing of the airways) or other allergic reactions, such as itching, runny nose, and swelling (urticaria, rhinitis, angioedema) after exposure to pain relievers, such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, or naproxen.
• if you have a congenital deficiency of glucose-6-phosphate dehydrogenase (a congenital defect associated with the risk of red blood cell breakdown).
• if you have acute intermittent porphyria (a hereditary disease associated with disturbances in hemoglobin synthesis).
• if you are in the last trimester of pregnancy.

Warnings and precautions

Before taking Pixalzina, you should discuss it with your doctor or pharmacist if:

• you have signs and symptoms of blood disorders (e.g., general weakness, infection, persistent fever, bruising, bleeding, pallor), you should contact your doctor immediately. This condition can be called pancytopenia (decrease in the number of all types of blood cells),
• you have any of the following diseases, as there is an increased risk of severe hypersensitivity reactions to metamizole:
• asthma and concurrent nasal mucosa inflammation,
• prolonged and/or chronic urticaria,
• hypersensitivity to dyes (e.g., tartrazine) or preservatives (e.g., benzoates),
• hypersensitivity to alcohol, i.e., if you react to small amounts of alcoholic beverages with sneezing, tearing, and pronounced facial flushing,
• you have low blood pressure, dehydration, unstable fluid volume, or impending circulatory failure or high fever. In these cases, there is an increased risk of severe hypotensive reactions (reactions related to a decrease in blood pressure). Particular caution is required when administering metamizole, and if metamizole is administered in such circumstances, close medical supervision is required. To reduce the risk of a severe hypotensive reaction, preventive measures are necessary. Administration of metamizole may cause hypotensive reactions unrelated to the above diseases. These reactions seem to be dose-dependent,
• you have severe coronary heart disease or significantly narrowed blood vessels supplying blood to the brain. In these cases, it is absolutely necessary to avoid lowering blood pressure, so metamizole should only be administered under close monitoring of circulatory function,
• you have kidney or liver disease. In this case, you should not take high doses of metamizole, as its elimination from the body is reduced,
• your doctor will perform all laboratory tests, as metamizole may affect the results of some tests (e.g., creatinine level in the blood, fats, cholesterol HDL, or uric acid).

Agranulocytosis (severely decreased number of white blood cells)
Pixalzina may cause agranulocytosis, a severely decreased 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 membranes, 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 you are taking metamizole for fever, some symptoms of developing agranulocytosis may remain unnoticed. Similarly, symptoms may also be masked if you are taking antibiotics.
Agranulocytosis may develop at any time during Pixalzina treatment and even for a short time after stopping metamizole.
Agranulocytosis may occur even if metamizole was previously taken without complications.
Liver disorders
Patients taking metamizole have reported liver inflammation with symptoms appearing within a few days to a few months after starting treatment.
You should stop taking Pixalzina and contact your doctor if you experience 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 your liver function.
You should not take Pixalzina if you have previously taken a medicinal product containing metamizole and had liver disorders.
Severe skin reactions
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with metamizole treatment. You should stop taking metamizole and seek medical attention immediately if you experience any symptoms of these severe skin reactions, described in section 4. If you have ever had severe skin reactions, you should never take Pixalzina again (see section 4).

Children and adolescents

Pixalzina should not be given to children and adolescents under 15 years of age.

Pixalzina 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, especially:

• Methotrexate (a medicine used to treat cancer or certain rheumatic diseases). The combination with metamizole may increase the potential risk of hematological disorders caused by methotrexate, especially in the elderly. Therefore, this combination should be avoided.
• Cyclosporine (a medicine that lowers the body's immune system). Pixalzina may decrease cyclosporine levels in the blood. If you are taking cyclosporine at the same time, it may be necessary to increase the dose of cyclosporine.
• Efavirenz (a medicine used to treat HIV/AIDS).
• Methadone (a medicine used to treat opioid addiction).
• Valproate (a medicine used to treat epilepsy or bipolar disorder).
• Tacrolimus (a medicine used to prevent organ rejection in patients who have had a transplant).
• Sertraline (a medicine used to treat depression).
• Acetylsalicylic acid. Metamizole may reduce the effect of acetylsalicylic acid on platelets. If you are taking acetylsalicylic acid in low doses to protect your heart, you should be cautious when taking Pixalzina.
• Bupropion (a medicine used to treat depression or as an aid to smoking cessation).

Pixalzina and alcohol

You should not drink alcohol while taking Pixalzina.

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
Metamizole should not be used during the first 6 months of 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, when there are no other treatment options, single doses of metamizole during the first 6 months of pregnancy may be acceptable, after consultation with your doctor or pharmacist and careful consideration of the benefits and risks associated with metamizole.
You should not take Pixalzina during the last 3 months of pregnancy due to the increased risk of complications for the mother and child (bleeding, premature closure of the ductus arteriosus in the unborn child, which normally closes after birth).
Breastfeeding
You should not breastfeed if you are taking this medicine repeatedly. Metamizole metabolites may pass into breast milk in significant amounts and pose a risk to the breastfed child. If you take a single dose of metamizole, you 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, there are no known effects on reaction and attention. However, at higher doses, you should avoid operating machinery, driving, and performing other hazardous activities, as there is a possibility of adverse effects. This is especially true for people who consume alcohol.

Pixalzina contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains 32.7 mg of sodium (the main component of common salt) per tablet. This corresponds to 1.6% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Pixalzina

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Recommended dose

Dosage depends on the severity of pain or fever and individual response to Pixalzina.
You should always take the smallest effective dose to relieve pain and/or fever. Your doctor will inform you about the dose and duration of Pixalzina treatment.
The recommended dose for adults and adolescents over 15 years of age (with a body weight over 53 kg) is 1 to 2 tablets (corresponding to 500 to 1000 mg of metamizole), which can be taken up to 4 times a day at 6- to 8-hour intervals. The maximum daily dose is 8 tablets (corresponding to 4000 mg of metamizole).
You can expect the effects of Pixalzina within 30-60 minutes, and they last for about 4 hours.
Tablets should be swallowed whole, without chewing, with a sufficient amount of water (about half a glass).
Pixalzina can be taken with or without food.
You should not take Pixalzina for more than 3-5 days.

Use in children and adolescents

Pixalzina is not recommended for children and adolescents under 15 years of age. Other pharmaceutical forms and/or strengths of this medicine are available for younger children and adolescents.
If you have any further doubts, you should consult your doctor or pharmacist.

Elderly patients, patients in poor general condition, or with renal impairment

The dose should be reduced in elderly patients, weakened patients, and those with impaired renal function, as the elimination of metamizole metabolites may be delayed.

Patients with renal or hepatic impairment

Since the elimination rate is slower in patients with impaired renal or hepatic function, you should avoid repeated administration of high doses. It is not necessary to reduce the dose for short-term use.
There is a lack of experience with long-term use.

Overdose of Pixalzina

In case of overdose, you should contact your doctor immediately so that appropriate measures can be taken.
Symptoms of overdose are nausea (malaise), vomiting (nausea), abdominal pain, impaired renal function, and rarely neurological symptoms (dizziness, drowsiness, loss of consciousness, convulsions). Significant overdose may also lead to a drop in blood pressure (sometimes to shock) and rapid heartbeat.
After taking very high doses, a harmless metabolite may be excreted, causing red discoloration of the urine, which disappears after stopping treatment.

Missed dose of Pixalzina

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, Pixalzina can cause side effects, although not everybody gets them.

The following side effects may be serious; you should stop taking Pixalzina and immediately contact your doctor:

if you experience any of the following:

If any of the following side effects occur suddenly or develop rapidly, as some reactions (e.g., severe hypersensitivity reactions, severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, agranulocytosis, pancytopenia) can be life-threatening. In these cases, you should not take Pixalzina without medical supervision. Immediate withdrawal of the medicine may be crucial for recovery.

• Hypersensitivity reactions (anaphylactic or anaphylactoid reactions) - rare side effects. Typical signs of mild reactions include symptoms such as burning eyes, coughing, runny nose, nasal congestion, chest pain, facial flushing (especially of the face and head), urticaria, and facial edema - and rarely - nausea and stomach cramps. Warning signs are a feeling of burning, itching, and redness on the surface or under the tongue, and on the palms and soles of the feet. Such mild reactions can progress to more severe reactions with severe urticaria, severe angioedema (swelling, including of the larynx), severe bronchospasm (constrictive narrowing of the airways), rapid heartbeat (sometimes too slow), arrhythmia, drop in blood pressure (sometimes with previous increase in blood pressure), loss of consciousness, and shock. These reactions can also occur even if metamizole was previously taken without complications and may have a severe or life-threatening course, and in some cases even fatal consequences. In patients with aspirin-induced asthma syndrome, hypersensitivity reactions usually manifest as asthma attacks (see section 2 "When not to take Pixalzina").
• Red, flat, plate-like, or round patches on the torso, often with blisters in the center, peeling 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 or toxic epidermal necrolysis) - frequency not known.
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• 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 symptoms may be signs of liver damage. See also section 2 "Warnings and precautions". A significantly decreased number of certain white blood cells (agranulocytosis), including cases with a fatal outcome, or a decreased number of platelets (thrombocytopenia) - rare side effects. These reactions are likely to be immune-related. They may also occur when metamizole was previously taken without complications. If you experience symptoms of agranulocytosis, pancytopenia (see below), or thrombocytopenia, you should stop taking Pixalzina immediately, without waiting for laboratory test results. Blood morphology (with smear) must be monitored by your doctor. You should not take Pixalzina if you experience any of the following symptoms, which may indicate possible agranulocytosis:
• Sudden worsening of general condition (e.g., fever, chills, sore throat, difficulty swallowing).
• If fever does not subside or recurs.
• If painful changes in the mucous membranes occur, especially in the mouth, nose, and throat, or in the genital or anal area.

Symptoms of thrombocytopenia include increased bleeding and petechiae (spot bleeding in the skin and mucous membranes).
Decreased blood volume with accompanying bone marrow disorders (aplastic anemia), decreased number of white and red blood cells, and platelets (pancytopenia), including cases with a fatal outcome. Symptoms of pancytopenia and aplastic anemia are general malaise (weakness), infection, persistent fever, bruising, bleeding, and pallor.

Other side effects

Uncommon (may affect up to 1 in 100 people):

• Drop in blood pressure (isolated hypotensive reaction), which is likely to be caused by the direct effect of the medicine and is not accompanied by other symptoms of hypersensitivity reactions. Only in rare cases does this reaction cause a significant drop in blood pressure. The risk of a drop in blood pressure may be increased in patients with very high fever (hyperpyrexia). Typical symptoms of a significant drop in blood pressure include rapid heartbeat, pallor, trembling, dizziness, nausea, and loss of consciousness.

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

• Decreased number of white blood cells in the blood (leukopenia) or red blood cells (aplastic anemia).
• Skin rash.

Very rare (may affect up to 1 in 10,000 people):

• Impaired renal function, in some cases manifested by absence or reduced urine output (oliguria or anuria), proteinuria, or development of acute renal failure.

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

• Myocardial infarction, as part of an allergic reaction (Kounis syndrome).
• There have been reports of gastrointestinal bleeding.
• Hepatitis, jaundice, and increased liver enzyme activity in the blood.
• Purple to dark red skin rash, sometimes with blisters (drug rash).
• Renal failure (acute interstitial nephritis).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 Pixalzina

The medicine should be stored out of sight and reach of children.
You should 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 stated.
There are no special precautions for storage.
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 Pixalzina contains

• The active substance is metamizole sodium monohydrate. Each tablet contains 500 mg of metamizole sodium monohydrate.
• The other ingredients are: Tablet core: cornstarch; lactose monohydrate; macrogol 6000; povidone (K 25); magnesium stearate; potato starch. Coating: talc; methacrylic acid butyl copolymer; titanium dioxide (E171); magnesium stearate, purified castor oil.

What Pixalzina looks like and contents of the pack

Coated tablet.
Pixalzina is a white to slightly yellowish, elongated, coated tablet, approximately 16.2 x 8.2 mm in size, with one dividing line. The dividing line is only intended to facilitate breaking the tablet to make it easier to swallow, not to divide it into equal doses.
Pixalzina is packaged in a non-transparent blister pack with PVC/Aluminum foil and a cardboard box.
Pixalzina is available in packs of 12, 20, 30 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zentiva, k.s.,
U kabelovny 130,
Dolní Měcholupy,
102 37 Prague 10,
Czech Republic

Manufacturer

S.C. Zentiva S.A.
B-dul Theodor Pallady, Nr. 50
032266, Sector 3, Bucharest
Romania
G.L. Pharma GmbH
Industriestraße 1
8502 Lannach, Austria

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

Czech Republic
Afexil
Austria
Metagelan 500 mg Filmtabletten
Poland
Pixalzina
Romania
Algocalmin 500 mg film-coated tablets
Slovakia
Nofebran 500 mg film-coated tablets
Hungary
Nofebran 500 mg film tablet

For further information on this medicine, you should contact the representative of the marketing authorization holder in Poland:

Zentiva Poland Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:May 2025