METAMIZOL 500 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Metamizol Dr. Max, 500 mg, Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Metamizol Dr. Max and what is it used for
4. Important information before taking Metamizol Dr. Max
   1. When not to take Metamizol Dr. Max
   2. Warnings and precautions
   3. Children and adolescents
   4. Metamizol Dr. Max and other medicines
   5. Metamizol Dr. Max and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Metamizol Dr. Max contains sodium
5. How to take Metamizol Dr. Max
   1. Use in children and adolescents
   2. Elderly patients and patients with impaired renal function
   3. Patients with renal or hepatic impairment
   4. Overdose of Metamizol Dr. Max
   5. Missed dose of Metamizol Dr. Max
6. Possible side effects
   1. Other side effects:
   2. Reporting side effects
7. How to store Metamizol Dr. Max
8. Contents of the pack and other information
   1. What Metamizol Dr. Max contains:
   2. What Metamizol Dr. Max 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:
   7. Date of last revision of the package leaflet: 11/2024

Package Leaflet: Information for the Patient

Metamizol Dr. Max, 500 mg, Tablets

Metamizolum natricum monohydricum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet or as directed by the doctor or pharmacist.

• Keep this package leaflet, so you can read it again if you need to.
• If you need advice or additional information, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 3-5 days there is no improvement or you feel worse, contact your doctor.

Metamizol Dr. Max may cause a severely decreased number of white blood cells (agranulocytosis), which can lead to severe and life-threatening infections (see section 4). Stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms: fever, chills, sore throat, painful mouth ulcers, or ulcers in the genital or anal area. If you have ever had agranulocytosis while taking metamizol or similar medicines, do not take this medicine again (see section 2).

Table of Contents of the Package Leaflet

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

1. What is Metamizol Dr. Max and what is it used for

Metamizol Dr. Max is a pain reliever (analgesic) and belongs to the group of pyrazolones. In addition to its pain-relieving effect, Metamizol Dr. Max has a spasmolytic (relaxing) and antipyretic (fever-reducing) effect. The effect of Metamizol Dr. Max starts within 30 to 60 minutes and lasts for about 4 hours. Metamizol Dr. Max is used in adults and adolescents over 15 years of age to treat severe, acute, or chronic pain and high fever when other treatment methods are ineffective. Consult your doctor if you do not improve or feel worse after 3-5 days.

2. Important information before taking Metamizol Dr. Max

When not to take Metamizol Dr. Max

• if you are allergic to metamizol or other pyrazolone derivatives (e.g., phenazone, propyphenazone) or pyrazolidines (e.g., phenylbutazone, oxyphenbutazone) or any of the other ingredients of this medicine (listed in section 6).

other ingredients of this medicine (listed in section 6).

• if you have ever had asthma or allergic reactions, such as hives or so-called angioedema (swelling of the face and mucous membranes of the respiratory or gastrointestinal tract) in connection with the use of painkillers (salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, or naproxen).
• if you have ever had a significant decrease in the number of white blood cells called granulocytes caused by metamizol or other similar medicines called pyrazolones or pyrazolidines.
• if you have bone marrow disorders (e.g., after cancer treatment) or a disease that affects the production or function of blood cells.
• if you have blood disorders (hematopoiesis).
• if you have a congenital deficiency of glucose-6-phosphate dehydrogenase (a hereditary condition with a risk of red blood cell breakdown).
• if you have severe liver disease, such as porphyria (risk of triggering a porphyria attack).
• if you are in the last three months of pregnancy.

Warnings and precautions

Before taking Metamizol Dr. Max, discuss it with your doctor or pharmacist. Agranulocytosis (a severely decreased number of white blood cells) Metamizol Dr. Max may cause agranulocytosis, a severely decreased number of a certain type of white blood cell called granulocytes, which play an important role in fighting infections (see section 4). Stop taking metamizol 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 or anal area. Your doctor will order a laboratory test to check your blood cell count. If metamizol 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 Metamizol Dr. Max, even after a short period of treatment. Agranulocytosis can occur even if metamizol was previously taken without complications. Be particularly cautious when taking Metamizol Dr. Max:

• if you experience objective and subjective symptoms suggesting blood disorders (such as general malaise, infection, persistent fever, bruising, bleeding, and pallor), contact your doctor immediately. These may be symptoms of pancytopenia (a decrease in the number of all types of blood cells).
• if you have asthma or atopy (a type of allergy), as there is an increased risk of anaphylactic shock after taking metamizol (a life-threatening allergic reaction).
• if you have any of the following conditions associated with an increased risk of severe anaphylactoid reactions to metamizol:
• bronchial asthma and concurrent nasal mucositis
• chronic urticaria
• alcohol intolerance, characterized by sneezing, tearing, and severe flushing of the face in response to even small amounts of alcohol
• hypersensitivity to dyes (e.g., tartrazine) or preservatives (e.g., benzoates).
• if you have low blood pressure, dehydration, unstable fluid volume, or circulatory failure in the early stages or high fever. In these cases, there is an increased risk of severe hypotensive reactions (reactions related to a drop in blood pressure). The administration of metamizol should be carefully considered, and if metamizol is administered in these circumstances, close medical supervision is required. To reduce the risk of a severe hypotensive reaction, preventive measures are necessary. Metamizol may cause hypotensive reactions not related to the above-mentioned diseases. These reactions may be dose-dependent.
• if you have severe coronary heart disease or significant narrowing of the blood vessels supplying blood to the brain. In these cases, it is essential to avoid lowering blood pressure, so metamizol should only be administered under close cardiovascular monitoring.
• if you have kidney or liver function disorders. In this case, do not take high doses of metamizol, as its elimination is reduced.

If you belong to any of these risk groups, tell your doctor before taking Metamizol Dr. Max. Severe skin reactions Severe skin reactions have been reported with metamizol, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS syndrome). If you experience any of these symptoms of severe skin reactions listed in section 4, stop taking metamizol and seek medical help immediately. If you have ever had severe skin reactions, do not restart treatment with Metamizol Dr. Max at any time (see section 4). Liver function disorders Liver inflammation has been reported in patients taking metamizol, with symptoms appearing within a few days to a few months after starting treatment. Stop taking Metamizol Dr. Max and contact your doctor if you experience symptoms of liver function disorders, such as nausea (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. Do not take Metamizol Dr. Max if you have previously taken metamizol-containing medicines and had liver function disorders. Effect on laboratory tests Before undergoing any laboratory tests, inform your doctor that you are taking Metamizol Dr. Max, as metamizol may affect the results of some tests (e.g., serum creatinine, lipids, HDL cholesterol, or uric acid).

Children and adolescents

Metamizol Dr. Max should not be used in children and adolescents under 15 years of age. Other forms and/or strengths of this medicine may be available for children; ask your doctor or pharmacist.

Metamizol Dr. Max and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Metamizol may reduce the effect of the following medicines:

• bupropion, a medicine used to treat depression or 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
• cyclosporine, a medicine that suppresses the immune system
• tacrolimus, a medicine used to prevent organ rejection in transplant patients
• sertraline, a medicine used to treat depression.

If you take Metamizol Dr. Max with any of these medicines, your doctor will closely monitor you. Concomitant administration of metamizol with methotrexate (a medicine used to treat cancer or certain rheumatic diseases) may increase the potential risk of hematotoxicity (blood cell damage) by methotrexate, especially in elderly patients. Therefore, this combination should be avoided. Metamizol Dr. Max should be used with caution in patients taking low doses of acetylsalicylic acid to prevent heart attack.

Metamizol Dr. Max and alcohol

Do not drink alcohol while taking Metamizol Dr. Max.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy There is limited data on the use of metamizol during the first three months of pregnancy, but it does not indicate a harmful effect on the fetus. In selected cases, when there are no other treatment options, single doses of metamizol may be acceptable during the first and second trimester after consulting a doctor or pharmacist and carefully weighing the benefits and risks of taking metamizol. However, metamizol is not recommended during the first and second trimester. Do not take Metamizol Dr. 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 after birth). Breastfeeding Metamizol metabolites pass into breast milk in significant amounts, and a risk to the breastfed child cannot be excluded. Therefore, Metamizol Dr. Max should be avoided during breastfeeding. If Metamizol Dr. Max is taken, mothers should express and discard breast milk for 48 hours after taking the medicine.

Driving and using machines

At the recommended dose, this medicine does not affect the ability to drive or use machines. Taking higher than recommended doses or taking Metamizol Dr. Max with alcohol may impair your ability to react and concentrate. In these cases, do not drive or operate machinery.

Metamizol Dr. Max contains sodium

This medicine contains 32.7 mg of sodium (the main component of common salt) per tablet, which is 1.64% of the maximum recommended daily intake of sodium for adults.

3. How to take Metamizol Dr. Max

Always take this medicine exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. The dose depends on the severity of the pain or fever and individual sensitivity to Metamizol Dr. Max. Always choose the smallest dose necessary to relieve pain and/or fever. Adults and adolescents over 15 years of age (with a body weight over 53 kg) can take a maximum of 1000 mg of metamizol as a single dose (2 tablets), which can be taken up to 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 and usually lasts about 4 hours.

Use in children and adolescents

Metamizol Dr. Max should not be used in children and adolescents under 15 years of age. Other forms and/or strengths of this medicine may be available for younger children and adolescents; ask your doctor or pharmacist.

Elderly patients and patients with impaired renal function

In elderly patients, weakened patients, and patients with impaired renal function, the dose should be reduced, as the elimination of metamizol metabolites may be delayed.

Patients with renal or hepatic impairment

Due to the reduced elimination rate in patients with renal or hepatic impairment, avoid taking high doses repeatedly. For short-term use, there is no need to reduce the dose. There is a lack of experience with long-term use. After taking very high doses, the excretion of a harmless metamizol metabolite may cause urine to turn red, which disappears after stopping treatment. Administration This medicine is for oral use. Swallow the tablets whole with a sufficient amount of water (e.g., a glass of water). The dividing line on the tablet is only for easier breaking of the tablet if the patient has difficulty swallowing it whole. Metamizol Dr. Max can be taken with or without food. Duration of treatment Do not take this medicine for more than 3-5 days without consulting your doctor. If after 3-5 days there is no improvement or you feel worse, contact your doctor.

Overdose of Metamizol Dr. Max

In case of overdose, contact your doctor immediately to take appropriate measures. Symptoms of overdose:

• nausea, vomiting, abdominal pain
• kidney function disorders, including acute kidney failure
• dizziness, drowsiness, loss of consciousness
• seizures
• blood pressure drop, up to circulatory shock (shock)
• rapid heartbeat (tachycardia).

Missed dose of Metamizol Dr. Max

Do not take a double dose to make up for a missed dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Metamizol Dr. Max and contact your doctor immediately if you experience any of the following symptoms: nausea (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 indicate liver function disorders. See also section 2 "Warnings and precautions".

Other side effects:

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

• blood disorders: reduced number of red blood cells due to bone marrow suppression (aplastic anemia), reduced or absent number of one type of white blood cell (agranulocytosis), reduced number of all blood cell types (pancytopenia), including fatal cases, reduced number of white blood cells (leukopenia), and reduced number of platelets (thrombocytopenia). Typical symptoms of reduced granulocytes: inflammatory changes in the mucous membranes, mainly in the mouth, nose, and throat, and inflammatory changes in the anal and genital areas, sore throat, and fever (unexpectedly persistent or recurrent). These symptoms may be mild in patients taking antibiotics (medicines used to treat bacterial infections). Red blood cell sedimentation is significantly accelerated, and lymph node enlargement is mild or completely absent. Typical symptoms of reduced platelets: increased tendency to bleed and small brownish-red spots (petechiae) on the skin and mucous membranes.
• allergic reactions (anaphylactic shock, anaphylactoid or anaphylactic reactions), which can be severe or life-threatening, and in some cases even fatal. They can occur even if metamizol was previously tolerated without complications. These reactions usually occur within the first hour after taking Metamizol Dr. Max, but can also occur immediately or several hours later. Mild allergic reactions usually take the form of skin and mucous membrane symptoms (e.g., itching, burning, redness, hives, swelling), respiratory problems, and less frequently gastrointestinal symptoms. However, these symptoms can develop into severe forms with hives all over the body, severe swelling of the face, tongue, throat, or mucous membranes of the respiratory or gastrointestinal tract (angioedema), severe shortness of breath, irregular heartbeat (arrhythmia), blood pressure drop (which may sometimes be preceded by a blood pressure increase), and shock. These reactions occur in patients with bronchial asthma in the form of an asthma attack.
• skin rash.

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

• transient worsening of kidney function with low urine output (oliguria) or absence of urine (anuria) or acute kidney failure with proteinuria.

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

• heart disease in the context of an allergic reaction (Kounis syndrome)
• transient (only exceptionally critical) isolated blood pressure drop without other symptoms of hypersensitivity
• liver inflammation, jaundice, and increased liver enzyme levels in the blood
• severe skin reactions: Stop taking metamizol and seek medical help immediately if you experience any of the following severe side effects:
• red, hairless, target-like, or circular spots on the torso, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• kidney inflammation (interstitial nephritis).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 Metamizol Dr. Max

Keep the medicine out of the sight and reach of children. There are no special storage instructions. Store in the original package to protect from light. Do not use this medicine after the expiry date stated on the carton or blister after: EXP. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Metamizol Dr. Max contains:

• The active substance is metamizol sodium monohydrate. Each tablet contains 500 mg of metamizol sodium monohydrate.
• The other ingredients are: maize starch, pregelatinized maize starch, macrogol 6000, crospovidone (type A), magnesium stearate, and anhydrous colloidal silica.

What Metamizol Dr. Max looks like and contents of the pack

White or almost white, round, flat tablets (about 12.5 mm in diameter) with a dividing line on one side. The dividing line on the tablet is only for easier breaking of the tablet to facilitate swallowing and not for dividing into equal doses. The tablets are packaged in white, non-transparent blisters of PVC/Aluminum, protected against children with aluminum foil laminated with parchment paper or non-protected with aluminum foil. The blisters are placed in a cardboard box. Pack sizes: 6, 10, 12, 20, or 50 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Dr. Max Pharma s.r.o. Na Florenci 2116/15 Nové Město 110 00 Prague 1 Czech Republic tel.: (+420) 516 770 199

Manufacturer:

Sofarimex Industria Quimica e Farmaceutica S.A. Alto De Colaride, Avenida Das Industrias 2735-213 Agualva-Cacém Portugal

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

Czech Republic: Metamizol Medreg Romania: Metamizol Gemax Pharma 500 mg comprimate Slovakia: Metamizol Medreg Poland: Metamizol Dr. Max

Date of last revision of the package leaflet: 11/2024