Metamizol Biofarm

1. What is Metamizol Biofarm and what is it used for

Metamizol Biofarm contains metamizol sodium monohydrate and is a pain-relieving and antipyretic medicine, belonging to a group of medicines called pyrazolones. Metamizol Biofarm is used for:
 severe pain after injuries or operations,
 colic (spasmodic abdominal pain),
 cancer pain,
 other severe and prolonged pain when other treatment methods are contraindicated,
 high fever that does not respond to other treatment methods.

2. Important information before taking Metamizol Biofarm

When not to take Metamizol Biofarm:

 If the patient has a history of significant reduction in white blood cell count (granulocytopenia) caused by metamizol or other similar medicines called pyrazolones or pyrazolidines,
 if the patient has bone marrow disorders or a condition that affects the production or function of blood cells,
 if the patient is allergic to metamizol or other pyrazolones (e.g., phenazone, propyphenazone) or pyrazolidines (e.g., phenylbutazone, oxyphenbutazone)
 if the patient is allergic to any of the other ingredients of the medicine (listed in section 6),
 if the patient has a known intolerance to painkillers (aspirin-induced asthma or analgesic intolerance with urticaria and/or angioedema). This applies to patients who, after exposure to painkillers such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, or naproxen, experience bronchospasm (sudden narrowing of the airways) or other symptoms of hypersensitivity, such as itching, rhinitis, and angioedema,
 if the patient has ever had an allergic reaction, such as a severe skin reaction to this medicine (see also section 4 below),
 if the patient has bone marrow disorders after cancer treatment,
 if the patient has a congenital defect associated with the risk of red blood cell breakdown (genetically determined glucose-6-phosphate dehydrogenase deficiency),
 if the patient has porphyria (a rare inherited disease related to red blood cell disorders),
 if the patient has acute renal or liver failure, acute hepatic porphyria (a genetic disorder related to hemoglobin synthesis),
 if the patient is in the last three months of pregnancy.

Warnings and precautions

Before starting treatment with Metamizol Biofarm, you should discuss it with your doctor. Metamizol Biofarm contains metamizol, which is associated with a rare but life-threatening risk of:
 sudden cardiac arrest,
 agranulocytosis (a severe disorder caused by a significant reduction in the number of certain white blood cells).
Low white blood cell count (agranulocytosis)
Metamizol Biofarm may cause agranulocytosis, a very low number of a certain type of white blood cell called granulocytes, which play an important role in fighting infections (see section 4). You should 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 sores, especially in the mouth, nose, and throat or in the genital or anal area. Your doctor will order a blood test to check your blood cell count.
If you are taking metamizol for fever, some symptoms of developing agranulocytosis may go unnoticed. Similarly, symptoms may also be masked if you are taking antibiotics.
Agranulocytosis can develop at any time during treatment with Metamizol Biofarm, and even for a short time after stopping metamizol.
Agranulocytosis can occur even if metamizol was previously taken without complications.
If you experience symptoms of reduced blood cell count (pancytopenia), such as general malaise, infection, persistent fever, bruising, bleeding, pallor, or low platelet count (thrombocytopenia), such as increased bleeding tendency, small bleeding in the skin and mucous membranes, you should immediately stoptaking Metamizol Biofarm drops and consult your doctor(see section 4 "Possible side effects").
If you have an allergic reaction to Metamizol Biofarm drops, you are also particularly susceptible to a similar reaction to other painkillers.
If you have an allergic reaction or other immune system reaction (e.g., agranulocytosis) to Metamizol Biofarm drops, you are also particularly susceptible to a similar reaction to other pyrazolones and pyrazolidines (similar chemical substances), such as phenazone, propyphenazone, phenylbutazone, oxyphenbutazone.
If you have an allergic reaction or other immune system reaction to other pyrazolones and pyrazolidines or other painkillers, there is a high risk of a similar reaction to Metamizol Biofarm drops.
Severe hypersensitivity reactions
The risk of severe hypersensitivity reactions is higher when taking Metamizol Biofarm in the following circumstances:
 allergy to painkillers and anti-rheumatic medicines with symptoms such as itching and swelling (urticaria, angioedema) (aspirin-induced asthma or analgesic intolerance with urticaria and angioedema, see section 2 "When not to take Metamizol Biofarm"),
 bronchial asthma attacks caused by bronchial constriction, especially if accompanied by nasal congestion and sinusitis (sinusitis),
 chronic urticaria,
 allergy or intolerance to preservatives (benzoates) or dyes (tartrazine),
 alcohol intolerance (tearing, sneezing, and intense flushing of the face after drinking small amounts of alcohol, which may indicate previously undiagnosed analgesic intolerance, see section 2 "When not to take Metamizol Biofarm").
Patients with an increased risk of hypersensitivity reactions to Metamizol Biofarm drops should only be given the medicine after careful evaluation of the benefit-to-risk ratio (see section 2 "When not to take Metamizol Biofarm"). In such cases, the patient must be under close medical supervision, with the possibility of providing assistance in an emergency.
Particularly in patients with allergies, anaphylactic shock may occur (see section 4).
Therefore, when taking the medicine, it is recommended to exercise particular caution in patients with asthma or a predisposition to hypersensitivity reactions.
Severe skin reactions
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), have been reported with metamizol treatment. If you experience any of these symptoms of severe skin reactions listed in section 4, you should stop taking metamizol and seek medical attention immediately. If you have ever had severe skin reactions, you should never take Metamizol Biofarm again (see section 4).
Liver function disorders
Patients taking metamizol have experienced hepatitis, with symptoms appearing within a few days to several months after starting treatment.
You should stop taking Metamizol Biofarm and contact your doctor if you experience any liver-related symptoms, 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 Metamizol Biofarm if you have previously taken any medicinal products containing metamizol and had liver-related symptoms.
Low blood pressure (isolated hypotensive reactions)
When taking Metamizol Biofarm, a decrease in blood pressure may occur (see section 4).
The risk of such reactions is increased:
 if you have low blood pressure (pre-existing hypotension), severe dehydration, or poor circulation, or in the early stages of circulatory failure (e.g., after a heart attack or severe injury),
if you have a high fever.

• if you are taking other medicines that lower blood pressure.

Careful consideration of the use, close monitoring, and, if necessary, preventive measures (e.g., stabilization of circulation) are necessary to reduce the risk of decreased blood pressure.
Metamizol Biofarm drops should only be used when circulation parameters are closely monitored, and it is essential to avoid drops in blood pressure if you have, for example:

• severe coronary artery disease
• narrowing of the cerebral vessels

Patient with kidney or liver function disorders
In patients with kidney or liver function disorders, Metamizol Biofarm should only be used after careful consideration of the benefit-to-risk ratio and with appropriate precautions (see section 3, subsection "Patients with kidney or liver function disorders").
Effect on laboratory tests
Before performing laboratory tests, you should inform your doctor about taking Metamizol Biofarm, as metamizol may affect the results of some tests (e.g., creatinine, lipid, cholesterol HDL, or uric acid levels).
Children and adolescents
The medicine should not be given to children under 3 months of age or weighing less than 5 kg due to the lack of sufficient clinical data.

Metamizol Biofarm and other medicines

You should tell your doctor or pharmacist 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, in particular, about the following medicines, as they may interact with Metamizol Biofarm:
 bupropion, a medicine used to treat depression or to help quit smoking,
 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,
 cyclosporine, a medicine used to suppress the immune system,
 tacrolimus, a medicine used to prevent organ rejection in transplant patients,
 sertraline, a medicine used to treat depression.
The effectiveness and/or concentration of the medicine in the blood should be monitored by your doctor.
In particular, you should inform your doctor about the following medicines, which may interact with Metamizol Biofarm and vice versa:

• methotrexate, a medicine used to treat cancer or rheumatic diseases. Concurrent use may increase the harmful effect of methotrexate on the hematopoietic system, especially in elderly patients. Therefore, it is recommended to avoid combining these medicines.
• acetylsalicylic acid, taken in small doses to protect the heart. Concurrent use may reduce the effect of acetylsalicylic acid on platelets.
• chlorpromazine, a medicine used to treat mental disorders. Concurrent use may cause a significant drop in body temperature (severe hypothermia).

Active substances from the pyrazolone group, a group of medicines to which Metamizol Biofarm belongs, may interact with certain medicines:

• anticoagulants
• captopril, a medicine used to treat high blood pressure and certain heart diseases
• lithium, a medicine used to treat mental disorders
• diuretics, e.g., triamterene
• hypotensive agents. It is not known to what extent Metamizol Biofarm leads to such interactions.

Metamizol Biofarm with food, drink, and alcohol

You should not consume alcohol while taking Metamizol Biofarm.

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 metamizol 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 your doctor or pharmacist, you may take a single dose of metamizol in the first and second trimester, provided that the benefits and risks associated with taking the medicine are carefully weighed. Taking metamizol in the first and second trimester is not recommended.
You should not take Metamizol Biofarm 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 in the child, which normally closes only after birth).
Breastfeeding
Metamizol breakdown products pass into breast milk in significant amounts, and the risk to the breastfed infant cannot be excluded. Therefore, it is recommended to avoid repeated use of metamizol during breastfeeding.
In the case of single administration of metamizol, you should discard and discard breast milk for 48 hours after administration.

Driving and using machines

Within the recommended dose range, no adverse effects have been observed that affect reaction and concentration.
However, as a precaution, when taking higher doses, you should consider the possibility of impaired ability to react and concentrate and refrain from operating machinery, driving vehicles, or performing activities that involve risk. This applies especially to concurrent use with alcohol.

Metamizol Biofarm contains sodium

The medicine contains 34.52 mg of sodium (a major component of table salt) per 1 mL of solution (20 drops). This corresponds to 1.7% of the maximum recommended daily sodium intake in the diet for adults. If you need to follow a low-sodium diet, you should take this into account.

Metamizol Biofarm contains glucose (flavoring component)

If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking the medicine.

3. How to take Metamizol Biofarm

This medicine should always be taken as directed by your doctor. If you have any doubts, you should consult your doctor.
The dose depends on the severity of the pain or fever and the individual's response to Metamizol Biofarm.
You should always choose the smallest dose necessary to control the pain and/or fever. Your attending doctor will tell you how to take Metamizol Biofarm.
The following table shows the recommended single doses and maximum daily doses depending on body weight or age:
Single doses can be administered up to four times a day, depending on the maximum daily dose.
A noticeable effect can be expected within 30 to 60 minutes after oral administration.
Use in children and adolescents
Use in children and adolescents
In the treatment of pain in children and adolescents up to 14 years of age, Metamizol Biofarm can be administered in a single dose of 8 to 16 mg per kilogram of body weight (see table above). In the case of fever in children, a dose of Metamizol Biofarm of 10 mg per kilogram of body weight is usually sufficient:

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 metamizol breakdown products.
Patient with kidney or liver function disorders
Due to the reduced elimination rate in patients with kidney or liver function disorders, it is recommended to 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.
Administration
Oral administration.
It is recommended to take the drops with a small amount of water (about ½ glass).
The medicine can be taken regardless of meals.
To open the bottle, you should unscrew the cap by turning it counterclockwise. Then, you should turn the bottle upside down so that the opening is facing down. If the drops do not come out immediately, you can gently tap the bottom of the bottle with your finger. The drops will come out at equal intervals, allowing for precise dosing.
After use, you should tightly screw the cap back on by turning it clockwise. Store the bottle in the carton.
Duration of treatment
The duration of treatment depends on the type and severity of symptoms and is determined by your doctor.
You should not take painkillers for more than 3 to 5 days unless you have consulted your doctor again.
Taking a higher dose of Metamizol Biofarm than recommended
If you have taken a higher dose of the medicine than recommended, you should immediately consult your doctor or pharmacist.

• When overdosing, the following symptoms may occur: nausea, vomiting, abdominal pain, dizziness, drowsiness, loss of consciousness, decreased blood pressure, shock, worsening of renal function up to acute renal failure, seizures, and rapid heartbeat.

Note: After taking very high doses, the excretion of a harmless metabolite (rubazonic acid) may cause red discoloration of the urine.

If you miss a dose of Metamizol Biofarm

You should not take a double dose if you miss a previous 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.

Side effects that may have serious consequences and require immediate discontinuation of Metamizol Biofarm and urgent medical attention.

If you experience any of the following side effects, you should contact your doctor immediately. Some side effects (e.g., severe hypersensitivity reactions, severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, agranulocytosis, pancytopenia) can be life-threatening. You should never take Metamizol Biofarm without medical supervision. Stopping the medicine at the right time may be crucial.
If you experience symptoms of agranulocytosis, pancytopenia, or thrombocytopenia (see below), you should immediately stop taking Metamizol Biofarm and have a blood test (including a blood smear) performed by your doctor. Treatment should be stopped immediately, and you should not wait for the laboratory test results.

You should stop taking Metamizol Biofarm and contact your doctor immediately if you experience any of the following symptoms:

 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 possible side effects:

Uncommon side effects (occurring in less than 1 in 100 people)

 purple to dark red skin rash, sometimes with blisters (drug rash),
 excessive decrease in 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, tremors, dizziness, nausea, and loss of consciousness.

Rare side effects (occurring in less than 1 in 1,000 people)

 allergic reactions (anaphylactoid or anaphylactic reactions). Typical symptoms of mild reactions may include: burning eyes, cough, nasal symptoms, nasal congestion, chest pain, facial flushing (especially of the face and head), urticaria, and angioedema - and rarely - nausea and stomach cramps. Particularly important symptoms are a feeling of heat on and under the tongue and especially on the palms and soles.
Such mild reactions can progress to more severe forms, with generalized urticaria, severe angioedema (including laryngeal edema), severe bronchial constriction (constrictive narrowing of the airways), increased heart rate (sometimes decreased), arrhythmias, decreased blood pressure (sometimes preceded by an increase), loss of consciousness, and shock. These reactions can occur even if the medicine was previously taken without complications and can be life-threatening, sometimes leading to death.
In patients with aspirin-induced asthma, allergic reactions are manifested by asthma attacks (see section 2 "When not to take Metamizol Biofarm").
 decreased white blood cell count (leukopenia),
 skin rash (e.g., maculopapular rash).

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

 significant decrease in the number of certain white blood cells (agranulocytosis), including cases with a fatal outcome, or decrease in platelet count (thrombocytopenia). These reactions are probably immunological. They can also occur when metamizol was previously taken without complications.
Symptoms of agranulocytosis: fever, chills, sore throat, difficulty swallowing, and inflammatory conditions of the mouth, nose, throat, and genital or anal area. However, in patients taking antibiotics (medicines used to treat bacterial infections), these symptoms may be less severe. The erythrocyte sedimentation rate is significantly increased, while lymph nodes are usually only slightly or not at all enlarged.
Symptoms of thrombocytopenia include increased bleeding tendency and petechiae (small bleeding spots in the skin and mucous membranes).
 asthma attacks (constrictive narrowing of the airways),
 formation of extensive blisters and skin changes (Stevens-Johnson syndrome and toxic epidermal necrolysis),
 worsening of renal function, in some cases with decreased or absent urine output (oliguria or anuria), proteinuria, or acute renal 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),
 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. Symptoms of pancytopenia and aplastic anemia include: general malaise, infection, persistent fever, bruising, bleeding, and pallor.
 gastrointestinal bleeding,
 hepatitis, jaundice, and increased liver enzyme activity in the blood,
 severe skin reactions.
You should stop taking Metamizol Biofarm and seek medical attention immediately if you experience any of the following severe side effects:
 red, flat spots on the torso in the shape of a target or round, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genital or anal area, and eyes. The occurrence of such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
 widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
The excretion of a harmless metabolite of metamizol (rubazonic acid) may cause red discoloration of the urine.
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, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 Metamizol Biofarm

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 after "EXP".
The expiry date refers to the last day of the month stated.
There are no special storage instructions for the medicinal product.
Store in the original packaging to protect from light.
Do not use for more than 6 months after opening.
Do not use this medicine if you notice any change in the appearance of the solution.
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 Metamizol Biofarm contains

The active substance of the medicine is metamizol sodium monohydrate.
Each 1 mL (20 drops) contains 500 mg of metamizol sodium monohydrate.
1 drop contains 25 mg of metamizol sodium monohydrate.
The other ingredients are: sodium citrate, sodium cyclamate, sodium saccharin, citric acid.
Strawberry flavor:
Flavoring substances (cis-3-hexenol, furaneol, maltol, methyl cinnamate, ethyl 2-methylbutyrate, ethyl caproate, 2-methylbutyric acid, ethyl butyrate, trans-2-hexenal, gamma-decalactone)
Natural flavoring substances (capronic acid Nat)
Carrier (anhydrous glucose syrup, corn, gum arabic, silicon dioxide)
Purified water

What Metamizol Biofarm looks like and what the packaging contains

Oral drops, solution
Clear, light yellow solution.
Bottle made of orange glass type III with an HDPE screw cap and an LDPE dropper, in a cardboard box.
Metamizol Biofarm is available in a 20 mL (400 drops) packaging.

Marketing authorization holder and manufacturer

Marketing authorization holder

Solinea Sp. z o.o.
Elizówka, Szafranowa 6
21-003 Ciecierzyn
Phone: +48 81 463-48-82

Manufacturer

Chemax Pharma Ltd
8A, Goritsa Str, Sofia
1618, Bulgaria
Date of last revision of the leaflet: