Metamizolum natricum monohydricum
Metamizol-SF contains the active substance metamizole sodium monohydrate and is a pain-relieving and antipyretic medicine belonging to the group of medicines called pyrazolones.
Metamizol-SF is used to treat:
The solution for injection is used only when treatment with other pharmaceutical forms (tablets, oral solution, suppositories) is not possible.
Before starting treatment with Metamizol-SF, you should discuss it with your doctor.
Agranulocytosis (a severely decreased number of white blood cells)
Metamizol-SF 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).
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 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 can develop at any time during treatment with Metamizol-SF, even after a short period of treatment.
Agranulocytosis can occur even if metamizole was previously administered without complications.
Metamizol-SF contains metamizole, which is associated with a rare but life-threatening risk of:
If the patient has experienced symptoms of a decrease in the number of all blood cells (pancytopenia), such as general malaise, infection, persistent fever, bruising, bleeding, pallor, or a decrease in platelet count (thrombocytopenia), such as increased bleeding tendency, small bleeding in the skin and mucous membranes, you should stop taking Metamizol-SF immediately and consult your doctor as soon as possible (see section 4 "Possible side effects").
If the patient has an allergic reaction to Metamizol-SF, they are also particularly at risk of a similar reaction to other painkillers.
If the patient has had an allergic reaction or other immune system reaction (e.g. agranulocytosis) to Metamizol-SF, they are also particularly at risk of a similar reaction to other pyrazolones and pyrazolidines (similar chemical substances), such as phenazone, propyphenazone, phenylbutazone, oxyphenbutazone.
If the patient has had 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-SF (see section 2 "When not to take Metamizol-SF").
When choosing the method of administration, it should be taken into account that parenteral administration (intramuscular or intravenous) is associated with a higher risk of hypersensitivity reactions.
Severe hypersensitivity reactions
The risk of severe hypersensitivity reactions is higher during treatment with Metamizol-SF than during treatment with medicines containing metamizole in oral or suppository form.
If the patient has one of the following conditions, the risk of severe hypersensitivity reactions to Metamizol-SF is significantly increased:
Patient with an increased risk of hypersensitivity reactions can be given Metamizol-SF only after careful assessment of the benefit-risk ratio (see section 2 "When not to take Metamizol-SF"). In such cases, the patient must be under close medical supervision, with the possibility of providing assistance (rescue equipment) in case of an emergency.
Particularly in patients with allergies, anaphylactic shock may occur (see section 4 "Possible side effects"). Therefore, during treatment with this medicine, special caution is recommended 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), 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 had severe skin reactions, they should never be treated with Metamizol-SF again (see section 4 "Possible side effects").
Liver disorders
Metamizole has been associated with cases of liver inflammation, with symptoms appearing within a few days to a few months after starting treatment.
You should stop taking Metamizol-SF 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.
The patient should not take Metamizol-SF if they have previously taken any medicinal products containing metamizole and had liver disorders.
Decrease in blood pressure
Metamizol-SF may cause a decrease in blood pressure (see section 4 "Possible side effects"). This reaction occurs more frequently after intravenous injection than after oral administration.
The risk of such a reaction is higher:
In order to minimize the risk of a decrease in blood pressure, the use of Metamizol-SF must be carefully considered (see section 2 "When not to take Metamizol-SF") and closely monitored. Appropriate preventive measures (e.g. correction of circulatory disorders) may also be necessary.
Metamizol-SF can only be used if the patient's circulatory parameters are closely monitored, if the patient should avoid decreases in blood pressure, e.g.:
In order to minimize the risk of a severe decrease in blood pressure and to ensure that the administration of the medicine can be terminated at the first signs of a hypersensitivity reaction, the intravenous injection of Metamizol-SF should be very slow, i.e. no faster than 1 ml (500 mg metamizole) per minute.
Patient with impaired liver or kidney function
If the patient has impaired liver or kidney function, Metamizol-SF can only be administered after careful assessment of the benefit-risk ratio and with appropriate preventive measures (see section 3 "Patients with impaired renal or hepatic function").
Metamizol-SF should not be used with other medicines if the possibility of incompatibility has not been previously established.
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.
In particular, you should inform your doctor about the following medicines that may interact with Metamizol-SF and medicines that may be affected by Metamizol-SF:
Active substances from the pyrazolone group (to which metamizole belongs) may interact with certain medicines:
The extent to which metamizole leads to such interactions is not known.
Effect on laboratory test results
Before performing any laboratory tests, you should inform your doctor that you are taking Metamizol-SF, as metamizole may affect the results of certain tests, e.g. determination of creatinine, triglycerides, HDL cholesterol, or uric acid levels in the blood.
You should not consume alcohol while taking Metamizol-SF.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Available data on the use of metamizole during the first 3 months of pregnancy are limited, but do not indicate a harmful effect on the fetus. In selected cases, if there are no other treatment options, after consulting a doctor or pharmacist, a woman may take a single dose of metamizole during the first and second trimester, provided that the benefits and risks associated with taking the medicine are carefully weighed. Administration of metamizole during the first and second trimester is not recommended.
You should not take Metamizol-SF during the last three months of pregnancy due to the increased risk of complications in the mother and child (bleeding, premature closure of the fetal ductus arteriosus, which normally closes after birth).
Breastfeeding
Metamizole metabolites pass into breast milk in significant amounts, and the risk to the breastfed infant cannot be excluded. Therefore, repeated use of metamizole during breastfeeding should be avoided. In the case of a single administration of metamizole, mothers should be advised to discard breast milk for 48 hours after administration.
Within the recommended dose range, no impairment of concentration and reaction time has been observed. However, as a precaution, you should take into account the possibility of impaired concentration and reaction time, especially when taking higher doses, and avoid operating machinery, driving, or performing activities that involve risk. This is especially true when combining with alcohol.
The medicine contains 32.7 mg of sodium (a major component of table salt) per ml. This corresponds to 1.64% of the maximum recommended daily intake of sodium in the diet for adults.
The dose depends on the severity of the pain or fever and the individual's response to Metamizol-SF. Metamizol-SF will be administered by intravenous or intramuscular injection.
If a single dose is not sufficiently effective or if the analgesic effect weakens over time, your doctor may administer another dose, without exceeding the maximum daily dose specified below.
You should always use the smallest effective dose that allows you to control the pain and fever.
A noticeable effect of the medicine can be expected within 30 minutes of administration. Depending on the maximum daily dose, a single dose can be administered up to 4 times a day, at intervals of 6-8 hours.
Adults and adolescents aged 15 and over
Adults and adolescents aged 15 and over (with a body weight over 53 kg) can be given 1-2 ml intravenously or intramuscularly as a single dose; if necessary, the single dose can be increased to a maximum of 5 ml (corresponding to 2500 mg Metamizol-SF). The maximum daily dose is 8 ml; if necessary, the daily dose can be increased to a maximum of 10 ml (corresponding to 5000 mg Metamizol-SF).
Infants and children
You should follow the dosage schedule below for single intravenous or intramuscular doses:
Age range in children (body weight)
Single dose
Maximum daily dose
Infants aged 3-11 months (5-8 kg)
0.1 – 0.2 ml
0.4 – 0.8 ml
1-3 years (9-15 kg)
0.2 – 0.5 ml
0.8 – 2.0 ml
4-6 years (16-23 kg)
0.3 – 0.8 ml
1.2 – 3.2 ml
7-9 years (24-30 kg)
0.4 – 1.0 ml
1.6 – 4.0 ml
10-12 years (31-45 kg)
0.5 – 1.4 ml
2.0 – 5.6 ml
13-14 years (46-53 kg)
0.8 – 1.8 ml
3.2 – 7.2 ml
Special patient groups
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 metamizole metabolites.
Patient with impaired renal or hepatic function
Due to the decreased elimination rate in patients with impaired renal or hepatic function, high doses should be avoided. In the case of short-term use, dose reduction is not required. There is a lack of data on long-term use.
Duration of treatment
The duration of treatment depends on the type and severity of the disease and will be determined by your doctor.
You should not take painkillers for more than 3 to 5 days, unless you have consulted your doctor or dentist.
Symptoms of overdose are:
If you have taken more than the recommended dose, you should contact your doctor immediately to receive appropriate countermeasures.
Note: In the case of high doses, the excretion of a harmless metamizole metabolite may cause red discoloration of the urine.
If you have any further doubts about the use of this medicine, you should consult your doctor.
Like all medicines, Metamizol-SF can cause side effects, although not everybody gets them.
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. In no case should you take Metamizol-SF without medical supervision.
Stopping the treatment may be crucial.
If you experience symptoms of agranulocytosis, pancytopenia, or thrombocytopenia (see below and section 2 "Warnings and precautions"), you should stop taking Metamizol-SF immediately, and your doctor should order a blood test, including a blood smear. Treatment should be discontinued even before the laboratory test results are available.
You should stop taking Metamizol-SF 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".
You should stop taking Metamizol-SF and seek medical attention immediately if you experience any of the following severe side effects:
Red discoloration of the urine may occur due to the excretion of a harmless metamizole metabolite.
Local reactions
At the injection site, pain and local reactions may occur, very rarely leading to phlebitis.
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. 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.
The medicine should be stored out of sight and reach of children.
There are no special storage instructions for the medicine. Do not store in the refrigerator or freeze.
Store the ampoule in the outer packaging to protect it from light.
The medicine should be used immediately after opening or dilution.
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.
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.
1 ml of Metamizol-SF contains 500 mg of metamizole sodium monohydrate.
Clear, colorless to yellowish solution for injection.
Metamizol-SF is available in ampoules made of orange glass type I with a break point (OPC), containing 2 or 5 ml of solution, in a cardboard box.
Pack sizes:
5 ampoules of 2 ml,
10 ampoules of 2 ml,
5 ampoules of 5 ml,
10 ampoules of 5 ml.
Not all pack sizes may be marketed.
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
phone: +48 22 350 66 69
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
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The dose of the medicine depends on the severity of the pain or fever and the individual's sensitivity to Metamizol-SF.
The choice of the smallest effective dose that allows control of pain and fever is crucial.
In children and adolescents under 14 years of age, metamizole can be administered in a single dose of 8 to 16 mg per kilogram of body weight. In the case of fever in children, a dose of 10 mg per kilogram of body weight is usually sufficient. Adults and adolescents over 15 years of age (body weight >53 kg) can be given a maximum of 1000 mg of metamizole as a single dose.
Depending on the maximum daily dose, a single dose can be administered up to 4 times a day, at intervals of 6-8 hours.
If necessary, the single dose can be increased to 5 ml (corresponding to 2500 mg of metamizole), and the daily dose can be increased to 10 ml (corresponding to 5000 mg of metamizole).
Since the decrease in blood pressure in response to the injection of the medicine may depend on the dose, the administration of a dose of Metamizol-SF greater than 2 ml (1000 mg of metamizole) must be strictly justified.
Method of administration and precautions
Metamizol-SF is administered intravenously or intramuscularly. Intramuscular injection should always be performed using a solution at body temperature.
Metamizol-SF can be diluted or mixed with a 0.9% sodium chloride solution. However, such a mixture has only limited stability, so it should be administered immediately.
Due to the possibility of incompatibility, it is not recommended to administer Metamizol-SF in the form of injections or infusions together with other medicines.
Parenteral administration of Metamizol-SF must be performed with the patient in a supine position and under close medical supervision.
In the event of symptoms of agranulocytosis, pancytopenia, thrombocytopenia, or severe skin reactions (see "Warnings and precautions" in section 2), you should stop taking Metamizol-SF immediately.
In order to minimize the risk of hypotensive reactions and to ensure that the administration of the medicine can be terminated at the first signs of a hypersensitivity reaction, the intravenous injection of Metamizol-SF should be very slow, i.e. no faster than 1 ml (500 mg of metamizole) per minute.
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