Patient Information Leaflet

Metamizol-SF, 500 mg/ml, solution for injection
Metamizolum natricum monohydricum
Metamizol-SF may cause a severely low white blood cell count (agranulocytosis), which
can lead to severe and life-threatening infections (see section 4).
You must stop using the medicine and contact your doctor immediately if any of the
following symptoms occur: fever, chills, sore throat, painful sores in the nose, mouth,
throat, genital area or around the anus.
If the patient has ever had agranulocytosis while taking metamizole or similar medicines,
this medicine must never be used again in the future (see section 2).
Please read this leaflet carefully before using the medicine, as it contains information
important for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Metamizol-SF is and what it is used for
Important information before using Metamizol-SF
How to use Metamizol-SF
Possible side effects
How to store Metamizol-SF
Contents of the pack and other information

1. What Metamizol-SF is and what it is used for

Metamizol-SF contains the active substance metamizole sodium monohydrate and is a
medicine with analgesic and antipyretic effects, belonging to a group of medicines called
pyrazolones.
Metamizol-SF is used to treat:

acute, severe pain following injuries or surgery,
colicky abdominal pain (colic),
pain in cancer diseases,
other acute and prolonged severe pain when other treatment methods are not indicated,
high fever unresponsive to other treatments.

The solution for injection is used only when treatment with other pharmaceutical forms
(tablets, oral solution, suppositories) is not possible.

2. Important information before using Metamizol-SF

When not to use Metamizol-SF:

if the patient has previously experienced a significant decrease in the number of white blood cells called granulocytes, caused by metamizole or other similar medicines known as pyrazolones or pyrazolidines;
if the patient has impaired bone marrow function or a disorder affecting the production or function of blood cells;
if the patient is allergic to metamizole or other pyrazolones (e.g. propyphenazone, phenazone) or pyrazolidines (e.g. phenylbutazone, oxyphenbutazone); This also applies to patients who have experienced severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)) after using these substances (see section "Warnings and precautions");
if the patient is allergic to any of the excipients listed in section 6;
if the patient has intolerance to painkillers (analgesic asthma syndrome or intolerance to painkillers, manifesting as urticaria, angioedema); This applies to patients who react with sudden narrowing of the airways or other hypersensitivity reactions such as urticaria with itching and blisters, rhinitis, angioedema, to painkillers such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin or naproxen;
if the patient has a hereditary condition (congenital defect) associated with a risk of red blood cell breakdown (congenital glucose-6-phosphate dehydrogenase deficiency);
if the patient has a hereditary condition causing disturbances in haemoglobin synthesis (acute intermittent porphyria);
if the patient has low blood pressure or circulatory disorders;
if the patient is in the last three months of pregnancy (third trimester of pregnancy).

Warnings and precautions
Before starting treatment with Metamizol-SF, discuss this with your doctor.
Low white blood cell count (agranulocytosis)
Metamizol-SF 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 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 laboratory tests to check your blood cell count.
If metamizole is used for fever, some symptoms of developing agranulocytosis may remain unnoticed. Similarly, symptoms may also be masked if the patient is receiving antibiotics.
Agranulocytosis may develop at any time during treatment with Metamizol-SF, and even shortly after stopping metamizole.
Agranulocytosis may occur even if metamizole was previously administered without complications.
Metamizol-SF contains metamizole, the use of which is associated with a rare but life-threatening risk of:

sudden circulatory shock (circulatory collapse);
agranulocytosis (acute disorder caused by a significant decrease in the number of granulocytes, a type of white blood cells).

If the patient develops symptoms of decreased number of all blood cells (pancytopenia), e.g. general malaise, infection, persistent fever, bruising, bleeding, pallor, or of platelets (thrombocytopenia), e.g. increased tendency to bleed, small bleedings in the skin and mucous membranes, treatment with Metamizol-SF must be stopped immediately and medical advice sought as soon as possible (see section 4 "Possible side effects").
If the patient experiences an allergic-type reaction to Metamizol-SF, they are also particularly at risk of a similar reaction to other painkillers.
If the patient has or has had an allergic reaction or another immunological 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 or has had an allergic reaction or another immunological 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 use Metamizol-SF").
When choosing the route of administration, it should be taken into account that parenteral administration (intramuscular or intravenous) carries a higher risk of hypersensitivity reactions.
Severe hypersensitivity reactions
The risk of severe hypersensitivity reactions is greater when using Metamizol-SF than when using medicines containing metamizole in oral form or suppositories.
If the patient has any of the following conditions, the risk of severe hypersensitivity reactions to Metamizol-SF is significantly increased:

intolerance to drugs used to treat pain and rheumatism, manifesting as, e.g., urticaria with itching and blisters or angioedema; In such cases, Metamizol-SF should not be used. More information can be found in section 2 "When not to use Metamizol-SF".
asthma attacks, e.g. associated with asthma, especially when occurring simultaneously with nasal polyps or rhinosinusitis;
chronic urticaria;
hypersensitivity to certain dyes (e.g. tartrazine) or preservatives (e.g. benzoates);
alcohol intolerance; If the patient reacts even to small amounts of alcohol with sneezing, tearing eyes and severe facial flushing, this may indicate previously undiagnosed intolerance to painkillers (see section 2 "When not to use Metamizol-SF").

Metamizol-SF may be administered to patients at increased risk of hypersensitivity reactions only after a thorough benefit-risk assessment (see section 2 "When not to use Metamizol-SF"). In such cases, the patient must be under strict medical supervision, with emergency equipment available.
Particularly in patients with allergies, anaphylactic shock may occur (see section 4 "Possible side effects"). Therefore, particular caution is advised when using the medicine in patients with asthma or 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 metamizole treatment. If the patient develops any of these symptoms related to severe skin reactions listed in section 4, metamizole treatment must be discontinued and immediate medical help sought.
If the patient has ever experienced severe skin reactions, Metamizol-SF treatment should never be repeated in the future (see section 4 "Possible side effects").
Liver-related disorders
Cases of hepatitis have occurred in patients taking metamizole, with symptoms appearing from several days to several months after starting treatment.
Metamizol-SF treatment should be discontinued and medical advice sought if the patient experiences liver-related symptoms such as: malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, jaundice (yellowing of the skin or whites of the eyes), itching, rash, or upper abdominal pain. The doctor will check the patient's liver function.
The patient should not take Metamizol-SF if they have previously used any medicinal products containing metamizole and experienced liver-related disorders.
Decrease (lowering) of blood pressure
Metamizol-SF may cause a decrease in blood pressure (see section 4 "Possible side effects"). This reaction occurs more frequently after injection of the medicine than after oral administration, e.g. tablets.
The risk of such a reaction is higher:

if intravenous administration is too rapid;
if the patient has low blood pressure, is severely dehydrated, has circulatory disorders or early-stage circulatory failure (e.g. patients with myocardial infarction or severe trauma);
if the patient has high fever.

To reduce the risk of decreased blood pressure, the use of Metamizol-SF must be carefully considered (see section 2 "When not to use Metamizol-SF") and closely monitored. Preventive measures may also be necessary (e.g. correction of circulatory disturbances).
Metamizol-SF may only be used when circulatory parameters are carefully monitored, if the patient should avoid drops in blood pressure, e.g.:

if the patient has severe coronary artery disease;
if the patient has significant cerebral vessel stenosis (reduced blood flow in brain vessels).

To minimize the risk of severe drop in blood pressure and ensure that administration can be stopped at the first signs of hypersensitivity reaction, intravenous injection of Metamizol-SF should be very slow, i.e. no faster than 1 ml (500 mg of metamizole) per minute.
Patients with impaired liver or kidney function
If the patient has impaired liver or kidney function, Metamizol-SF may only be administered after a thorough benefit-risk assessment and with appropriate preventive measures (see section 3 "Patients with impaired kidney or liver function").
Metamizol-SF should not be used with other medicines if the possibility of incompatibility has not been previously established.
Metamizol-SF and other medicines
You should tell your doctor or pharmacist about all medicines currently or recently used, as well as any medicines you plan to use.
In particular, inform your doctor about the following medicines, which may affect Metamizol-SF and medicines which may be affected by Metamizol-SF:

cyclosporine, a medicine used to suppress the immune system. In case of concomitant use, the doctor will monitor cyclosporine blood levels;
methotrexate, a medicine used in cancer or rheumatic disease treatment. Concomitant use may increase the harmful effects of methotrexate on the haematopoietic system, especially in elderly patients. Therefore, combination of these medicines should be avoided;
acetylsalicylic acid, taken in low doses for heart protection. Metamizole may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and clot formation) if these medicines are used simultaneously. Therefore, caution is advised when using metamizole in patients receiving acetylsalicylic acid;
bupropion, a medicine used to treat depression or as an aid in smoking cessation. Concomitant use may reduce bupropion blood levels;
efavirenz, a medicine used to treat HIV infection (AIDS);
methadone, a medicine used in the treatment of addiction to illegal narcotics (so-called opioids);
valproate, a medicine used to treat epilepsy or bipolar affective disorder;
tacrolimus, a medicine used to prevent organ rejection in transplant patients;
sertraline, a medicine used to treat depression;
chlorpromazine, a medicine used to treat psychiatric disorders. Concomitant use may lead to severe lowering of body temperature.

Active substances from the pyrazolone group (including metamizole) may cause interactions with some medicines:

anticoagulants (oral anticoagulants),
captopril (a medicine used to treat hypertension and certain heart conditions),
lithium (a medicine used to treat psychiatric disorders),
diuretics used to increase urine output (e.g. triamterene),
antihypertensives (medicines used to treat hypertension).

It is not known to what extent metamizole causes such interactions.
Effect on laboratory test results
Before undergoing any laboratory tests, inform your doctor about the use of Metamizol-SF, as metamizole may affect the results of certain tests, e.g. blood creatinine levels, triglycerides, HDL cholesterol or uric acid levels.
Metamizol-SF and alcohol
Do not consume alcohol while taking Metamizol-SF.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Available data on the use of metamizole during the first 3 months of pregnancy are limited, but do not indicate harmful effects on the embryo. In selected cases, if no other treatment options are available, after consultation with a doctor or pharmacist, the patient may take single doses of metamizole during the first and second trimesters, provided that the benefits and risks of taking the medicine are carefully considered. Administration of metamizole during the first and second trimesters is not recommended.
Metamizol-SF must not be taken during the last three months of pregnancy due to increased risk of complications for mother and child (bleeding, premature closure in the unborn child of an important vessel, the so-called Botalli duct, which normally closes only after birth).
Breastfeeding
Metamizole metabolites pass into breast milk in significant amounts, and risk to the breastfed infant cannot be excluded. Therefore, repeated use of metamizole should be particularly avoided during breastfeeding. After a single dose of metamizole, mothers should be advised to express and discard milk for 48 hours after administration.
Driving and operating machinery
At the recommended dosage range, no impairment of concentration or reaction ability has been observed. However, as a precaution, especially when higher doses are used, the possibility of impaired ability should be considered, and operation of machinery, driving vehicles or performing tasks involving risk should be avoided. This is particularly relevant in case of concomitant use with alcohol.
Metamizol-SF contains sodium
The medicine contains 32.7 mg of sodium (main component of table salt) in each ml. This corresponds to 1.64% of the maximum recommended daily sodium intake in the diet of adults.

3. How to use Metamizol-SF

The dose depends on the severity of pain or fever and the individual's response to Metamizol-SF.
Metamizol-SF will be administered as intravenous or intramuscular injections.
If a single dose is insufficiently effective or if the analgesic effect diminishes over time, the doctor may administer another dose, without exceeding the maximum daily dose specified below.
The lowest effective dose that controls pain and fever should always be used.
A noticeable effect of the medicine can be expected within 30 minutes after administration. Depending on the maximum daily dose, a single dose may be administered up to 4 times daily, at intervals of 6–8 hours.

Adults and adolescents aged 15 years and older
For adults and adolescents aged 15 years or older (with body weight exceeding 53 kg), a single intravenous or intramuscular dose of 1–2 ml may be administered; if necessary, the single dose may be increased up to a maximum of 5 ml (corresponding to 2500 mg of Metamizol-SF). The maximum daily dose is 8 ml; if necessary, the daily dose may be increased up to a maximum of 10 ml (corresponding to 5000 mg of Metamizol-SF).

Infants and children
The following dosing schedule should be followed for single intravenous or intramuscular doses:

| Age group in children (body weight) | Single dose | Maximum daily dose | |-------------------------------------|-------------|--------------------| | Infants 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, debilitated patients, and patients with impaired renal function, the dose should be reduced due to the possibility of prolonged elimination of metamizole metabolites.

Patients with impaired renal or hepatic function
Due to reduced elimination rate in patients with impaired renal or hepatic function, repeated administration of high doses should be avoided. Dose reduction is not required for short-term use. There are no data available regarding long-term use.

Duration of treatment
The duration of treatment depends on the type and stage of the disease and will be determined by the physician.
Analgesic medicines should not be used for longer than 3 to 5 days unless otherwise advised by a doctor or dentist.

Use of a higher than recommended dose of Metamizol-SF
Symptoms of overdose include:

nausea, vomiting, abdominal pain;
impaired renal function up to acute renal failure;
dizziness, drowsiness, loss of consciousness;
seizures;
drop in blood pressure up to circulatory shock;
rapid heartbeat.

In case of overdose, immediate contact with a physician is required to initiate appropriate countermeasures.
Note: After administration of higher doses, excretion of a harmless metabolite of metamizole may cause red discoloration of urine.
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions that may have serious consequences, requiring immediate
discontinuation of Metamizol-SF and prompt contact with a physician.
If any of the following adverse reactions occur suddenly or progress rapidly in a patient, immediate medical advice must be sought. Some adverse reactions (e.g. severe hypersensitivity reactions, severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, agranulocytosis, pancytopenia) may be life-threatening. Under no circumstances should Metamizol-SF be used without medical supervision. Prompt discontinuation of the drug may be crucial.
If symptoms of agranulocytosis, pancytopenia or thrombocytopenia occur (see below and section 2 "Warnings and precautions"), Metamizol-SF must be discontinued immediately and the physician should order a blood test, including a blood smear examination. The drug should be discontinued even before laboratory results are available.
Metamizol-SF must be discontinued and immediate medical help sought if any of the following symptoms occur:
General malaise (nausea or vomiting), fever, feeling of 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".

Other adverse reactions
Uncommon (may occur in up to 1 in 100 people)

Purple to dark red rash, sometimes vesicular (drug eruption);
Decrease in blood pressure, which is likely due to the direct effect of the drug and not accompanied by other signs of hypersensitivity. Only in rare cases do these reactions lead to a significant drop in blood pressure. Rapid intravenous injection increases the risk of hypotension. The risk of hypotension may be greater in patients with high fever. Typical symptoms of excessive drop in blood pressure include rapid heartbeat, pallor, tremors, dizziness, nausea and loss of consciousness.

Rare (may occur in up to 1 in 1,000 people)

Hypersensitivity reactions (anaphylactic or anaphylactoid reactions); Symptoms of milder reactions include:
- Burning sensation in the eyes,
- Cough, runny nose, sneezing,
- Feeling of tightness in the chest,
- Skin redness, especially in the face and head area,
- Urticaria and facial swelling,
- Less frequently - nausea and abdominal cramps. Symptoms requiring particular attention include burning, itching and sensation of warmth on the tongue and underneath it, as well as on the palms and soles. These milder reactions may progress to more severe forms such as:
- Severe urticaria,
- Severe angioedema (swelling, including in the larynx),
- Severe bronchospasm,
- Rapid heartbeat, sometimes abnormally slow heartbeat, cardiac arrhythmia,
- Drop in blood pressure, sometimes preceded by a rise,
- Loss of consciousness, circulatory shock. These reactions may occur particularly after intravenous administration, may be severe or life-threatening, and in some cases may even be fatal. They may occur despite previous uneventful use of this medicine. In patients with analgesic asthma syndrome, hypersensitivity reactions manifest as typical asthma attacks (see section 2 "When not to use Metamizol-SF").
Decreased number of white blood cells in blood (leukopenia);
Skin rash (e.g. maculopapular).

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

Agranulocytosis (marked decrease in granulocytes, a type of white blood cells), including fatal cases, decreased number of blood platelets (thrombocytopenia) (see section 2 "Warnings and precautions"). These reactions are likely immunologically mediated. The above reactions may occur even if metamizole was previously used without complications or even shortly after discontinuation of metamizole. Typical symptoms of agranulocytosis include fever, chills, sore throat, difficulty swallowing, inflammation in the oral cavity, nose, throat, genital organs and rectum. Sedimentation rate of red blood cells is markedly accelerated, while lymph nodes may remain unchanged or only slightly enlarged.
Typical symptoms of thrombocytopenia include, for example, increased bleeding and small hemorrhages in the skin and mucous membranes.
Asthma attacks;
Large areas of skin affected by blisters and skin peeling (Stevens-Johnson syndrome or toxic epidermal necrolysis);
Sudden worsening of kidney function, with some cases developing oliguria or anuria, proteinuria, acute kidney failure, kidney inflammation (acute interstitial nephritis).

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

Sudden circulatory shock due to severe allergic reaction (anaphylactic shock);
Myocardial infarction occurring during an allergic reaction (Kounis syndrome);
Anemia occurring with impaired bone marrow function (aplastic anemia), decreased number of white and red blood cells and platelets (pancytopenia), including fatal cases; Symptoms of aplastic anemia and pancytopenia include general malaise, infections, persistent fever, bruising, bleeding, pallor.
Gastrointestinal bleeding;
Hepatitis, jaundice (yellowing of skin and whites of the eyes), increased liver enzyme activity in blood;
Severe skin reactions.

Metamizole must be discontinued and immediate medical help sought if any of the following severe adverse reactions occur in a patient:

Red, flat spots on the trunk in the shape of a target or circular, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genital organs and eyes. Such severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Red discoloration of urine may occur, caused by excretion of a harmless metabolite of metamizole.

Local reactions
At the injection site, pain and local reactions may occur, very rarely leading to phlebitis.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Metamizol-SF

The medicine should be stored out of sight and reach of children.
There are no special storage temperature requirements for this medicine. Do not store in a
refrigerator or freeze.
Store the ampoule in the outer packaging to protect 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 stated month.
Medicines must 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 package and other information

What Metamizol-SF contains

The active substance is sodium metamizole monohydrate. One vial (2 ml) of Metamizol-SF contains 1000 mg of sodium metamizole monohydrate. One vial (5 ml) of Metamizol-SF contains 2500 mg of sodium metamizole monohydrate.

1 ml of Metamizol-SF contains 500 mg of sodium metamizole monohydrate.

Other ingredient: water for injections.

What Metamizol-SF looks like and contents of the pack
A clear, colourless to yellowish solution for injection.
Metamizol-SF is available in vials made of amber type I glass with an opening point (OPC), containing 2 ml or 5 ml of solution, packed in a cardboard box.
Pack sizes:
5 vials of 2 ml,
10 vials of 2 ml,
5 vials of 5 ml,
10 vials of 5 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
tel. + 48 22 350 66 69

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

Information intended exclusively for healthcare professionals:

Dosage and administration
The dose of the drug depends on the severity of pain or fever and the individual patient's sensitivity to the drug.
It is essential to select the lowest dose sufficient to control pain and fever.
In children and adolescents up to 14 years of age, metamizole may be administered as a single dose of
8 to 16 mg per kilogram of body weight. In children with fever, a dose of
metamizole of 10 mg per kilogram of body weight is usually sufficient. Adults and adolescents aged 15 years and older
(body weight >53 kg) may receive a maximum single dose of 1000 mg of metamizole.
Depending on the maximum daily dose, the single dose may be administered no more frequently than
4 times daily at intervals of 6-8 hours.
If necessary, the single dose may be increased to 5 ml (corresponding to 2500 mg
of metamizole), and the daily dose to 10 ml (corresponding to 5000 mg of metamizole).
Since the reduction in blood pressure in response to drug injection may be dose-dependent,
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 may be diluted or mixed with 0.9% sodium chloride solution. However,
such a mixture has limited stability and should therefore be administered immediately.
Due to the possibility of incompatibility, co-administration of Metamizol-SF with other drugs via the same injection or infusion is not recommended.
Parenteral administration of Metamizol-SF must be performed while the patient is in a lying position and under strict medical supervision.
If symptoms of agranulocytosis, pancytopenia, thrombocytopenia, or severe skin reactions occur (see "Warnings and precautions" in section 2. Information before using Metamizol-SF), treatment with Metamizol-SF must be discontinued immediately.
To minimize the risk of hypotensive reactions and to ensure that administration can be stopped at the first signs of an anaphylactoid or anaphylactic reaction, intravenous injection of Metamizol-SF should be administered very slowly, i.e., no faster than 1 ml (500 mg of metamizole) per minute.

Metamizol-sf