Universal reference book for medicines
Product name: BARALGIN ® M (BARALGIN M)

Active ingredient: metamizole sodium

Type: Analgesic-antipyretic

Manufacturer: SANOFI INDIA (India) manufactured by SANOFI INDIA (India) packed FarmThirm SOTEKS (Russia)
Composition, form of production and packaging
Tablets
from white to almost white, round, flat, engraved "BARALGIN-M" on one side, risk - on the other and a facet on both sides.

1 tab.

metamizole sodium 500 mg

Excipients: macrogol 4000 - 47 mg, magnesium stearate - 3 mg.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (5) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

An analgesic non-narcotic agent, a derivative of pyrazolone, nonselectively blocks COX and reduces the formation of prostaglandins from arachidonic acid.

It prevents painful extra and proprioceptive impulses along the Gaull and Burchard beams, raises the threshold of excitability of thalamic centers of pain sensitivity, increases heat transfer.

A distinctive feature is the slight severity of the anti-inflammatory effect, which causes a weak effect on water-salt metabolism (sodium and water retention) and gastrointestinal mucosa.
Has analgesic, antipyretic and some spasmolytic (with respect to the smooth muscles of the urinary and bile ducts) action.
PHARMACOKINETICS

Metamizole is absorbed well and quickly in the digestive tract.
After oral administration metamizole is completely metabolized with the formation of active 4-N-methylaminoantipyrine.
The association of the active metabolite with the blood plasma proteins is 50-60%.

It is mainly excreted by the kidneys.
After taking 1 g of metamizole, the kidney clearance for 4-N-methylaminoantipyrine was 5 ml ± 2 ml / min. T 1/2 - 2.7 h.
In therapeutic doses penetrates into breast milk.

In patients with cirrhosis of the liver, the half-life of 4-N-methylaminoantipyrine increased 3-fold and was about 10 hours.

INDICATIONS

- pain syndrome of different etiology (mild and moderate severity): incl.
neuralgia, myalgia, arthralgia, biliary colic, intestinal colic, renal colic, trauma, burns, decompression sickness, shingles, orchitis, radiculitis, myositis, postoperative pain syndrome, headache, toothache, algodismenorea;
- febrile syndrome (infectious and inflammatory diseases, insect bites - mosquitoes, bees, gadflies, etc., posttransfusion complications).

DOSING MODE

A single dose for adults and adolescents over 15 years is 500 mg (1 tablet).
The maximum single dose can reach 1000 mg (2 tablets). Unless otherwise prescribed, a single dose can be taken up to 2-3 times / day. The maximum daily dose is 2000 mg (4 tablets).
Duration of admission is no more than 5 days when prescribed as an anesthetic and no more than 3 days as an antipyretic agent.

Tablets should be washed down with a sufficient amount of water.
An increase in the daily dose of the drug or the duration of treatment is possible only under the supervision of a physician.
SIDE EFFECT

Side effects were classified as follows: very often (? 10%), frequent (? 1, <10%), infrequently (? 0.1, <1%), rarely (? 0.01, <0.1%), very rarely (<0.01 %), the frequency is unknown (according to available data it is impossible to estimate the incidence of side effects).

From the heart: the frequency is unknown - the syndrome of Kounis (allergic angina or allergic myocardial infarction).

From the immune system: rarely - metamizole sodium can cause anaphylactic or anaphylactoid reactions, which can be severe and life threatening;
in some cases, anaphylactic reactions can lead to death. In the case of anaphylactic / anaphylactoid reactions, it is necessary to immediately stop taking the drug, take measures to provide patients with emergency medical care, and conduct an extensive clinical blood test. These reactions can occur even if the drug was previously used many times without any complications. Such drug reactions can develop immediately or a few hours after taking metamizole sodium, but usually they are observed for one hour. Usually milder anaphylactic or anaphylactoid reactions manifest themselves as skin symptoms and symptoms from the mucous membranes (itching, burning, flushing, urticaria, edema), dyspnea or complaints from the gastrointestinal tract.
Lighter reactions can progress to severe forms with generalized urticaria, severe angioedema, especially with involvement of the larynx, severe bronchospasm, cardiac rhythm disturbances, a sharp decrease in blood pressure (which is sometimes preceded by an increase in blood pressure), and the development of circulatory shock.

Very rarely - in patients with complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in anamnesis), the reactions of intolerance usually manifest as asthma attacks.

The frequency is unknown - anaphylactic shock.

From the skin and subcutaneous tissues: infrequently - except for manifestations of anaphylactic / anaphylactoid reactions on the skin and mucous membranes listed above, infrequently a fixed drug rash may occur;
rarely - rash may occur; very rarely - possibly the development of Stevens-Johnson syndrome or Lyell's syndrome (toxic epidermal necrolysis).
On the part of the blood and lymphatic system: rarely - leukopenia;
very rarely - agranulocytosis (including cases with fatal outcome), thrombocytopenia; frequency unknown - aplastic anemia, pancytopenia, including fatal cases. These reactions are immunological in nature. They can occur even if the drug was previously taken many times without any complications. Typical symptoms of agranulocytosis are mucosal lesions (oral cavity and pharynx, anorectal area and genital organs), sore throat, fever. It should be borne in mind that if a patient receives antibiotic therapy, typical manifestations of agranulocytosis can be minimally expressed. The rate of erythrocyte sedimentation increases significantly, while the increase in lymph nodes is weak or absent. Typical symptoms of thrombocytopenia are increased tendency to bleeding and the appearance of petechiae on the skin and mucous membranes.
In case of the development of the above violations from the blood and lymphatic system, it is necessary to stop taking the drug and conduct a detailed clinical analysis of the blood (see section "Special instructions").

From the side of the vessels

Isolated hypotonic reactions: infrequently - after administration of the drug, an isolated transient decrease in the blood pressure of anaphylactic / anaphylactoid reactions is possible);
rarely - a decrease in blood pressure can be very pronounced.
From the side of the kidneys and urinary tracts: infrequently - it is possible to stain urine red due to the presence in the urine of the metabolite - rubric acid;
very rarely - there may be a sharp deterioration in kidney function (acute renal failure), especially in patients with kidney disease, in some cases with oliguria, anuria or proteinuria; in some cases, acute interstitial nephritis may occur.
CONTRAINDICATIONS

- Hypersensitivity to metamizole and other components of the drug, as well as to other pyrazolones (phenazone and propiphenazone) or to pyrazolidines (phenylbutazone, oxyphenbutazone), including, for example, indications of an anamnesis on the development of agranulocytosis with the administration of one of these drugs;

- disorders of bone marrow hematopoiesis (for example, after treatment with cytostatics) or diseases of the hematopoietic system;

- An indication of an anamnesis for bronchospasm or other anaphylactic reactions (eg urticaria, rhinitis, angioedema) with analgesics such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen;

- Congenital insufficiency of glucose-6-phosphate dehydrogenase (risk of hemolysis);

- Children's age (up to 15 years);

- Pregnancy (I and III trimester);

- lactation period;

- acute intermittent hepatic porphyria (risk of developing porphyria attacks).

If you have any of these diseases or conditions before taking the drug, check with your doctor.

With caution

- arterial hypotension (systolic blood pressure below 100 mm Hg), decrease in the volume of circulating blood, unstable hemodynamics (myocardial infarction, multiple trauma, beginning shock), heart failure, high fever (increased risk of sudden BP decrease);

- diseases in which a significant reduction in blood pressure may have an increased risk (patients with severe coronary artery disease and stenosis of the cerebral arteries);

- Alcoholism .;

- bronchial asthma, especially in combination with concomitant polyposis rhinosinusitis;
chronic urticaria and other atopy (allergic diseases, in the development of which a significant role belongs to a genetic predisposition to sensitization: pollinosis, allergic rhinitis, etc.) (increased risk of anaphylactic / anaphylactoid reactions);
- alcohol intolerance (reaction even to small amounts of certain alcoholic beverages with symptoms such as itching, lacrimation and pronounced reddening of the face) (increased risk of anaphylactic / anaphylactoid reactions);

- intolerance to dyes (eg tartrazine) or preservatives (eg benzoates) (increased risk of anaphylactic / anaphylactoid reactions);

- pronounced violations of the liver and kidneys (recommended the use of low doses in connection with the possibility of slowing the excretion of metamizole sodium);

- Pregnancy (II trimester).

If you have any of these diseases or conditions before taking the drug, check with your doctor.

PREGNANCY AND LACTATION

Pregnancy

There is insufficient clinical data for the use of metamizole sodium in pregnant women, so use in pregnancy is not recommended.
Metamizole sodium penetrates the placenta. During the first trimester of pregnancy, you can not take Baralgin® M. In the second trimester of pregnancy, the drug Baralgin ® M should be taken under strict medical conditions, and if the expected benefit for the mother exceeds the potential risk to the fetus. The use of sodium metamizole in the third trimester of pregnancy is also contraindicated: it is impossible to exclude the possibility of premature closure of the arterial (botallova) duct and perinatal complications due to the effect on aggregation of platelets of the mother and fetus (as metamizole of sodium is a COX inhibitor, although weak).
Breastfeeding period

Metabolites of metamizole sodium are excreted in breast milk.

In the case of taking the drug during breastfeeding, breastfeeding should be discontinued for at least 48 hours.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution apply the drug to patients with severe renal dysfunction (recommended the use of low doses in connection with the possibility of slowing the excretion of metamizole sodium).

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution apply the drug to patients with severe violations of the liver (recommended the use of low doses in connection with the possibility of slowing the excretion of metamizole sodium).

APPLICATION FOR CHILDREN

Contraindicated use of the drug for children and adolescents under the age of 15 years.

SPECIAL INSTRUCTIONS

In the treatment of patients receiving cytotoxic drugs, the use of metamizole sodium should only be performed under the supervision of a physician.

Anaphylactic / apaphylactoid reactions

During pregnancy, especially in the first 3 months and the last 3 months, you can not use any non-steroidal anti-inflammatory drugs.

The increased risk of hypersensitivity reactions to metamizole sodium is caused by the following conditions:

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in anamnesis);

- chronic urticaria;

- Alcohol intolerance (hypersensitivity to alcohol), against which, even with the intake of a small amount of some alcoholic beverages, patients experience sneezing, lacrimation and severe reddening of the face.
Alcohol intolerance may indicate a previously unidentified syndrome of aspirin asthma;
- intolerance or hypersensitivity to dyes (for example, to tartrazine) or to preservatives (for example, benzoate).

Before using metamizole sodium it is necessary to conduct a thorough questioning of the patient.
If the risk of developing an anaphylactoid reaction is detected, admission may be possible only after determining the risk / benefit ratio.
In the case of sodium metamizole, these patients need strict medical supervision of their condition and need to have the means to provide them with emergency care in case of anaphylactic / anaphylactoid reactions.

In predisposed patients, anaphylactic shock can occur, so patients with asthma or atopy metamizole sodium should be administered with caution.

Severe skin reactions

With the use of metamizole sodium, life-threatening skin reactions, such as Stevens-Johnson syndrome (SSD) and toxic epidermal necrolysis (TEN), have been described.
When symptoms of SSD or TENS (such as a progressive skin rash, often with blisters or mucosal lesions) appear, treatment with methamizole should be stopped immediately, and should not be re-started. Patients should be aware of the symptoms of these diseases. They should carefully monitor skin reactions, especially during the first weeks of treatment.
Agranulocytosis

With prolonged use, it is necessary to monitor the picture of peripheral blood.
At any time against the background of metamizole sodium treatment may develop agranulocytosis. It occurs very rarely, lasts at least a week, does not depend on the dose, can be severe, threaten life and even lead to death.
In this regard, if symptoms appear to be associated with neutropenia (fever, chills, sore throats, difficulty swallowing, stomatitis, erosive ulceration of the oral cavity, vaginitis or proctitis, a decrease in the number of neutrophils in the peripheral blood is less than 1500 / mm), it is necessary discontinue drug treatment and consult a doctor.

Pancytopenia

In case of development of pancytopenia, treatment should be stopped immediately, it is necessary to monitor the indicators of the developed blood test up to their normalization.

All patients should be aware that when symptoms of abnormal blood changes (eg, general malaise, infections, persistent fever, formation of hematomas, bleeding, pallor) occur with metamizol sodium, medical attention should be sought immediately.

Acute abdominal pain

It is inadmissible to use the drug to relieve acute pain in the abdomen (until finding out their cause).

Impaired liver and kidney function

In patients with impaired liver and kidney function, it is recommended that metamizole sodium should not be taken at high doses due to a decrease in the rate of drug clearance.

Impact on ability to drive vehicles or engage in other potentially hazardous activities

When taking recommended doses, there was no undesirable effect on concentration of attention and reactivity.
However, when using high doses, consideration should be given to the possible disruption of concentration and reactivity, which poses a risk when performing manipulations of particular importance (for example, driving or machinery), especially after drinking alcohol.
OVERDOSE

Symptoms

In case of an overdose, the following symptoms may appear: nausea, vomiting, abdominal pain, decreased kidney function / acute renal failure with oliguria (for example, due to the development of interstitial nephritis), more rarely symptoms from the central nervous system (dizziness, drowsiness, tinnitus, impaired consciousness, coma, convulsions) and a sharp decrease in blood pressure (sometimes progressing to shock), as well as heart rhythm disturbances (tachycardia), hypothermia, dyspnea, acute agranulocytosis, hemorrhagic syndrome, acute liver failure, paralysis
uh respiratory muscles. After taking high doses, the excretion through the kidneys of a non-toxic metabolite (rubanzone acid) can cause red staining of urine.
Treatment

If after taking the drug has passed no more than 1-2 hours, you can cause vomiting, to conduct a gastric lavage through the probe;
give salt laxatives, activated charcoal. Overdose shows forced diuresis. The main metabolite (4-N-methylaminoantipyrine) can be excreted by hemodialysis, haemofiltration, hemoperfusion or plasma filtration. With the development of convulsive syndrome - IV injection of diazepam and high-speed barbiturates.
DRUG INTERACTION

With cyclosporine

Metamizole sodium can reduce the concentration of cyclosporine in the blood serum, so when combined, the concentrations of cyclosporin should be monitored.

With other non-narcotic analgesics

The simultaneous use of metamizole sodium with other non-narcotic analgesics can lead to a mutual enhancement of toxic effects.

With tricyclic antidepressants, oral contraceptives, allopurinol

Tricyclic antidepressants, oral contraceptives, allopurinol disrupt the metabolism of metamizole sodium in the liver and increase its toxicity.

With barbiturates, phenylbutazone and other inducers of microsomal liver enzymes

Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium.

With sedatives and tranquilizers
Sedatives and tranquilizers enhance analgesic effect Metamizole. With simultaneous application Metamizole and chlorpromazine may develop severe hypothermia.
With drugs having high correlation with the protein (oral hypoglycemic agents, oral anticoagulants, corticosteroids and indomethacin)
Metamizole, displacing connection with plasma proteins oral hypoglycemic agents, oral anticoagulants, corticosteroids and indomethacin, amplifies their effect.
Since myelotoxicity drugs
myelotoxicity drugs enhance expression gematotoksichnosti Metamizole.
With methotrexate
Adding Metamizole to methotrexate treatment may enhance gematotoksicheskim methotrexate, especially in elderly patients. Therefore, this combination must be avoided.
With Thiamazolum and sarcolysine
Thiamazole and sarcolysin increase the risk of developing leukopenia.

From Codeine, blockers of H 2 -gistamiiovyh receptors and propranolol
Codeine, blockers of H 2 histamine receptors and enhance the effects of propranolol Metamizole. Radiopaque substances, colloidal and penicillin blood substitutes should not be used during treatment metamizole sodium (increased risk of anaphylactic / anaphylactoid reactions).
With acetylsalicylic acid
When combined metamizole sodium may reduce the effect of aspirin on platelet aggregation. Therefore, this sequence should be used with caution in patients taking low dose aspirin for cardioprotection (prevention of thrombus formation).
Since bupropion
Metamizole can reduce the concentration of bupropion in the blood, which should be taken into consideration while applying Metamizole and bupropion.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be protected from light and the reach of children at a temperature of from 8 ° C to 25 ° C.
Shelf life - 4 years.
Do not use the drug after the expiry date stated on the package.
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