контрактне виробництво
свічки контактне виробництво
виробництво торгова марка
ANALGIN
Release form
Tablets
For children
From 12 years old
For pregnant women
Contraindicated
For nursing mothers
Contraindicated
For drivers
Does not affect
Storage temperature
Until 25 °C
INSTRUCTION
storage
active substance: metamizole sodium; 1 tablet contains metamizole sodium 500 mg; excipients: potato starch, calcium stearate, talc.
Medicinal form
Tablets. Main physico-chemical properties: tablets of white or slightly yellowish color, with a flat surface, beveled edges and a line.
Pharmacotherapeutic group
Analgesics and antipyretics. Metamizole sodium. ATX code N02B B02.
Pharmacological properties
Pharmacodynamics. Analgesic, antipyretic, antispasmodic (for the smooth muscles of the urinary and biliary tracts) means of the group of pyrazolone derivatives. The anti-inflammatory effect is weakly expressed. The mechanism of action is due to the inhibition of cyclooxygenase, which causes a decrease in the synthesis of prostaglandins, which cause the development of pain in the focus of inflammation, an increase in temperature and an increase in tissue permeability, as well as a violation of the conduction of painful extra- and proprioceptive impulses, an increase in the threshold of excitation of thalamic centers of pain sensitivity, and an increase in heat output. Pharmacokinetics. Metamizole sodium is well absorbed in the digestive tract. In the intestinal wall, it is hydrolyzed with the formation of an active metabolite (unchanged metamizol is absent in the blood). The therapeutic concentration of the active metabolite in the blood is reached approximately 0.5 hours after administration; the maximum concentration – after 1–1.5 hours (after taking a dose of 6 mg/kg of body weight). The connection of the active metabolite with blood proteins is 50–60%. Metabolized in the liver, excreted by the kidneys. Penetrates through the placental barrier and into breast milk.
Indication
Pain syndrome of various origins: headache, toothache, neuralgia, myalgia, radiculitis, myositis, pain during menstruation. As an auxiliary tool, it can be used to reduce pain after surgical and diagnostic interventions. Hyperthermic syndrome in infectious and inflammatory diseases.
Contraindication
Hypersensitivity to metamizole sodium or other pyrazolone derivatives. Changes in the composition of peripheral blood: agranulocytosis, leukopenia. Blood diseases: anemia of any etiology, cytostatic or infectious neutropenia. Pronounced changes in the functions of the liver or kidneys (porphyrin metabolism). Congenital deficiency of glucose-6-phosphate dehydrogenase. Bronchial asthma. Suspicion of acute surgical pathology
Interaction with other medicinal products and other forms of interaction
Ethanol – the sedative effect of ethanol is enhanced. Chlorpromazine or other phenothiazine derivatives - simultaneous use can lead to the development of severe hypothermia. Radiopaque substances, colloidal blood substitutes and penicillin should not be used during treatment with metamizole sodium. Cyclosporin - with simultaneous use, the concentration of cyclosporin in the blood decreases. Oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids, phenytoin, ibuprofen and indomethacin - sodium metamizole increases the activity of these drugs by displacing them from protein binding. Phenylbutazone, glutethimide, barbiturates and other inducers of microsomal liver enzymes - when used simultaneously reduce the effectiveness of metamizole sodium. Non-narcotic analgesics, tricyclic antidepressants (amizol, doxepin), hormonal contraceptives and allopurinol - the simultaneous use of metamizole sodium with these drugs can lead to increased toxicity. Other non-steroidal anti-inflammatory drugs - their analgesic and antipyretic effect increases and the probability of additive unwanted side effects increases. Sedatives and tranquilizers (sibazone, trioxazine, valocordin) - enhance the analgesic effect of metamizole sodium. Sarcolysin, Mercazolil, Thiamazole, drugs that inhibit the activity of the bone marrow, including gold drugs - the probability of hematotoxicity increases, including the development of leukopenia. Codeine, histamine H2-blockers and propranolol (anaprilin) - enhance the effect of metamizole sodium. Caution is necessary when using the drug simultaneously with sulfonamide hypoglycemic drugs (increased hypoglycemic effect) and diuretics (furosemide). Methotrexate - metamizole in high doses can lead to an increase in the concentration of methotrexate in the blood plasma and increase its toxic effects (on the digestive system and hematopoietic system).
Features of use
Before starting treatment with the drug, you should consult a doctor. Do not exceed the recommended doses of the drug. Do not use the drug to relieve acute abdominal pain (until the cause is determined). Since metamizole sodium has anti-inflammatory and analgesic properties, it can mask signs of infection, symptoms of non-infectious diseases and complications with pain syndrome, which can make their diagnosis difficult. When using the drug, you should refrain from drinking alcoholic beverages. The drug should be used with caution in patients: • elderly - may lead to an increase in the frequency of adverse reactions, especially from the digestive system; • with allergic diseases (including hay fever), atopic bronchial asthma, including in the anamnesis, the risk of allergic reactions increases; • with kidney function disorders, with a history of kidney diseases (pyelonephritis, glomerulonephritis); • with inflammatory bowel diseases, including non-specific ulcerative colitis and Crohn's disease; • with pronounced arterial hypotension, cardiovascular insufficiency; • with a history of alcoholism; • with the simultaneous use of cytostatic drugs (only under the supervision of a doctor). When used in children, constant medical control is required. When using the drug, it is necessary to monitor the composition of peripheral blood (leukocyte formula). Regular long-term use of the drug is not recommended due to the myelotoxicity of metamizole sodium salt. With long-term use of the drug (more than 7 days), it is necessary to monitor the composition of peripheral blood (due to the myelotoxicity of metamizole), kidney and liver function. Patients should be warned before the start of treatment that if chills, fever, sore throat, difficulty swallowing, stomatitis, bleeding gums, pale skin, asthenia, or vaginitis or proctitis develop, the drug should be stopped immediately. Also, the use of the drug should be stopped in case of rashes on the skin and mucous membranes. If such symptoms appear, you should immediately consult a doctor. Severe skin reactions Severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), which may be fatal, have been reported with metamizole. Patients should be informed of the signs and symptoms of skin reactions and monitored closely. If signs and symptoms suggestive of these reactions appear, treatment with metamizole should be discontinued and in no case should it be restarted (see section "Contraindications"). Risk of drug damage to the liver In patients who took metamizole sodium, cases of acute hepatitis, mainly of a hepatocellular nature, were observed, the manifestations of which appeared in the period from several days to several months after the start of treatment with the drug. Symptoms included elevated serum liver enzymes, with or without jaundice, often in the context of hypersensitivity reactions to other drugs (eg, skin rash, blood dyscrasias, fever, and eosinophilia) or with manifestations of autoimmune hepatitis. Most patients recovered after discontinuation of metamizole sodium; however, progression of liver failure to the point of requiring liver transplantation has been reported in isolated cases. The mechanism of liver damage induced by sodium metamizole is not clearly elucidated, but the available data indicate an immunoallergic mechanism. Patients should be instructed to notify their physician of symptoms suggestive of liver damage. If liver damage is suspected, patients should stop taking metamizole sodium; patients should be evaluated for indicators that characterize the functional state of the liver. Cases of liver damage during treatment with metamizole sodium are very rare, but the exact frequency of this adverse reaction cannot be calculated. In some patients, relapses of liver damage were observed with repeated use of metamizole sodium. If a patient has had liver damage during treatment with metamizole sodium in the past and no other cause of liver damage has been identified, he should not re-use drugs containing metamizole sodium. When using the drug, it is possible to color the urine in a red color due to the excretion of the metamizole sodium metabolite. The drug should not be used longer than the prescribed period without consulting a doctor. If the symptoms of the disease do not begin to disappear or, on the contrary, the state of health worsens, or undesirable phenomena appear, it is necessary to suspend the use of the drug and consult a doctor about further use. Use during pregnancy or breastfeeding. The drug is contraindicated during pregnancy. Breastfeeding should be stopped during treatment, as metamizole sodium passes into breast milk. The ability to influence the speed of reaction when driving vehicles or other mechanisms. Does not affect. but the exact frequency of development of this side reaction cannot be calculated. In some patients, relapses of liver damage were observed with repeated use of metamizole sodium. If a patient has had liver damage during treatment with metamizole sodium in the past and no other cause of liver damage has been identified, he should not re-use drugs containing metamizole sodium. When using the drug, it is possible to color the urine in a red color due to the excretion of the metamizole sodium metabolite. The drug should not be used longer than the prescribed period without consulting a doctor. If the symptoms of the disease do not begin to disappear or, on the contrary, the state of health worsens, or undesirable phenomena appear, it is necessary to suspend the use of the drug and consult a doctor about further use. Use during pregnancy or breastfeeding. The drug is contraindicated during pregnancy. Breastfeeding should be stopped during treatment, as metamizole sodium passes into breast milk. The ability to influence the speed of reaction when driving vehicles or other mechanisms. Does not affect. but the exact frequency of development of this side reaction cannot be calculated. In some patients, relapses of liver damage were observed with repeated use of metamizole sodium. If a patient has had liver damage during treatment with metamizole sodium in the past and no other cause of liver damage has been identified, he should not re-use drugs containing metamizole sodium. When using the drug, it is possible to color the urine in a red color due to the excretion of the metamizole sodium metabolite. The drug should not be used longer than the prescribed period without consulting a doctor. If the symptoms of the disease do not begin to disappear or, on the contrary, the state of health worsens, or undesirable phenomena appear, it is necessary to suspend the use of the drug and consult a doctor about further use. Use during pregnancy or breastfeeding. The drug is contraindicated during pregnancy. Breastfeeding should be stopped during treatment, as metamizole sodium passes into breast milk. The ability to influence the speed of reaction when driving vehicles or other mechanisms. Does not affect.
Methods of application
It is taken orally after a meal, washed down with a small amount of water. Adults and children over 14 years of age are usually prescribed 250–500 mg 1–2 times a day. The maximum daily dose is 1 g. Children aged 12–14 years are given 250 mg 1–2 times a day. The duration of taking the drug is no more than 3 days. Children. The drug is used for children over 12 years old.
Overdose
Symptoms: hypothermia, palpitations, pronounced decrease in blood pressure, tachycardia, dysphagia, shortness of breath, tinnitus, nausea, vomiting, stomach pain, gastralgia/gastritis, weakness, drowsiness, delirium, impaired consciousness, convulsive syndrome; possible development of acute agranulocytosis, hemorrhagic syndrome, oliguria, anuria, acute renal and hepatic failure, paralysis of respiratory muscles. Treatment: withdrawal of the drug, induction of vomiting, gastric lavage, administration of saline laxatives, enterosorbents, forced diuresis, symptomatic therapy aimed at maintaining vital functions. In severe cases, hemodialysis, blood alkalinization, hemoperfusion, peritoneal dialysis may be required. When a convulsive syndrome develops, diazepam and fast-acting barbiturates are administered intravenously. At the first symptoms of overdose, you should immediately seek medical help!
Side effects
From the side of the skin and subcutaneous tissue: 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 (see section 4.4). The frequency is unknown. Allergic reactions: possible manifestations of hypersensitivity reactions, including rashes on the skin and mucous membranes, conjunctivitis, skin hyperemia, itching, urticaria, angioedema (Angioedema), bronchospastic syndrome, anaphylactic shock, very rarely - Stevens syndrome - Johnson, Lyell's syndrome. From the side of the blood and lymphatic system: with long-term use, agranulocytosis, leukopenia, thrombocytopenia, anemia, granulocytopenia are possible. On the part of the urinary system: usually in patients with impaired kidney function and/or when using excessive doses - transient oliguria, anuria, proteinuria, interstitial nephritis, red coloration of urine. On the part of the hepatobiliary system: increased activity of hepatic transaminases, impaired liver function, hepatitis, jaundice, drug-induced liver damage, including acute hepatitis (see section "Particulars of use"). Others: decrease in blood pressure. In the event of the appearance of any undesirable reactions, it is necessary to stop using the drug and consult a doctor.
Expiration date
5 years.
Storage conditions
Store in the original packaging at a temperature not higher than 25 oC. Keep out of the reach of children.
Packaging
10 tablets in blisters. 10 tablets in a blister; 2 or 10 blisters in a pack.
Leave category
Without a prescription - No. 10. With a prescription - No. 20, No. 100.
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.