Instructions Analgin tablets 500 mg blister No. 10
Composition
active ingredient: metamizole sodium;
1 tablet contains metamizole sodium 500 mg;
excipients: potato starch, calcium stearate, stearic acid.
Dosage form
Pills.
Main physicochemical properties: solid, regular, round cylinders, the upper and lower surfaces of which are flat, the edges of the surfaces are beveled, a dividing line is applied, white or slightly yellowish in color, bitter in taste.
Pharmacotherapeutic group
Analgesics and antipyretics. Pyrazolones. ATX code N02B B02.
Pharmacological properties
Pharmacodynamics.
Pyrazolone derivative, cyclooxygenase blocker. Reduces the formation of prostaglandins from arachidonic acid. Differs from other cyclooxygenase blockers in a slightly pronounced anti-inflammatory effect with a pronounced analgesic, antipyretic and antispasmodic effect. The antispasmodic effect is manifested on the smooth muscles of the urinary and biliary tracts.
It prevents the conduction of painful extra- and proprioceptive impulses along the bundles of Hall and Burdach, increases the threshold of excitability of thalamic centers of pain sensitivity, and increases heat transfer.
Pharmacokinetics.
Rapidly absorbed from the digestive tract. Hydrolyzed in the intestinal wall to form an active metabolite. Not present in the blood in an unchanged state. The active metabolite is 50-60% bound to plasma proteins. The time to reach maximum concentration in plasma is 1-2 hours. The half-life is 2.5 hours. It is excreted mainly by the kidneys.
Indication
Pain syndrome of various origins: headache, toothache, neuralgia, radiculitis, myositis, pain during menstruation. As an auxiliary agent, it can be used to reduce pain after surgical and diagnostic interventions. Hyperthermic syndrome in infectious and inflammatory diseases.
Contraindication
Hypersensitivity to the components of the drug, pyrazolone derivatives. Changes in the composition of peripheral blood; diseases of the blood system: agranulocytosis, leukopenia, anemia of any etiology, cytostatic or infectious neutropenia; pronounced changes in liver and kidney functions (porphyrin metabolism); congenital deficiency of glucose-6-phosphate dehydrogenase; bronchial asthma; suspicion of acute surgical pathology.
Interaction with other medicinal products and other types of interactions
Ethanol. Enhances the effect of ethanol.
Chlorpromazine or other phenothiazine derivatives. Concomitant use may lead to the development of severe hypothermia.
Radiocontrast agents, colloidal blood substitutes and penicillin. Should not be used during treatment with analgin.
Cyclosporine. With simultaneous use, the concentration of cyclosporine in the blood decreases.
Oral hypoglycemic drugs. Analgin increases the activity of these drugs by displacing them from their connection with blood proteins, and increases the sedative activity of alcohol.
The drug increases the activity of indirect coagulants, glucocorticosteroids and indomethacin (releases it from its connection with blood proteins), and the sedative activity of alcohol.
Phenylbutazone, glutethamide, barbiturates and other hepatoinducers. When used simultaneously, they reduce the effectiveness of analgin.
Non-narcotic analgesics, tricyclic antidepressants, hormonal contraceptives and allopurinol. Simultaneous use of analgin with these drugs may lead to increased toxicity.
Other nonsteroidal anti-inflammatory drugs. Their analgesic and antipyretic effects are enhanced and the likelihood of additive undesirable side effects increases.
Sedatives and tranquilizers (sibazon, trioxazine, valocardin). Enhance the analgesic effect of analgin.
Thiamazole and sarcolysin. Increase the risk of leukopenia.
Codeine, histamine H2 blockers and propranolol. Enhance the effect of analgin.
Caution is required when using the drug simultaneously with sulfonamide-type 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 an increase in its toxic effects (on the digestive tract and the hematopoietic system).
Application features
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 complicate their diagnosis.
When using the drug, you should refrain from drinking alcoholic beverages.
The drug should be used with caution in patients:
- elderly age - may lead to an increased frequency of adverse reactions, especially from the digestive tract;
- with existing allergic diseases (including hay fever) or with a history of such diseases - the risk of allergic reactions increases;
- with inflammatory bowel diseases, including ulcerative colitis and Crohn's disease;
- with severe arterial hypotension, cardiovascular insufficiency;
- with a long-term history of alcohol dependence;
- with simultaneous use of cytostatic drugs (only under the supervision of a doctor).
Risk of drug-induced liver damage
Cases of acute hepatitis, predominantly hepatocellular in nature, have been reported in patients taking metamizole sodium, with onset ranging from a few days to a few months after initiation of treatment. Symptoms included elevations in serum liver enzymes, with or without jaundice, often in the context of hypersensitivity reactions to other drugs (e.g. skin rashes, blood dyscrasias, fever and eosinophilia) or in association with autoimmune hepatitis. Most patients recovered after discontinuation of metamizole sodium; however, in isolated cases, progression of liver failure to the point of requiring liver transplantation has been reported.
The mechanism of development of liver damage induced by metamizole sodium is not clearly understood, but available data suggest an immunoallergic mechanism.
Patients should be instructed to report any symptoms suggestive of liver damage to their physician. If liver damage is suspected, patients should discontinue metamizole sodium; patients should have liver function tests evaluated.
Cases of liver damage during treatment with metamizole sodium are very rare, but the exact frequency of this adverse reaction cannot be calculated. Some patients have experienced recurrence of liver damage when re-administered metamizole sodium. If a patient has previously experienced liver damage during treatment with metamizole sodium and no other cause of liver damage has been identified, he should not be re-administered with metamizole sodium-containing medicinal products.
The drug should be discontinued immediately and a doctor should be consulted immediately if asthenia, chills of unknown cause, fever, sore throat, difficulty swallowing, bleeding gums, pale skin, skin and mucous membrane rashes, vaginitis or proctitis develop. If symptoms of liver dysfunction occur, including gastrointestinal disorders, jaundice and increased liver enzymes, the drug should be discontinued. The doctor should be informed of the following symptoms: hot flashes, increased sweating, headache, increased fatigue, jaundice, nausea, discomfort in the stomach, constipation.
Severe skin adverse reactions
Severe cutaneous adverse reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), which can be fatal, have been reported with metamizole sodium (see section 4.8). Before initiating therapy with Analgin, patients should be informed of the signs and symptoms of severe cutaneous reactions. Patients should be closely monitored for the appearance of these characteristic symptoms during treatment. If symptoms suggestive of severe cutaneous adverse reactions occur, the drug should be discontinued immediately and should not be used again (see section 4.8).
When used in children, constant medical supervision 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 prolonged 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 starting treatment that if chills, fever, sore throat, difficulty swallowing, bleeding gums, pale skin, asthenia, or vaginitis or proctitis develop without any apparent cause, the drug should be discontinued immediately.
When using the drug, urine may turn red due to the excretion of the metabolite metamizole sodium.
The drug should not be used for longer than the prescribed period without consulting a doctor.
If the signs of the disease do not 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 regarding further use.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy.
If it is necessary to use the drug during lactation, breastfeeding should be discontinued.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Method of administration and doses
The tablets are taken after meals, with a small amount of water.
Adults and children over 14 years of age are usually prescribed ½-1 tablet 1-2 times a day.
The maximum daily dose is 1000 mg.
The duration of treatment is no more than 3 days.
Children.
The drug is not prescribed for children under 12 years of age.
Overdose
Symptoms: nausea, vomiting, stomach pain, gastralgia/gastritis, oliguria, anuria, hypothermia, pronounced decrease in blood pressure, tachycardia, palpitations, shortness of breath, dysphagia, tinnitus, drowsiness, weakness, delirium, impaired consciousness, acute agranulocytosis, acute renal or hepatic failure, hemorrhagic syndrome, convulsions, paralysis of the respiratory muscles.
Treatment: drug withdrawal, induction of vomiting, gastric lavage, administration of saline laxatives, enterosorbents, forced diuresis, symptomatic therapy aimed at supporting vital functions. In severe cases, hemodialysis, hemoperfusion, peritoneal dialysis may be required.
At the first symptoms of overdose, you should seek medical help immediately.
Adverse reactions
On the part of the immune system: angioedema, anaphylactic shock.
Skin and subcutaneous tissue disorders: hypersensitivity reactions, including skin and mucous membrane rashes (including urticaria), itching, skin hyperemia, severe skin reactions such as polymorphic exudative erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome); increased skin photosensitivity (photosensitivity), exfoliative dermatitis.
From the blood system: with prolonged use, thrombocytopenia, granulocytopenia, leukopenia, anemia, agranulocytosis are possible.
On the part of the urinary system: usually in patients with impaired renal function and/or when using excessive doses - transient oliguria, anuria, proteinuria, interstitial nephritis, red urine color.
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 "Special instructions").
On the part of the respiratory system: with a tendency to bronchospasm, it is possible to provoke an attack, bronchospastic syndrome.
Others: conjunctivitis, decreased blood pressure.
If any adverse reactions occur, you should stop using the drug and consult a doctor.
Reporting of suspected adverse reactions.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
5 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in blisters.
10 tablets in a blister, 1 or 10 blisters in a pack.
Vacation category
Without a prescription - No. 10.
According to the recipe - No. 100.
Producer
JSC "Lubnypharm".
Location of the manufacturer and address of its place of business.
Ukraine, 37500, Poltava region, Lubny, Barvinkova st., 16.
