Instructions for Andipal-B tablets No. 20
Composition
active ingredients: metamizole sodium (analgin); bendazole hydrochloride; papaverine hydrochloride;
1 tablet contains metamizole sodium (analgin) 250 mg (0.25 g), bendazole hydrochloride 20 mg (0.02 g), papaverine hydrochloride 20 mg (0.02 g);
excipients: potato starch, calcium stearate, talc.
Dosage form
Pills.
Main physicochemical properties: tablets of white or white with a faint yellowish tint, with a flat surface, beveled edges and a score.
Pharmacotherapeutic group
Analgesics and antipyretics.
ATX code N02B B52.
Pharmacological properties
Pharmacodynamics
A combined drug with analgesic, antispasmodic and vasodilator effects due to the specific action of its components. The drug also has antihypertensive and antipyretic effects.
Metamizole sodium is a nonsteroidal anti-inflammatory drug (NSAID) of the pyrazolone derivative group, which exhibits anti-inflammatory, analgesic, and antipyretic effects, the mechanism of action of which is due to inhibition of COX and blocking the synthesis of prostaglandins from arachidonic acid, as well as impaired conduction of pain extra- and proprioceptive impulses, increased threshold of excitability of thalamic centers of pain sensitivity, and increased heat dissipation.
Bendazole hydrochloride has a vasodilator, antispasmodic, hypotensive effect, and also has a stimulating effect on the functions of the spinal cord and promotes the restoration of peripheral nerve functions, and has a moderate immunostimulating effect.
Papaverine hydrochloride has a myotropic, antispasmodic, and hypotensive effect. Blocks phosphodiesterase, promotes the accumulation of cAMP and a decrease in calcium content in the cell, and relaxes the smooth muscles of blood vessels and internal organs.
Pharmacokinetics
When taken orally, it is rapidly and completely absorbed. It is hydrolyzed in the intestinal walls to form an active metabolite. The effect develops after 20-40 minutes and reaches a maximum after 2 hours. It is metabolized in the liver. It is excreted by the kidneys.
Indication
Pain syndrome associated with spasm of blood vessels or smooth muscles of internal organs.
Contraindication
Known or suspected hypersensitivity to any of the substances included in the preparation, pyrazolone derivatives (butadione, tribuzone, antipyrine); suspected acute surgical pathology; diseases occurring with decreased muscle tone, convulsive syndrome; glaucoma, traumatic brain injury, severe heart failure, AV block, arterial hypotension, diabetes mellitus, hypothyroidism, adrenal insufficiency, prostatic hypertrophy, congenital deficiency of glucose-6-phosphate dehydrogenase, anemia of any etiology, cytostatic or infectious neutropenia, leukopenia, agranulocytosis, thrombocytopenia, hepatoporphyria, severe liver and kidney dysfunction, porphyria, chronic nephritis with edema and impaired nitrogen-excreting kidney function, bronchial asthma, coma, respiratory depression, broncho-obstructive syndrome, gastric and duodenal ulcer accompanied by bleeding; hypotonic colitis, habitual constipation; simultaneous use of monoamine oxidase inhibitors (MAO). Age over 75 years (risk of hyperthermia).
Interaction with other medicinal products and other types of interactions
Radiocontrast agents, colloidal blood substitutes, penicillin: should not be used during treatment with metamizole sodium.
Nonsteroidal anti-inflammatory drugs: their analgesic and antipyretic effects are potentiated and the likelihood of additive undesirable side effects increases.
Oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids, phenytoin, indomethacin: metamizole sodium increases the activity of these drugs by displacing them from protein binding.
Methotrexate: metamizole sodium in high doses may lead to an increase in the concentration of methotrexate in the blood plasma and an increase in its toxic effects (primarily on the digestive tract and the hematopoietic system).
Diuretics (furosemide): possible reduction of the diuretic effect.
Sulfonamide antidiabetic drugs: increased hypoglycemic effect.
Ethanol: metamizole sodium enhances its sedative effect.
Levodopa, methyldopa: reduction of the hypotensive effect of methyldopa and the antiparkinsonian effect of levodopa.
Cyclosporine: with simultaneous use, the concentration of cyclosporine in the blood decreases.
Nitrofurantoin: there is evidence of the development of hepatitis when used concomitantly with the drug.
Sarcolysin, thiamazole (methimazole), drugs that suppress bone marrow activity, including gold preparations: the likelihood of hematotoxicity, including the development of leukopenia, increases.
Phenylbutazone, glutethimide, barbiturates and other inducers of liver microsomal enzymes reduce the effectiveness of metamizole sodium.
Tricyclic antidepressants (amitriptyline, doxepin, etc.), hormonal contraceptives and allopurinol: simultaneous use of metamizole sodium with these drugs may lead to increased toxicity.
Antihypertensive drugs (drugs that affect the renin-angiotensin system), antidepressants, antispasmodics, sedatives, diuretics, saluretics, procainamide, reserpine, quinidine, phentolamine: increased hypotensive effect.
Chlorpromazine or other phenothiazine derivatives: severe hypothermia may develop.
Phentolamine: potentiates the effect of papaverine on the corpus cavernosum of the penis.
Cardiac glycosides: pronounced increase in myocardial contractile function due to a decrease in total peripheral vascular resistance.
Morphine: possible reduction of the antispasmodic activity of papaverine.
Adsorbents, astringents and enveloping agents: reduced absorption of the drug from the digestive tract.
The effectiveness of the drug is reduced by smoking.
Caution is required when using the drug simultaneously with salicylates.
Application features
Do not exceed the recommended doses of the drug. 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. Do not use the drug to relieve acute abdominal pain until the cause is determined.
When using the drug, you should refrain from drinking alcohol and drugs that depress the central nervous system.
The drug should be used with caution in patients:
with existing allergic diseases (including hay fever) or with a history of such diseases due to an increased risk of allergic reactions;
with inflammatory bowel diseases, including ulcerative colitis and Crohn's disease;
with cardiovascular failure;
with a tendency to arterial hypotension;
with supraventricular tachycardia;
with a history of kidney disease (pyelonephritis, glomerulonephritis);
with impaired liver and/or kidney function.
The drug should be used with caution in patients with a long history of alcohol abuse, debilitated individuals; in elderly people due to the risk of hyperthermia and increased incidence of adverse reactions, especially from the digestive tract; with simultaneous use of cytostatic drugs (only under the supervision of a physician). The drug should be used with caution in cases of reduced intestinal peristalsis.
The drug should be discontinued immediately and a doctor should be consulted immediately if unexplained chills, fever, sore throat, difficulty swallowing, bleeding gums, pale skin, skin and mucous membrane rashes, asthenia, vaginitis or proctitis develop. If symptoms of liver dysfunction appear, including gastrointestinal disorders, jaundice and increased liver enzymes, the drug should be discontinued. The doctor should be informed of the following symptoms: hot flashes, sweating, headache, fatigue, jaundice, nausea, stomach discomfort, constipation.
Severe skin reactions
Severe skin 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 treatment.
Patients should be informed about the signs and symptoms of skin reactions and monitored closely.
If symptoms indicating these reactions appear, metamizole treatment should be discontinued and under no circumstances should it be restarted (see section "Contraindications").
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 several months after initiation of treatment. Symptoms included elevations of 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.
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.
When using the drug, urine may turn red due to the excretion of the metabolite of metamizole sodium, which has no clinical significance. When taking the drug, the development of orthostatic hypotension is possible.
When using the drug, it is necessary to monitor the composition of peripheral blood (leukocyte formula).
Do not use the drug for longer than the prescribed period without consulting a doctor. Regular long-term use of the drug is not recommended due to the myelotoxicity of metamizole sodium. 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.
When used in children, constant medical supervision is required.
Smoking impairs the effectiveness of the drug.
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
Not recommended for use during pregnancy or breastfeeding.
The ability to influence the reaction speed when driving or working with other mechanisms
During treatment with the drug, driving and working with complex mechanisms should be avoided.
Method of administration and doses
Adults and children over 12 years of age should take 1-2 tablets orally 2-3 times a day. The maximum daily dose is 6 tablets.
The course of treatment depends on the nature and course of the disease, the achieved effect, the nature of the complex pharmacotherapy used, but the duration of treatment should not exceed 3 days.
Children
Not recommended for use in children under 12 years of age.
Overdose
Symptoms: hypothermia, pronounced decrease in blood pressure, arrhythmia, tachycardia, partial or complete atrioventricular block, acute agranulocytosis, neutropenia, hemorrhagic syndrome, paralysis of respiratory muscles, hyperventilation, decreased tissue perfusion, headache, anxiety, lethargy, drowsiness, dizziness, delirium, impaired consciousness, visual impairment, ataxia, nystagmus, diplopia, tinnitus, central nervous system depression, convulsive syndrome, collapse, coma, cyanosis, metabolic acidosis, hyperglycemia, hyperkalemia, oliguria, anuria, dysphagia, nausea, vomiting, diarrhea, constipation, gastrointestinal disorders, gastralgia, gastritis, liver dysfunction, acute renal and/or hepatic failure, skin rash, shortness of breath, moderate dyspnea, skin flushing, general weakness, palpitations, feeling hot, increased sweating.
Treatment: drug withdrawal, induction of vomiting, gastric lavage, maintenance of blood pressure, administration of enterosorbents, saline laxatives, forced diuresis, symptomatic therapy aimed at maintaining vital functions. In severe cases, hemodialysis, hemoperfusion, peritoneal dialysis are possible.
At the first symptoms of overdose, you should seek medical help immediately.
Side effects
Skin and subcutaneous tissue disorders: 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). Frequency unknown.
On the part of the immune system: possible manifestations of hypersensitivity reactions, including rashes on the skin and mucous membranes, itching, facial flushing, skin hyperemia, urticaria, conjunctivitis, burning in the throat, dry cough, runny nose, difficulty breathing, angioedema, bronchospastic syndrome, anaphylactic shock, Stevens-Johnson syndrome, Lyell's syndrome.
From the side of the central nervous system: drowsiness, increased sweating, dizziness, headache, anorexia.
From the cardiovascular system: AV block, arrhythmias, ventricular extrasystole, decreased cardiac output, decreased blood pressure, pain in the heart area, hot flashes, palpitations, feeling of heat, hyperthermia, weakness, numbness, tremor, loss of consciousness; with prolonged use - deterioration of ECG parameters, ventricular fibrillation, asystole, ventricular flutter, orthostatic hypotension, collapse, apnea.
From the blood and lymphatic system: with prolonged use, leukopenia, granulocytopenia, agranulocytosis, anemia, thrombocytopenia; eosinophilia are possible.
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 urinary system: usually in patients with impaired renal function and/or when using excessive doses - transient oliguria, anuria, proteinuria, interstitial nephritis, red urine color.
If any adverse reactions occur, you should stop using the drug and consult a doctor.
Expiration date
2 years.
Storage conditions
In the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 tablets in strips;
10 tablets in a strip; 1 strip in a paper envelope;
10 tablets in a strip; 2 or 10 strips in a cardboard pack;
10 tablets in a blister; 1, or 2, or 10 blisters in a cardboard pack.
Vacation category
Without a prescription - No. 10.
According to the recipe - No. 20, No. 100.
Producer
PJSC "Monpharm".
Address
Ukraine, 19161, Cherkasy region, Uman district, Avramivka village, Zavodska st., 8.
