контрактне виробництво
свічки контактне виробництво
виробництво торгова марка
ANDIPAL-V
Release form
Tablets
For children
From 12 years old
For pregnant women
Not recommended
For nursing mothers
Not recommended
For drivers
Not recommended
Storage temperature
to 25 °C
INSTRUCTION
storage
active ingredients: metamizol sodium (analgin); bendazol 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.
Medicinal form
Tablets. The main physicochemical properties: tablets are white or white with a slight yellowish tinge, with a flat surface, beveled edges and a line.
Pharmacotherapeutic group
Analgesics and antipyretics. ATX code N02B B52.
Pharmacological properties
Pharmacodynamics. Combined drug with analgesic, antispasmodic and vasodilator effects due to the specific action of its components. The drug also has an antihypertensive and antipyretic effect. Metamizole sodium is a non-steroidal anti-inflammatory drug (NSAID) of the group of pyrazolone derivatives, which exhibits anti-inflammatory, analgesic and antipyretic effects, the mechanism of action of which is due to the inhibition of COX and the blocking of the synthesis of prostaglandins from arachidonic acid, as well as the violation of pain extra- and proprioceptive impulses, increasing the threshold of thalamic excitability centers of pain sensitivity, by increasing heat transfer. Bendazol hydrochloride has a vasodilator, antispasmodic, hypotensive effect, and also has a stimulating effect on the functions of the spinal cord and helps restore the functions of peripheral nerves, has a moderate immunostimulating effect. Papaverine hydrochloride has a myotropic, antispasmodic, hypotensive effect. Blocks phosphodiesterase, contributes to the accumulation of cAMP and the reduction of calcium content in the cell, relaxes the smooth muscles of blood vessels and internal organs. Pharmacokinetics. When taken internally, it is quickly and completely absorbed. In the intestinal walls, it is hydrolyzed with the formation of an active metabolite. The action 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); suspicion of acute surgical pathology; diseases that occur with a decrease in muscle tone, convulsive syndrome; glaucoma, craniocerebral trauma, severe heart failure, AV block, arterial hypotension, diabetes, hypothyroidism, adrenal insufficiency, prostatic hypertrophy, congenital glucose-6-phosphate dehydrogenase deficiency, anemia of any etiology, cytostatic or infectious neutropenia, leukopenia, agranulocytosis, thrombocytopenia, hepatoporphyria, severe liver and kidney function disorders, porphyria, chronic nephritis with edema and impaired nitrogen excretory function of the kidneys, bronchial asthma, comatose state, respiratory depression, broncho-obstructive syndrome, stomach and duodenal ulcer accompanied by bleeding; hypotonic colitis, habitual constipation; simultaneous use of monoamine oxidase (MAO) inhibitors. Age over 75 years (risk of hyperthermia).
Interaction with other medicinal products and other forms of interaction
Radiopaque substances, 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 unwanted 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 can lead to an increase in the concentration of methotrexate in the blood plasma and increase its toxic effects (primarily on the digestive tract and hematopoietic system). Diuretics (furosemide): a possible decrease in the diuretic effect. Sulfanilamide hypoglycemic drugs: strengthening of the hypoglycemic effect. Ethanol: sodium metamizole enhances its sedative effect. Levodopa, methyldopa: reduction of hypotensive effect of methyldopa and antiparkinsonian effect of levodopa. Cyclosporine: with simultaneous use, the concentration of cyclosporine in the blood decreases. Nitrofurantoin: there are data on the development of hepatitis with simultaneous use with the drug. Sarcolysin, thiamazole (methimazole), drugs that suppress bone marrow activity, including gold drugs: the likelihood of hematotoxicity increases, including the development of leukopenia. Phenylbutazone, glutethimide, barbiturates and other inducers of microsomal liver enzymes reduce the effectiveness of metamizole sodium. Sedatives, tranquilizers (diazepam, trimethosin, etc.), codeine, anaprilin, blockers of H2-histamine receptors and propranolol enhance the analgesic effect of metamizole sodium. Tricyclic antidepressants (amitriptyline, doxepin, etc.), hormonal contraceptives and allopurinol: simultaneous use of metamizole sodium with these drugs can lead to increased toxicity. Hypotensive drugs (agents affecting the renin-angiotensin system), antidepressants, antispasmodics, sedatives, diuretics, saluretics, procainamide, reserpine, quinidine, phentolamine: enhancement of the hypotensive effect. Chlorpromazine or other phenothiazine derivatives: severe hypothermia may develop. Phentolamine: potentiates the effect of papaverine on the cavernous bodies of the penis. Cardiac glycosides: pronounced strengthening of the contractile function of the myocardium due to a decrease in the total peripheral vascular resistance. Morphine: a possible decrease in the antispasmodic activity of papaverine. Adsorbents, binders and encapsulants: reducing absorption of the drug from the digestive tract. The effectiveness of the drug decreases with smoking. Caution is required when using the drug simultaneously with salicylates.
Features of use
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 before finding out the cause. 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 such diseases in the anamnesis due to an increased risk of allergic reactions; - with inflammatory bowel diseases, including non-specific ulcerative colitis and Crohn's disease; - with cardiovascular insufficiency; - with a tendency to arterial hypotension; – with supraventricular tachycardia; - with a history of kidney disease (pyelonephritis, glomerulonephritis); - with liver and/or kidney function disorders. The drug should be used with caution in patients with a long history of alcoholism, weakened persons; elderly people due to the risk of hyperthermia and increased frequency of adverse reactions, especially from the digestive tract; with the simultaneous use of cytostatic drugs (only under the supervision of a doctor). The drug should be used with caution when intestinal peristalsis is reduced. It is necessary to immediately cancel the drug and immediately consult a doctor in case of unmotivated chills, fever, sore throat, difficulty swallowing, bleeding gums, pale skin, rashes on the skin and mucous membranes, asthenia, vaginitis or proctitis. If symptoms of liver dysfunction appear, in particular, gastrointestinal disorders, jaundice, and an increase in the level of liver enzymes, it is necessary to stop using the drug. The following symptoms should be reported to the doctor: hot flushes, 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 may be fatal, have been reported with metamizole. Patients should be informed of the signs and symptoms of skin reactions and monitored closely. If symptoms indicating 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, 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). The drug should not be used 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 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. When used in children, constant medical control is required. Smoking impairs the effectiveness of the drug. 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. It is not recommended to use during pregnancy or breastfeeding. The ability to influence the speed of reaction when driving vehicles or other mechanisms. During treatment with the drug, you should avoid driving vehicles and working with complex mechanisms. 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, 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). The drug should not be used 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 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. When used in children, constant medical control is required. Smoking impairs the effectiveness of the drug. 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. It is not recommended to use during pregnancy or breastfeeding. The ability to influence the speed of reaction when driving vehicles or other mechanisms. During treatment with the drug, you should avoid driving vehicles and working with complex mechanisms. 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, 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). The drug should not be used 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 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. When used in children, constant medical control is required. Smoking impairs the effectiveness of the drug. 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. It is not recommended to use during pregnancy or breastfeeding. The ability to influence the speed of reaction when driving vehicles or other mechanisms. During treatment with the drug, you should avoid driving vehicles and working with complex mechanisms. 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, 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). The drug should not be used 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 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. When used in children, constant medical control is required. Smoking impairs the effectiveness of the drug. 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. It is not recommended to use during pregnancy or breastfeeding. The ability to influence the speed of reaction when driving vehicles or other mechanisms. During treatment with the drug, you should avoid driving vehicles and working with complex mechanisms. 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, 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). The drug should not be used 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 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. When used in children, constant medical control is required. Smoking impairs the effectiveness of the drug. 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. It is not recommended to use during pregnancy or breastfeeding. The ability to influence the speed of reaction when driving vehicles or other mechanisms. During treatment with the drug, you should avoid driving vehicles and working with complex mechanisms. Smoking impairs the effectiveness of the drug. 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. It is not recommended to use during pregnancy or breastfeeding. The ability to influence the speed of reaction when driving vehicles or other mechanisms. During treatment with the drug, you should avoid driving vehicles and working with complex mechanisms. Smoking impairs the effectiveness of the drug. 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. It is not recommended to use during pregnancy or breastfeeding. The ability to influence the speed of reaction when driving vehicles or other mechanisms. During treatment with the drug, you should avoid driving vehicles and working with complex mechanisms.
Methods of application
Adults and children over 12 years of age use 1-2 tablets 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 effect achieved, the nature of the complex pharmacotherapy used, but the duration of treatment should not exceed 3 days. Children. It is not recommended for 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, respiratory muscle paralysis, hyperventilation, decreased tissue perfusion, headache, restlessness, inhibition, drowsiness, dizziness, delirium, impaired consciousness, visual impairment, ataxia, nystagmus, diplopia, tinnitus, depression of the central nervous system, convulsive syndrome, collapse, coma, cyanosis, metabolic acidosis, hyperglycemia, hyperkalemia, oliguria, anuria, dysphagia, nausea, vomiting, diarrhea . Treatment: withdrawal of the drug, 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 is possible. 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. From the side of the immune system: possible manifestations of hypersensitivity reactions, including rashes on the skin and mucous membranes, itching, redness of the face, hyperemia of the skin, urticaria, conjunctivitis, burning in the throat, dry cough, runny nose, difficulty breathing, angioneurotic edema , 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 side of the cardiovascular system: AV block, arrhythmias, ventricular extrasystole, decrease in cardiac output, decrease in blood pressure, pain in the heart area, hot flushes, palpitations, feeling of heat, hyperthermia, weakness, numbness, tremors, loss of consciousness; with long-term use - worsening of ECG indicators, ventricular fibrillation, asystole, ventricular flutter, orthostatic hypotension, collapse, apnea. From the side of the blood and lymphatic system: with long-term use, leukopenia, granulocytopenia, agranulocytosis, anemia, thrombocytopenia are possible; eosinophilia. From the side of the digestive tract: dry mouth, nausea, discomfort in the stomach, constipation, increased activity of liver transaminases, jaundice, hepatitis. 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"). 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. In the event of the appearance of any undesirable reactions, it is necessary to stop using the drug and consult a doctor.
Expiration date
2 years.
Storage conditions
In the original packaging at a temperature not higher than 25 ºС. Keep out of the 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.
Leave category
Without a prescription - No. 10. According to the recipe - No. 20, No. 100.
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.