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виробництво торгова марка
ANDIPAL-FORTE
Release form
Tablets
For children
Do not use in this dosage
For pregnant women
Not recommended
For nursing mothers
Not recommended
For drivers
Not recommended
Storage temperature
to 25 °C
INSTRUCTION
storage
active substances: 1 tablet contains metamizole sodium 500 mg (0.5 g), bendazole hydrochloride 40 mg (0.04 g), papaverine hydrochloride 40 mg (0.04 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. Metamizole sodium, combinations without psycholeptics. 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 nonsteroidal 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 cyclooxygenase (COX) and the blocking of the synthesis of prostaglandins from arachidonic acid, as well as the violation of pain extra- and proprioceptive impulses, increasing threshold of excitability of thalamic centers of pain sensitivity, by increasing heat transfer. Bendazol hydrochloride - has a vasodilating, 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, causes the accumulation of cyclic adenosine monophosphate (cAMP) and decreases the calcium content in the cell, relaxes the smooth muscles of blood vessels and internal organs. Pharmacokinetics. When taken orally, it is quickly and completely absorbed. In the intestinal walls, it is hydrolyzed with the formation of 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 metamizole sodium salt, pyrazolone derivatives (butadione, tribuzone, antipyrine); suspicion of acute surgical pathology; anemia of any etiology, cytostatic or infectious neutropenia; leukopenia; agranulocytosis; thrombocytopenia; hepatoporphyria; deficiency of glucose-b-phosphate dehydrogenase; bronchial asthma; respiratory depression; broncho-obstructive syndrome; diseases that occur with a decrease in muscle tone, convulsive syndrome; glaucoma. Severe heart failure, atrioventricular (AV) blockade. Arterial hypotension. Pronounced disorders of liver and kidney function. Chronic nephritis with edema and impaired nitrogen excretory function of the kidneys. Gastric and duodenal ulcer accompanied by bleeding. Diabetes. Hypotonic colitis; habitual constipation; brain injury; hypothyroidism; insufficiency of the adrenal glands; hypertrophy of the prostate gland; simultaneous use of monoamine oxidase (MAO) inhibitors. The patient's age is 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 salt. Chlorpromazine or other phenothiazine derivatives: severe hypothermia may develop. Oral hypoglycemic drugs, indirect anticoagulants, phenytoin, glucocorticosteroids, indomethacin, ibuprofen: metamizole sodium salt increases the activity of these drugs by displacing them from protein binding. Glutethimide: reduces the effectiveness of metamizole sodium. Other nonsteroidal anti-inflammatory drugs: potentiate their analgesic and antipyretic effects and increase the likelihood of additive unwanted side effects. Sarcolysin, thiamazole (methimazole), drugs that inhibit 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. Methotrexate: metamizole sodium salt 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. Sedatives and tranquilizers (sibazone, diazepam, trimethosine, trioxazine, valocardine, codeine, anaprilin, H2-receptor blockers and propranolol): enhance the analgesic effect of metamizole sodium salt. Tricyclic antidepressants (amitriptyline, amisole, doxepin), hormonal contraceptives and allopurinol: the simultaneous use of metamizole sodium with these drugs can lead to increased toxicity. Phentolamine, hypotensive drugs (agents affecting the renin-angiotensin system), antidepressants, sedatives, diuretics, saluretics, procainamide, reserpine, quinidine: when combined with bendazol, the hypotensive effect increases. 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. Cardiac glycosides: pronounced strengthening of the contractile function of the myocardium due to a decrease in the total peripheral vascular resistance. Adsorbents, binders and encapsulants: reducing absorption of the drug from the gastrointestinal tract. Morphine: a possible decrease in the antispasmodic activity of papaverine hydrochloride. Phentolamine: potentiates the effect of papaverine on the cavernous bodies of the penis with simultaneous administration. There are data on the development of hepatitis with simultaneous use with furadonin. 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. The drug should be used with caution in patients: - 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 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; - with the simultaneous use of cytostatic drugs (only under the supervision of a doctor). The drug should be used with caution in patients with a history of long-term alcohol consumption, weakened persons; elderly people - due to the risk of hyperthermia and increased frequency of adverse reactions, especially from the side of the digestive tract. Patients should be warned before the start of treatment that if chills appear for an unknown reason, fever, sore throat, difficulty swallowing, bleeding gums, pale skin, asthenia, if vaginitis or proctitis develops, the drug should be stopped immediately. It is also necessary to stop taking the drug at the first rashes on the skin and mucous membranes. If these symptoms appear, you should immediately consult a doctor. 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 salt; in the case of long-term use (more than 7 days), it is necessary to monitor the composition of peripheral blood, kidney and liver function. Severe skin reactions Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), which were life-threatening or fatal, have been reported with metamizole treatment. 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-induced liver damage 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 accompanied by manifestations of autoimmune hepatitis. Most patients recovered after discontinuation of metamizole; however, progression of liver failure to the point of requiring liver transplantation has been reported in isolated cases. The mechanism of development of liver damage induced by metamizole sodium salt is not clearly elucidated, but the available data indicate an immunoallergic mechanism. Patients should be instructed on the need to inform the doctor about the occurrence of symptoms indicating liver damage. If liver damage is suspected, patients should stop taking metamizole sodium salt; in patients, it is necessary to evaluate indicators that characterize the functional state of the liver. Cases of liver damage during treatment with metamizole 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 salt. If the patient has had liver damage during treatment with metamizole in the past and if no other cause of liver damage has been established, medicinal products containing metamizole sodium should not be re-administered. During the treatment period, the urine may turn red (due to the release of the metabolite), which has no clinical significance. Use with caution in debilitated patients with reduced intestinal peristalsis. 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). 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 flashes, sweating, headache, increased fatigue, jaundice, skin rash, nausea, stomach discomfort, constipation. When used in children, constant medical control is required. Smoking impairs the effectiveness of the drug. While taking the drug, you should refrain from drinking alcohol and drugs that depress the central nervous system. 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. 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; however, progression of liver failure to the point of requiring liver transplantation has been reported in isolated cases. The mechanism of development of liver damage induced by metamizole sodium salt is not clearly elucidated, but the available data indicate an immunoallergic mechanism. Patients should be instructed on the need to notify the doctor of the occurrence of symptoms indicating liver damage. If liver damage is suspected, patients should stop taking metamizole sodium salt; in patients, it is necessary to evaluate indicators that characterize the functional state of the liver. Cases of liver damage during treatment with metamizole 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 salt. If the patient has had liver damage during treatment with metamizole in the past and if no other cause of liver damage has been established, medicinal products containing metamizole sodium should not be re-administered. During the treatment period, the urine may turn red (due to the release of the metabolite), which has no clinical significance. Use with caution in debilitated patients with reduced intestinal peristalsis. 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). 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 flashes, sweating, headache, increased fatigue, jaundice, skin rash, nausea, stomach discomfort, constipation. When used in children, constant medical control is required. Smoking impairs the effectiveness of the drug. While taking the drug, you should refrain from drinking alcohol and drugs that depress the central nervous system. 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. 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; however, progression of liver failure to the point of requiring liver transplantation has been reported in isolated cases. The mechanism of development of liver damage induced by metamizole sodium salt is not clearly elucidated, but the available data indicate an immunoallergic mechanism. Patients should be instructed on the need to inform the doctor about the occurrence of symptoms indicating liver damage. If liver damage is suspected, patients should stop taking metamizole sodium salt; in patients, it is necessary to evaluate indicators that characterize the functional state of the liver. Cases of liver damage during treatment with metamizole 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 salt. If the patient has had liver damage during treatment with metamizole in the past and if no other cause of liver damage has been established, medicinal products containing metamizole sodium should not be re-administered. During the treatment period, the urine may turn red (due to the release of the metabolite), which has no clinical significance. Use with caution in debilitated patients with reduced intestinal peristalsis. 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). 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 flashes, sweating, headache, increased fatigue, jaundice, skin rash, nausea, stomach discomfort, constipation. When used in children, constant medical control is required. Smoking impairs the effectiveness of the drug. While taking the drug, you should refrain from drinking alcohol and drugs that depress the central nervous system. 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. 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. If liver damage is suspected, patients should stop taking metamizole sodium salt; in patients, it is necessary to evaluate indicators that characterize the functional state of the liver. Cases of liver damage during treatment with metamizole 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 salt. If the patient has had liver damage during treatment with metamizole in the past and if no other cause of liver damage has been established, medicinal products containing metamizole sodium should not be re-administered. During the treatment period, the urine may turn red (due to the release of the metabolite), which has no clinical significance. Use with caution in debilitated patients with reduced intestinal peristalsis. 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). 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 flashes, sweating, headache, increased fatigue, jaundice, skin rash, nausea, stomach discomfort, constipation. When used in children, constant medical control is required. Smoking impairs the effectiveness of the drug. While taking the drug, you should refrain from drinking alcohol and drugs that depress the central nervous system. 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. 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. If liver damage is suspected, patients should stop taking metamizole sodium salt; in patients, it is necessary to evaluate indicators that characterize the functional state of the liver. Cases of liver damage during treatment with metamizole 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 salt. If the patient has had liver damage during treatment with metamizole in the past and if no other cause of liver damage has been established, medicinal products containing metamizole sodium should not be re-administered. During the treatment period, the urine may turn red (due to the release of the metabolite), which has no clinical significance. Use with caution in debilitated patients with reduced intestinal peristalsis. 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). 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 flashes, sweating, headache, increased fatigue, jaundice, skin rash, nausea, stomach discomfort, constipation. When used in children, constant medical control is required. Smoking impairs the effectiveness of the drug. While taking the drug, you should refrain from drinking alcohol and drugs that depress the central nervous system. 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. 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. Use with caution in debilitated patients with reduced intestinal peristalsis. 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). 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 flashes, sweating, headache, increased fatigue, jaundice, skin rash, nausea, stomach discomfort, constipation. When used in children, constant medical control is required. Smoking impairs the effectiveness of the drug. While taking the drug, you should refrain from drinking alcohol and drugs that depress the central nervous system. 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. 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. Use with caution in debilitated patients with reduced intestinal peristalsis. 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). 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 flashes, sweating, headache, increased fatigue, jaundice, skin rash, nausea, stomach discomfort, constipation. When used in children, constant medical control is required. Smoking impairs the effectiveness of the drug. While taking the drug, you should refrain from drinking alcohol and drugs that depress the central nervous system. 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. 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
It is taken inside after a meal, washed down with a small amount of water. Adults are prescribed 1 tablet 1-2 times a day. The maximum daily dose is 2 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. In this dosage, the medicine is not used for children.
Overdose
Symptoms: hypothermia, pronounced decrease in blood pressure, arrhythmia, tachycardia, partial or complete atrioventricular blockade, acute agranulocytosis, increased sweating, headache, feeling of heat, dizziness, dysphagia, delirium, possible development of acute agranulocytosis, acute renal or hepatic failure, respiratory paralysis muscles, decreased tissue perfusion, restlessness, inhibition, visual impairment, ataxia, nystagmus, diplopia, depression of the central nervous system, convulsive syndrome, collapse, coma, cyanosis, metabolic acidosis, hyperventilation, hyperglycemia, hyperkalemia, oliguria, anuria, constipation, disorders of the gastrointestinal tract, gastralgia, gastritis, nausea, vomiting, diarrhea, skin rash, shortness of breath, moderate dyspepsia, tinnitus, drowsiness, redness of the skin, general weakness, palpitations. With long-term use in high doses: impaired liver function, neutropenia, hemorrhagic syndrome, possible convulsions and impaired consciousness. 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. If a seizure occurs, consult a doctor. 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 the section "Particulars of use") - frequency the occurrence of these reactions is unknown; from the gastrointestinal tract: nausea, constipation, increased activity of liver transaminases, jaundice, hepatitis, discomfort in the stomach, dry mouth; from the immune system: possible manifestations of hypersensitivity reactions, including rashes on the skin and mucous membranes, hyperemia of the skin, conjunctivitis, itching, urticaria, dry cough, runny nose, difficulty breathing, burning in the throat, facial redness, angioedema , bronchospastic syndrome, anaphylactic shock, Stevens-Johnson syndrome, Lyell's syndrome; from the blood system and lymphatic system: with long-term use, leukopenia, thrombocytopenia, granulocytopenia, anemia, eosinophilia, agranulocytosis are possible; from 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. from the cardiovascular system: AV-blockade, ventricular extrasystole, decrease in cardiac output, decrease in blood pressure, weakness, numbness, tremor, loss of consciousness, palpitations, arrhythmias, pain in the heart area, with long-term use - worsening of ECG indicators, orthostatic hypotension, ventricular fibrillation, asystole, ventricular flutter, collapse, apnea; from the side of the central nervous system: drowsiness, increased sweating, dizziness, headache, feeling of heat, hot flushes, anorexia; 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"). In the event of the appearance of any undesirable phenomena, the patient should consult a doctor.
Expiration date
2 years.
Storage conditions
Store 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; 2 or 10 strips in a cardboard pack.
Leave category
Without a prescription.
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.