Bellalgin tablets №10×1

Name:
Bellalgin tab. in blister. in pack No. 10×1
Description:
Main physical and chemical properties: tablets of round shape, with a flat surface, from light brown to brownish-yellow color with patches, with beveled edges (beveled) and risk. Active ingredients: metamizole sodium salt, benzocaine, thick belladonna extract ((4.8-5.2): 1) (Belladonnae extractum spissum) (extractant 20% (v/v) ethanol)), sodium bicarbonate. 1 tablet contains metamizole sodium salt – 250 mg, benzocaine – 250 mg, sodium bicarbonate – 100 mg, thick belladonna extract ((4.8-5.2): 1) (Belladonnae extractum spissum) (extractant 20% (v / v ) ethanol)) – 15 mg. excipients: microcrystalline cellulose, mannitol (E 421), croscarmellose sodium, magnesium stearate, anhydrous colloidal silicon dioxide. Pharmacotherapeutic groupBelladonna alkaloids and their derivatives in combination with painkillers. ATC code A03D B Indications for use As a symptomatic analgesic for diseases of the gastrointestinal tract and biliary tract, accompanied by spasms of smooth muscles. Contraindications Hypersensitivity to belladonna, benzocaine, others; amide anesthetics, metamizole sodium and other pyrazolone derivatives; .to any component of the drug. Cardiovascular diseases in which an increase in heart rate may be undesirable: atrial fibrillation, tachycardia, chronic heart failure, coronary heart disease, mitral stenosis, severe arterial hypertension. Patients with a known analgesic-induced asthma syndrome or with a known intolerance to analgesics in the form of urticaria and combined angioedema, i.e. patients who have experienced bronchospasm or other forms of anaphylactoid reactions (for example, urticaria, rhinitis, angioedema / angioedema) to salicylates, paracetamol or other non-narcotic analgesics, such as diclofenac, ibuprofen, indomethacin or naproxen. Glaucoma. Urinary retention or susceptibility to it. (porphyrin metabolism). Congenital deficiency of glucose-6-phosphate dehydrogenase. Methemoglobinemia. Suspicion of acute surgical pathology. Children under 18 years of age. Pregnancy and lactation. Precautions Before starting treatment with Bellalgin, you should consult your doctor. Do not exceed the recommended doses of the drug. Do not use to relieve acute abdominal pain (until the cause is clarified). When using the drug, you should refrain from drinking alcoholic beverages. Belladonna extract is thick. It should be used with caution in patients: with prostatic hypertrophy without obstruction of the urinary tract; with Down’s disease, with cerebral palsy, brain damage; with a history of kidney disease (pyelonephritis, glomerulonephritis), with hepatic and renal insufficiency; with reflux esophagitis, esophageal hernia orifices of the diaphragm, associated with reflux esophagitis; with inflammatory bowel disease, including ulcerative colitis and Crohn’s disease; with megacolon; with xerostomia (dry mouth), elderly or debilitated patients; with chronic lung diseases accompanied by low sputum production , which is difficult to separate, especially in debilitated patients; with chronic lung diseases without reversible obstruction; with autonomic (autonomous) neuropathy; with hyperthermia (fever), especially in the elderly, debilitated patients, increased hyperthermia is possible; at high ambient temperature (risk of heat stroke due to inhibition of sweat gland activity). Metamizole sodium. Regular long-term use of the drug is not recommended due to the myelotoxicity of metamizole; with prolonged use (more than 7 days), it is necessary to control the qualitative and quantitative composition of peripheral blood, especially the leukocyte formula. Agranulocytosis When using the drug, the development of agranulocytosis is possible, and therefore, if unmotivated fever, chills, sore throat, difficulty swallowing, stomatitis, and inflammation of the external genitalia and anus are detected, immediate withdrawal of the drug is necessary. If signs of agranulocytosis or thrombocytopenia occur, a general blood test (formula) should be performed. Stopping treatment should not be delayed until laboratory testing. Pancytopenia If pancytopenia occurs, treatment should be followed by complete blood count results until they normalize. All patients should be advised that they should immediately consult a doctor if signs of illness or symptoms appear during treatment that indicate pathological changes in the blood system (for example, poor general health or malaise, fever, bleeding, bleeding, pallor). Anaphylactic / anaphylactoid reactions The risk of potential possible severe anaphylactoid reactions to metamizole sodium is significantly increased in patients with: allergic diseases (including hay fever) or those in history; analgesic-induced asthmatic syndrome or intolerance to analgesics in the form of urticaria and combined angioedema; bronchial asthma, especially in combination with rhinosinusitis and nasal polyps; chronic urticaria; intolerance to dyes (for example, tartrazine) or preservatives (for example, benzoates); alcohol intolerance. Anaphylactic shock may occur predominantly in susceptible patients. Therefore, special care is needed when used in patients with bronchial asthma or atopy. Severe skin reactions Cases of life-threatening skin reactions have been reported: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with metamizole sodium. If signs of SJS or TEN develop (such as a progressive skin rash, often with blisters and/or mucosal lesions), treatment with metamizole sodium should be stopped immediately and never restarted. Isolated hypotensive reactions Metamizole sodium may cause hypotensive reactions. These reactions may be dose dependent and are more likely to be expected with parenteral administration. The risk of such reactions is also increased: in patients with previous hypotension, blood volume deficiency or dehydration, unstable blood circulation or with incipient circulatory failure (for example, in patients with myocardial infarction, multiple injuries); in the treatment of cytostatics; in chronic alcoholism; in patients with high temperature. Therefore, in such patients, careful verification of indications and regular follow-up is required. Precautionary measures (eg, circulatory stabilization) may be necessary. When taking the drug, it is possible to stain the urine red due to the excretion of the metamizole sodium metabolite, which has no clinical significance. Benzocaine. There is a risk of methemoglobinemia when using drugs containing benzocaine, mainly in patients with congenital defects, for example, glucose-6-phosphate dehydrogenase deficiency, NADH-methemoglobin reductase deficiency, pyruvate kinase deficiency, hemoglobinosis M. Do not use the drug beyond the prescribed period without consultation doctor. If the signs of the disease do not begin to disappear or, on the contrary, the state of health worsens, or undesirable effects appear, it is necessary to stop taking the drug and seek medical advice regarding further use. Use during pregnancy or lactation Use during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. If necessary, the use of the drug breast-feeding should be discontinued. The ability to influence the reaction rate when driving vehicles or working with other mechanisms When using the drug, you should refrain from driving vehicles or working with other mechanisms due to possible side effects from the nervous system, organs of vision. Children Clinical data on the efficacy and safety of use in children are not available, so the drug should not be used in patients under 18 years of age. Interaction with other drugs If you are taking any other drugs, be sure to inform your doctor. Interactions that may be due to metamizole sodium X-ray contrast agents, colloidal blood substitutes, penicillin – should not be used in the treatment of metamizole sodium. Chlorpromazine or other phenothiazine derivatives – severe hypothermia may develop. Oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids, indomethacin – metamizole sodium increases activity these drugs by displacing them from their connection with the protein. Phenylbutazone, glutethimide, barbiturates and other inducers of microsomal liver enzymes – the effectiveness of metamizole sodium decreases. analgesic and antipyretic effect and increases the likelihood of additive unwanted side effects. Sedatives and tranquilizers (sibazon, trioxazine, val cordin), codeine, anaprilin, histamine H2 receptor blockers, propranolol – enhance the analgesic effect of metamizole sodium. Sarcolysin, mercazolil, thiamazole – the likelihood of developing leukopenia increases. Cyclosporine – the concentration of cyclosporine in the blood plasma decreases. Sulfonylamide hypoglycemic drugs – their hypoglycemic effect may increase Diuretics (furosemide) – a decrease in the diuretic effect is possible. Metamizole sodium enhances the sedative effect of alcohol. Interactions that may be due to belladonna extract and benzocaine Amantadine, antiarrhythmic anticholinergic drugs (including quinidine), tricyclic antidepressants, glutethimide – the anticholinergic effects of Bellalgin are enhanced. Opioid analgesics and drugs that depress the central nervous system (including phenothiazines) – there is a dangerous inhibition of the central nervous system. Butyrophenones (haloperidol), organic nitrates – intraocular pressure increases. Corticosteroids for systemic use – the effect of corticosteroids is reduced and intraocular pressure may increase. Pilocarpine – its effect is reduced in the treatment of glaucoma. M-anticholinergics – anticholinergic effects are enhanced. Furosemide – orthostatic hypotension is possible. Reserpine, MAO inhibitors, guanethidine, antacids, ascorbic acid, attapulgite – the effect of Bellalgin is reduced. its dosage should be adjusted. Some antihistamines (including meklizin) – the antihistamine effect is enhanced. Beta-adrenergic receptor blockers – their effect is reduced. Hormonal contraceptives – the contraceptive effect is reduced. Non-selective inhibitors of neuronal reuptake of monoamines – the sedative effect is enhanced. digitoxin, doxycycline, metoclopramide, metronidazole – the effect of these drugs is reduced. Ketoconazole – increasing the pH of gastric juice with Bellalgin reduces the absorption of ketoconazole, so Bellalgin should be taken no earlier than 2 hours after ema ketoconazole. Sulfonamides – their antibacterial activity decreases. Indapamide, nizatidine – their effect increases. Potassium chloride – damage to the mucous membrane of the gastrointestinal tract is possible. Method of application and dosage Bellalgin is intended for symptomatic short-term use, therefore, the dose and course of treatment are selected individually. Applied by adults inside 1 tablet for pain (as needed). The maximum daily dose is 10 tablets. Overdose Belladonna extract. Symptoms: increased manifestations of adverse reactions, nausea, vomiting, tachycardia, lowering blood pressure, agitation, irritability, tremor, convulsions, insomnia, drowsiness, hallucinations, hyperthermia, depression of the central nervous system, depression of the activity of the respiratory and vasomotor centers. Metamizole sodium. Symptoms: hypothermia, pronounced decrease in blood pressure, palpitations, shortness of breath, tinnitus, nausea, vomiting, stomach pain, oliguria, anuria, tachycardia, weakness, drowsiness, delirium, impaired consciousness, convulsive syndrome; possible development of acute agranulocytosis, hemorrhagic syndrome, acute renal and hepatic insufficiency, paralysis of the respiratory muscles. Benzocaine. Long-term use of the drug in doses higher than recommended, or too frequent use within a short period of time, can lead to methemoglobinemia. When the first signs of intoxication appear, the use of the drug should be immediately discontinued. Depending on the degree of oxidation of hemoglobin, mild overdose symptoms may appear, such as headache, cyanosis, fatigue, shortness of breath. In more severe forms of methemoglobinemia, palpitations, convulsions, cardiac arrhythmia, and coma can sometimes be observed. Treatment: gastric lavage, administration of saline laxatives, activated charcoal. Carrying out forced diuresis, hemodialysis, alkalization of blood, symptomatic therapy aimed at supporting vital functions. With the development of a convulsive syndrome, intravenous administration of diazepam and fast-acting barbiturates, parenteral administration of cholinomimetics and anticholinesterase agents are carried out. Treatment is symptomatic. Treatment of methemoglobinemia includes the introduction of 100% oxygen, in more severe cases, an antidote is used – methylene blue, and gastrointestinal decontamination (gastric lavage, ingestion of activated charcoal) is also indicated. At the first symptoms of an overdose, you should immediately seek medical help. Side effect Belladonna extract. Nervous system: headache, dizziness. Urinary system: difficulty and retention of urination. Digestive tract: dry mouth, feeling of thirst, impaired taste sensations, dysphagia, decreased intestinal motility, up to atony, decreased tone of the biliary tract and gallbladder. Organs of vision: dilated pupils, photophobia, accommodation paralysis, blurred vision, increased intraocular pressure. Cardiovascular system: facial flushing, hot flashes, palpitations, arrhythmias (including extrasystole), myocardial ischemia. Respiratory system and mediastinal organs: decrease in secretory activity and tone of the bronchi, leading to the formation of viscous sputum, which is difficult / expectorated. Immune system: possible manifestations of hypersensitivity reactions, including anaphylactic reactions, anaphylactic shock. Skin and subcutaneous tissue: skin rash, hyperemia, urticaria, exfoliative dermatitis, hyperemia. Other: decreased sweating, dry skin and mucous membranes, dysarthria. Metamizole sodium. The frequency of possible side effects listed below is defined as: very often (? 1/10); often (? 1/100 to < 1/10); infrequently (? 1/1000 to < 1/100); rare (? 1/10,000 to < 1/1,000); very rarely (< 1/10,000); unknown (cannot be estimated from available data). Blood and lymphatic system Rarely - leukopenia; very rarely - agranulocytosis, including cases with a fatal outcome, thrombocytopenia; frequency unknown - aplastic anemia, pancytopenia, including a fatal case. These reactions may also occur, even if in previous cases the use of metamizole took place without complications. There is some evidence that the risk of agranulocytosis may increase if metamizole is used for more than one week. This reaction is not dose dependent and may occur at any time during treatment. It is manifested by high fever, chills, sore throat, difficulty swallowing, and inflammation of the mucous membranes of the mouth, nose, throat, genitals, and/or anal area. In patients receiving antibiotics, these symptoms may be minimal. Enlargement of the lymph nodes or spleen is slight or absent. Erythrocyte sedimentation is significantly accelerated, the number of granulocytes is significantly reduced or they are completely absent. As a rule, but not always, there are normal values of hemoglobin, erythrocytes and platelets. For recovery, the immediate withdrawal of the drug is crucial. Therefore, it is strongly recommended to immediately stop the use of metamizole, without waiting for the results of laboratory diagnostic tests, with an unexpected deterioration in the general condition, with the preservation of fever or its resumption, with painful changes in the mucous membranes, especially in the oral cavity, nose and pharynx. If pancytopenia occurs, treatment with the drug should be stopped immediately, the indicators of a complete blood count should be monitored until they normalize. The immune system. Rarely - anaphylactoid or anaphylactic reactions *. Very rarely - analgesic-induced asthmatic syndrome. In patients with analgesic-induced asthmatic syndrome, intolerance reactions usually manifest themselves in the form of asthmatic attacks. The frequency is not known - anaphylactic shock *. *These reactions may occur more frequently after parenteral administration, generally within the first hour after administration, and may be serious and life-threatening, in some cases fatal. They can occur even if in previous cases the use of metamizole took place without complications. Milder reactions are usually manifested as skin and mucosal reactions (eg, itching, burning, redness, urticaria, swelling), dyspnea, and, rarely, gastrointestinal disturbances. These reactions can transform into more severe forms, manifested by generalized urticaria, severe angioedema (also in the larynx), severe bronchospasm, cardiac arrhythmias, arterial hypotension (sometimes with a previous increase in blood pressure), circulatory shock. Therefore, if skin reactions occur, the use of Bellalgin should be immediately discontinued. From the side of the heart. Frequency unknown - Kounis syndrome. Vascular system. Infrequently - hypotensive reactions during or after use, which may be pharmacologically determined and are not accompanied by other signs of anaphylactoid or anaphylactic reactions. Such reactions can lead to a sharp drop in blood pressure. Also, with hyperthermia, a dose-dependent critical decrease in blood pressure can occur without other signs of hypersensitivity reactions. Skin and subcutaneous adipose/connective tissue. Infrequently - a fixed drug exanthema. Rarely - rash (for example, maculopapular rash). Very rarely - Stevens-Johnson syndrome or toxic epidermal necrolysis (treatment withdrawal). Urinary system. Very rarely - an acute deterioration in kidney function, against which, in very rare cases, proteinuria, oliguria, anuria or toxic nephropathy in various forms, including acute renal failure, acute interstitial nephritis, may develop. It is possible to stain urine red, which has no clinical significance and may be associated with the excretion of a harmless metabolite of metamizole present in low concentrations - rubazonic acid. Benzocaine. The frequency of side effects is indicated in accordance with the generally accepted classification: very often (? 1/10); often (? 1/100 to < 1/10); infrequently (? 1/1000 to < 1/100); rare (? 1/10,000 to < 1/1,000); very rarely (<1/10,000), including isolated cases. Rare cases include: bluish color of the nails; lips, palms. A number of adverse reactions were detected with an unknown frequency. These include the following: burning, dryness, or flaking of the skin; dark color of urine; difficulty breathing; dizziness, fainting, headache, drowsiness, lethargy, fatigue; fever; paresthesia; irritability; tachycardia; sore throat; methemoglobinemia. In case of any adverse reactions, you should stop taking the drug and be sure to consult a doctor. Shelf life 3 years. Do not use the drug after the expiration date indicated on the package. Storage conditions In the original packaging to protect from light at a temperature not exceeding 25 °C. Keep out of the reach of children. Packing: 10 tablets in a blister made of PVC film and aluminum foil with thermal varnish coating on one side and printing on the other side. One blister, together with instructions for the medical use of the drug or leaflet, is placed in a pack of cardboard. Vacation conditions Without a prescription. Buy Bellalgin tablets No. 10x1 Price for Bellalgin tablets No. 10x1