Name Benalgin tablets in a blister in pack No. 10×2 Main active ingredient Metamizole sodium + caffeine + thiamine Release form Round, flat tablets of white or almost white color, with a risk on one side, 13 mm in diameter. 10 (ten) tablets of the medicinal product Benalgin tablets are packed in blisters from a transparent colorless film of aluminum foil. Release of the drug Without a prescription Pharmacological action Metamizole sodium in combination with other drugs (excluding psycholeptics). Benalgin is a combination drug, the action of which is due to the action of its individual components (metamisole, caffeine and vitamin III). Metamizole has analgesic and antipyretic effects. Caffeine has a stimulating effect on the central nervous system and enhances the action of metamizole, facilitating its penetration into the brain tissue. Vitamin B1 improves metabolism and conduction of nerve impulses. Indications for useHeadache, tension headache, toothache, moderate pain syndrome, including dysmenorrhea, acute pain after surgery or injury, other types of pain (if other measures are impossible), fever of various origins, poorly controlled by other means. Use during pregnancy and lactation: Before taking any medicines, consult your doctor or pharmacist. This drug should not be used during pregnancy. If taking Benalgin during breastfeeding is absolutely necessary, feeding should be stopped, since some components of the drug pass into breast milk. Precautions Please note the following when using this medicinal product: Caution should be exercised in patients with impaired renal and/or hepatic function, active peptic ulcer, arrhythmia, insomnia, severe unexplained headache, severe drug or food allergy, and other atopy. When conducting a longer course of treatment, periodic monitoring of the blood picture is necessary. Caffeine may interfere with test results using adenosine or dipyridamole, so Benalgin should not be taken less than 12 hours before a test. The drug contains a pyrazolone derivative metamizole, the use of which is associated with a rare but life-threatening risk of a shock reaction or agranulocytosis (especially for patients with hypersensitivity to other non-narcotic analgesics), agranulocytosis. If there are signs of agranulocytosis or thrombocytopenia, you should immediately stop taking the drug and do a clinical blood test (including a comparative hemogram). Stopping the drug should not be delayed until the results of laboratory tests are available. Pancytopenia. If signs of pancytopenia occur, treatment should be stopped immediately, a clinical blood test should be done and the drug should not be taken until the indicators return to normal. If during treatment with the drug, there are signs and symptoms of an illness that indicates pathological changes in the blood (for example, general malaise, fever for a long time, infection, bruising, bleeding, pallor), you should immediately consult a doctor. Severe skin reactions. When taking metamizole, such life-threatening skin reactions as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been identified. If symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis (a progressive skin rash often accompanied by blisters or mucosal lesions) appear, the drug should be stopped immediately and never resumed. Patients should be alert to the onset of symptoms and watch for skin reactions, especially in the first weeks of treatment. Patients with impaired liver and kidney function can use Benalgin, strictly guided by the risk/benefit ratio and observing appropriate precautions. It is unacceptable to use the drug for the relief of acute abdominal pain (until the cause is clarified). When using the drug, excessive consumption of coffee, strong tea, other tonic drinks, alcohol and drugs containing caffeine should be avoided. The recommended dose of the drug contains about the same amount of caffeine as is in a cup of coffee. When taking the drug for a long time, mental dependence may develop. Abrupt discontinuation of treatment leads to increased inhibition of the central nervous system (drowsiness, depression). The action of the drug largely depends on the type of nervous system and can be manifested by both excitation and inhibition of higher nervous activity. Caffeine can cause a false increase in blood uric acid as determined by the Bittner method. With caution, the drug should be used in patients with a history of peptic ulcer of the digestive tract. Do not take simultaneously with other NSAIDs and metamizole. When using analgesics every other day or more often, an existing headache may appear or increase after prolonged treatment with analgesics (more than 3 months). Headache caused by excessive use of analgesics should not be treated with an increase in their dose. In these cases, treatment should be discontinued after consulting a doctor. The wheat starch in the formula may contain only traces of gluten and is considered safe for people with celiac disease. The drug should be used with caution in patients with prostatic hypertrophy with urinary retention. Interactions with other drugs Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, even if they have not been prescribed for you. Interactions that may be due to the presence of caffeine: Barbiturates, coDeine, paracetamol, H2 receptor blockers, propranolol: increased effects. Sarcolysin, mercazoli, thiamazole, drugs that suppress bone marrow activity, including gold preparations: an increase in the likelihood of hematotoxicity, including the development of leukopenia. Ketoconazole, disulfiram, ciprofloxacin, norfloxacin, enoxacin, pipemidic acid may slow down the excretion of caffeine and increase its concentration in the blood. Oral antidiabetic agents: increase in their hypoglycemic activity. Cyclosporine: decrease in its concentration in blood plasma. Ergotamine: caffeine may increase its effect. Fluvoxamine: increased plasma levels of caffeine. Mexietine: 50% reduction in caffeine excretion. Nicotine: Increasing the rate of caffeine elimination. Methoxsalen: a decrease in the excretion of caffeine from the body with a possible increase in its effect and the development of a toxic effect. Clozapine: increased plasma concentrations of clozapine. Theophylline and other xanthines: reduced clearance of these drugs, increased risk of additive pharmacodynamic and toxic effects. Lithium: increased urinary excretion of lithium. Other drugs whose effects may be altered by interaction with caffeine: idrocypamide, phenylpropanolamine, phenytoin, pentobarbital, diazepam. MAO inhibitors, furazolidone, procarbazine and selegiline: a dangerous increase in blood pressure is possible. Antipyretic analgesics: caffeine enhances their effect (improves bioavailability). Psychostimulants, ?- and, ? – adrenomimetics: potentiation of their effects. Cimetidine, hormonal contraceptives, isoniazid: increased effect of caffeine. Opioid analgesics, anxiolytics, hypnotics and sedatives: caffeine reduces their effect. Caffeine is an antagonist of drugs for anesthesia and other drugs that depress the central nervous system, a competitive antagonist of drugs of adenosine, ATP. Thyrotropic drugs: increased thyroid effect. Drinks and medicines containing caffeine, when used together with the drug, may lead to excessive stimulation of the central nervous system. High doses of caffeine can cause jitters and palpitations. Interactions that may be due to the presence of metamizole sodium: Chlorpromazine or other phenothiazine derivatives: severe hypothermia may develop. X-ray contrast agents, colloidal blood substitutes and penicillin: should not be used in the treatment of metamizole sodium. Indirect anticoagulants, glucocorticosteroids and indomethacin: metamizole sodium increases the activity of these drugs by displacing them from protein binding. Phenylbutazone, other inducers of microsomal liver enzymes: a decrease in the effectiveness of metamizole sodium. Tricyclic antidepressants, hormonal contraceptives and allopurinol: it is possible to increase the toxicity of metamizole sodium. Sedatives and tranquilizers (sibazon, trioxazine), valocordin: increased analgesic action of metamizole sodium. Non-narcotic analgesics, other non-steroidal anti-inflammatory drugs (NSAIDs): their analgesic and antipyretic effects are potentiated, and the likelihood of additive unwanted side effects is increased. 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 (primarily on the digestive tract and the hematopoietic system). Sulfonamide oral hypoglycemic drugs: it is possible to increase their hypoglycemic effect when used with NSAIDs, including metamizole sodium. Diuretics (furosemide): may reduce the diuretic effect. Therapeutic doses of vitamin B6 may reduce the effect of levodopa. The use of pyridoxine antagonists (isoniazid, D-penicillinamine, cycloserine), alcohol, as well as long-term use of oral contraceptives containing estrogens can lead to vitamin B6 deficiency. Thiamine is inactivated by 5-fluorouracil, which blocks thiamine phosphorylation, is incompatible with oxidizing and reducing substances, as well as phenobarbital, riboflavin, benzylpenicillin, and dextrose. The use of Benalgin and food and drink intake There are no restrictions on the use of the drug and the intake of food and drinks. Contraindications Benalgin is not used for allergies to active ingredients (pyrazolones, methylxanthines) or excipients of the drug. This drug should not be taken with a tendency to allergic reactions (analgesic-induced asthmatic syndrome, bronchospasm, urticaria, rhinitis, angioedema) due to hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs (salicylates, paracetamol, other non-narcotic analgesics such as diclofenac, ibuprofen, indomethacin , naproxen, etc.); with blood diseases, or impaired bone marrow function (for example, after treatment with cytostatics); patients with congenital deficiency of glucose-b-phosphate dehydrogenase; severe diseases of the liver and kidneys; acute intermittent hepatic porphyria (danger of provoking an attack); with systolic blood pressure below 100 mm Hg, as well as uncontrolled arterial hypertension; with organic diseases of the cardiovascular system (including acute myocardial infarction, paroxysmal tachycardia, atherosclerosis); with glaucoma; sleep disorders; with increased excitability in children. The drug is not used in children under 14 years of age, as well as during pregnancy and lactation. Composition Medicinal substances in one tablet: Metamizole sodium (in the form of metamizole sodium monohydrate) 500 mg, caffeine 50 mg, thiamine hydrochloride 38.75 mg. Excipients: Microcrystalline cellulose, wheat starch, talc, magnesium stearate, gelatin, colloidal silicon dioxide (anhydrous). Dosage and Administration Always take Benalgin exactly as directed in this package leaflet. Benalgin is prescribed for adults and children over 14 years of age, 1/2 or 1 tablet 2-3 times a day. Do not chew the tablets, drink a little water. The recommended dose for adults is 1 tablet 3 times a day. The recommended dose for children from 14 to 16 years old is 1/2 – 1 tablet 3 times a day. The maximum dose should not exceed 3 tablets per day. The course of treatment with Benalgin without consulting a doctor is no more than 3 days. The tablet may be divided into two equal doses. It is recommended to use the minimum effective dose of the drug. Elderly patients are prescribed a lower dose of the drug. In patients with renal or hepatic insufficiency, high doses of the drug should be avoided. When taking the drug for a short time, dose reduction is not required. There are no experimental data on long-term use of the drug. duration of treatment. The duration of treatment is no more than 3 days. If the symptoms of the disease do not disappear within 3 days, you should consult a doctor regarding the further use of the drug. If you have the impression that Benalgin is too weak or too strong, talk to your doctor or pharmacist. Overdose When taking a high dose of the drug, consult a doctor immediately! Overdose of metamizole sodium: hypothermia, palpitations, trembling, pronounced decrease in blood pressure, tachycardia, dysphagia, shortness of breath, tinnitus, nausea, vomiting, gastralgia / gastritis, weakness, drowsiness, delirium, impaired consciousness, convulsive syndrome; possible development of acute agranulocytosis, hemorrhagic syndrome, oliguria, anuria, acute renal and hepatic failure, paralysis of the respiratory muscles. Caffeine overdose: gastralgia, anxiety, agitation, nervousness, dizziness, insomnia, irritability, affective state, facial flushing, psychomotor agitation, confusion, delirium, dehydration, tachycardia, arrhythmia, hyperthermia, increased urination frequency, increased respiratory rate, headache, increased tactile or pain sensitivity, tremor or muscle twitching; nausea and vomiting, sometimes with an admixture of blood, pain in the epigastric region, ringing in the ears, convulsive seizures (in acute overdose, tonic-clonic convulsions). Treatment: gastric lavage, forced diuresis, administration of enterosorbents, support for lung ventilation and oxygenation; with convulsive seizures – intravenous diazepam, phenobarbital or phenytoin; maintaining fluid and salt balance. In severe cases, hemodialysis, hemoperfusion, peritoneal dialysis is possible. Symptomatic therapy is aimed at maintaining vital functions. Overdose of thiamine hydrochloride: Not described If symptoms of an overdose appear, consult a doctor immediately! If you miss a dose of Benalgin If you miss one dose of the medicine, do it during the next regular dose without increasing the dose. If you have any further questions on the use of this medicine, please ask your doctor or pharmacist. Side effects Like all medicines, Benalgin can cause side effects, although not everybody gets them. The following adverse drug reactions are possible: To display the frequency of possible adverse reactions, the following criteria are used: very often (?1/10), often (?1/100, <10), sometimes (?1/1000, <100) , rare (≥1/10000, 400), very rare (<1/10000), frequency unknown (cannot be estimated from the available data). Blood and lymphatic system On the part of the blood and lymphatic system: rare: leukopenia; very rare: agranulocytosis, including cases of death, thrombocytopenia; the frequency of occurrence is unknown: aplastic anemia, pancytopenia, including cases of death. There are isolated reports of a possible increase in the risk of developing agranulocytosis due to the use of the drug for more than one week. This reaction is independent of dosage and may occur at any stage of therapy. It manifests itself in fever, chills, sore throat, complaints of difficulty swallowing, as well as in inflammatory processes in the mouth, nose, pharynx and genitals or anus. However, these signs may be minimal in patients receiving antibiotic therapy. Swollen lymph nodes or inflammation of the spleen may be mild or absent. The erythrocyte sedimentation rate is significantly increased, the content of granulocytes is significantly reduced or completely absent. As a rule, but not always, hemoglobin, red blood cells and platelets remain normal. Prompt discontinuation of the drug is critical to recovery. In this regard, it is strongly recommended to immediately stop taking the drug and not wait for the results of laboratory diagnostic studies, in case of an unexpected deterioration in general well-being, lack of dynamics in reducing body temperature or in case of its repeated increase, as well as in view of the manifestation of changes in the mucous membrane, especially the oral cavity , nose and throat. In case of manifestation of pancytopenia, therapy should be stopped immediately and a complete blood count should be monitored until the condition normalizes. Immune system: rare: anaphylactoid or anaphylactic reactions (usually with parenteral administration); very rare: analgesic-induced asthmatic syndrome In patients with analgesic-induced asthmatic syndrome, drug intolerance reactions usually manifest as asthma attacks. Heart: the frequency of occurrence is unknown - Kounis syndrome. Vascular diseases: sometimes: possible hypotension with anaphylactoid or anaphylactic reactions to intravenous or intramuscular administration in systemic blood pressure? 100 mmHg, palpitations, arrhythmia, tachycardia. Skin and subcutaneous tissue: sometimes: drug exanthema; rare: rash (eg, maculopapular rash) very rare: toxic epidermal necrolysis and Stevens-Johnson syndrome (stop treatment). Kidneys and urinary tract: very rare: sudden deterioration in kidney function, which very rarely can develop proteinuria, oligo- or anuria and acute renal failure, acute interstitial nephritis, increased frequency of urination, increased creatinine clearance, increased excretion of sodium and calcium. Nervous system: agitation, anxiety, tremor, restlessness, dizziness, tachypnea, insomnia. Digestive tract: nausea, vomiting, diarrhea, exacerbation of peptic ulcer. Allergic reactions: skin rash, itching, urticaria, angioedema, bronchospasm. If any side reaction becomes serious, or if you experience any side effects not listed in this leaflet, please contact your doctor or pharmacist. Storage conditions: At a temperature not exceeding 25 0 C. Keep out of the reach of children! Shelf life from date of manufacture: 2 years. Do not use after the expiration date indicated on the package! Buy Benalgin tablets No. 10x2 Price for Benalgin tablets No. 10x2
INN | METAMIZOL SODIUM+CAFFEINE+THIAMIN |
---|---|
The code | 1 124 |
Barcode | 3 800 712 031 616 |
Active substance | Metamizole sodium, caffeine, thiamine g/h |
Manufacturer | Balkanpharma-Dupnitsa AD, Bulgaria |
Trademark | Actavis |
trade line | Benalgin |
Importer | Foreign unitary trade and manufacturing enterprise "Belinvestfarma", Minsk, Leshchinskogo st., 8/4-2; Komfarm LLC, Minsk, 220131 Minsk, Sosnovy Bor st., 4, office 1; Limited Liability Company "Farmiko", Minsk district, Senitsky s / s, Kolyadichi village, Lazurnaya st., 9; Additional Liability Company "Farmin", 220125 Minsk, Independence Avenue, 177, room 62; IOOO "Interfarmaks", Republic of Belarus, 223028, Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Zvezdnaya, 19A-5, pom. 5-2 |
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