Spazmalgon tablets №10×1

Description The main active ingredient Metamizole sodium + pitofenone + fenpiverinium bromide Release form Tablets Pharmacological action Spasmalgon is a combination drug that combines analgesic and relaxing smooth muscles action. Indications for use Symptomatic treatment of mild or moderate pain syndrome with spasms of smooth muscles of internal organs: – renal colic and inflammatory diseases of the urinary tract, occurring with pain and dysuric disorders; spasms of the stomach and intestines, hepatic colic, biliary dyskinesia; spastic dysmenorrhea. Dosage and Administration Always take Spasmalgon exactly as directed in this leaflet. If you are not sure about something, ask your doctor or pharmacist! Tablets are taken orally, after meals. Tablets should be swallowed whole with a sufficient amount of liquid (a glass of water). Recommended daily doses: Adults and children over 15 years old – 1-2 tablets 2-3 times a day. The maximum daily dose is 6 tablets. Children: from 12 to 15 years – 1 tablet 2-3 times a day. The maximum daily dose is 3 tablets, from 10 to 12 years old – 1/2 tablet 2-3 times a day. The maximum daily dose is 2 tablets. duration of treatment. The duration of treatment depends on the type and severity of the disease. When treated with painkillers for a long time, regular monitoring of blood tests, including white blood cells, is necessary. For elderly patients, as well as for weakened general health and limited creatinine clearance, the dosage should be reduced. In patients with impaired renal or hepatic function, high doses of the drug should be avoided. If you have the impression that the effect of Spasmalgon is stronger than expected or insufficient, contact your doctor or pharmacist. Use during pregnancy and lactation Before taking any medicines, consult your doctor or pharmacist. The active ingredients in Spazmalgon pass into breast milk and can harm the fetus when taken during pregnancy, so Spazmalgon is not used during pregnancy and during breastfeeding. PrecautionsWarnings for use 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. The drug is prescribed with caution to patients with impaired renal and / or liver function, with certain diseases of the stomach (achalasia – the inability to relax the lower esophageal sphincter when swallowing and the absence of normal esophageal peristalsis; gastroesophageal reflux, pyloric stenosis), with prostatic hypertrophy, with increased thyroid function glands (hyperthyroidism), with a tendency to lower blood pressure (hypotension), with severe arrhythmias, coronary heart disease (especially after a recent myocardial infarction), patients with chronic congestive heart failure, with chronic bronchitis and bronchospasm (due to increased viscosity bronchial secretions), if there is evidence of hypersensitivity to non-steroidal anti-inflammatory drugs or non-narcotic analgesics or other manifestations of allergies (allergic rhinitis, bronchial asthma). With prolonged use of the drug (more than 7 days), it is necessary to monitor the state of peripheral blood and liver function. With prolonged treatment with analgesics (more than three months), when they are taken every other day or more often, a headache may appear or worsen an existing one. Headache caused by overuse of painkillers should not be treated with an increase in their dose. In such cases, analgesic treatment should be discontinued after consulting a doctor. Metabolites (degradation products) of metamizole can color the urine red, which has no clinical significance. 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. Metamizole increases plasma concentrations of chloroquine, reduces plasma concentrations and effects of coumarin anticoagulants and cyclosporine. Increases the toxic effect of myelotoxic drugs, chloramphenicol. Neuroleptics and tranquilizers enhance the analgesic effect of metamizole. Tricyclic antidepressants, oral contraceptives, allopurinol disrupt the metabolism of metamizole and increase its toxicity. Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes may reduce the effect of metamizole. The simultaneous use of Spasmalgon with other analgesics and non-steroidal anti-inflammatory drugs increases the risk of allergic reactions. Metamizole reduces plasma concentrations of cyclosporine A and may pose a risk in the presence of tissue transplantation. The combination of Spasmalgon and other drugs requires special care due to the content of metamizole, which is an enzyme inducer. If you need to use these or other drugs at the same time, you should consult your doctor. Contraindications Do not take Spasmalgon: in case of hypersensitivity to the active ingredient and other pyrazolones (pyrazolidins) – in particular, the drug should not be used in patients who develop agranulocytosis as a result of taking it, and other excipients in the composition of the drug; with a tendency to allergic reactions (analgesic-induced asthmatic syndrome , bronchospasm, urticaria, rhinitis, Quincke’s edema) 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.); in violation of bone marrow function ( for example, after treatment with cytostatics); with certain blood diseases (changes in the cellular composition of the blood, such as agranulocytosis and leukopenia); with congenital deficiency of glucose-6-phosphate dehydrogenase; with acute intermittent porphyria (danger of an attack); with severe renal and hepatic insufficiency ty; during pregnancy and lactation; children under 10 years old; with gastrointestinal obstruction and megacolon (expansion of the colon wall); with difficulty emptying as a result of muscle weakness (atony) of the gallbladder and bladder; with angle-closure glaucoma. substances in one tablet: metamizole sodium 500 mg, pitofenone hydrochloride 5 mg and fenpiverinium bromide 0.1 mg. Excipients: lactose monohydrate, wheat starch, gelatin, talc, magnesium stearate, sodium bicarbonate. Overdose When taking a high dose of the drug, consult a doctor immediately! Overdose symptoms: In acute overdose of the drug, the following symptoms were identified: nausea, vomiting, abdominal pain, acute renal failure; from the nervous system – dizziness, drowsiness, convulsions; hypotension and tachycardia. When taking very high doses of the drug, precipitation of rubazonic acids may occur and, as a result, staining of urine in red. Treatment: There is no specific antidote for metamizole. In case of an overdose, you should immediately stop taking the drug and take measures to quickly remove it from the body – conduct a primary detoxification (for example, induce vomiting, gastric lavage or take activated charcoal). If symptoms of an overdose appear, consult a doctor immediately! Side effects Like all medicines, Spasmalgon can cause side effects, although not everybody gets them. The frequency of occurrence of adverse reactions is defined as follows: very common (? 1/10), frequent (? 1/100 to < 1/10), not often (? 1/1000 to < 1/100), rare (? 1/10000 up to < 1/1000), very rare (< 1/10000), with an unknown frequency (an estimate cannot be made from existing data). On the part of the blood and lymphatic system: rare: leukopenia; very rare: agranulocytosis, thrombocytopenia; the frequency of occurrence is unknown: aplastic anemia, pancytopenia. 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, and also due to the manifestation of 7 changes in the mucous membrane, primarily in the cavity mouth, 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. From the immune system: rarely: anaphylactoid and anaphylactic reactions *; very rarely: analgesic asthma syndrome. Patients with analgesic asthma syndrome show severe intolerance reactions, usually in the form of asthmatic attacks. Frequency unknown: anaphylactic shock*. *Reactions appear mainly in the form of skin reactions and mucosal reactions (eg, itching, burning, redness, urticaria, swelling), dyspnea and, less commonly, gastrointestinal complaints. Mild reactions of this kind can develop into a more severe form of generalized urticaria, severe angioedema (also in the larynx), severe bronchospasm, heart rhythm disturbances, rapid decrease in blood pressure (also sometimes with a previous increase in blood pressure), acute circulatory dysfunction (shock). In view of this, treatment with the drug should be immediately discontinued in case of skin reactions. On the part of the skin and subcutaneous adipose tissue: infrequently: fixed drug exanthema; rarely: rash (eg, maculopapular exanthema); very rarely: Stevens-Johnson syndrome or toxic epidermal necrolysis. From the digestive tract: discomfort, dry mouth, constipation, exacerbation of gastritis and peptic ulcer of the stomach and duodenum. From the side of the cardiovascular system: palpitation, lowering blood pressure, tachycardia, cardiac arrhythmias, Kounis syndrome. Infrequently: hypotensive reactions during or after use, possibly due to the pharmacological action of the drug and not accompanied by other signs of an anaphylactoid or anaphylactic reaction. A reaction of this kind 8 can cause a significant acute decrease in blood pressure. Also, against the background of hyperpyrexia, depending on the dosage, a critical acute decrease in blood pressure may develop without the manifestation of other symptoms of an intolerance reaction. From the side of the kidneys and urinary system: very rarely - a sharp decrease in kidney function, while very rarely proteinuria, oliguria or anuria and / or acute renal failure can develop; acute interstitial nephritis. There is evidence of red staining of urine, which may be due to the presence of a low concentration of harmless rubazonic acid in metamizole metabolites. Other: blurred vision, hepatitis, decreased sweating, dizziness. If any side reaction becomes serious, or if you experience any side effects not described in this leaflet, please contact your doctor or pharmacist. Storage conditionsAt a temperature not higher than 25°C. Keep out of the reach of children! Shelf life 2 (two) years. Do not use Spasmalgon after the expiration date indicated on the package! Buy Spasmalgon tablets No. 10x1 Price for Spasmalgon tablets No. 10x1