Tempalgin tablets p/o 500mg/20mg №10×1

Name:
Tempalgin tab p/o 500mg/20mg in a blister. in pack No. 10×1
Description:
Round, biconvex film-coated tablets, green, odorless. Pharmacological action Tempalgin is a combined drug that contains the active substances metamizole sodium and triacetonamine-4-toluenesulfonate. It has a pronounced and prolonged analgesic effect due to the non-narcotic analgesic metamizole sodium, which inhibits the synthesis of prostaglandins. Triacetonamine-4-toluenesulfonate reduces motor agitation and has a calming effect. Indications for use Acute pain after trauma or surgery Colic Pain in neoplastic diseases Other acute or chronic severe pain when other therapeutic measures are contraindicated or not effective High temperature that is not relieved by other methods. who have been diagnosed with agranulocytosis after the use of these substances) or any other ingredients of analgin. In patients with a history of aspirin asthma or analgesic intolerance syndrome (urticaria, angioedema), in patients with bronchospasm or other forms of anaphylactoid reactions to salicylates, paracetamol or other non-narcotic analgesics such as diclofenac, ibuprofen, indomethacin and naproxen). If there is a violation of the function of the bone marrow (for example, after treatment with cytostatics) or diseases of the hematopoietic system. Hereditary hemolytic anemia I associated with a deficiency of glucose-6-phosphate dehydrogenase. Patients with systolic blood pressure below 100 mm Hg. With acute intermittent porphyria (risk of an attack of porphyria). In the last trimester of pregnancy. During breastfeeding. With suspected acute surgical pathology. Children under the age of 15. Special instructions Take special care when using Tempalgin contains a pyrazolone derivative metamizole and has a rare but life-threatening risk of shock and agranulocytosis. Patients with atopic bronchial asthma and hay fever have an increased risk of developing hypersensitivity reactions. Patients with anaphylactoid reactions to metamizole are most vulnerable to the entire group of non-narcotic analgesics. Patients with anaphylactoid reactions or other immunologically mediated reactions (eg, agranulocytosis) may react similarly to other pyrazolones and pyrazolidines. When using the drug, the development of agranulocytosis is possible. In this connection, if an unmotivated increase in temperature, chills, sore throat, difficulty swallowing, stomatitis, as well as inflammation of the external genitalia and anus is detected, immediate withdrawal of the drug is necessary. When choosing a method of application, it is important to remember that parenteral administration of analgin is associated with an increased risk of anaphylactic or anaphylactoid reactions. The risk of potentially severe anaphylactoid reactions to analgin increases significantly in patients with: asthma syndrome to analgesics or angioedema to non-narcotic analgesics; bronchial asthma, especially with concomitant rhinosinusitis and polyps in the nose; chronic urticaria; intolerance to dyes (eg, tartrazine) and preservatives (eg, benzoates); intolerance to alcohol. These patients may react to even small amounts of alcoholic beverages with symptoms such as sneezing, watery eyes, and severe facial flushing. Such alcohol intolerance may be a sign of previously diagnosed asthma for analgesics. When prescribing to patients with acute cardiovascular pathology, careful monitoring of hemodynamics is necessary. Use with caution in patients with blood pressure levels below 100 mm Hg. Art., with myocardial infarction, multiple trauma, with anamnestic indications of liver and kidney diseases (pyelonephritis, glomerulonephritis), in the treatment of cytostatics, in chronic alcoholism, aggravated allergic history, blood diseases. Analgin can lead to hypotensive reactions. These reactions may be dose dependent. Usually these reactions occur with parenteral administration, and not enteral. The risk of developing such reactions increases: with rapid intravenous administration; in patients with previous hypotension, dehydration or dehydration, unstable blood pressure, or with incipient circulatory failure (for example, in patients with multiple injuries or a heart attack); in patients with high fever. Patients require careful examination and careful monitoring. Preventive measures (such as circulatory stabilization) may be necessary to reduce the risk of hypotensive reactions. In exceptional cases, analgin can be used in patients in whom a decrease in blood pressure is unacceptable, for example, in severe coronary heart disease or corresponding stenosis of the cerebral arteries. Application is possible only after careful monitoring of hemodynamic parameters. Patients with renal or hepatic insufficiency should only take analgin after a careful assessment of the benefits, risks and necessary precautions. It is necessary to consult with the patient before the introduction of analgin. In patients with an increased risk of anaphylactic reactions, analgin can be used only after a thorough analysis of the possible risks in relation to the expected benefit. When taking analgin in such cases, the patient must be carefully monitored to ensure medical care and emergency preparedness. Important information about some of the ingredients This medicine contains wheat starch, which is acceptable for people with celiac disease. Patients with wheat allergy (other than celiac disease) should not use this medicine. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medicines. Treatment may be affected by the simultaneous use of drugs that suppress the central nervous system, painkillers, anti-inflammatory drugs, contraceptive drugs, coumarin anticoagulants (reduce blood clotting), chlorpromazine (for the treatment of mental illness), chloramphenicol (antibiotic), cyclosporine (used for tumor diseases ), sleeping pills. Use with food and drink Preferably, tablets are taken after a meal with plenty of water. During treatment with Tempalgin, alcohol consumption is not recommended, since side effects of the drug may increase. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before using any medicine. Pregnancy It is not recommended to use Tempalgin during pregnancy. Breastfeeding The use of the drug during breastfeeding is undesirable. If drug treatment is required, breast-feeding should be discontinued. Driving vehicles and working with mechanisms When using Tempalgin, do not drive vehicles and do not work with mechanisms, as this drug reduces the ability to concentrate and slows down conditioned reflexes. Method of application Dosage depends on the intensity of pain or fever and individual sensitivity to metamizole. In principle, the lowest dose that successfully controls pain and/or fever should be chosen. Before the onset of the effect usually takes from 30 to 60 minutes after oral administration. Adults and adolescents aged 15 years (> 53 kg) up to 1000 mg metamizole per dose (2 tablets). In case of insufficient effect, it is possible to increase a single dose, depending on the maximum daily dose – up to 4 times a day (it is not permissible to exceed the daily dose). Elderly In elderly patients, the dose should be reduced because the excretion of metabolites may be delayed. General condition and decrease in creatinine clearance In patients with reduced status and reduced creatinine clearance, the dose should be reduced, since the excretion of metabolic products of metamizole may be prolonged. Renal and hepatic function With impaired renal and hepatic function, the rate of elimination decreases, multiple doses and high doses should be avoided. Dose adjustment is usually not required. Route of administration The route of administration is based on the desired therapeutic effect and the condition of the patient. In many cases, oral administration is sufficient to provide a satisfactory effect (other dosage forms of metamizole for intravenous or intramuscular administration exist to achieve a rapid effect, but, in general, parenteral administration of the drug is associated with a higher risk of anaphylactic or anaphylactoid reactions). The tablets should be swallowed whole with plenty of liquid (eg 1 glass of water). Duration of treatment The duration of treatment depends on the type and severity of the disease and is determined by the doctor. With long-term treatment with metamizole, regular monitoring of blood parameters is required, including counting differentiated leukocytes. If you take a higher dose than you need If you take a higher dose of the drug, you may experience: nausea, dizziness, abdominal pain, weakness to the point of passing out, a severe drop in blood pressure to shock (loss of consciousness with a drop in blood pressure), and heart rhythm disturbances . If some of these symptoms appear, you should immediately stop using the drug and consult a doctor! If you miss a dose of Tempalgin If you miss one dose, take it as soon as possible. If it’s time for your next dose, take it as usual. Do not use a double dose to make up for a missed one. Continue to use the medicine according to the directions in this leaflet. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Possible side effects The frequency of possible side effects listed below is defined as follows: very often (> 1/10), common (> 1/100 to <1/10), sometimes (> 1/1000 to <1/100), rare (> 1/10000 to <1/1000), very rare (< 1/10000), not known (cannot be estimated from the available data). Skin allergic reactions. Sometimes: rash. Rare: maculopapular exanthema. Anaphylactic or anaphylactoid reactions, especially after parenteral use. Such reactions can develop later, during the injection or immediately after the injection, as well as after 10-12 hours. But they occur mainly within the first hour after ingestion. Reactions are usually manifested in the gastrointestinal mucosa and in the form of skin reactions (such as itching, burning, redness, rash, swelling), rarely shortness of breath. These reactions can occur with more severe forms such as: urticaria, severe Quincke's edema (including the larynx), severe bronchospasm, cardiac arrhythmias, arterial hypotension (sometimes preceded by an increase in blood pressure). Reception of analgin with the appearance of skin reactions should be immediately discontinued. In patients with aspirin asthma, reactions usually manifest as asthma attacks. Very rare: analgesic-induced asthma, Stevens-Johnson syndrome or Lyell's syndrome, shock. Blood and lymphatic system. Rare: leukopenia. Very rare: agranulocytosis or thrombocytopenia. These reactions are probably immunological. They may occur even if metamizole has been given on previous occasions without complications. The risk of developing agranulocytosis may be increased if analgin is taken for more than 1 week. Agranulocytosis is manifested by high fever, chills, sore throat, difficulty swallowing, stomatitis, inflammation of the mucous membranes of the nose, throat and genitals, or anal itching. In patients receiving antibiotics, these symptoms may be minimal. ESR is significantly accelerated, granulocytes are significantly reduced or completely absent. As a rule, but not always, laboratory values of hemoglobin, erythrocytes and platelets remain within the normal range. Reception of analgin should be immediately stopped in case of an unexpected deterioration in the general condition, not associated with a decrease in temperature and the manifestation of colds or inflammatory diseases. The cardiovascular system. Infrequently: hypotensive reactions during or after use, which may be pharmacologically dependent, and not accompanied by anaphylactoid reactions. These reactions can lead to a serious drop in blood pressure. Rapid intravenous administration increases the risk of hypotensive reactions. Even with hyperthermia, a critically dose-dependent decrease in blood pressure can occur without any signs of a hypersensitivity reaction. Diseases of the kidneys and urinary tract. Very rare: acute deterioration of renal function - deterioration, after which proteinuria, oligo- or anuria and acute renal failure, acute interstitial nephritis can very rarely develop. Red staining of urine. Storage conditions In the original packaging at a temperature not exceeding 25 ° C in a place protected from moisture. Keep out of the reach of children. Medicines should not be disposed of in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you do not use. These measures will contribute to the protection of the environment. Shelf life Shelf life is 4 (four) years. Do not take after the expiry date which is stated on the package. Composition Each coated tablet contains active substances: metamizole sodium monohydrate 500 mg, triacetonamine-4-toluetssulfonate 20 mg. Excipients: wheat starch, microcrystalline cellulose (type 101), magnesium stearate, talc, povidone K 25. Shell: Opadry II green 85 F21526 (polyvinyl alcohol - partially hydrolyzed, macrogol 3350, talc, titanium dioxide (E 171), aluminum varnish based on quinoline yellow (E 104), FCF aluminum lacquer based on brilliant blue (E 133) Packaging Primary packaging: 10 film-coated tablets packed in a PVC/aluminum foil blister Secondary packaging: 1 (one) or 2 (two) or 10 (ten) blisters are packed together with a leaflet for the consumer in a cardboard box. 20mg No. 10x1 Instructions for use for Tempalgin tablets p/o 500mg/20mg No. 10x1