Tempalgin 20 tablets — Made in Bulgaria — Free Delivery

Pharmacological properties

Pharmacodynamics. Metamizole sodium as an analgesic has analgesic and anti-inflammatory effects. it inhibits the synthesis of prostaglandins, inhibiting cog, has a known membrane-stabilizing effect, inhibits the formation of endogenous pyrogens.

Tempidone has a pronounced anxiolytic activity and eliminates the state of anxiety, fear and tension. Reduces motor excitement, has a central N-anticholinergic effect, enhances and lengthens the analgesic effect of metamizole. Tempidone also has a beneficial effect on the emotional component of pain.

The combination of metamizole sodium and tempidone enhances the analgesic effect of metamizole and increases the duration of its action.

Pharmacokinetics. Resorption. After oral administration, metamizole is hydrolyzed in the gastrointestinal tract. The active metabolites are 4-methyl-aminoantipyrine (MAA) and 4-aminoantipyrine (AA). MAA is characterized by rapid and complete resorption. Cmax in blood plasma is achieved within 1-2 hours. MAA bioavailability is about 90%. Food does not affect the pharmacokinetics of metamizole.

Tempidone is resorbed in the upper gastrointestinal tract. Therapeutic plasma concentrations are established 30 minutes after administration.

Cmax in blood plasma of 0.8 μg / ml is achieved within 60 minutes.

Distribution. Metamizole sodium partially binds to blood plasma proteins.

The data obtained in experimental studies on animals show that the distribution of tempidone in tissues is significant.

Metabolism. Metamizole sodium is extensively metabolized in the liver. Its main metabolites - 4-MAA, 4-AA - are pharmacologically active.

Excretion. It is excreted in the urine in the form of metabolites, and only 3% of the excreted amount of metamizole is detected unchanged. Metamizole metabolites are excreted in breast milk.

Tempidone is excreted in the urine unchanged, in the amount of ⅔ of the applied dose.

Patients with impaired liver function: T½ of the active metabolite of MAA in patients with impaired liver function is approximately 3 times lengthened. These patients are recommended to be treated with metamizole in lower doses.

Patients with impaired renal function: in patients with impaired renal function, the degree of excretion of some metabolites is reduced. These patients are recommended to be treated with metamizole in lower doses.

Indications

Short-term symptomatic treatment of pain syndrome, from mild to moderate, in the following conditions: headache, toothache and dental manipulations, myalgia, neuralgia, arthralgia.

Application

The tablets are taken orally with water, mainly after meals.

The course of treatment should not be more than 3 days. The use of the preparation for a longer period or in higher doses is possible only after consulting a doctor.

The dose depends on the severity of pain and individual sensitivity to the preparation .

Adults. The usual dose is 1 tablet 1-2 times a day, depending on the severity of the clinical symptoms. The maximum single dose should not exceed 1 tablet. The maximum daily dose is 2 tablets.

For dental procedures - 1 tablet 30 minutes before the intervention.

Children over the age of 15. 1 tablet per day. The maximum daily dose is 1 tablet.

Patients over the age of 65. No dose reduction is usually required. In patients with age-related impairment of kidney and liver function, treatment with the preparation should be short-lived. The maximum daily dose should not exceed 2 tablets.

Patients with impaired liver function. In such patients, an increase in T½ of metamizole metabolites is possible. In patients with moderate or severe liver damage, it is recommended to use ½ the recommended dose for adults (maximum daily dose is 1 tablet).

Patients with impaired renal function. Metamizole and its metabolites are excreted by the kidneys. In patients with impaired renal function, treatment with Tempalgin should be carried out using ½ the recommended dose for adults (the maximum daily dose is 1 tablet).

Contraindications

Hypersensitivity to active or auxiliary substances of the preparation; hypersensitivity to other pyrazolone derivatives; acute hepatic porphyria; congenital insufficiency of glucose-6-phosphate dehydrogenase (threat of hemolysis); severe kidney and / or liver disease; dysfunction of the bone marrow (for example, after treatment with cytostatics); diseases of the blood system (aplastic anemia, leukopenia and agranulocytosis), changes in the composition of peripheral blood; anemia of any etiology, cytostatic or infectious neutropenia; arterial hypotension with blood pressure values ​​of 100 mm Hg. Art .; suspicion of acute surgical pathology.

Side effects

When using the preparation tempalgin, possible side effects are often caused by metamizole sodium.

Adverse reactions are classified by organs and systems.

On the part of the blood and lymphatic system: agranulocytosis, leukopenia, aplastic anemia, thrombocytopenia, hemolytic anemia. The risk of developing agranulocytosis cannot be foreseen. Agranulocytosis can also occur in patients who have used metamizole in the past without side effects. The risk of agranulocytosis increases with prolonged use (1 week) of metamizole.

From the immune system: fixed preparation exanthema, maculopapular rash, anaphylactic or anaphylactoid reactions. Lighter actions are manifested by typical reactions from the skin and mucous membranes - itching, burning, redness, urticaria, edema (generalized or local), dyspnea, and rarely - gastrointestinal disorders. Such mild reactions can turn into more severe forms with generalized urticaria, severe angioedema (including laryngeal edema), severe bronchospasm, cardiac arrhythmias, decreased blood pressure (sometimes preceded by an increase in blood pressure), asthmatic attack (in patients with aspirin asthma), Stevens syndrome - Johnson and Lyell, circulatory shock.

From the side of metabolism and nutrition: decreased appetite.

From the nervous system: headache, dizziness.

From the side of the cardiovascular system: palpitation, tachycardia, cyanosis, arterial hypotension.

From the digestive tract: nausea, vomiting, pain and discomfort in the abdomen; in isolated cases - ulceration and bleeding.

On the part of the hepatobiliary system: increased levels of liver enzymes (AST, ALT), cholestasis, hyperbilirubinemia.

From the kidneys and urinary tract: polyuria, oliguria, anuria, proteinuria, interstitial nephritis. When using the preparation in high doses - renal dysfunction.

Special instructions

Treatment with tempalgin (due to the content of metamizole) is carried out only for a short period, when there is no alternative method of therapy.

Before starting treatment, patients should be warned that if bleeding from the gums, pale skin, asthenia, rashes on the skin and mucous membranes occur, the preparation should be discontinued and immediately consult a doctor.

With longer treatment with Tempalgin, it is required to control the blood picture, including the leukocyte count, due to the increased risk of agranulocytosis.

The recommended dose of the preparation should not be exceeded. Since metamizole has anti-inflammatory and analgesic properties, it can mask signs of infection, symptoms of non-communicable diseases and complications of pain, which can complicate their diagnosis.

In children, it should be used under constant medical supervision. It is necessary to control the qualitative and quantitative composition of peripheral blood.

It should be used with caution in patients with allergic diseases, hypersensitivity to analgesics and antirheumatic preparations (intolerance to analgesics) and other preparations or food products due to an increased risk of allergic reactions and asthmatic attacks.

It should be used with caution in patients of the following categories: elderly - may lead to an increase in the frequency of adverse reactions, especially from the digestive tract; with impaired renal function, with a history of kidney disease (pyelonephritis, glomerulonephritis); with inflammatory bowel diseases, including ulcerative colitis and Crohn's disease; with cardiovascular insufficiency; with chronic alcoholism.

Metamizole can provoke hypotensive reactions. Treatment with Tempalgin should be carried out with extreme caution in patients with arterial hypotension, volume deficit or dehydration, and unstable blood circulation.

When used simultaneously with alcohol, the risk of side effects increases.

It should be used with caution in patients with moderate liver dysfunction or renal dysfunction.

When taking the preparation, urine may turn red due to the elimination of the metabolite sodium metamizole.

You should not use the preparation for longer than the prescribed period without consulting a doctor!

If the signs of the disease do not begin to disappear or, conversely, the health condition deteriorates, or undesirable phenomena appear, it is necessary to stop taking the preparation and seek medical advice regarding further use.

Wheat starch, which is part of the preparation, may contain only traces of gluten and is considered safe for people with celiac disease.

The recommended dose of the preparation should not be exceeded.

Use in children should be under constant medical supervision.

Use during pregnancy and lactation

Pregnancy. There have been no controlled clinical studies in pregnant women and there are no observational data on the use of the preparation in this group. Despite the fact that metamizole is a weak inhibitor of prostaglandin synthesis, there is a possibility of premature closure of the duct botallus and perinatal complications as a result of a decrease in platelet aggregation in the fetus and mother. Treatment with the preparation is contraindicated in pregnant women.

Lactation. Metamizole metabolites pass into breast milk. If necessary, treatment with Tempalgin, breastfeeding should be discontinued.

Children. Do not use in children under 15 years of age.

The ability to influence the reaction rate when driving or working with other mechanisms. Tempalgin reduces the ability to concentrate and slows down conditioned reflexes, so it should not be prescribed to vehicle drivers and persons whose work requires a high speed of mental and physical reactions.

Interactions

The action of tricyclic antidepressants (imipramine, amitriptyline), oral contraceptives, analgesics, allopurinol and alcohol is potentiated when used simultaneously with the preparation tempalgin.

Concomitant use with other analgesics and NSAIDs increases the risk of developing manifestations of hypersensitivity and other side effects.

Barbiturates, glutethimide and phenylbutazone reduce the severity and time of the pharmacodynamic effects of metamizole due to the induction of liver enzymes.

Metamizole reduces the activity of coumarin anticoagulants with simultaneous use as a result of the induction of hepatic enzymes.

The analgesic effect of the preparation is enhanced by sedatives and tranquilizers (diazepam, combined preparations containing phenobarbital, ethyl bromisovalerianate, codeine, etc.).

Metamizole reduces the concentration of cyclosporine in the blood plasma.

With simultaneous use with chlorpromazine, hypothermia may occur.

Cytostatics (sacrolysin, methotrexate), gold preparations, thiamazole, chloramphenicol and other preparations that inhibit hematopoiesis, increase the myelotoxic effect of metamizole.

Caution is needed when used concomitantly with diuretics (furosemide).

Radiopaque preparations, colloidal blood substitutes and penicillin should not be used during treatment with metamizole sodium.

Tempidone potentiates the sedative effect of hypnotics, general anesthetics, narcotic and non-narcotic analgesics.

When used simultaneously with NSAIDs, including metamizole sodium, the hypoglycemic effect of sulfonamide oral hypoglycemic preparations is enhanced.

Overdose

Symptoms: gastrointestinal syndrome (nausea, vomiting, stomach pain, with high doses - hematemesis and melena); cerebral syndrome (less-like phenomena, tinnitus, weakness, ataxia, drowsiness, apnea, impaired consciousness, delirium, coma with arterial hypotension and tonic-clonic seizures); hematological syndrome (agranulocytosis, aplastic or hemolytic anemia, hemorrhagic diathesis); metabolic syndrome (metabolic alkalosis); renal (renal) syndrome (from oliguria to anuria); acute liver failure and opn; toxic-allergic syndrome (bullous-urticarial and petechial, sometimes kore- or typhoid-like rash; some patients may develop toxic-allergic shock); hypothermia, palpitations, marked decrease in blood pressure, tachycardia, dysphagia, dyspnea, gastralgia / gastritis, respiratory muscle paralysis.

At the first symptoms of an overdose, you should immediately seek medical help!

Treatment: symptomatic therapy - gastric lavage, monitoring of the respiratory and cardiovascular systems, fluid administration, forced diuresis, if necessary - hemodialysis.

Storage conditions

In its original packaging at a temperature not exceeding 25 ° C.