Tempalgin, 500 mg+20 mg 20 pcs

Pharmacological action – anxiolytic, analgesic, antipyretic, anti-inflammatory.

Pharmacodynamics

An analgesic-antipyretic of combined composition.

It has analgesic, antipyretic, mild anti-inflammatory and sedative effects.

The drug contains the non-opioid analgesic methamisole sodium and the anxiolytic (tranquilizer) tempidone.

Pharmacokinetics

There are no data on the pharmacokinetics of Tempalgin.

Indications

Pain syndrome is moderate and mild (including headache and toothache, migraine, neuritis, lumbago, neuralgia, myalgia, arthralgia, algodismenorrhea), especially in patients with increased nervous excitability,
pain syndrome in renal, hepatic, intestinal colic is mild (in combination with antispasmodics),
pain syndrome after surgical and diagnostic interventions (as part of combination therapy),
febrile syndrome in ARVI and other infectious and inflammatory diseases.

Pharmacological effect

Pharmacological action – anxiolytic, analgesic, antipyretic, anti-inflammatory.

Pharmacodynamics

Analgesic-antipyretic combined composition.

It has analgesic, antipyretic, mild anti-inflammatory and sedative effects.

The drug contains the non-opioid analgesic metamizole sodium and the anxiolytic (tranquilizer) tempidone.

Pharmacokinetics

Data on the pharmacokinetics of the drug Tempalgin are not provided.

Special instructions

Tempalgin should be used with caution in patients with impaired liver or kidney function, with bronchial asthma, or with a predisposition to arterial hypotension.

X-ray contrast agents, colloidal blood substitutes and penicillin should not be prescribed when using metamizole sodium.

You should not drink alcohol while taking the drug.

The use of the drug in patients receiving cytostatics should only be done under medical supervision.

During the use of metamizole sodium, the development of agranulocytosis is possible, and therefore, if an unclear genesis of a rise in temperature, chills, sore throat, difficulty swallowing, stomatitis is detected, as well as with the development of vaginitis or proctitis, discontinuation of the drug is necessary.

With long-term (more than 7 days) use of the drug, monitoring of the blood picture and the functional state of the liver is necessary.

Tempalgin should not be used to relieve acute abdominal pain (until the cause is determined).

Impact on the ability to drive vehicles and other mechanisms that require increased concentration

Due to the anxiolytic effect of the drug, during the period of taking Tempalgin, you should refrain from engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Active ingredient

Metamizole sodium, Triacetonamine-4-toluenesulfonate

Composition

Active ingredients:

metamizole sodium 500 mg;

triacetonamine 4-toluene sulfonate (tempidone) 20 mg.

Excipients:

wheat starch,

microcrystalline cellulose,

talc,

magnesium stearate,

crospovidone (kollidon K25),

titanium dioxide,

polyethylene glycol 400,

castor oil,

glycerol,

dibutyl phthalate,

Eudrajit L acetone 12.5,

green dye.

Contraindications

Severe liver failure;
severe renal failure;
chronic heart failure;
arterial hypotension (decrease in systolic blood pressure below 100 mmHg);
inhibition of hematopoiesis (granulocytopenia, leukopenia, agranulocytosis, cytostatic or infectious neutropenia);
deficiency of glucose-6-phosphate dehydrogenase;
“aspirin” asthma;
pregnancy and lactation (breastfeeding);
children’s age (up to 14 years);
hypersensitivity to metamizole sodium, pyrazolone derivatives or triacetonamine-4-toluene sulfonate.

With caution: kidney disease (pyelonephritis, glomerulonephritis, including a history); moderate liver/renal failure; bronchial asthma; predisposition to the development of arterial hypotension; long-term alcohol abuse.

Side Effects

From the digestive system: rarely – a burning sensation in the epigastric region, dry mouth, cholestasis, jaundice, increased activity of liver transaminases, hyperbilirubinemia.

From the side of the central nervous system: headache, dizziness; in some cases – hallucinations.

From the cardiovascular system: decreased or increased blood pressure, tachycardia, cyanosis.

From the hematopoietic system: agranulocytosis, leukopenia, thrombocytopenia.

From the urinary system: when used in high doses – renal dysfunction (oliguria, anuria, proteinuria, interstitial nephritis); red coloration of urine.

Allergic reactions: skin rash, itching, urticaria (including on the conjunctiva and on the mucous membranes of the nasopharynx), Quincke’s edema, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), bronchospasm, anaphylactic shock.

Interaction

Tempalgin enhances the effects of ethanol.

Concomitant use of Tempalgin with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia.

Sedatives and tranquilizers enhance the analgesic effect of the drug.

When used simultaneously, thiamazole and cytostatics increase the risk of developing leukopenia.

With simultaneous use of metamizole sodium with cyclosporine, the concentration of the latter in the blood plasma decreases.

Metamizole sodium, displacing oral hypoglycemic drugs, indirect anticoagulants, corticosteroids and indomethacin from protein binding, increases their effect.

When used simultaneously, barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effect of metamizole sodium.

Concomitant use of metamizole sodium with other non-opioid analgesics, tricyclic antidepressants, oral contraceptives, and allopurinol may lead to mutually enhanced toxic effects.

Codeine, histamine H2 receptor blockers and propranolol slow down the excretion of metamizole sodium and enhance its effect.

Overdose

Symptoms: vomiting, drowsiness, oliguria, shortness of breath, nausea, epigastric pain, tachycardia, decreased blood pressure, tinnitus, impaired consciousness, convulsions.

Treatment: administration of saline laxatives and activated carbon; forced diuresis, gastric lavage, in severe cases – hemodialysis, symptomatic therapy, with the development of convulsive syndrome – intravenous administration of diazepam and fast-acting barbiturates.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25°C.
Keep out of the reach of children.

Shelf life

4 years.

Manufacturer

Sopharma JSC, Bulgaria