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

Headache, Headache, Gallstone disease, Pain, Arthrosis and arthritis, Urticaria, Colic, Neuritis, Toothache, Joint pain (arthralgia), Migraine, Myalgia (muscle pain), Flu

• Moderate to mild pain syndrome (incl. Headache, toothache, migraine, neuritis, lumbago, neuralgia, myalgia, arthralgia, algodysmenorrhea), especially in patients with increased nervous excitability,
• Pain syndrome in renal, hepatic, intestinal colic mild (in combination with antispasmodics),Pain syndrome after surgical and diagnostic interventions (as part of combination therapy),
• fever syndrome in acute respiratory infections and other inflammatory diseases.

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Active ingredient

Sodium metamizole, Triacetonamine-4-toluenesulfonate

Composition

Active substances:

Methamisole sodium 500 mg;

Triacetonamine 4-toluenesulfonate (tempidone) 20 mg.

Auxiliary substances:

wheat starch,

microcrystalline cellulose,

talc,

magnesium stearate,

crospovidone (collidon K25),

titanium dioxide,

Polyethylene glycol 400,

castor oil,

glycerol,

dibutyl phthalate,

eudrajit L acetone 12.5,

dye green.

How to take, the dosage

The tablets are taken orally, without chewing, with enough liquid, during or after meals.

Adults take 1 tablet 1-3 times a day; if it is not effective, one more tablet may be taken.

The maximum single dose is 2 tablets, the maximum daily dose is 6 tablets.

The duration of use is no more than 5 days.

Extending the daily dose or increasing the duration of treatment is only possible under the supervision of a physician.

Interaction

Tempalgin enhances the effects of ethanol.

The concomitant use of Tempalgin with chlorpromazine or other phenothiazine derivatives may lead to severe hyperthermia.

Sedatives and tranquilizers increase the analgesic effect of the drug.

Concomitant use of thiamazole and cytostatics increases the risk of leukopenia.

Concomitant use of metamizole sodium with cyclosporine decreases the plasma concentration of the latter.

Sodium metamizole displaces oral hypoglycemic drugs, indirect anticoagulants, GCS and indomethacin from binding to protein and increases their effect.

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

The concomitant use of metamizole sodium with other non-opioid analgesics, tricyclic antidepressants, oral contraceptives, allopurinol may lead to a mutual enhancement of toxic effects.

Codeine, histamine H 2 -receptor blockers and propranololol retard excretion of metamizole sodium and increase its effects.

Special Instructions

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

Rentgen contrast agents, colloidal blood substitutes and penicillin should not be administered when using metamizole sodium.

Alcohol should not be consumed while taking the drug.

The use of the drug in patients receiving cytostatics should only be under the supervision of a physician.

The drug may cause agranulocytosis with metamizole sodium, therefore if fever, chills, sore throat, difficulty swallowing, stomatitis, and if vaginitis or proctitis occur with unclear cause, the drug should be stopped.

When taking the drug for a long time (more than 7 days) it is necessary to monitor the blood picture and the functional state of the liver.

The use of Tempalgin to relieve acute abdominal pain is unacceptable (until the cause is clarified).

Impact on ability to drive vehicles and other mechanisms requiring increased concentration

In view of the anxiolytic effect of the drug, during administration of Tempalgin, you should refrain from engaging in potentially dangerous activities requiring increased attention and rapid psychomotor reactions.

Contraindications

• Developed hepatic failure
• developed renal failure
• chronic heart failure
• harteric hypotension (decrease in systolic BP below 100 mmHg.
• Hematopoiesis depression (granulocytopenia, leukopenia, agranulocytosis, cytostatic or infectious neutropenia);
• deficiency of glucose-6-phosphate dehydrogenase;
• “aspirin” asthma;

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• pregnancy and lactation (breastfeeding);
• children (under 14 years);
• high sensitivity to sodium metamizole, pyrazolone derivatives or triacetonamine-4-toluenesulfonate.

With caution: renal diseases (pyelonephritis, glomerulonephritis, including in anamnesis); moderate degree of hepatic/renal failure; bronchial asthma; predisposition to develop arterial hypotension; long-term alcohol abuse.

Side effects

Digestive system disorders: rare – a burning sensation in the epigastric region, dry mouth, cholestasis, jaundice, increased liver transaminases activity, hyperbilirubinemia.

CNS disorders: headache, dizziness; in some cases – hallucinations.

Cardiovascular system disorders: decreased or increased BP, tachycardia, cyanosis.

Hematopoietic system: agranulocytosis, leukopenia, thrombocytopenia.

Urinary system disorders: when used in high doses – renal disorders (oliguria, anuria, proteinuria, interstitial nephritis); staining of urine red.

Allergic reactions: skin rash, pruritus, urticaria (including conjunctivitis and nasopharyngeal mucosa), Quincke’s edema, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), bronchospasm, anaphylactic shock.

Overdose

Symptoms: vomiting, drowsiness, oliguria, shortness of breath, nausea, epigastric pain, tachycardia, decreased BP, tinnitus, impaired consciousness, seizures.

The treatment: administration of saline laxatives and activated charcoal; forced diuresis, gastric lavage, in severe cases – hemodialysis, symptomatic therapy, in case of convulsive syndrome – intravenous infusion of diazepam and quick-acting barbiturates.