Tempalgin, pills, 100 pcs.

Composition

Active ingredients: 

metamizole sodium 500 mg;

triacetonamine 4-toluenesulfonate (tempidone) 20 mg.

Auxiliary substances:

wheat starch,

microcrystalline cellulose,

talc,

magnesium stearate,

crospovidone (collidone K 25),

titanium dioxide,

polyethylene glycol 400,

castor oil,

glycerol,

dibutyl phthalate,

eudrazhit L acetone 12.5,

green dye.

Pharmacological action

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

Pharmacodynamics

Analgesic-antipyretic combined composition.

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

The composition of the drug includes a non-opioid analgesic metamizole sodium and an anxiolytic (tranquilizer) tempidone.

Pharmacokinetics

Data on the pharmacokinetics of Tempalgin are not available.

Indications

• Pain syndrome of mild and moderately (including headache, dental pain, migraine, neuritis, lumbago, neuralgia, myalgia, arthralgia, algomenorrhea), especially in patients with increased nervous excitability,
• pain in kidney, liver, intestinal colic mild (in combination with antispasmodics),
• pain syndrome after diagnostic and surgical interventions (in combination therapy),
• febrile syndrome SARS and other infectious and inflammatory diseases.

Use during pregnancy and lactation

The drug is contraindicated for use in children under 14 years of age, during pregnancy.

Do not use the drug during lactation, because both components are excreted in breast milk.

Contraindications

• Severe hepatic impairment;
• severe renal failure;
• chronic heart failure;
• hypotension (systolic blood pressure below 100 mm Hg. St. )
• blood oppression (granulocytopenia, leukopenia, agranulocytosis, cytostatic or infectious neutropenia);
• deficiency of glucose-6-phosphate dehydrogenase;
• “aspirin” asthma;
• pregnancy and lactation (breastfeeding);
• children’s age (under 14 years);
• hypersensitivity to Metamizole sodium, pyrazolone derivative or triacetonamine-4-toluenesulfonate.

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

Side effects

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

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

From the cardiovascular system: decrease or increase in blood pressure, tachycardia, cyanosis.

From the hematopoietic system: agranulocytosis, leukopenia, thrombocytopenia.

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

Allergic reactions: skin rash, pruritus, urticaria (including conjunctiva and nasopharyngeal mucosa), angioedema, 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 may lead to severe hyperthermia.

Sedatives and tranquilizers enhance the analgesic effect of the drug.

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

When metamizole sodium is co-administered with cyclosporine, the concentration of the latter in the blood plasma decreases.

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

When used concomitantly, 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 a mutual increase in toxic effects.

Codeine, histamine H2-receptor blockers, and propranolol slow down the elimination of metamizole sodium and enhance its action.

How to take, course of administration and dosage

Tablets are taken orally, without chewing, with a sufficient amount of liquid, during or after a meal.

Adults are prescribed 1 tablet 1-3 times / day, with insufficient effectiveness, you can take another 1 tablet.

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

Duration of admission – no more than 5 days.

Increasing the daily dose or increasing the duration of treatment is possible only under the supervision of a doctor.

Overdose

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

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

Special instructions

Use with caution Tempalgin in patients with impaired liver or kidney function, with bronchial asthma, with a predisposition to arterial hypotension

Radiopaque drugs, colloidal blood substitutes and penicillin should not be prescribed when using metamizole sodium.

Do not drink alcohol while taking the drug.

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

Against the background of the use of metamizole sodium, agranulocytosis may develop, and therefore, if an unclear genesis of fever, chills, sore throat, difficulty swallowing, stomatitis is detected, as well as with the development of vaginitis or proctitis phenomena, the drug should be discontinued.

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.

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

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

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

Form of production

Film-coated tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

4 years

Active ingredient

Metamizole sodium, Triacetonamine-4-Toluene sulfonate

Dosage form

Tablets

Description

Children over 14 years old, For adults

Indications

Neuritis, Osteoarthritis and Arthritis, Sinusitis, Urolithiasis, Flu, Cold, Cholelithiasis, Migraine

Weight

Weight: 101 g.