Tempanginol^® (Tablets) Instructions for Use

Marketing Authorization Holder

Balkanpharma-Dupnitsa, AD (Bulgaria)

ATC Code

N02BB72 (Metamizole sodium in combination with psycholeptics)

Dosage Form

Tempanginol®

Film-coated tablets: 10, 20, 300, or 1000 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets round, biconvex; on the break – a white core with a fine-grained structure, surrounded by a continuous green layer of the film coating.

Excipients: wheat starch, microcrystalline cellulose, povidone, talc, magnesium stearate, ethanol, purified water.

Coating composition Eudragit L, talc, titanium dioxide, macrogol 400, glycerol, castor oil, polysorbate 80, dyes (Eurocert Quinoline Yellow 70 (E104), Spectracol Patent blue V (E131)), purified water, acetone, isopropanol.

10 pcs. – blisters (1) – cardboard boxes.

Clinical-Pharmacological Group

Combination analgesic-antipyretic

Pharmacotherapeutic Group

Combined non-narcotic analgesic agent

Pharmacological Action

The instructions were approved by the Pharmacological Committee of the Ministry of Health of Russia on September 27, 2001.

Tempanginol^® is a combined preparation containing the non-narcotic analgesic metamizole (analgin) and the tranquilizer triacetonamine 4-toluenesulfonate. It has analgesic, antipyretic, weak anti-inflammatory, and sedative effects.

Indications

• Moderate or mild pain syndrome, especially in patients with increased nervous excitability: headache, toothache, migraine pain, neuralgia, radicular syndrome, myalgia, dysmenorrhea;
• For mild pains of visceral origin (renal, hepatic, intestinal colic) in combination with antispasmodic agents;
• As an auxiliary agent, it can be used to reduce pain after surgical and diagnostic interventions;
• Elevated temperature in colds and other infectious and inflammatory diseases.

ICD codes

Dosage Regimen

The tablets are taken orally, without chewing, with a sufficient amount of liquid, during or after a meal. The usual dose for adults is 1 tab. 1-3 times/day. The maximum single dose is 2 tabs, the maximum daily dose is 6 tabs. The duration of administration is no more than 5 days. Increasing the daily dose of the drug or the duration of treatment is possible only under medical supervision. With long-term (more than a week) use of the drug, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

Adverse Reactions

In some cases, a burning sensation in the epigastric region, dry mouth, and headache have been noted.

Allergic reactions in case of hypersensitivity to some components (skin rash, itching, Quincke’s edema), rarely – anaphylactic shock.

From the nervous system dizziness, extremely rarely hallucinations.

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

From the hematopoietic system agranulocytosis, leukopenia, thrombocytopenia.

From the respiratory system in case of a tendency to bronchospasm, an attack may be provoked.

From the digestive system cholestasis, jaundice, increased transaminase levels, hyperbilirubinemia.

From the genitourinary system impaired renal function (in high doses).

Due to the tranquilizing effect of triacetonamide 4-toluenesulfonate, the drug should not be used when driving vehicles and other activities requiring increased attention.

Contraindications

• Hypersensitivity to analgin (sodium metamizole), pyrazolone derivatives or triacetone-4-toluenesulfonate;
• Severe impairment of liver and kidney function;
• Heart failure;
• Arterial hypotension;
• Inhibition of hematopoiesis (agranulocytosis);
• Hereditary hemolytic anemia associated with glucose-6-phosphate dehydrogenase deficiency;
• Pregnancy;
• Breastfeeding period;
• Childhood (up to 14 years).

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated: severe impairment of liver function.

Use in Renal Impairment

Contraindicated: severe impairment of kidney function.

Pediatric Use

Contraindicated: childhood (up to 14 years).

For adolescents under 18 years of age, use only as prescribed by a doctor.

Special Precautions

Use with caution in patients with impaired liver or kidney function, with a tendency to arterial hypotension, and in patients with allergies.

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

It is not recommended to consume alcohol during the drug intake.

For adolescents under 18 years of age, use only as prescribed by a doctor.

Overdose

Nausea, vomiting, pain in the epigastric region. The victim should consult a doctor immediately.

First aid gastric lavage, administration of activated charcoal.

Drug Interactions

Concomitant use of Tempanginol^® with other non-narcotic analgesics may lead to mutual enhancement of toxic effects. Tricyclic antidepressants, oral contraceptives, and allopurinol also increase its toxicity. Barbiturates and phenylbutazone weaken the effect of analgin.

Concomitant use of Tempanginol^® with cyclosporine reduces the blood level of the latter.

Sedatives and anxiolytics enhance the analgesic effect of the drug.

When used concomitantly, Tempanginol^® enhances the effects of oral hypoglycemic agents, indirect anticoagulants, glucocorticosteroids, and indomethacin.

Storage Conditions

In a dry, light-protected place, out of reach of children, at a temperature of 15-25°C (59-77°F).

Shelf Life

Shelf life – 4 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.