Termopsol^® antitussive tablets (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmstandard-Tomskkhimpharm OJSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

ATC Code

R05CA10 (Expectorants in combination)

Active Substances

Sodium bicarbonate (BP British Pharmacopoeia)

Thermopsidis lanceolatae herba (Grouping name)

Dosage Form

Termopsol® antitussive tablets

Tablets 0.0067 g+0.25 g: 10, 20, 30 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets from greenish-gray to greenish-gray with a yellowish tint, flat-cylindrical in shape; the presence of dark inclusions is allowed.

Excipients: potato starch – 0.0279 g, talc – 0.0054 g.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with expectorant effect

Pharmacotherapeutic Group

Drugs used for cough and colds; expectorants, excluding combinations with antitussives; expectorants

Pharmacological Action

Expectorant of herbal origin.

Thermopsis herb has an expectorant effect, exerting a moderate irritating effect on the receptors of the gastric mucosa, reflexively increases the secretion of the bronchial glands.

The alkaloids contained in thermopsis (cytisine, methylcytisine, pachycarpine, anagyrine, thermopsine and thermopsidine) have an excitatory effect on the respiratory and, in high doses, on the vomiting centers.

Sodium bicarbonate stimulates the secretion of the bronchial glands and helps reduce the viscosity of sputum.

Pharmacokinetics

Well absorbed from the gastrointestinal tract. C_max is reached within 30-60 minutes and is maintained for 2-6 hours.

It is excreted from the body by the kidneys, the mucous membrane of the respiratory tract and the bronchial glands.

Indications

Cough with difficult-to-expectorate sputum (bronchitis, tracheitis); as part of complex therapy.

ICD codes

Dosage Regimen

Administer orally with an adequate amount of water.

For adults and children over 12 years of age, take one tablet three times per day.

Adhere to a dosing interval of approximately 6-8 hours.

The maximum daily dosage is three tablets.

The duration of treatment is determined by the physician based on clinical response and is typically 5 to 7 days.

To enhance the expectorant effect, consume plenty of warm fluids.

Do not exceed the recommended dose.

Discontinue use and consult a physician if cough persists for more than one week, is accompanied by fever, rash, or persistent headache, or if adverse reactions occur.

Avoid concomitant use with antitussive medications (e.g., codeine) as this may impede sputum clearance.

Adverse Reactions

From the digestive system: nausea.

Other: allergic reactions.

Contraindications

Hypersensitivity; peptic ulcer of the stomach and duodenum in the acute phase, children under 12 years of age, lung cancer and tuberculosis with bleeding, pregnancy, breastfeeding period.

With caution

Diabetes mellitus, a diet with reduced carbohydrate and low sodium content.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

To improve the liquefaction and separation of sputum, it is recommended to prescribe plenty of warm drinks.

Patients with diabetes mellitus and persons on a diet with reduced carbohydrate content should take into account that one dose contains 0.0279 g of carbohydrates.

Drug Interactions

Adsorbents, astringents and coating agents may reduce the absorption of alkaloids that are part of thermopsis herb in the gastrointestinal tract.

Should not be used simultaneously with drugs containing codeine and other antitussive medications, as this makes it difficult to cough up sputum.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.