Antitussin

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ANTI-TUSSIN

Composition:

Active ingredients: 1 tablet contains: powdered herb of Thermopsis lanceolata (Herba Thermopsidis lanceolata) 0.0067 g, sodium bicarbonate 0.25 g;

Excipients: talc, calcium stearate, potato starch.

Pharmaceutical form. Tablets.

Main physicochemical properties: tablets are greenish-gray or yellow-brown, flat cylindrical in shape, with beveled edges and a score line. Specks may be present.

Pharmacotherapeutic group.

Combined preparations used for cough and colds.

ATC code R05X.

Pharmacological properties.

Pharmacodynamics. Thermopsis herb has an expectorant effect and exerts a moderate irritant action on the gastric mucosa receptors, reflexively increasing bronchial gland secretion.

Alkaloids (cytisine, methylcytisine, pachycarpine, anagyrine, thermopsine, thermopsidine) present in thermopsis herb stimulate the respiratory center, and at high doses – also the vomiting center.

Sodium bicarbonate stimulates bronchial gland secretion and promotes reduction of sputum viscosity.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

In complex therapy for diseases of the upper respiratory tract accompanied by cough with difficult-to-extract sputum (tracheitis, bronchitis).

Contraindications.

Hypersensitivity to the components of the drug, active peptic ulcer of the stomach and duodenum, hemoptysis.

Interaction with other medicinal products and other types of interactions.

Adsorbents, astringents, and coating agents may reduce the absorption of alkaloids from Thermopsis herb in the gastrointestinal tract. The drug should not be used simultaneously with codeine-containing preparations or with other cough-suppressant drugs.

To improve sputum liquefaction and expectoration, it is recommended to drink large amounts of warm fluids.

Usage Notes.

Use during pregnancy or breastfeeding.

Contraindicated.

Ability to affect reaction speed when driving or operating machinery.

Studies on the influence on the ability to drive or operate machinery have not been conducted.

Dosage and Administration.

Adults should take 1 tablet three times a day for 3–5 days; children aged 12 years and older should take ½–1 tablet three times a day for 3–5 days.

Children.

The use of the drug in children under 12 years of age is contraindicated.

Overdose.

Nausea, vomiting, weakness, diarrhea, dizziness, cold sweat, pallor, cyanosis of mucous membranes; in severe poisoning, disturbances of consciousness, excitement, hallucinations, and convulsions may occur.

Treatment: gastric lavage, saline laxatives, activated charcoal, symptomatic therapy.

Side effects.

In case of individual hypersensitivity to the drug, allergic reactions may develop, including hyperemia, rash, itching, and skin swelling. With large doses – vomiting.

Shelf life. 4 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

Tablets: № 10 in blisters (without a carton) or № 20 (10×2) in blisters (in a carton).

Availability. Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

Manufacturer's address / Applicant's address.

4 Fabrychna St., Ternopil, Ukraine, 46010.

Tel./fax: (0352) 521-444, www.ternopharm.com.ua.