Antitussive tablets (Tablets) Instructions for Use
ATC Code
R05CA10 (Expectorants in combination)
Active Substances
Sodium bicarbonate (BP British Pharmacopoeia)
Thermopsidis lanceolatae herba (Grouping name)
Clinical-Pharmacological Group
Herbal preparation with expectorant effect
Pharmacotherapeutic Group
Drugs used for cough and colds; expectorants, excluding combinations with antitussives; expectorants
Pharmacological Action
Thermopsis herb has an expectorant effect, exerting a moderate irritant effect on the receptors of the gastric mucosa, reflexively increasing the secretion of the bronchial glands.
The alkaloids contained in thermopsis herb (cytisine, methylcytisine, pachycarpine, anagyrine, thermopsine, thermopsidine) have an excitatory effect on the respiratory center and, in high doses, on the vomiting center.
Sodium bicarbonate stimulates the secretion of the bronchial glands and helps reduce sputum viscosity.
Pharmacokinetics
The components of the drug are well absorbed in the gastrointestinal tract. The maximum effect occurs 30-60 minutes after oral administration and lasts for 2-6 hours. They are excreted from the body by the kidneys, the mucous membrane of the respiratory tract, and the bronchial glands.
Indications
Diseases of the respiratory tract accompanied by cough with difficult-to-separate sputum (tracheitis, bronchitis) – as part of complex therapy.
ICD codes
| ICD-10 code | Indication |
| J04 | Acute laryngitis and tracheitis |
| J20 | Acute bronchitis |
| J37 | Chronic laryngitis and laryngotracheitis |
| J42 | Unspecified chronic bronchitis |
| R05 | Cough |
| ICD-11 code | Indication |
| CA05 | Acute laryngitis or tracheitis |
| CA0G | Chronic laryngitis or laryngotracheitis |
| CA20.1Z | Chronic bronchitis, unspecified |
| CA42.Z | Acute bronchitis, unspecified |
| MD12 | Cough |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Tablets
Orally, adults are prescribed 1 tablet 3 times a day. The course of treatment is 3-5 days. The highest single dose in terms of thermopsis is 0.1 g (14 tablets). The highest daily dose in terms of thermopsis is 0.3 g (42 tablets).
Children over 12 years old – 1 tablet 2-3 times a day. The course of treatment is 3-5 days. The necessity of prescribing a repeated course is determined by the doctor.
Adverse Reactions
Allergic reactions are possible; nausea.
Contraindications
Hypersensitivity to the components of the drug, gastric and duodenal ulcer in the acute phase, children’s age (under 12 years).
Use in Pregnancy and Lactation
Use during pregnancy and breastfeeding is contraindicated.
Pediatric Use
Contraindicated: children’s age (under 12 years).
Special Precautions
To improve sputum thinning and separation, it is recommended to prescribe plenty of warm drinks.
Antitussive tablets do not affect driving vehicles and operating machinery.
Overdose
Symptoms nausea, vomiting.
Treatment gastric lavage, symptomatic.
Drug Interactions
Adsorbents, astringents, and coating agents may reduce the absorption of alkaloids that are part of thermopsis herb in the gastrointestinal tract. Antitussive tablets should not be used simultaneously with drugs containing codeine and other antitussive drugs, as this makes it difficult to cough up sputum.
Storage Conditions
In a dry place, protected from light, at a temperature not exceeding 25°C (77°F). Keep out of reach of children.
Shelf Life
Shelf life. 4 years. Do not use after the expiration date printed on the package.
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Tablets 6.7 mg+250 mg: 10 or 20 pcs.
Marketing Authorization Holder
Alvils, LLC (Russia)
Manufactured By
Pharmapol-Volga, LLC (Russia)
Dosage Form
 |
Antitussive tablets | Tablets 6.7 mg+250 mg: 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
Tablets from greenish-gray to yellow-brown in color, round, flat-cylindrical in shape, with a bevel and a score; the presence of dark inclusions is allowed.
| 1 tab. | |
| Thermopsis lanceolata herb powder | 0.0067 g |
| Sodium bicarbonate | 0.25 g |
Excipients : talc – 0.004 g, calcium stearate – 0.0023 g, potato starch – 0.027 g.
10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – non-cell contour packs (2) – cardboard packs.
Tablets 0.0067 g+0.25 g: 10 or 20 pcs.
Marketing Authorization Holder
Vifitech, CJSC (Russia)
Dosage Form
|
Antitussive tablets | Tablets 0.0067 g+0.25 g: 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
Tablets from greenish-gray to gray with a brownish tint, flat-cylindrical in shape, with a bevel; the presence of darker and lighter inclusions is allowed.
| 1 tab. | |
| Thermopsis lanceolata herb powder | 0.0067 g |
| Sodium bicarbonate | 0.25 g |
Excipients : potato starch – 0.0279 g, talc – 0.0054 g.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – non-cell contour packs (2) – cardboard packs.
Tablets 6.7 mg+250 mg: 10 pcs.
Marketing Authorization Holder
Dalkhimpharm, JSC (Russia)
Dosage Form
|
Antitussive tablets | Tablets 6.7 mg+250 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
Tablets flat-cylindrical, greenish-gray in color, with a bevel; the presence of dark inclusions is allowed.
| 1 tab. | |
| Thermopsis lanceolata herb powder | 6.7 mg |
| Sodium bicarbonate | 250 mg |
Excipients : potato starch 27.9 mg, talc 5.4 mg.
10 pcs. – non-cell contour packs.
10 pcs. – blister packs.
Tablets 6.7 mg+250 mg: 10 or 20 pcs.
Marketing Authorization Holder
Marbiopharm, JSC (Russia)
Dosage Form
|
Antitussive tablets | Tablets 6.7 mg+250 mg: 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
Tablets greenish-gray in color, round, flat-cylindrical in shape, with a bevel; the presence of dark inclusions is allowed.
| 1 tab. | |
| Thermopsis lanceolata herb powder | 6.7 mg |
| Sodium bicarbonate | 250 mg |
Excipients : potato starch – 0.0279 g, talc – 0.0054 g.
10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – non-cell contour packs (2) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
Tablets: 10, 20, or 30 pcs.
Marketing Authorization Holder
Mikfetin, LLC (Russia)
Manufactured By
YUGPHARM, LLC (Russia)
Dosage Form
|
Antitussive tablets | Tablets: 10, 20, or 30 pcs. |
Dosage Form, Packaging, and Composition
Tablets from greenish-gray to gray with a brownish tint, round, flat-cylindrical, with a bevel; the presence of darker and lighter inclusions is allowed.
| 1 tab. | |
| Thermopsis lanceolata herb powder | 6.7 mg |
| Sodium bicarbonate | 250 mg |
* which corresponds to 0.08-0.12 mg of the sum of alkaloids in terms of thermopsine
Excipients : corn starch – 27.9 mg, talc – 5.4 mg.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
Tablets: 20 pcs.
Marketing Authorization Holder
Moscow Pharmaceutical Factory CJS (Russia)
Dosage Form
|
Antitussive tablets | Tablets: 20 pcs. |
Dosage Form, Packaging, and Composition
Tablets
| 1 tab. | |
| Thermopsis lanceolata herb powder | 6.7 mg |
| Sodium bicarbonate | 250 mg |
10 pcs. – non-cell contour packs (2) – cardboard packs.
Tablets: 10, 20, 30, 40, 50, 60, or 100 pcs.
Marketing Authorization Holder
Tatkhimpharmpreparaty, JSC (Russia)
Dosage Form
|
Antitussive tablets | Tablets: 10, 20, 30, 40, 50, 60, or 100 pcs. |
Dosage Form, Packaging, and Composition
Tablets greenish-gray in color, round, flat-cylindrical, with a bevel; the presence of darker and lighter inclusions is allowed.
| 1 tab. | |
| Thermopsis lanceolata herb powder | 6.7 mg |
| Sodium bicarbonate | 250 mg |
Excipients : potato starch – 27.9 mg, talc – 5.4 mg.
10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – non-cell contour packs (2) – cardboard packs.
10 pcs. – non-cell contour packs (3) – cardboard packs.
10 pcs. – non-cell contour packs (4) – cardboard packs.
10 pcs. – non-cell contour packs (5) – cardboard packs.
10 pcs. – non-cell contour packs (6) – cardboard packs.
10 pcs. – non-cell contour packs (10) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
Tablets: 10, 20, 30, 50, or 60 pcs.
Marketing Authorization Holder
Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)
Dosage Form
|
Antitussive tablets | Tablets: 10, 20, 30, 50, or 60 pcs. |
Dosage Form, Packaging, and Composition
Tablets greenish-gray in color, round, flat-cylindrical in shape, with a bevel; the presence of dark inclusions is allowed.
| 1 tab. | |
| Thermopsis lanceolata herb powder | 6.7 mg |
| Sodium bicarbonate | 250 mg |
Excipients : potato starch, talc.
10 pcs. – blister packs – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – non-cell contour packs (200) – cardboard boxes (for hospitals).
10 pcs. – non-cell contour packs (400) – cardboard boxes (for hospitals).
10 pcs. – non-cell contour packs (500) – cardboard boxes (for hospitals).
10 pcs. – non-cell contour packs (600) – cardboard boxes (for hospitals).
10 pcs. – non-cell contour packs (800) – cardboard boxes (for hospitals).
10 pcs. – non-cell contour packs (1000) – cardboard boxes (for hospitals).
Tablets: 10, 20, 30, 50, or 60 pcs.
Marketing Authorization Holder
Formula-FR, LLC (Russia)
Manufactured By
YUGPHARM, LLC (Russia)
Dosage Form
|
Antitussive tablets | Tablets: 10, 20, 30, 50, or 60 pcs. |
Dosage Form, Packaging, and Composition
Tablets from greenish-gray to gray with a brownish tint, round, flat-cylindrical, with a bevel; the presence of darker and lighter inclusions is allowed.
| 1 tab. | |
| Thermopsis lanceolata herb (Thermopsidis lanceolatae herba) powder | 6.7 mg, |
| Which corresponds to the content of the sum of alkaloids in terms of thermopsine | Not less than 0.10 mg |
| Sodium bicarbonate | 250 mg |
Excipients : corn starch, talc.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
20 pcs. – blister packs (1) – cardboard packs.
20 pcs. – blister packs (3) – cardboard packs.
30 pcs. – blister packs (1) – cardboard packs.
30 pcs. – blister packs (2) – cardboard packs.
Tablets: 10, 20, or 30 pcs.
Marketing Authorization Holder
YUGPHARM, LLC (Russia)
Dosage Form
|
Antitussive tablets | Tablets: 10, 20, or 30 pcs. |
Dosage Form, Packaging, and Composition
Tablets from greenish-gray to gray with a brown tint, round, flat-cylindrical in shape, with a bevel; the presence of darker and lighter inclusions is allowed.
| 1 tab. | |
| Thermopsis lanceolata herb | 0.0067 g |
| Sodium bicarbonate | 0.25 g |
Excipients: corn 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.
Tablets 6.7 mg+250 mg: 10, 20, or 30 pcs.
Marketing Authorization Holder
Obnovlenie Pfc, JSC (Russia)
Dosage Form
|
Antitussive tablets Renewal | Tablets 6.7 mg+250 mg: 10, 20, or 30 pcs. |
Dosage Form, Packaging, and Composition
Tablets are round, flat-cylindrical, from greenish-gray to brownish-gray in color with a bevel; the presence of darker and lighter inclusions is allowed.
| 1 tab. | |
| Thermopsis lanceolata herb powder | 6.7 mg |
| Sodium bicarbonate | 250 mg |
Excipients: potato starch, talc.
10 pcs. – contour cell pack (1) – cardboard packs.
10 pcs. – contour cell pack (2) – cardboard packs.
10 pcs. – contour cell pack (3) – cardboard packs.
![Antitussive tablets [Tablets] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Antitussive tablets [Tablets] 2")