Mixtura sicca contra tussim pro adultis (Powder) Instructions for Use
ATC Code
R05CA10 (Expectorants in combination)
Clinical-Pharmacological Group
Expectorant
Pharmacotherapeutic Group
Herbal expectorant
Pharmacological Action
A combined preparation that has an expectorant and anti-inflammatory effect.
Dry extract of thermopsis enhances the secretion of bronchial glands. Dry extract of licorice has an anti-inflammatory, expectorant, and spasmolytic effect. Sodium bicarbonate shifts the pH of bronchial mucus to the alkaline side and reduces sputum viscosity. Licorice root has an anti-inflammatory and spasmolytic effect. Sodium benzoate and Ammonium chloride have an expectorant effect.
Indications
Use as an expectorant for the symptomatic treatment of cough associated with specific respiratory tract conditions.
- Respiratory tract diseases accompanied by a cough with difficult-to-expectorate sputum.
- Conditions include tracheitis, bronchitis, and bronchopneumonia.
ICD codes
| ICD-10 code | Indication |
| J04 | Acute laryngitis and tracheitis |
| J15 | Bacterial pneumonia, not elsewhere classified |
| 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 |
| CA40.0Z | Bacterial pneumonia, 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. |
Administer orally. For adult patients, dissolve the entire contents of one single-dose sachet in 15 ml (one tablespoon) of cooled, boiled water.
Take the prepared solution 3 to 4 times per day, following meals. The recommended treatment course is 2 to 3 weeks in duration. Do not exceed the stated dosage.
Adverse Reactions
Gastrointestinal disturbances such as nausea, vomiting, and diarrhea may occur. The preparation can exert a direct irritating effect on the gastric mucosa.
Hypersensitivity reactions, including various allergic reactions, are possible. Monitor for skin rashes, itching, or other signs of intolerance. Discontinue use if adverse reactions manifest.
Contraindications
Do not use in patients with known hypersensitivity or a history of allergic reactions to any of the formulation’s components.
- Pregnancy and the breastfeeding period.
- Pre-existing renal conditions, specifically acute glomerulonephritis and acute pyelonephritis.
- Hereditary metabolic disorders: sucrase/isomaltase deficiency, fructose intolerance, and glucose-galactose malabsorption.
- Use in the pediatric population under 18 years of age.
Use in Pregnancy and Lactation
The use of the drug is contraindicated during pregnancy and breastfeeding.
Use in Renal Impairment
Contraindicated in acute glomerulonephritis and acute pyelonephritis.
Pediatric Use
Contraindicated in children and adolescents under 18 years of age.
Special Precautions
Information for patients with diabetes mellitus: the carbohydrate content in a single dose of the drug corresponds to 0.06 XE (Bread Units).
Effect on the ability to drive vehicles and mechanisms
The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Overdose
No specific cases of overdose have been reported. Symptoms of overdose are anticipated to be an exaggeration of the known adverse reactions, particularly severe gastrointestinal irritation manifesting as nausea, vomiting, and diarrhea.
In the event of suspected overdose, discontinue the medication immediately and initiate symptomatic and supportive care. There is no known specific antidote.
Drug Interactions
Avoid concomitant use with antitussive drugs (e.g., codeine, dextromethorphan). This combination is not recommended as it may lead to undesirable retention of bronchial secretions due to the suppression of the cough reflex.
Concurrent administration with other drugs that reduce sputum formation is also contraindicated. Exercise caution and monitor for decreased therapeutic efficacy when used with other agents affecting mucus viscosity or production.
Storage Conditions
In a dry place at a temperature not exceeding 25°C (77°F). Keep out of reach of children.
Shelf Life
The shelf life is 2 years.
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Powder for oral solution: sachet 1.7 g
Marketing Authorization Holder
Vifitech, CJSC (Russia)
Dosage Form
 |
Mixtura sicca contra tussim pro adultis | Powder for oral solution: sachet 1.7 g |
Dosage Form, Packaging, and Composition
Powder for the preparation of an oral solution in the form of a heterogeneous powder mixture from grayish-brown to brownish-gray with a pinkish tint, with lighter and darker inclusions, with the smell of anise oil; caking is allowed during storage; the aqueous solution of the drug (1:10) should have a brown color.
| 1 sachet | |
| Dry extract of thermopsis | 0.045 g, |
| Which corresponds to the content of the sum of alkaloids in terms of thermopsin and absolutely dry substance | 1% |
| Dry extract of licorice | 0.15 g, |
| Which corresponds to the content of glycyrrhizic acid in terms of monoammonium salt of glycyrrhizic acid hydrate and absolutely dry substance | 17% |
| Sodium bicarbonate | 0.3 g |
| Sodium benzoate | 0.3 g |
| Ammonium chloride | 0.15 g |
| Anise oil | 0.0037 g |
Excipients: sucrose (sugar) – 0.75 g.
1.7 g – heat-sealable sachets.
1.7 g – heat-sealable sachets.
Powder for oral solution: 1.7 g sachet 3, 6, 10, 20, or 40 pcs.
Marketing Authorization Holder
Ivanovo Pharmaceutical Factory PJSC (Russia)
Dosage Form
|
Mixtura sicca contra tussim pro adultis | Powder for oral solution: 1.7 g sachet 3, 6, 10, 20, or 40 pcs. |
Dosage Form, Packaging, and Composition
Powder for the preparation of an oral solution heterogeneous light yellowish-brown or brownish-gray in color with white and darker inclusions, with the smell of anise oil, hygroscopic; the aqueous solution of the drug (1:10) has a yellow-brown or brown color.
| 1 sachet | |
| Dry extract of Thermopsis lanceolata herb | 0.045 g |
| Dry extract of licorice roots | 0.150 g |
| Sodium benzoate | 0.300 g |
| Sodium bicarbonate | 0.300 g |
| Ammonium chloride | 0.150 g |
Excipients: anise oil, sucrose.
1.7 g – sachets (3) – cardboard packs.
1.7 g – sachets (6) – cardboard packs.
1.7 g – sachets (10) – cardboard packs.
1.7 g – sachets (20) – cardboard packs.
1.7 g – sachets (40) – cardboard packs.
Powder for oral solution: sachet 1.7 g 100, 200, or 600 pcs.
Marketing Authorization Holder
Lumi, LLC (Russia)
Dosage Form
|
Mixtura sicca contra tussim pro adultis | Powder for oral solution: sachet 1.7 g 100, 200, or 600 pcs. |
Dosage Form, Packaging, and Composition
Powder for the preparation of an oral solution in the form of a heterogeneous powder mixture of brownish-gray color with white inclusions, with the smell of anise oil; caking is possible; the aqueous solution of the drug (1:10) has a brown color.
| 1 sachet | |
| Dry extract of thermopsis | 0.045 g |
| Dry extract of licorice | 0.15 g |
| Sodium bicarbonate | 0.3 g |
| Sodium benzoate | 0.3 g |
| Ammonium chloride | 0.15 g |
| Anise essential oil | 0.0037 g |
Excipients: sucrose – 0.75 g.
1.7 g – heat-sealable sachets (100) – cardboard boxes.
1.7 g – heat-sealable sachets (200) – cardboard boxes.
1.7 g – heat-sealable sachets (600) – cardboard boxes
Powder for oral solution: 1.7 g sachet 5, 10, 12, 15, 20, 25, 30, 40, 50, 100, or 200 pcs.
Marketing Authorization Holder
Meligen FP, CJS (Russia)
Dosage Form
|
Mixtura sicca contra tussim pro adultis | Powder for oral solution: 1.7 g sachet 5, 10, 12, 15, 20, 25, 30, 40, 50, 100, or 200 pcs. |
Dosage Form, Packaging, and Composition
Powder for the preparation of an oral solution in the form of a heterogeneous powder mixture brownish-gray with white inclusions, with the smell of anise oil; caking is allowed during storage; the aqueous solution of the drug (1:10) has a brown color.
| 1 sachet | |
| Dry extract of thermopsis herb | 0.045 g |
| Dry extract of Glycyrrhiza glabra roots | 0.15 g |
| Sodium bicarbonate | 0.3 g |
| Sodium benzoate | 0.3 g |
| Ammonium chloride | 0.15 g |
Excipients: sucrose (sugar) – 0.75 g, anise oil – 0.0037 g.
1.7 g – heat-sealable sachets (5) – cardboard packs.
1.7 g – heat-sealable sachets (10) – cardboard packs.
1.7 g – heat-sealable sachets (12) – cardboard packs.
1.7 g – heat-sealable sachets (15) – cardboard packs.
1.7 g – heat-sealable sachets (20) – cardboard packs.
1.7 g – heat-sealable sachets (25) – cardboard packs.
1.7 g – heat-sealable sachets (30) – cardboard packs.
1.7 g – heat-sealable sachets (40) – cardboard packs.
1.7 g – heat-sealable sachets (50) – cardboard packs.
1.7 g – heat-sealable sachets (100) – cardboard packs.
1.7 g – heat-sealable sachets (200) – cardboard packs.
Powder for oral solution: sachet 1.7 g 5 or 10 pcs.
Marketing Authorization Holder
Moscow Pharmaceutical Factory CJS (Russia)
Dosage Form
|
Mixtura sicca contra tussim pro adultis | Powder for oral solution: sachet 1.7 g 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Powder for the preparation of an oral solution in the form of a heterogeneous powder mixture of brownish-gray color with lighter inclusions, with the smell of anise oil; the aqueous solution of the drug (1:10) has a brown color.
| 1 sachet | |
| Dry extract of thermopsis | 0.045 g |
| Dry extract of licorice | 0.15 g |
| Sodium bicarbonate | 0.3 g |
| Sodium benzoate | 0.3 g |
| Ammonium chloride | 0.15 g |
| Anise essential oil | 0.0037 g |
Excipients: sucrose (refined sugar) – up to 0.75 g.
1.7 g – heat-sealable sachets made of combined material (5) – cardboard packs.
1.7 g – heat-sealable sachets made of combined material (10) – cardboard packs.
Powder for oral solution: sachet 1.7 g
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Mixtura sicca contra tussim pro adultis | Powder for oral solution: sachet 1.7 g |
Dosage Form, Packaging, and Composition
Powder for the preparation of an oral solution brownish-gray in color with lighter inclusions, with the smell of anise oil; aqueous solution (1:10) – brown in color.
| 1 sachet | |
| Dry extract of thermopsis | 0.045 g |
| Dry extract of Glycyrrhiza glabra roots | 0.15 g |
| Sodium benzoate | 0.3 g |
| Sodium bicarbonate | 0.3 g |
| Ammonium chloride | 0.15 g |
Excipients: anise oil 0.0037 g, sucrose up to 1.70 g.
1.7 g – Sachets made of combined material.
Powder for oral solution: sachet, bottles 200 ml
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Mixtura sicca contra tussim pro adultis | Powder for oral solution: sachet, bottles 200 ml |
Dosage Form, Packaging, and Composition
| Powder for the preparation of an oral solution | 1 sachet |
| Dry extract of thermopsis herb | |
| Which corresponds to the content of the sum of alkaloids in terms of thermopsin and absolutely dry substance 1% | |
| Dry extract of Glycyrrhiza glabra roots | |
| Which corresponds to the content of glycyrrhizic acid in terms of monoammonium salt of glycyrrhizic acid hydrate and absolutely dry substance 17% | |
| Sodium bicarbonate | |
| Sodium benzoate | |
| Ammonium chloride | |
| Anise oil |
Laminated paper sachets.
200 ml – children’s milk bottles.
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