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Tussamag (Solution, Syrup) Instructions for Use

ATC Code

R05CA (Expectorants)

Active Substance

Thyme (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Herbal preparation with expectorant effect

Pharmacotherapeutic Group

Herbal expectorant

Pharmacological Action

A herbal preparation with an expectorant effect; it thins sputum and reduces its viscosity, facilitating better expectoration.

The active substances of the 9% syrup – thymol and carvacrol – also have an antimicrobial effect.

Pharmacokinetics

In accordance with the International Convention (EMEAHMPWG11/99), isolated investigation of pharmacokinetic parameters is not required during clinical trials of herbal medicinal products.

Indications

  • Diseases of the upper respiratory tract with difficult sputum expectoration (bronchitis, tracheitis, tracheobronchitis).

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
R09.3 Sputum
ICD-11 code Indication
CA05 Acute laryngitis or tracheitis
CA0G Chronic laryngitis or laryngotracheitis
CA20.1Z Chronic bronchitis, unspecified
CA42.Z Acute bronchitis, unspecified
MD10 Abnormal sputum
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.

Solution

It is taken orally as a prepared herb infusion, 50-100 ml warm, 2-4 times/day after meals; for gastrointestinal diseases – 15-30 minutes before meals. When used as finished dosage forms, it is applied in accordance with the recommended dosing regimen.

For topical use for rinsing the oral cavity and pharynx, use 1/2 -1 glass of warm infusion 3-4 times/day.

Syrup

Tussamag oral drops can be used undiluted, diluted with water, or on a piece of sugar.

Adults are prescribed 40-60 drops 3-4 times/day.

Children over 5 years of age and adolescents are prescribed 20-50 drops 3 times/day.

Children aged from 1 to 5 years are prescribed 10-25 drops 2-3 times/day.

Tussamag syrup and 9% syrup should be taken orally, preferably after meals.

Adults are prescribed 2-3 teaspoonfuls (10-15 ml) 3-4 times/day.

Children over 5 years of age and adolescents are prescribed 1-2 teaspoonfuls (5-10 ml) 3-4 times/day.

Children aged from 1 to 5 years are prescribed 1 teaspoonful (5 ml) 2-3 times/day.

Adverse Reactions

Possible allergic reactions, nausea (for syrup and oral drops).

Possible allergic reactions (for 9% syrup).

Contraindications

  • Chronic heart failure in the stage of decompensation;
  • Renal failure;
  • Hepatic failure;
  • Pregnancy;
  • Breastfeeding period;
  • Children under 1 year of age;
  • Hypersensitivity to the components of the drug.

With caution, Tussamag oral drops should be used in alcoholism, severe liver diseases.

With caution, Tussamag syrup should be used in patients with diabetes mellitus.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

The use of Tussamag syrup and oral drops is contraindicated in hepatic failure.

With caution, Tussamag syrup and oral drops should be used in severe liver diseases.

Use in Renal Impairment

The use of Tussamag syrup and oral drops is contraindicated in renal failure.

Pediatric Use

Contraindication: children under 1 year of age.

Tussamag oral drops can be used undiluted, diluted with water, or on a piece of sugar.

Children over 5 years of age and adolescents are prescribed 20-50 drops 3 times/day.

Children aged from 1 to 5 years are prescribed 10-25 drops 2-3 times/day.

Tussamag syrup and 9% syrup should be taken orally, preferably after meals.

Children over 5 years of age and adolescents are prescribed 1-2 teaspoonfuls (5-10 ml) 3-4 times/day.

Children aged from 1 to 5 years are prescribed 1 teaspoonful (5 ml) 2-3 times/day.

Special Precautions

Tussamag oral drops contain 19% v/v ethanol, syrup and 9% syrup contain 4% v/v ethanol.

When prescribing Tussamag 9% syrup (175 g bottle) to patients with diabetes mellitus, it should be considered that 1 teaspoon of sugar-free syrup contains 1.85 g of sorbitol, which is 0.15 XE.

When prescribing Tussamag syrup (200 g bottle) to patients with diabetes mellitus, it should be considered that 1 teaspoon of syrup contains 3.3 g of sucrose, which is 0.28 XE.

The preparation contains a herbal extract, which may cause slight cloudiness of the solution or the appearance of sediment in the bottle; however, this does not affect the efficacy of the preparation.

Overdose

To date, there have been no reports of overdose cases.

Drug Interactions

Concomitant use of Tussamag syrup and oral drops with antitussive drugs and medicinal products that reduce sputum formation impedes the coughing up of liquefied sputum.

No interaction of Tussamag 9% syrup with other drugs has been identified.

Storage Conditions

Tussamag oral drops should be stored out of the reach of children at a temperature not exceeding 25°C (77°F). Tussamag syrup and 9% syrup should be stored out of the reach of children at a temperature not exceeding 30°C (86°F). Do not freeze the preparation!

Shelf Life

The shelf life of the preparation is 3 years.

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 Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

CT-Arzneimittel Chemische Tempelhof GmbH (Germany)

Dosage Form

Bottle OTC Icon Tussamag Oral drop solution 500 mg/1 g: dropper bottle 20 g or 50 g

Dosage Form, Packaging, and Composition

Oral drop solution 1 g 100 g
Liquid extract of thyme 500 mg 50 g

20 g – dropper bottles of dark glass (1) – cardboard packs.
50 g – dropper bottles of dark glass (1) – cardboard packs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Merckle, GmbH (Germany)

Dosage Forms

Bottle OTC Icon Tussamag Syrup 9% (sugar-free): bottle 175 g
Oral drops 50 g/100 g: 20 g or 50 g dropper bottle
Syrup 9.001 g/100 g: bottle 200 g

Dosage Form, Packaging, and Composition

Syrup 9% (sugar-free) as a brown liquid with the odor of thyme.

1 g 100 g
Liquid extract of thyme 90 mg 9 g

Excipients : potassium sorbate – 0.1 g, citric acid monohydrate – 0.08 g, caramel 15750 – 0.2 g, glycerol 85% – 20 g, sorbitol 70% – 45 g, purified water – 25.62 g.

175 g – bottles of dark glass (1) – cardboard packs.

Syrup as a brown liquid with a characteristic odor.

1 g 100 g
Liquid alcoholic extract of thyme herb 90 mg 9 g

Excipients : sodium benzoate – 0.147 g, thick alcoholic extract of chestnut leaves – 1.755 g, hydrochloric acid 25% – 0.149 g, glycerol 85% – 0.633 g, caramel cerestar 15750 – 0.4 g, sucrose 66.5% – 79.7 g, purified water – 8.215 g.

200 g – bottles of dark glass (1) – cardboard packs.

Oral drops as a clear reddish-brown liquid with a characteristic odor of thyme.

100 g
Liquid alcoholic extract of thyme herb 50 g

Excipients : liquid non-crystallizing sorbitol – 50 g.

20 g – bottles of dark glass with a dropper cap (1) – cardboard packs.
50 g – bottles of dark glass with a dropper cap (1) – cardboard packs.

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