Orvis^® Broncho Thyme (Syrup) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

Contact Information

Evalar, CJSC (Russia)

ATC Code

R05CA (Expectorants)

Active Substance

Thyme (Ph.Eur. European Pharmacopoeia)

Dosage Form

Orvis® Broncho Thyme

Syrup: bottle 100 ml

Dosage Form, Packaging, and Composition

Syrup as a brown liquid with a characteristic odor.

* Thyme herb liquid extract is obtained from Thyme herb (Thymus vulgaris L., fam. Lamiaceae). The ratio of herbal drug substance to extract is 1:2-2.5.
Extraction solvents: Ammonia 25% solution, glycerol 100%, ethanol 95%, purified water – in a ratio of 1:42.5:162.5:294.

Excipients: potassium sorbate, citric acid monohydrate, caramel color, glycerol (glycerin), liquid sorbitol (non-crystallizing), purified water.

100 ml – dark glass bottles (1) – cardboard packs.

A measuring cup may be included in the cardboard pack.

Clinical-Pharmacological Group

Herbal preparation with expectorant effect

Pharmacotherapeutic Group

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

Pharmacological Action

The drug has an expectorant effect, thins sputum and reduces its viscosity. The active substances of the drug – thymol and carvacrol – also have an antimicrobial effect.

Pharmacokinetics

The action of the drug is the result of the combined action of the active substances of Thyme herb extract, therefore conducting pharmacokinetic studies is not possible; all components together cannot be tracked using markers or bioassays.

Indications

For adults and children aged 1 year and older

• In the complex therapy of infectious and inflammatory diseases of the respiratory tract, accompanied by cough with difficult-to-discharge sputum (including bronchitis, tracheitis, tracheobronchitis, whooping cough).

ICD codes

Dosage Regimen

Orally, regardless of meals. The syrup can be taken undiluted or diluted with water.

Adults

2-3 teaspoons (10-15 ml) of syrup 3-4 times/day. The duration of use of the drug is determined by therapeutic necessity and the duration of the disease.

Children

The dosage regimen for children over 12 years does not differ from the dosage regimen for adults.

At the age of 5 to 12 years – 1-2 teaspoons (5-10 ml) of syrup 3-4 times/day.

At the age of 1 to 5 years – 1 teaspoon (5 ml) of syrup 2-3 times/day.

The safety of the drug Orvis^® Broncho Thyme in children from 0 to 1 year has not been established. Data are not available.

Adverse Reactions

Possible occurrence of allergic reactions.

Due to the sorbitol content, irritation of the gastric mucosa and diarrhea may occur when taking the drug.

If side effects not described in this instruction occur, the patient should discontinue the drug and inform the attending physician.

Contraindications

• Hypersensitivity to Thyme herb extract or to any of the excipients included in the drug;
• Cardiac decompensation;
• Gastritis;
• Peptic ulcer of the stomach and duodenum in the acute phase;
• Hereditary fructose intolerance; sucrase/isomaltase deficiency; glucose-galactose malabsorption;
• Children under 1 year of age.

With caution

• Liver diseases;
• Alcoholism;
• Traumatic brain injury;
• Brain diseases;
• Children aged 1 year and older.

Use in Pregnancy and Lactation

Pregnancy

The drug Orvis^® Broncho Thyme is not recommended for use during pregnancy (due to the lack of sufficient clinical experience in this category of patients).

Breastfeeding period

The drug Orvis^® Broncho Thyme is not recommended for use during breastfeeding (due to the lack of sufficient clinical experience in this category of patients).

Fertility

Data are not available.

Use in Hepatic Impairment

Use with caution in liver diseases.

Pediatric Use

Contraindicated for use in children under 1 year of age.

Special Precautions

Due to the ethanol content, children under 12 years of age should take the drug on the recommendation and under the supervision of a physician. The ethyl alcohol content in the drug is not more than 4%.

One teaspoon of the drug (5 ml) contains not more than 0.16 g of absolute ethyl alcohol (i.e., anhydrous ethyl alcohol).

For children from 1 to 5 years, the maximum single dose contains not more than 0.16 g of absolute ethyl alcohol, the maximum daily dose contains not more than 0.48 g of absolute ethyl alcohol.

For children from 5 to 12 years, the maximum single dose contains not more than 0.32 g of absolute ethyl alcohol, the maximum daily dose contains not more than 1.28 g of absolute ethyl alcohol;

For adults and children over 12 years, the maximum single dose contains not more than 0.48 g of absolute ethyl alcohol, the maximum daily dose contains not more than 1.92 g of absolute ethyl alcohol.

Excipients

The drug Orvis^® Broncho Thyme contains sorbitol. Patients with rare hereditary fructose intolerance should not take this drug.

100 g of the drug contains 31.5 g of sorbitol (calculated as anhydrous sorbitol).

1 teaspoon of syrup (5 ml) contains 1.85 g of sorbitol, which corresponds to 0.15 XE.

Effect on ability to drive vehicles and mechanisms

When using the drug Orvis^® Broncho Thyme, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving a car and other vehicles, working with moving mechanisms, work of a dispatcher and operator).

Overdose

Symptoms: possible irritation of the gastrointestinal mucosa, vomiting, diarrhea.

Treatment: symptomatic.

Drug Interactions

The drug should not be used simultaneously with drugs containing codeine and other antitussive drugs, as this makes it difficult to cough up liquefied sputum.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F). Shelf life – 3 years. Do not use after the expiration date.

After opening the bottle, the drug is suitable for use within 1 year.

Dispensing Status

The drug is available without a prescription.

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.