Stoptussin Phyto (Syrup) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Czech Industries, s.r.o. (Czech Republic)

Contact Information

TEVA (Israel)

ATC Code

R05X (Other remedies for the treatment of colds)

Active Substances

Thymi herba (BP British Pharmacopoeia)

Thymus serpyllum (DAB German Pharmacopoeia)

Plantaginis lanceolatae herba (DAB German Pharmacopoeia)

Dosage Form

Stoptussin Phyto

Syrup 4.1624 g+4.163 g+4.1666 g/100 g: 100 ml bottle with measuring cap included

Dosage Form, Packaging, and Composition

Syrup in the form of a thick brown liquid with a characteristic odor.

Excipients: honey, sodium benzoate, sucrose, glycerol 85%, water.

100 ml – dark glass bottles (1) complete with a measuring cap – cardboard packs^×.

^× protective stickers may also be applied.

Clinical-Pharmacological Group

Herbal preparation with expectorant and anti-inflammatory effects

Pharmacotherapeutic Group

Herbal expectorant

Pharmacological Action

An expectorant preparation of herbal origin.

It has an expectorant and anti-inflammatory effect and helps to reduce the viscosity of sputum.

Pharmacokinetics

Data on the pharmacokinetics of Stoptussin Phyto are not provided.

Indications

As part of complex therapy for acute and chronic inflammatory diseases of the respiratory tract, accompanied by cough with difficult-to-discharge sputum

• Tracheitis;
• Bronchitis;
• Tracheobronchitis.

ICD codes

Dosage Regimen

The drug is administered orally, after meals (due to the possibility of decreased appetite).

Adults and children over 15 years old – 1 tablespoon 3-5 times/day.

Children aged from 1 year to 5 years – 1/2-1 teaspoon 2-3 times/day, from 5 to 10 years – 1-2 teaspoons 3 times/day, from 10 to 15 years – 2-3 teaspoons 3 times/day.

The average course of treatment is 7 days. Increasing the duration of treatment and conducting repeated courses is possible on the recommendation of a doctor.

Adverse Reactions

Possible allergic reactions.

Contraindications

• Cardiac decompensation;
• Liver diseases;
• Kidney diseases;
• Congenital fructose intolerance;
• Impaired absorption of glucose and galactose;
• Deficiency of the enzyme that breaks down sucrose and isomaltose;
• Pregnancy;
• Lactation period (breastfeeding);
• Children under 1 year of age;
• Hypersensitivity to the components of the drug.

With caution (due to the presence of ethanol in the preparation), the drug should be used in patients with alcoholism, epilepsy, brain diseases and injuries.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

The drug is contraindicated in liver diseases.

Use in Renal Impairment

The drug is contraindicated in kidney diseases.

Pediatric Use

Contraindication: children under 1 year of age. The drug should be prescribed with caution to children (due to the possible negative effect of ethanol).

Special Precautions

The drug contains 3.4% vol. ethanol; 1 teaspoon (5 ml) contains up to 0.14 g of ethanol; 1 tablespoon (15 ml) – up to 0.41 g of ethanol.

The drug contains 62% sucrose, so it should be used with caution in patients with diabetes mellitus and in persons on a low-carbohydrate diet. 1 teaspoon of the drug contains up to 3.1 g of sucrose, 1 tablespoon – up to 9.3 g of sucrose.

Use in pediatrics

The drug should be prescribed with caution to children (due to the possible negative effect of ethanol).

Overdose

Data on overdose of Stoptussin Phyto are not provided.

Drug Interactions

Stoptussin Phyto 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, in a light-protected place at a temperature from 10°C (50°F) to 25°C (77°F).

Shelf Life

Shelf life – 4 years.

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.