Broncho tuss drops

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BRONCHO TAISS DROPS

Composition:

Active substances: star anise oil (Star anise oil), liquid thyme herb extract (Extract Thymi fluid);

1 g of solution (24 drops) contains 50 mg of star anise oil (Star anise oil), 250 mg of liquid thyme herb extract (Extract Thymi fluid) (1:2–2.5), extracted with: 10 % ammonia solution/glycerol 85 %/ethanol 90 %/purified water (1/20/70/109);

Excipients:

propylene glycol; polyoxyl 40 hydrogenated castor oil; ethanol 96 %.

Pharmaceutical form. Oral drops.

Main physicochemical properties: brown liquid with a characteristic anise and thyme odour.

Pharmacotherapeutic group. Combined preparations used in cough and colds. ATC code R05CA10.

Pharmacological properties.

Pharmacodynamics.

Broncho Tuss drops contain star anise oil and liquid thyme extract.

Anise oil exerts secretolytic, spasmolytic, secretomotor, and antibacterial effects; at high concentrations, it also has antifungal activity.

Thyme extract has bronchospasmolytic and expectorant effects.

Pharmacokinetics.

Anise oil and thyme extract contain a mixture of components typical for herbal medicinal products. Methods for determining the pharmacokinetics of such components are not available.

Clinical characteristics.

Indications.

Symptomatic treatment of inflammatory respiratory tract diseases accompanied by cough and difficulty in expectorating thick mucus.

Contraindications.

Hypersensitivity to active ingredients of the medicinal product (star anise, thyme), to other plants of the Lamiaceae or Apiaceae families (fennel, cumin, celery, coriander, dill), to anethole, or to birch pollen (cross-reactivity possible), or to any excipients. Contraindicated in children with a history of acute laryngotracheitis with obstruction or asthma.

Do not use in children under 12 years of age due to lack of data and because of the presence of estragole.

Interaction with other medicinal products and other forms of interaction.

Interaction is unknown.

If simultaneous use with any other medicinal products is necessary, consult a physician.

Special precautions for use.

If symptoms worsen during treatment and/or dyspnea, fever, or purulent sputum appear, medical advice must be sought immediately. If symptoms persist after one week of treatment, a physician should be consulted.

This medicinal product contains 48 vol. % ethanol (alcohol), i.e. 300 mg per dose, equivalent to 8.5 ml of beer or 3.5 ml of wine in each dose. It is harmful for patients suffering from alcoholism. Caution should be exercised when used in pregnant and breastfeeding women, children, patients with liver disorders, and patients with epilepsy.

Polyoxylated hydrogenated castor oil may cause gastrointestinal disturbances and diarrhea.

The medicinal product contains 250 mg of propylene glycol in 20 drops, equivalent to 300 mg/g.

Use during pregnancy or breastfeeding.

The safety of using this medicinal product during pregnancy or breastfeeding has not been established. The product should not be taken during pregnancy or while breastfeeding.

Effect on the ability to drive and use machines.

Studies on the influence of this product on the ability to drive or operate machinery have not been conducted. The medicinal product contains 48 vol. % ethanol. This should be taken into account when driving or operating machinery.

Method of Administration and Dosage.

For adults and children aged 12 years and older: take 20 drops three times daily, added to water.

The duration of treatment is determined individually by a physician, depending on the course of the disease and the nature of combination therapy.

Children.

Do not use in children under 12 years of age due to lack of data and the presence of the substance estragole.

Overdose.

No cases of overdose have been reported to date.

In the event of overdose, a more pronounced manifestation of the described adverse reactions is possible.

Oral ingestion of 1 to 5 mL of anise oil has been associated with nausea, vomiting, seizures, and pulmonary edema.

In case of symptoms of intoxication or overdose, symptomatic treatment is required.

Side effects.

Immune system disorders: allergic reactions, including rash, itching, hyperemia, urticaria, angioedema, anaphylactic shock, dyspnea, bronchospasm; gastrointestinal disturbances, including cramps, nausea, vomiting, diarrhea.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºC. Keep out of reach of children.

Packaging.

30 ml in a glass dropper bottle, in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer/Applicant.

Dr. Theiss Naturwaren GmbH.

Manufacturer's address.

Michelinstrasse 10, 66424 Homburg, Germany.