Bronchipret

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Bronchipret® (Bronchipret®)

Composition:

Active substances: 10 g (corresponding to 8.92 ml) of syrup contain

1.5 g of liquid extract of thyme herb (1: (2–2.5)) (Herba Thymi vulgaris) (extractant: ammonium solution 10 %/glycerol 85 %/ethanol 90 %/purified water (1:20:70:109));

0.15 g of liquid extract of ivy leaves (1:1) (Folium Hederae helicis) (extractant: ethanol 70 %);

Excipients: ethanol 7 % v/v, liquid maltitol, potassium sorbate, citric acid monohydrate, hydroxypropyl betadex, purified water.

1 ml of syrup contains 0.07 ml ethanol (7 %).

Pharmaceutical form. Syrup.

Main physicochemical properties: clear light brown liquid with a sweet taste and aromatic odor. During storage, slight cloudiness and sediment formation may occur.

Pharmacotherapeutic group. Combined preparations used in cough and colds. ATC code R05X.

Pharmacological Properties

Pharmacodynamics.

The plant components contained in the medicinal product have secretolytic, spasmolytic, and partially antimicrobial properties.

The essential oils and flavonoids from the herb of thyme exert bronchospasmolytic and secretolytic effects. Saponins from ivy leaves also produce a secretolytic effect. In addition, preparations from ivy leaves exhibit spasmolytic action on smooth muscle and significantly reduce bronchoconstriction. The antibacterial effect of the preparation, attributed to the thymol component of the essential oil from thyme herb, has also been confirmed.

Pharmacokinetics.

Ivy saponins have a relatively low absorption rate. The thymol component of the essential oil from thyme herb is excreted predominantly via the lungs. Flavonoids (e.g., apigenin, luteolin) from thyme herb are metabolized by intestinal flora and are well absorbed into the bloodstream, being excreted either unchanged or as metabolites, mainly by the kidneys.

Clinical characteristics.

Indications. Treatment of acute bronchitis and inflammatory diseases of the respiratory tract associated with cough and production of viscous sputum.

Contraindications. Hypersensitivity to any of the components of the medicinal product, as well as to other medicinal plants of the Lamiaceae or Araliaceae families, to birch pollen, mugwort, and celery; children under 2 years of age due to the risk of worsening respiratory symptoms. Bronchipret® Syrup should not be used in patients with hereditary fructose intolerance.

Interaction with other medicinal products and other forms of interaction. No interactions with other medicinal products have been observed. This medicinal product may be used as part of combination therapy, including in combination with antibacterial agents.

Special precautions for use

If symptoms persist for more than 1 week or worsen during treatment, or if breathing difficulties, fever, or purulent or bloody sputum occur, the patient should consult a physician.

Due to the 7% ethanol content (v/v), the medicinal product should be used with caution in at-risk patient groups, particularly in patients with liver disease or epilepsy. Additionally, syrup doses exceeding the recommended amounts should not be administered to children.

Concomitant use of antitussive agents such as codeine or dextromethorphan is not recommended. Patients with gastritis or peptic ulcer disease should not use Bronchipret® syrup without first consulting a physician.

Persistent or recurrent cough in children aged 2 to 4 years requires medical diagnosis prior to treatment.

Note for diabetic patients. A single adult dose of syrup (5.4 mL) contains on average 0.18 bread units (BU).

Use during pregnancy or breastfeeding. Due to insufficient safety data, the product should not be used during pregnancy or breastfeeding.

Ability to influence reaction speed when driving or operating machinery. There is no direct evidence of the product's effect on the ability to drive or operate machinery at recommended doses; however, patients should be aware that the product contains ethanol.

Method of administration and dosage.

Take the medication using the measuring cap 3 times a day in doses indicated in the table according to age:

The undiluted syrup should be taken with a small amount of liquid (preferably water). For children under 6 years of age, the single dose of syrup should be diluted in 1 tablespoon of liquid. During storage, slight cloudiness or sediment formation may occur — this does not affect the efficacy of the medicinal product. The syrup should be shaken well before use.

The duration of treatment depends on the course of the disease. Usually, the treatment course lasts 7 days. If longer treatment is necessary or if symptoms persist for more than a week, the patient should consult a physician.

Bronchipret**®** syrup may be taken with food and drinks or independently of meals. If you have a sensitive stomach, Bronchipret**®** syrup should be taken after meals.

See also sections "Special precautions" and "Side effects".

Children. Should not be used in children under 2 years of age.

Overdose. Overdose may cause gastrointestinal disturbances, nausea, vomiting, diarrhea, and agitation. In case of overdose, seek medical advice immediately.

Symptomatic treatment is recommended.

Side effects.

Gastrointestinal disorders including cramps, nausea, vomiting, and diarrhea may occur infrequently. In isolated cases, hypersensitivity reactions are possible, including breathing difficulties, skin rashes, telangiectasia, itching, allergic dermatitis, urticaria, and swelling of the face, mouth, and/or throat.

At the first sign of any adverse reaction, discontinue use of the medicinal product and consult a physician.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

After opening the bottle, the preparation can be used for up to 6 months.

The shelf life is defined as valid until the last day of the specified month.

Storage conditions.

To protect from light, store in the original packaging at a temperature not exceeding 25°C, in a place inaccessible to children.

Packaging. 50 ml or 100 ml in a bottle with a measuring cap, placed in a cardboard box.

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

Manufacturer/Applicant. Bionorica SE / Bionorica SE.

Address of manufacturer's location and place of business / applicant's location and/or applicant's representative.

Kerschensteinerstrasse, 11-15, 92318 Neumarkt, Germany.

Contact details of the manufacturer's representative in Ukraine, LLC "Bionorica":

Phone: 044 521 86 00; Fax: 044 521 86 01, [email protected]