Bronchipret
Ukraine
Table of Contents
INSTRUCTIONS for medical use of the medicinal product Bronchipret® (Bronchipret®)
Composition:
Active ingredients: 1 ml (corresponding to 1 g) of solution contains:
| 0.5 mL |
liquid extract of thyme herb (Herba Thymi vulgaris) (1:(2–2.5)) (extracting agent: ammonium solution 10 %/ glycerol 85 %/ ethanol 90 %/ purified water (1:20:70:109)); |
| 0.03 mL |
liquid extract of ivy leaves (Folium Hederae helicis) (1:1) (extracting agent: ethanol 70 %); |
Excipients: ethanol 24% (v/v), hydroxypropyl betadex, sodium saccharin dihydrate, citric acid monohydrate, purified water.
Dosage form. Solution.
Main physicochemical properties: transparent or slightly cloudy brownish liquid with a thyme odor. During storage, slight turbidity or precipitation may occur.
Pharmacotherapeutic group. Combined preparations used in cough and colds. ATC code R05X.
Pharmacological properties.
Pharmacodynamics.
The herbal components contained in the medicinal product have secretolytic, spasmolytic, and partially antimicrobial properties.
The essential oils and flavonoids of thyme herb exert bronchospasmolytic and secretolytic effects. The saponins of ivy leaves also cause a secretolytic effect. In addition, ivy leaf preparations exert a spasmolytic effect on smooth muscle and significantly reduce bronchoconstriction. The antibacterial effect of the preparation has also been confirmed, which is due to the thymol component of the essential oil of thyme herb.
Pharmacokinetics.
Ivy saponins have a relatively low absorption rate. The thymol component of the essential oil of thyme herb is predominantly excreted via the lungs. Flavonoids (e.g., apigenin, luteolin) of thyme herb are metabolized by intestinal flora and well absorbed into the blood, and are excreted either unchanged or as metabolites, mainly by the kidneys.
Clinical characteristics.
Indications. Treatment of acute bronchitis and inflammatory diseases of the respiratory tract accompanied by cough with the production of viscous sputum.
Contraindications. Hypersensitivity to any component of the medicinal product, as well as to other medicinal plants of the Lamiaceae or Araliaceae families, to birch pollen, mugwort, and celery.
The medicinal product is not recommended for children under 6 years of age.
Interaction with other medicinal products and other forms of interaction. No interactions observed. May be used in combination with antibacterial medicinal products.
Special precautions for use.
If symptoms persist for more than 1 week or worsen during treatment, or if there is difficulty breathing, fever, or expectoration of purulent or bloody sputum, the patient should consult a physician.
Due to the ethanol content of 24% (v/v), the preparation should not be used in patients after successful anti-alcohol treatment or in those suffering from alcoholism. The alcohol content should also be taken into account when the medicinal product is used in children at doses exceeding the recommended doses, and in patients at risk, namely those with liver disease or epilepsy. Concomitant use of antitussive agents such as codeine or dextromethorphan is not recommended. Patients with gastritis or peptic ulcer should not use this medicinal product without consulting a physician.
Note for diabetic patients. A single dose of the medicinal product does not contain a significant amount of carbohydrate units (CU).
Use during pregnancy or breastfeeding. Due to insufficient experience with use during pregnancy and breastfeeding, the product is not recommended for use during these periods.
Ability to affect reaction speed when driving or operating machinery. There is no information on the direct effect of the product when used at recommended doses on the ability to drive or operate machinery; however, it should be noted that the product contains ethanol.
Dosage and Administration.
Adults should take 2.6 ml of the solution three times a day; children aged 12–17 years should take 1.8 ml of the solution three times a day. If necessary, the medicinal product can be taken with a small amount of liquid. Children aged 6–11 years should take 1.6 ml of the solution three times a day, diluted in 1 tablespoon of liquid.
The duration of treatment depends on the course of the disease. Usually, the treatment course lasts 7 days. If a longer treatment period is required or if symptoms persist for more than 7 days, the patient should consult a physician.
During storage, slight cloudiness or sedimentation may occur – this does not affect the efficacy of the medicinal product. Shake well before use! Measure the dose using the provided dosing cap. See also sections "Special Instructions" and "Adverse Reactions".
Children. Due to insufficient experience regarding safety, the product is not recommended for children under 6 years of age.
Overdose. Possible gastrointestinal disturbances, nausea, vomiting, diarrhea, and excitation. In case of overdose, seek medical advice.
Treatment: symptomatic therapy.
Side effects
Gastrointestinal disorders, including spasms, nausea, vomiting, and diarrhea, occur infrequently. In isolated cases, allergic reactions may occur in individuals with hypersensitivity, including dyspnea, telangiectasia, skin rashes, pruritus, allergic dermatitis, urticaria, and angioneurotic edema.
If signs of an allergic reaction occur, the medication should be discontinued and must not be used again.
If any adverse reactions occur, the patient should stop using the medication and consult a physician.
Expiry date. 2 years.
Do not use the medication after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
After first opening the bottle, the medication remains suitable for use for 6 months.
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/Marketing Authorization Holder. Bionorica SE / Bionorica SE.
Address of manufacturer and location of business activity / address of marketing authorization holder and/or its 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: [email protected]