Bronchipret® n

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BRONCHIPRET® ON (BRONCHIPRET ON)

Composition:

Active substances: 1 film-coated tablet contains:

160 mg of dry thyme herb extract (6–10 : 1) (Herba Thymi), (extraction solvent: ethanol 70% v/v);

60 mg of dry primrose root extract (6–7 : 1) (Rad游戏副本 Primulae), (extraction solvent: ethanol 47.4% v/v).

Excipients: dimethicone, lactose monohydrate, glucose, colloidal anhydrous silicon dioxide, microcrystalline cellulose, magnesium stearate, hypromellose, peppermint flavor (gum arabic, maltodextrin, lactose), povidone K25, crospovidone, propylene glycol, polyacrylate dispersion 30%, sodium saccharin, talc, riboflavin (E 101), chlorophyll (E 141) (copper chlorophyllin complexes, glucose), titanium dioxide (E 171).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex, film-coated tablets of green color with semi-matte surface.

Pharmacotherapeutic group. Medicinal products used in cough and common cold conditions. Other agents used in common cold conditions.

ATC Code R05X.

Pharmacological properties.

Pharmacodynamics.

The plant components contained in the medicinal product have secretolytic and expectorant effects.

Thyme extracts are able to enhance mucociliary clearance. Extracts of primula root cause reflexive increase in bronchial secretion, providing an expectorant mechanism of action. Significant anti-inflammatory properties of Bronchipret® N and its individual extracts, as well as a broncholytic effect, have been demonstrated in both in vivo and in vitro studies. The main mechanisms of action are diverse.

Moreover, in vitro studies of the tablets revealed antibacterial and antiviral activity against bacterial strains (e.g., S. pneumoniae and S. pyogenes) and viral strains (influenza A, respiratory syncytial virus, human rhinovirus) associated with respiratory tract infections. Antitussive action of the drug has also been demonstrated in a preclinical model.

Pharmacokinetics.

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 through the kidneys. Oral administration of a single dose of film-coated tablets to healthy volunteers resulted in a geometric mean Cmax of 90 ng/mL and AUC0-tlast of 794 h*ng/mL for thymol sulfate. The mean Tmax value was 2 hours, and the elimination half-life (t1/2) was 10 hours.

Clinical characteristics.

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

Contraindications. Hypersensitivity to any component of the medicinal product, as well as to other species of primrose or to other medicinal plants of the Lamiaceae (Labiatae) family, to birch, mugwort, and celery.

Interaction with other medicinal products and other forms of interaction. No interactions with other medicinal products have been observed. Concomitant use with antibacterial medicinal products is possible. Studies investigating potential interactions with other concurrently administered medicinal products are lacking.

Special precautions for use.

Due to the presence of glucose and lactose, the medicinal product should not be used in patients with hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

If symptoms persist for more than 2 weeks, or if breathing difficulties, fever, or purulent or bloody sputum occur, the patient should immediately consult a physician.

Patients with gastritis or gastric ulcer should use with caution.

Note for diabetic patients. 1 tablet contains on average 0.02 bread units (BU). The tablets do not contain gluten.

Use during pregnancy or breastfeeding.

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

Fertility.

There are no data on the effect of the medicinal product on female fertility. No effects on fertility were observed in experimental studies.

Ability to influence reaction speed when driving or operating machinery. No effect.

Dosage and Administration.

For adults and children aged 12 years and older: take 1 tablet three times daily.

The tablets should be taken whole, with sufficient fluid (preferably a glass of water), before meals.

The duration of treatment depends on the course of the disease. See also information in the sections "Special Precautions" and "Adverse Reactions".

Children. Due to insufficient safety data, the drug should not be used in children under 12 years of age.

Overdose. Cases of intoxication with preparations from thyme herb and primula root are currently unknown. In case of overdose, gastrointestinal disturbances, vomiting, and possibly diarrhea may occur.

Treatment: symptomatic therapy is required if signs of poisoning or overdose occur.

Side effects.

Gastrointestinal disorders, including cramps, nausea, vomiting, and diarrhea, occur infrequently. Hypersensitivity reactions are very rare and may include difficulty breathing, skin rashes, itching, urticaria, and swelling of the face, mouth, and/or throat.

If any adverse reactions occur, discontinue use of the medicinal product and consult a physician.

If an allergic reaction occurs, the tablets must not be used again.

Reporting of adverse reactions following registration of the medicinal product is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

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

Storage conditions. Store at temperatures not exceeding 25 ˚C.

Keep out of reach and sight of children.

Packaging. 20 tablets in a blister; 1 blister per cardboard box; 25 tablets in a blister; 2 or 4 blisters per cardboard box.

Pharmaceutical category. Over-the-counter.

Manufacturer/Marketing Authorization Holder. Bionorica SE / Bionorica SE.

Address of manufacturer and its place of business / 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; +38 (044) 594-66-88; [email protected]