Bronchipret® tp

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

Composition:

Active substances: 1 film-coated tablet contains:

160 mg of dry thyme herb extract (4–8 : 1) (Herba Thymi vulgaris),
(extracting solvent: ethanol 70% v/v);

60 mg of dry primrose root extract (5.3–7.8 : 1) (Radix Primulae),
(extracting solvent: ethanol 47.4% v/v);

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

Pharmaceutical form. Film-coated tablets.

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

Pharmacotherapeutic group. Combined products used for cough and common cold. ATC code R05X.

Pharmacological properties.

Pharmacodynamics.

The herbal components contained in the medicinal product have secretolytic and spasmolytic properties.

Saponins from the roots of primrose exert a secretolytic effect, which is achieved mainly through a reflex mechanism due to stimulation of sensory nerve endings of the vagus nerve in the gastrointestinal tract.

Essential oils and flavonoids from the herb of thyme exert bronchospasmolytic and secretolytic effects. The antimicrobial effect of the preparation, caused by the thymol component of the essential oil from thyme herb, has also been confirmed.

Pharmacokinetics.

The thymol component of the essential oil from thyme herb is excreted via the lungs. Flavonoids (e.g., apigenin, luteolin) from the thyme herb are metabolized by intestinal flora and well absorbed into the blood, and are excreted either unchanged or as metabolites, mainly through the kidneys.

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.

Special precautions for use

Due to the presence of glucose and lactose, this 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 1 week, 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 not use Bronchipret® TP coated tablets without prior medical consultation.

Note for diabetic patients. One tablet contains on average 0.02 bread units (BU). The tablets are gluten-free.

Use during pregnancy or breastfeeding.

Pregnancy.

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

Fertility.

There are no data on the effect of the medicinal product on female fertility. Experimental studies revealed no effect on fertility.

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, without chewing, with sufficient amount of liquid (preferably a glass of water), before meals.

The duration of treatment depends on the course of the disease. Typically, treatment lasts for 1 week. If longer treatment is required, patients should consult a physician. See also information in the sections "Special Warnings and Precautions for Use" and "Adverse Reactions".

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

Overdose. Possible gastrointestinal disturbances, vomiting, and diarrhea. Treatment is symptomatic.

Side effects

Gastrointestinal disorders including cramps, nausea, vomiting, and diarrhea occur infrequently. Very rarely, hypersensitivity reactions may occur, including breathing difficulties, skin rashes, itching, urticaria, and swelling of the face, mouth, and/or throat.

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

If an allergic reaction occurs, Bronchipret® TP tablets must not be used again.

Shelf life. 3 years.

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

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. 20 or 25 tablets in blisters of 20, 50, or 100, in a cardboard box.

Availability. Over-the-counter.

Manufacturer/Applicant. Bionorica SE / Bionorica SE.

Address of manufacturer and location of business operations / applicant 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]