Instructions for Bronchipret TP film-coated tablets No. 50
Composition
active ingredients: 1 film-coated tablet contains:
160 mg of dry thyme herb extract (4–8:1) (Herba Thymi vulgaris),
(extractant ethanol 70% (v/v));
60 mg of dry primrose root extract (5.3–7.8:1) (Radix Primulae),
(extractant ethanol 47.4% (v/v));
excipients: dimethicone, lactose monohydrate, glucose, colloidal anhydrous silica, 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).
Dosage form
Film-coated tablets.
Main physicochemical properties: round biconvex tablets, coated with a green shell with a semi-matte surface.
Pharmacotherapeutic group
Combined remedies used for coughs and colds. ATX code R05X.
Pharmacological properties
Pharmacodynamics.
The herbal components that make up the medicinal product have secretolytic and antispasmodic properties.
Saponins from primrose roots exhibit a secretolytic effect, which is achieved mainly through a reflex mechanism due to irritation of the sensory nerve endings of the vagus nerve of the digestive tract.
Essential oils and flavonoids of thyme herb have bronchospasmolytic and secretolytic effects. The antibacterial effect of the drug, due to the thymol component of the essential oil of thyme herb, has also been confirmed.
Pharmacokinetics.
The thymol component of thyme essential oil is excreted by the lungs. Flavonoids (e.g. apigenin, luteolin) of thyme are broken down by the intestinal flora and are well absorbed into the blood and excreted either unchanged or as metabolites, mainly by the kidneys.
Indication
Treatment of acute bronchitis and inflammatory diseases of the respiratory tract accompanied by cough with the formation of viscous sputum.
Contraindication
Increased individual sensitivity to any of the components of the drug, as well as to other types of primroses or to other medicinal plants of the Labiatae family, to birch, wormwood and celery.
Interaction with other medicinal products and other types of interactions
No interactions with other drugs have been observed. It can be used in combination with antibacterial drugs.
Application features
Due to the content of glucose and lactose, the drug should not be taken by patients with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
If symptoms persist for more than 1 week or difficulty breathing, fever, purulent or bloody sputum occurs, the patient should immediately consult a doctor.
Patients with gastritis or stomach ulcers should not use Bronchipret® TP film-coated tablets without consulting a doctor.
Note for diabetics. 1 tablet contains an average of 0.02 bread units (BTU). The tablets do not contain gluten.
Use during pregnancy or breastfeeding
Pregnancy.
Due to insufficient data on use, the drug should not be used during pregnancy or breastfeeding.
Fertility.
There is no data on the effect of the drug on the female ability to reproduce. In experimental studies, no effect on fertility was observed.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Adults and children over 12 years of age should take 1 tablet 3 times a day.
The tablets should be taken without chewing, with sufficient liquid (preferably a glass of water), before meals.
The duration of treatment depends on the course of the disease. Usually the course of treatment is 1 week. If longer treatment is necessary, the patient should consult a doctor. See also the information in the sections "Features of use" and "Adverse reactions".
Children Due to insufficient safety studies, the drug should not be used in children under 12 years of age.
Overdose
Stomach upset, vomiting and diarrhea are possible. Treatment is symptomatic.
Side effects
Gastrointestinal disorders, including cramps, nausea, vomiting, diarrhea, are uncommon. Hypersensitivity reactions, including difficulty breathing, skin rash, itching, hives, swelling of the face, mouth and/or throat, are very rare.
If any adverse reactions occur, discontinue use of the drug and consult a doctor.
If an allergic reaction occurs, Bronchipret® TP tablets should not be used again.
Expiration date
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, out of the reach of children.
Packaging
20 or 25 tablets in blisters No. 20 or 50 or 100 in a cardboard box.
Vacation category
Without a prescription.
Producer
Bionorica SE.
Location of the manufacturer and its business address/location of the applicant and/or the applicant's representative.
Kerchensteinerstrasse, 11-15, 92318 Neumarkt, Germany.
Contact details of the manufacturer's representative in Ukraine, LLC "Bionorika":
phone: 044 521 86 00; fax: 044 521 86 01, info@bionorica.ua
