Beross

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BEROZ

Composition:

Active ingredient: tincture (1 : 153.8) from flowers of everlasting (Helichrysum arenarium) (Helichrysi arenarii flos), chamomile flowers (Matricariae flos), St. John's wort herb (Hyperici herba);

100 ml of the preparation contains tincture (1 : 153.8) from flowers of everlasting (Helichrysum arenarium) (Helichrysi arenarii flos), chamomile flowers (Matricariae flos), St. John's wort herb (Hyperici herba) (extractant ethanol 40%) – 100 ml;

Excipients: sugar syrup, extractant.

Pharmaceutical form. Oral tincture.

Main physicochemical properties: clear light-yellow liquid with a characteristic aromatic odor. Sediment may form during storage.

Pharmacotherapeutic group. Agents affecting the digestive system and metabolic processes. ATC code A16AX.

Pharmacological properties.

Pharmacodynamics.

The medicinal product promotes an increase in the amount and rate of bile secretion, as well as enhances the concentration of cholesterol and bilirubin in bile. These effects are maintained in carbon tetrachloride-induced toxic hepatitis. In stress-induced gastric ulcers, the drug enhances and accelerates tissue regeneration, which is associated with its astringent, anti-inflammatory, bacteriostatic, and capillary-strengthening effects. It also enhances diuresis. The drug has no mutagenic, teratogenic, embryotoxic, or immunotoxic effects and does not accumulate in the body.

Pharmacokinetics.

Not determined.

Clinical characteristics.

Indications.

As part of complex treatment of chronic cholecystitis, biliary dyskinesia, as well as in combination with the aforementioned conditions and chronic gastritis with preserved or reduced gastric secretory function.

Contraindications.

Individual hypersensitivity to the biologically active substances contained in the medicinal product.

Arterial hypertension, obstructive jaundice, cholelithiasis with presence of stones larger than 10 mm in diameter, acute inflammatory diseases of the liver, gallbladder and pancreas, severe renal function impairment, increased gastric acidity, gastrointestinal tract bleeding, pronounced duodenogastric reflux, severe bradycardia.

Interaction with other medicinal products and other types of interactions.

The medicinal product enhances the effects of barbiturates, tranquilizers, and other agents affecting the central nervous system. It should not be administered concurrently with medicinal products containing metals.

It is not recommended for patients taking anticoagulants, antibiotics, sulfonamides, contraceptives, calcium channel blockers, female sex hormones, hypolipidemic agents (statins), and cardiac glycosides.

Instructions for use.

Should not be prescribed to patients with chronic alcoholism. The medicinal product contains sugar syrup, which should be taken into account in patients with diabetes mellitus.

Use during pregnancy or breastfeeding.

Do not use during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

Since the product contains ethanol, it is not recommended for use in individuals whose work requires increased attention (e.g., drivers, machine operators).

Dosage and Administration.

The drug should be taken 30 minutes before meals.

For adults: 30 ml (2 tablespoons) 2–3 times daily; it is advisable to dilute the drug in 1/3–1/4 of a glass of boiled water.

Maximum daily dose – 90 ml.

Duration of treatment depends on the nature of the disease, its manifestations, concomitant basic therapy, and the therapeutic effect achieved, and ranges from 7 to 15 days.

Repeated treatment courses may be conducted with a 14-day interval between them.

Children.

The drug should not be used in children.

Overdose.

In cases of poisoning, including those caused by drug overdose, enterosorbent suspensions and symptomatic therapy are prescribed.

Overdose and prolonged use may cause a bitter taste in the mouth and discomfort in the liver area.

Side effects.

Cholestasis; in individual cases, there may be an increased individual sensitivity to the drug in general and to its separate ingredients, manifested by dyspeptic symptoms and allergic reactions, including hyperemia, rashes, itching, skin swelling, increased blood pressure, and photosensitizing effect, which requires discontinuation of the drug and consultation with a physician.

Shelf life. 2 years.

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

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

100 ml in jars, 500 ml in bottles.

Prescription status.

100 ml in jars – over-the-counter.

500 ml in bottles – prescription only.

Manufacturer.

Private Joint-Stock Company "Biolyk".

Manufacturer's address and location of business activity.

131, Nezalezhnosti St., Ladizhin, Vinnytsia region, 24321, Ukraine.