Holosas

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT KHOLOSAS

Composition:

Active substance: liquid rosehip extract;

1 g of syrup (corresponding to 0.7 mL) contains liquid rosehip extract (Fructus Rosae) (1:0.7) (extraction solvent: purified water) with acidity not less than 3.5 % expressed in terms of malic acid – 0.4 g;

Excipient: sugar.

Pharmaceutical form. Syrup.

Main physicochemical characteristics: viscous syrup-like liquid of dark brown color with a specific odor.

Pharmacotherapeutic group.

Agents used in biliary pathology. ATC code A05AX.

Pharmacological properties.

Pharmacodynamics.

The action of the medicinal product Cholosas is associated with the effect of the complex of components contained in rosehip fruits, including vitamins B1, B2, C, E, K, PP, provitamin A, sugars – 14–16 %, malic and citric acids, flavonoids, pectins – 25 %, essential oils, dextrin, vanillin, lecithin, salts of K, Ca, Fe, Mg.

Cholosas enhances hepatic functional capacity, increases bile secretion, raises the concentration of bile salts in bile, and reduces bile viscosity. The choleretic effect of the drug is due to the presence of flavonoids. Rosehip extract also affects other body functions: it normalizes and stimulates gastric gland secretion, enhances enzymatic activity of gastric juice, and enhances intestinal peristalsis in cases of intestinal atony. It also promotes anti-inflammatory action due to the content of ascorbic acid (vitamin C).

Due to the presence of organic acids and pectins in rosehip fruits, Cholosas exhibits a diuretic effect.

Organic acids contained in the medicinal product Cholosas (malic, citric) stimulate salivary gland activity, influence bile and pancreatic juice secretion, improve appetite and digestion, and help reduce putrefactive processes in the body.

Ascorbic acid in rosehip extract exhibits anti-atherosclerotic and anti-inflammatory effects, activates enzyme systems and redox processes in the body, positively influences carbohydrate metabolism, enhances tissue regeneration, and increases the body's resistance to adverse environmental factors.

Clinical characteristics.

Indications.

As an adjunct in chronic non-calculous cholecystitis, cholangitis, chronic hepatitis; in vitamin C and vitamin P deficiencies; in drug- and alcohol-induced intoxications.

Contraindications.

Hypersensitivity to the components of the drug. Biliary tract obstruction, calculous cholecystitis, thrombophlebitis and predisposition to it, circulatory insufficiency, endocarditis, decompensated diabetes mellitus, severe kidney diseases.

Interaction with other medicinal products and other forms of interactions.

Does not require exclusion of other medicinal products from the comprehensive treatment regimen.
In case of biliary tract spasms, spasmolytic and atropine-like agents are indicated. In acute inflammatory processes of the biliary tract and gallbladder, concomitant use with antimicrobial agents is recommended.

If simultaneous use with any other medicinal products is necessary, consult a physician.

Special precautions for use

Use with caution in patients with diabetes mellitus (the preparation contains sugar), as well as in patients predisposed to thrombosis and development of allergic reactions.

If a patient has an intolerance to certain sugars, he or she should consult a physician before taking this medicinal product.

Use during pregnancy or breastfeeding

Use with caution during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery

No special warnings required.

Method of administration and dosage.

Take Holosas orally, 30 minutes before meals. For adults and children aged 14 years and older: 5 ml (1 teaspoon) 2–3 times daily. For children aged 3 to 6 years: 1.25 ml (\frac{1}{4} teaspoon) 2–3 times daily; for children aged 6 to 14 years: 2.5 ml (\frac{1}{2} teaspoon) 2–3 times daily.

The dose should be measured using a teaspoon or a measuring spoon.

The medication should be administered to children only as prescribed by a physician.

Duration of treatment is determined individually by a physician and depends on the nature and severity of the disease as well as concomitant therapy.

Children.

Do not administer the medication to children under 3 years of age. For children aged 3 years and older, the medication should be used only as directed by a physician.

Overdose.

Prolonged use of the medication may provoke the development of non-infectious jaundice.

Side effects.

Allergic reactions are possible, including hyperemia, rash, itching, skin swelling, and burning sensation. If any unusual reactions occur, discontinue use of the product and consult a physician.

Shelf life. 3 years.

Do not use the product 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.

130 g in jars in cartons; 130 g or 250 g in bottles in cartons.

130 g in jars in cartons with a measuring spoon; 130 g or 250 g in bottles in cartons with a measuring spoon.

130 g in jars without carton; 130 g or 250 g in bottles without carton.

Prescription status.

Over-the-counter.

Manufacturer.

JSC «VITAMINS».

Manufacturer's name and address of place of business.

Ukraine, 20300, Cherkasy region, Uman, Usypenska St., 31.