HOLOSAS - TERNOPHARM

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HOLOSAZ-THERNOPHARM

Composition:

Active substance: liquid extract of rosehip fruits;

1 g of syrup contains 0.4 g of liquid extract of rosehip fruits (Rosae fructus extractum fluidum) (1:0.7) (extraction solvent – purified water);

Excipient: confectionery sugar.

Pharmaceutical form. Syrup.

Main physico-chemical characteristics: thick, syrup-like dark brown liquid with a characteristic odor.

Pharmacotherapeutic group.

Agents used in biliary tract disorders. ATC code A05AX.

Pharmacological properties.

Pharmacodynamics.

The effect of the medicinal product Cholosas-Ternofarm is associated with the action 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, and salts of K, Ca, Fe, Mg.

Cholosas-Ternofarm enhances hepatic functional capacity, increases bile secretion, raises bile cholate content, and reduces bile viscosity. The choleretic effect of the drug is due to the presence of flavonoids. The rosehip extract contained in Cholosas-Ternofarm also affects other body functions: it normalizes and stimulates gastric gland secretion, enhances enzymatic activity of gastric juice, and improves intestinal peristalsis in cases of intestinal atony. It also contributes to 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-Ternofarm exhibits diuretic action.

Organic acids contained in the medicinal product Cholosas-Ternofarm (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 from the rosehip extract in Cholosas-Ternofarm demonstrates anti-atherosclerotic and anti-inflammatory effects, activates enzyme systems and redox processes in the body, positively affects carbohydrate metabolism, enhances tissue regeneration, and increases the body's resistance to adverse environmental factors.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

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

Contraindications.

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

Interaction with other medicinal products and other types 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, use concomitantly with antimicrobial agents.

If simultaneous use of 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/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.

Method of Administration and Dosage.

Take Holosas-Ternofarm 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 medication should be used in children only as prescribed by a physician.

Duration of treatment is determined individually by a physician.

Children.

Do not use the medication in 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 adverse reactions occur, discontinue use of the product and consult a physician.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

130 g or 250 g in a bottle No. 1; 1 bottle with a measuring spoon in a carton.

Availability.

Over-the-counter (without prescription).

Manufacturer/Marketing authorization holder.

LLC "Ternopharm".

Manufacturer's address and location of its business activities / Marketing authorization holder's address.

LLC "Ternopharm".

46010, Ternopil, Fabrychna St., 4, Ukraine.

Tel./fax: (0352) 521-444, www.ternopharm.com.ua