Ivitucin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IVITUSIN (IVITUSIN)

Composition:

Active substance: dry extract of ivy leaves;

1 ml of syrup contains 7 mg of dry extract of ivy leaves (Hedera helix L.) (4–8:1), extraction solvent: ethanol 30%;

Excipients: potassium sorbate; citric acid monohydrate; xanthan gum; sorbitol (E 420); food flavoring, cherry; purified water;

2.5 ml of syrup contains 0.963 g of the sugar substitute sorbitol = 0.08 bread unit.

Pharmaceutical form. Syrup.

Main physicochemical properties: clear light-brown liquid with a cherry odor and sweet fruity taste. During storage, opalescence may occur.

Pharmacotherapeutic group. Medicinal products used for cough and colds. Expectorants. ATC code R05CA.

Pharmacological Properties

Pharmacodynamics

A plant-derived medicinal product containing glycosidic saponins, which provide antitussive, expectorant, spasmolytic, and antimicrobial effects. Reduces sputum viscosity and facilitates its expulsion.

Pharmacokinetics

No data available.

Clinical characteristics.

Indications.

Use as an expectorant in productive cough.

Contraindications.

Hypersensitivity to the active substance, to plants of the Araliaceae family, or to any other component of the medicinal product. Fructose intolerance.

Age under 2 years — due to the general risk of worsening respiratory symptoms when taking secretolytic agents.

Interaction with other medicinal products and other forms of interaction.

No adverse effects have been observed when used concomitantly with other medicinal products. Therefore, it can be used together with other drugs, such as antibiotics.

Special precautions for use.

Prolonged or recurrent cough in children under 4 years of age requires medical diagnosis before treatment.

If disease symptoms persist or if dyspnea, fever, chills, or purulent or bloody sputum upon coughing appear, immediate medical consultation is necessary.

Concomitant use of opioid cough suppressants, such as codeine or dextromethorphan, is not recommended without medical advice.

Use with caution in patients with gastritis or peptic ulcer disease.

Contains sorbitol. Patients with rare hereditary fructose intolerance should not take this medicinal product. If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product.

Use during pregnancy or breastfeeding.

Due to lack of study data, this medicinal product should not be used during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

This medicinal product does not affect reaction speed when driving or operating machinery.

Method of Administration and Dosage.

Dosage.

Adults, including elderly patients, and children aged 12 years and older — 5 ml three times daily.

Children aged 6–12 years — 5 ml twice daily.

Children aged 2 to 6 years — 2.5 ml twice daily.

Method of Administration.

For oral administration using the dosing spoon provided.

The syrup must be shaken well before each use!

The medicinal product should be taken in the morning, during the day, and in the evening, regardless of food intake.

It is recommended to drink plenty of water or warm non-caffeinated beverages throughout the day during treatment.

Duration of Treatment.

The duration of treatment is determined individually by a physician. In uncomplicated cases, the treatment course lasts 1 week. To achieve a sustained therapeutic effect, treatment is recommended to be continued for an additional 2–3 days after the patient's condition improves.

If the patient's condition does not improve, consult a physician for further management.

Children. Do not use in children under 2 years of age.

Overdose.

Ingestion of doses exceeding the recommended amounts may cause nausea, vomiting, diarrhea, or nervous agitation. Treatment is symptomatic.

Side effects

Very rare (less than 1 case in 10,000) diarrheal effect may occur (due to sorbitol content).

Very rare (less than 1 case in 10,000) allergic reactions may occur: dyspnea, mucosal edema, skin rash, urticaria, itching.

In patients with increased sensitivity, gastrointestinal disturbances may occur, including nausea, vomiting, diarrhea, abdominal pain.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions.

Shelf life. 2 years.

Storage conditions

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

Keep out of reach of children.

During storage, slight opalescence may occur, which does not affect the therapeutic properties of the medicinal product.

After first opening of the packaging, the shelf life of the medicinal product is 3 months at a temperature not exceeding 25 °C.

Packaging

100 ml or 200 ml of syrup in a polymer bottle, 1 bottle with a dosing spoon in a carton.

100 ml of syrup in a jar, 1 jar with a dosing spoon in a carton.

Prescription status Over-the-counter.

Manufacturer

Public joint-stock company "Scientific and Production Center "Borshchahivskiy Chemical and Pharmaceutical Plant".

Manufacturer's address and place of business

17 Myru Street, Kyiv, 03134, Ukraine.