Ritossе® ivy

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Ritosse® Ivy (Ritosse Ivy)

Composition:

Active substance: extract of leaves of common ivy;

1 ml of syrup contains 7 mg of dry extract of common ivy leaves (Extr. Hederae helicis e folium spir. sicc. ((4–8):1), (extraction solvent: ethanol 30%);

Excipients: potassium sorbate; citric acid monohydrate; non-crystallizing liquid sorbitol; xanthan gum; purified water;

1 ml of syrup contains 550 mg of sugar substitute sorbitol, corresponding to 0.04 bread units.

Pharmaceutical form. Syrup.

Main physicochemical properties: light brown, slightly cloudy, viscous liquid with a specific odor. Presence of sediment is permissible.

Pharmacotherapeutic group. Agents used for cough and colds. Expectorants. ATC code R05CA12.

Pharmacological Properties

Pharmacodynamics

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

Pharmacokinetics

Not studied.

Clinical characteristics

Indications

Acute inflammatory diseases of the respiratory tract accompanied by cough.

Chronic inflammatory diseases of the bronchi — symptomatic treatment.

Contraindications

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

The medicinal product is not recommended for children under 2 years of age due to the risk of worsening respiratory symptoms.

Interaction with other medicinal products and other forms of interaction

Concomitant use with antitussive medicinal products, for example codeine or dextromethorphan, is not recommended without consulting a physician.

No adverse interactions of Hedera helix syrup Ritosse**®** Plus have been observed when used concomitantly with other medicinal products. Therefore, this medicinal product can be used together with other medicinal products, such as antibiotics.

Special precautions for use

Prolonged or recurrent cough in children requires medical diagnosis prior to treatment. If symptoms persist or if dyspnea, fever, chills, or purulent or bloody sputum upon coughing occur, immediate medical advice should be sought.

Concomitant use with antitussive medicinal products, such as codeine or dextromethorphan, is not recommended without consulting a physician.

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

Important information about excipients

This medicinal product contains potassium compounds. Caution is advised when administering to patients with impaired renal function or those on a low-potassium diet.

Ritossе® Ivy syrup contains sorbitol. If the patient has been diagnosed with intolerance to certain sugars, consult a physician before taking this medicinal product.

Use during pregnancy or breastfeeding

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

Ability to affect reaction speed when driving or operating machinery

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

Method of Administration and Dosage

Ritossé® Ivy, syrup, should be taken orally, measuring the dose using the measuring spoon provided.
Children aged 2 to 6 years: 2.5 mL twice daily.
Children aged 6 to 12 years: 5 mL twice daily.
Adults and children aged 12 years and older: 5 mL three times daily (in the morning, during the day, and in the evening).

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

The syrup must be shaken well before each use.

If no improvement in the patient's condition occurs, consult a physician for further management.

Children

Ritossé® Ivy, syrup, is used in pediatric practice. The medicinal product is not recommended for children under 2 years of age due to the risk of worsening respiratory symptoms.

Overdose

Do not exceed the recommended daily dose. Ingestion of doses exceeding the recommended amount may cause nausea, vomiting, diarrhea, or nervous excitement. Treatment is symptomatic.

Side effects

Very rare (less than 1 case in 10,000) allergic reactions are possible: shortness of breath, angioedema, skin rash, urticaria, itching.

Gastrointestinal disorders such as nausea, vomiting, diarrhea, abdominal pain, and laxative effect may occur in patients with hypersensitivity to components of the medicinal product, particularly sorbitol.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report any suspected adverse reactions and/or lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

After opening the bottle, the product may be used for up to 3 months.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

During storage, slight opalescence and minor change in taste of the syrup may occur, which does not affect the therapeutic properties of the medicinal product.

Packaging. 100 ml in a bottle, 1 bottle with a measuring spoon in a carton.

Availability category. Over-the-counter.

Manufacturer. JSC "Pharmaceutical company "Darnytsia".

Manufacturer's address and location of business activity.

13, Borysplis'ka Street, Kyiv, 02093, Ukraine.