Hedera syrup

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PLANTAGO SYRUP (IVYSYROP)

Composition:

Active substance: dry extract of ivy leaves;

1 ml of syrup contains 7 mg of dry extract of ivy leaves (Hedera helix L.) (5–7.5 : 1) (extraction solvent – ethanol 30%);

Excipients: sorbitol, potassium sorbate, apple pectin, cherry flavor, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: light brown, slightly cloudy liquid with a sweet fruity taste and cherry odor.

Pharmacotherapeutic group. Medicinal products used for cough and colds. Expectorants. ATC code R05C A12.

Pharmacological properties.

Pharmacodynamics. A herbal medicinal product. Its composition includes a dry extract of ivy leaves, which exerts expectorant, spasmolytic, anti-inflammatory, and antimicrobial effects due to the glycosides (saponins) present in it. Reduces sputum viscosity and facilitates its expulsion.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

• Acute inflammatory diseases of the respiratory tract accompanied by cough;
• symptomatic treatment of chronic inflammatory diseases of the bronchi.

Contraindications.

Hypersensitivity to the components of the medicinal product or to other plants of the Araliaceae family. Children under 2 years of age (due to the general risk of worsening respiratory symptoms when taking secretolytic agents).

Interaction with other medicinal products and other forms of interaction.

Concomitant use with antitussive agents, such as codeine or dextromethorphan, is not recommended without prior medical consultation.

Special precautions for use.

Prolonged or recurrent cough in children aged 2 to 4 years requires medical diagnosis before treatment.

If shortness of breath, fever, or purulent sputum occurs, consult a physician.

Concomitant use of opioid antitussive agents such as codeine or dextromethorphan is not recommended without medical consultation.

Use with caution in patients with gastritis or peptic ulcer.

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.

"Pluchy 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.

Use during pregnancy or breastfeeding is not recommended due to insufficient data.

Ability to affect reaction speed when driving or operating machinery.
There have been no reports regarding the effect of this medicinal product on the ability to drive or operate machinery.

Dosage and Administration.

For children aged 2 to 6 years – 2.5 ml of syrup* (½ teaspoon) three times daily.

For children aged 6 to 10 years – 5 ml of syrup* (1 teaspoon) three times daily.

For adults and children aged 10 years and older – 5–7.5 ml of syrup* (1–1½ teaspoons) three times daily.

The syrup should be taken in the morning, during the day, and in the evening. The syrup must be shaken well before each use.

The duration of treatment is determined individually by a physician. In mild cases, treatment lasts 7 days. To achieve a sustained therapeutic effect, it is recommended to continue therapy 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 treatment.

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

* Use the measuring cup provided, if available in the package.

Children.

This medicinal product is contraindicated in children under 2 years of age due to the risk of worsening respiratory symptoms. Use in children aged 2–4 years requires medical advice.

Overdose.

Overdose may cause nausea, vomiting, diarrhea, and excitation. Treatment is symptomatic.

Side effects.

Allergic reactions (mainly rash and others), couperosis, and dyspnea may occur during use.

Gastrointestinal disorders including nausea, vomiting, diarrhea, and abdominal pain may be observed in patients with increased sensitivity.

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after medicinal product registration is an important procedure. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national pharmacovigilance system.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging. 100 ml or 200 ml in a glass or polymer bottle in a carton. A measuring cup may be included with the bottle.

Supply category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063