Pectolvan® ivy

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PECTOLVAN® IVY (PECTOLVAN HEDERA HELIX)

Composition:

Active substance: dry extract of ivy leaves;

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

Excipients: sodium citrate; citric acid monohydrate; sorbitol (E 420); potassium sorbate; xanthan gum; cherry flavoring; purified water.

2.5 ml of syrup contain 963 mg of the sugar substitute sorbitol = 0.08 bread units.

Pharmaceutical form. Syrup.

Main physicochemical characteristics: clear, light brown liquid with a cherry odor and sweet fruity taste; slight opalescence may occur.

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

Pharmacological properties.

Pharmacodynamics.

A plant-derived medicinal product. Its composition includes a dry extract of ivy leaves, which exerts antitussive, expectorant, spasmolytic, anti-inflammatory, and antimicrobial effects due to the presence of glycosides (saponins).

Reduces sputum viscosity and facilitates its expulsion.

Clinical characteristics.

Indications.

Acute respiratory tract inflammatory diseases accompanied by cough; symptomatic treatment of chronic inflammatory bronchial diseases.

Contraindications.

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

No adverse interactions have been observed when used concomitantly with other drugs. Therefore, Pectolvan® Ivy can be used together with other medications, such as antibiotics. Concomitant use of cough suppressants such as codeine or dextromethorphan is not recommended without medical consultation.

Special precautions for use.

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

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

The medicinal product contains sorbitol. When used in recommended doses, the patient receives up to 1.925 g of sorbitol per dose. May have a mild laxative effect.

Use during pregnancy or breastfeeding.

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

Effect on ability to drive or operate machinery.

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

Method of administration and dosage.

Take orally, using the dosing spoon provided.

Children aged 2 to 6 years: Pectolvan® Ivy should be taken orally at 2.5 ml twice daily.
Children aged 6 to 12 years: 5 ml twice daily.
Adults and adolescents aged 12 years and older: 5 ml three times daily.

The syrup should be taken in the morning, during the day, and in the evening.

The duration of treatment is determined individually by a physician depending on the type and severity of symptoms. In uncomplicated cases, the treatment duration is 1 week.

The syrup must be shaken well before each use.

If there is no improvement in the patient's condition after one week of treatment, consult a physician for further management.

Children. The medication 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 amounts may cause nausea, vomiting, diarrhea, or anxious agitation. Treatment is symptomatic.

Side effects

Allergic reactions may occur: dyspnea, Quincke's edema (angioedema), skin rash, urticaria, pruritus. Frequency is unknown.

Gastrointestinal disturbances including nausea, vomiting, diarrhea, abdominal pain may occur in patients with hypersensitivity due to the presence of sorbitol.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after registration of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the use of this medicinal product. Medical and pharmaceutical personnel, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and 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. 2 years.

Shelf life after opening the bottle: 90 days.

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

Keep out of reach of children.

Packaging. 100 ml in a brown glass bottle. 1 bottle with a dosing spoon/doser in a carton.

Availability category. Over-the-counter (without prescription).

Manufacturer. JSC "Farmak".

Manufacturer's address and location of business activity.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.