Pectolvan® ivy

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

Composition:

Active substance: dried extract of ivy leaves;

1 capsule contains 52.5 mg of dried extract of common ivy leaves (Hederae helicis e folium) ((4–8):1) (extractant ethanol 30 %);

Excipients: microcrystalline cellulose, maltodextrin, maize starch, copovidone, magnesium stearate;

capsule shell composition: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132).

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules size № 3, capsule body and cap — dark green in color. The capsule contents — light brown powder containing small particles ranging from light to darker shades.

Pharmacotherapeutic group.

Medicinal products used in 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.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

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

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

No adverse interactions have been observed when Pectolvan® Ivy was used concomitantly with other medicinal products. Therefore, Pectolvan® Ivy may be used together with other drugs, 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 prior to treatment.

If disease symptoms persist or dyspnea, wheezing, fever, or purulent or bloody sputum upon coughing appear, immediate medical advice should be sought.

The medicinal product should be used with caution in patients with gastritis or peptic ulcer.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg/dose.

The daily dose of Pectolvan® Ivy capsules (3 capsules) contains 0.00675 XE, which should be taken into account by patients with diabetes mellitus.

Use during pregnancy or breastfeeding

Due to insufficient data, the use of this medicinal product during pregnancy or breastfeeding is not recommended.

Ability to influence reaction speed when driving or operating machinery

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

Method of Administration and Dosage.

For adults and children aged 12 years and older — 1 capsule three times daily.

The duration of treatment is determined individually by a physician, depending on the type and severity of symptoms. In mild cases, the treatment duration is 1 week. If the patient's condition does not improve after one week of treatment, consult a doctor regarding further management.

Children. The medicinal product can be used in children aged 12 years and older.

Overdose.

Do not exceed the recommended daily dose. Ingestion of doses higher than recommended may cause nausea, vomiting, diarrhea, or agitation. Treatment is symptomatic.

Side effects.

Allergic reactions may occur: shortness of breath, angioedema, skin rash, urticaria, itching. Frequency is unknown.

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

Reporting of suspected adverse reactions

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

Shelf life. 2 years.

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

Keep out of reach of children.

Packaging. 10 capsules per blister. 3 blisters per carton.

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

Manufacturer. JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.