Gederin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GEDERIN

Composition:

Active ingredient: dry ivy leaf extract;

1 capsule contains dry ivy leaf extract (Hedera helix L., folium extractum siccum) [(4–8) : 1] (extraction solvent – ethanol 30%) with a hedercoside C content of 14% – 52.5 mg;

Excipients: microcrystalline cellulose, lactose monohydrate, magnesium stearate.

Composition of hard gelatin capsule: gelatin, titanium dioxide (E 171), iron oxide (E 172), indigotine (E 132), patent blue V (E 131).

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules of greenish color with green caps, containing a powder ranging from light brown to dark brown in color with visible dark particles.

Pharmacotherapeutic group.

Medicinal products used for cough and colds. Expectorants.

ATC code R05C A12.

Pharmacological properties.

Pharmacodynamics.

A medicinal product of plant origin. It contains a dry extract of ivy leaves, which exerts antitussive, expectorant, spasmolytic, anti-inflammatory, and antimicrobial effects, due to the presence of glycosides (saponins). It 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 any component of the medicinal product or to other plants of the Araliaceae family.

Interaction with other medicinal products and other forms of interaction.

No adverse effects of the drug have been observed when used concomitantly with other medicinal products. Therefore, the drug can be used with other medicinal products, for example, antibiotics.

Special precautions for use

If disease symptoms do not resolve, or if dyspnea, fever, purulent sputum, or hemoptysis develops, immediate medical advice should be sought. Concomitant use with antitussive agents, such as codeine or dextromethorphan, is not recommended. Use with caution in patients with gastritis or peptic ulcer disease.

The medicinal product contains lactose; therefore, if the patient has been diagnosed with a sugar intolerance, medical advice should be sought before taking this medicinal product.

Use during pregnancy or breastfeeding

Due to insufficient data, use of the 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 2–3 times daily. The duration of treatment is determined individually by a physician and depends on the severity and course of the disease. 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 there is no improvement in the patient's condition, consult a physician for further treatment.

Children.

The medicinal product is not administered to children under 12 years of age.

Overdose.

Ingestion of doses exceeding the recommended amount may cause nausea, vomiting, diarrhea, or excitement. Treatment is symptomatic.

Side effects.

In patients with increased sensitivity, the following may occur: allergic reactions (mainly rash), including dyspnea, mucosal edema, urticaria, pruritus, telangiectasia; gastrointestinal disturbances, including nausea, vomiting, diarrhea, abdominal pain. If any adverse reactions occur, treatment should be discontinued and medical advice should be sought.

Shelf life. 3 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 pack, 2 or 3 blisters per box.

Supply category. Over-the-counter.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity.

4, Korolyova St., v. Stanishivka, Zhytomyr district, Zhytomyr region, 12430, Ukraine.