Gedelix® drops without alcohol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GEDelix® SPIRIT-FREE DROPS

Composition:

Active ingredient: ivy leaf dry extract;

1 ml (31 drops) of solution contains ivy leaf dry extract (Hederae helicis folii extractum spissum) (2.2 – 2.9:1) 0.04 g;

Excipients: propylene glycol, glycerol, star anise oil, eucalyptus oil, menthol, peppermint oil.

Pharmaceutical form. Oral drops, solution.

Main physicochemical characteristics: clear greenish-brown viscous solution with an aromatic odor.

Pharmacotherapeutic group. Preparations used for cough and colds. ATC code R05C A12.

Pharmacological properties.

Pharmacodynamics.

Hedelix® alcohol-free drops – a herbal medicinal product containing the active substance ivy leaf dry extract, whose therapeutic effect in inflammatory respiratory tract diseases is based on the secretolytic, mucolytic and spasmolytic actions of glycosidic saponins present in ivy leaves.

The therapeutic effect is presumed to result from irritation of the gastric mucosa, leading to reflex stimulation of bronchial secretory glands of the bronchial mucosa via sensory fibers of the parasympathetic system.

Pharmacokinetics.

No data available from conducted studies.

Clinical characteristics.

Indications.

Symptomatic treatment of cough associated with respiratory tract colds and 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 risk of worsening respiratory symptoms, bronchial asthma and other respiratory tract diseases associated with marked airway sensitivity, argininosuccinate synthetase deficiency (a metabolic disorder in the urea cycle).

Predisposition to laryngospasm.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions for use

If there is no improvement in the patient's condition, symptoms persist for a prolonged period (more than 4–5 days), or if attacks of suffocation occur, purulent sputum or sputum with blood is produced, or body temperature rises, medical advice should be sought immediately.

Since Gedelex® alcohol-free drops do not contain ethanol or sugar, they can be used in patients with diabetes mellitus.

If there is no improvement in the patient's condition, or if dyspnea, purulent sputum, or elevated body temperature occur, a physician should be consulted.

Use in children aged 2–4 years should be under medical recommendation. Concurrent use with antitussive agents (e.g., codeine or dextromethorphan) without consulting a physician is not recommended. Use with caution in patients with gastritis or peptic ulcer.

Use during pregnancy or breastfeeding

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

Ability to influence reaction rate while driving or operating machinery

It is assumed that the medicinal product does not affect the ability to drive or operate machinery.

Method of administration and dosage.

Gedelix® alcohol-free drops should be taken undiluted, regardless of food intake, washed down with an adequate amount of water.

For children, it is recommended to administer the medicine diluted in fruit juice or tea.

The duration of treatment depends on the type and severity of the disease; however, even in mild respiratory tract diseases, the treatment should last for at least one week. After the symptoms have disappeared, treatment should be continued for another 2–3 days.

The duration of using the medicine without consulting a doctor should not exceed several days.

Below is a table of dosage recommendations for different age groups.

Children

Contraindicated in children under 2 years of age due to the risk of worsening respiratory symptoms.

Overdose.

Symptoms: nausea, vomiting, diarrhea, gastroenteritis, and excitement may occur.

Treatment: symptomatic.

Side effects.

Immune system.

Allergic reactions (mainly rash), including dyspnea, mucosal edema, angioedema; exanthema and urticaria, pruritus, skin reactions (skin rash), couperosis.

Gastrointestinal tract.

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

Shelf life. 5 years.

Shelf life after opening the bottle – 6 months.

Formation of sediment and turbidity of the preparation, which may occur during storage within the shelf life, does not reduce the activity of the preparation and is not a hindrance to its use.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging.

Dropper bottle of 50 ml, 1 dropper bottle in a cardboard box.

Availability category. Over-the-counter.

Manufacturer.

Krewel Meuselbach GmbH.

Manufacturer's address and place of business.

Krewelstrasse 2, 53783 Eitorf, Germany.