GEDELIX® COUGH SYRUP

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEDYLIKâ COUGH SYRUP

Composition:

Active substance: ivy leaf extract, dry;

5 ml of syrup contain ivy leaf dry extract (Hedera helix L., folii extractum spissum) (2.2 – 2.9:1) 0.04 g; (extraction solvent: ethanol* 50% (v/v): propylene glycol 98:2 (m/m));

*The final product does not contain ethanol;

Excipients: macrogol glycerol hydroxystearate; star anise oil; hydroxyethylcellulose; sorbitol solution 70%, non-crystallizing (E 420); propylene glycol; glycerol; purified water.

Pharmaceutical form. Syrup.

Main physico-chemical characteristics: viscous liquid ranging from yellow to yellowish-brown in color with a characteristic odor.

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

Pharmacological properties.

Pharmacodynamics.

Hedelixâ Cough Syrup is a herbal medicinal product containing the active ingredient: ivy leaf dry extract. The 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 be due to irritation of the gastric mucosa, leading to reflex stimulation of bronchial secretory glands in 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, argininosuccinate synthetase deficiency (disorder of metabolism in the urea cycle). The medicinal product should not be used in hereditary fructose intolerance.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions for use

Since Gedelix® Cough Syrup does not contain ethanol or sugar, it can be used in patients with diabetes mellitus.

Gedelix® Cough Syrup is suitable for use in patients with diabetes mellitus: 5 ml of syrup contain 1.75 g of sorbitol (equivalent to 0.44 g of fructose), which corresponds to approximately 0.15 carbohydrate exchange units (CEU). One CEU corresponds to a quantity of food products containing 12 g of carbohydrates.

Sorbitol may cause a mild laxative effect. Macrogol glycerol hydroxystearate may cause gastrointestinal disturbances and diarrhea.

Concomitant use with other antitussive agents such as codeine or dextromethorphan is not recommended without prior medical consultation. Use with caution in patients with gastritis or peptic ulcer.

Use in children aged 2–4 years requires medical recommendation. Prolonged or recurrent cough in children aged 2–4 years requires medical diagnosis prior to treatment. If there is no improvement in the patient's condition, or if symptoms persist for more than a week, or if dyspnea, fever, chills, or purulent sputum upon coughing occur, immediate medical consultation is required.

Use during pregnancy or breastfeeding

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

Ability to influence reaction speed when driving or operating machinery

There are no studies on the effect of this medicinal product on the ability to drive or operate machinery.

Dosage and Administration.

Gedelixâ Cough Syrup should be taken undiluted, regardless of food intake, with sufficient fluid (preferably water).

The duration of treatment depends on the type and severity of the disease. However, even in mild respiratory tract diseases, treatment with the medicinal product should last at least one week. After disappearance of disease symptoms, treatment should be continued for another 2–3 days.

The duration of using the medicinal product without consulting a physician should not exceed several days.

Below is the dosage of Gedelixâ Cough Syrup for different age groups.

The packaging of the medicinal product Hedelixâ Cough Syrup contains a measuring spoon with a capacity of 5 ml, which has markings at 1/4, 1/2, and 3/4, corresponding to 1.25 ml, 2.5 ml, and 3.75 ml, respectively.

Children.

The medicinal product is contraindicated in children under 2 years of age due to the risk of worsening respiratory symptoms.

Overdose.

Symptoms: ingestion of doses exceeding the recommended amounts may cause nausea, vomiting, diarrhea, gastroenteritis, and anxious agitation.

Treatment: symptomatic.

Adverse reactions.

The frequency of occurrence of the adverse reactions listed below is defined as follows:

very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1,000, < 1/100); rare (> 1/10,000, < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).

Immune system.

Not known: allergic reactions (mainly rash and others), including anaphylactic reactions such as dyspnea, angioedema, exanthema, urticaria, pruritus, skin reactions (skin rash), couperosis.

Gastrointestinal tract.

Not known: gastrointestinal disorders, including nausea, vomiting, diarrhea, abdominal pain, may occur in patients with increased sensitivity.

If any other adverse reactions not mentioned above occur, a physician should be consulted.

Shelf life. 3 years.

Shelf life after first opening of the container – 6 months.

During storage, sediment may form, which causes turbidity upon shaking.

Storage conditions.

Store at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging.

100 ml in a bottle; 1 bottle with a measuring spoon in a cardboard box.

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

Manufacturer.

Krewel Meuselbach GmbH.

Manufacturer's address and place of business.

Krewelstrasse 2, 53783 Eitorf, Germany.