Cough syrup dr. theiss with ivy extract

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DR. THEISS COUGH SYRUP WITH IVY EXTRACT

Composition:

Active substance: dry extract of ivy leaves (Hedera helix L. folium);

100 ml of syrup contain 154 mg of dry extract of ivy leaves (Hedera helix L. folium) (4–8:1), extraction solvent: ethanol 30% (m/m);

Excipients: potassium sorbate, hydroxyethylcellulose, blackcurrant flavor, maltitol liquid, anhydrous citric acid, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: brownish-yellow, slightly turbid solution with a characteristic blackcurrant odor.

Pharmacotherapeutic group. Medicinal products used for cough and common cold. Expectorants. ATC code R05C A12.

Pharmacological properties.

Pharmacodynamics.

"Dr. Theiss Cough Syrup with Ivy Extract" is a herbal preparation containing glycosidic saponins, which provide antitussive, expectorant, spasmolytic, and antimicrobial effects. It reduces sputum viscosity and facilitates its expulsion. The mechanism of action is unknown.

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Clinical characteristics.

Indications.

Used as an expectorant in productive cough.

Contraindications.

Hypersensitivity to the active substance, plants of the Araliaceae family, or to any of the excipients.

Children under 2 years of age (due to the general risk of worsening respiratory symptoms when taking secretolytic agents).

Interaction with other medicinal products and other forms of interaction.

There have been no reports of "Dr. Theiss Cough Syrup with Ivy Extract" affecting the efficacy of other medicinal products. Interaction studies have not been conducted.

Special precautions for use.

Prolonged or recurrent cough in children aged 2 to 4 years requires medical diagnosis prior to treatment.

If shortness of breath, fever, or purulent sputum occurs, consult a physician.

Concomitant use of opioid cough suppressants such as codeine or dextromethorphan is not recommended without medical advice.

Caution is advised for patients with gastritis or peptic ulcer disease.

"Dr. Theiss Cough Syrup with Ivy Extract" contains liquid maltitol. This medicinal product should not be used by patients with rare hereditary fructose intolerance. 10 ml of syrup contain approximately 4 g of liquid maltitol, corresponding to about 0.3 bread units. This should be taken into account by people suffering from diabetes mellitus. The energy value of 1 g of maltitol is 2.3 kcal. Liquid maltitol 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.

Ability to affect reaction speed when driving or operating machinery.

There have been no reports regarding the effect of this medicine on the ability to drive or operate machinery.

Dosage and Administration

For adults and children aged 12 years and older: take orally 15 ml three times a day (corresponding to a daily dose of 69.30 mg of dried ivy leaf extract); for children aged 6 to 12 years: 15 ml twice daily (corresponding to a daily dose of 46.20 mg of dried ivy leaf extract); for children aged 2 to 6 years: 10 ml twice daily (corresponding to a daily dose of 30.80 mg of dried ivy leaf extract).

For accurate dosing, use the measuring cup provided.

Due to lack of data in patients with renal and/or hepatic impairment, dosage recommendations cannot be provided. Consult a physician before taking "Dr. Theiss Ivy Cough Syrup".

"Dr. Theiss Ivy Cough Syrup" should be taken undiluted, independent of food intake. It is recommended to drink plenty of fluids or warm, non-caffeinated beverages throughout the day during treatment.

Duration of use. If symptoms persist for longer than one week of using this product, consult a physician.

Children

Do not use in children under 2 years of age.

Overdose

Ingestion of doses exceeding the recommended amounts may cause nausea, vomiting, diarrhea, or nervous agitation. Treatment is symptomatic. One case of accidental ingestion of 1.8 g of ivy leaves (equivalent to 195 ml of "Dr. Theiss Ivy Cough Syrup") in a 4-year-old child has been reported, followed by aggression and diarrhea.

Side effects

Gastrointestinal disorders (nausea, vomiting, diarrhea) have been reported. The frequency of these reactions is unknown.

Allergic reactions (urticaria, skin rash, dyspnea, anaphylactic reaction) have been reported. The frequency is unknown.

If any other adverse reactions occur that are not mentioned above, consult a physician.

Shelf life. 3 years.

Shelf life after first opening of the bottle – 6 weeks.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºC.

Keep out of reach of children.

Packaging.

100 ml or 250 ml of syrup in a glass bottle; 1 bottle with a polypropylene measuring cup in a cardboard box.

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

Manufacturer.

Dr. Theiss Naturwaren GmbH.

Manufacturer's address.

Michelinstrasse 10, 66424 Homburg, Germany.