COUGH SYRUP DR. THEISS

INSTRUCTIONS FOR MEDICAL USE OF DR. THEISS COUGH SYRUP

Composition:

Active substance: liquid extract of ribwort plantain (Plantaginis lanceolatae folium);

100 g of syrup contains 5 g of liquid extract of ribwort plantain (Plantaginis lanceolatae folium) (1:1), extractant: ethanol 20% (m/m);

(5 ml of syrup contains 0.32 g of liquid extract of ribwort plantain (1:1));

Excipients: beet sugar syrup, honey, potassium sorbate, peppermint oil, invert sugar syrup, purified water.

Pharmaceutical form. Syrup.

Main physicochemical characteristics: viscous, dark brown liquid with a pleasant odour, sweet to taste.

Pharmacotherapeutic group. Expectorants. ATC code R05C A.

Pharmacological Properties.

Pharmacodynamics.

The main active ingredients of Plantago lanceolata are mucilage, iridoid glycosides (aucubin, catalpol), phenolic acids (chlorogenic acid) and their glycosides (verbascoside), saponins, flavonoids, and tannins. Due to these components, Plantago lanceolata possesses anti-inflammatory, secretolytic, and antibacterial properties. It liquefies mucus and promotes expectoration.

Pharmacokinetics.

Pharmacokinetic studies have not been conducted.

Clinical characteristics.

Indications.

Symptomatic treatment of cough in infectious-inflammatory diseases of the respiratory tract.

Contraindications.

Hypersensitivity to ribwort plantain (Plantago lanceolata) or to plants of the plantain family (Plantaginaceae), or to any of the excipients.

Interaction with other medicinal products and other forms of interaction.

Do not use simultaneously with antitussive agents and medicinal products that reduce sputum secretion.

Special precautions for use.

If shortness of breath, fever, or purulent sputum occurs during the use of this medicinal product, consult a physician.

This medicinal product contains 1.62% v/v ethanol, i.e. 190 mg/dose (15 ml), equivalent to 4.8 ml of beer or 2 ml of wine per dose. It is harmful for patients suffering from alcoholism. Caution should be exercised when used during pregnancy and breastfeeding, in children, patients with liver disorders, and in patients with epilepsy.

If you have known intolerance to certain sugars, consult your doctor before taking this medicinal product. The product contains 2.8 g of glucose, 2.7 g of fructose, and 4.3 g of sucrose per dose (15 ml). Use with caution in patients with diabetes mellitus. The product should not be taken by patients with rare hereditary forms of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

May be harmful to teeth.

Use with caution in patients suffering from hyperacidic gastritis, peptic ulcer disease with increased acidity, or reflux esophagitis.

Use during pregnancy or breastfeeding.

The safety of use during pregnancy or breastfeeding has not been established. Due to lack of sufficient data, this medicinal product should not be used during pregnancy or breastfeeding.

Ability to influence reaction speed when driving vehicles or operating machinery.

Studies on the influence on the ability to drive vehicles or operate machinery have not been conducted.

Method of Administration and Dosage.

Take the medication every 2–3 hours with equal intervals between doses (5–7 times daily): for children aged 2 to 6 years – 2.5 ml, for children aged 6 to 12 years – 5 ml, for adults and children aged 12 years and older – 15 ml. A measuring cup should be used for accurate dosing.

The duration of treatment is determined individually by a physician and averages 5–7 days. If the patient's condition does not improve during the treatment period, medical advice should be sought.

Children.

Do not use in children under 2 years of age.

Overdose.

Cases of overdose have not been reported.

In case of overdose, for example, accidental ingestion of the entire contents of the bottle, gastrointestinal disturbances may occur.

Side effects.

Allergic reactions (including hyperemia, rash, itching, skin swelling), heartburn, diarrhea.

If any adverse reactions occur, discontinue use of the product and consult a physician immediately.

Shelf life. 3 years.

Shelf life after opening the bottle – 3 months.

Storage conditions.

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

Keep out of reach of children.

Packaging.

50 ml, or 100 ml, or 250 ml in a bottle; 1 bottle with a polypropylene measuring cup in a cardboard box.

Supply category. Over-the-counter.

Manufacturer/Applicant.

Dr. Theiss Naturwaren GmbH.

Manufacturer's address and place of business.

Michelinstrasse 10, 66424 Homburg, Germany.