Capsules with anise oil dr. theiss

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DR. THEISS ANISEED OIL CAPSULES

Composition:

Active substance: star anise essential oil;

1 capsule contains star anise essential oil (Anisi stellati aetheroleum) 0.1 mg;

Excipients: refined rapeseed oil, gelatin, purified water, glycerol 85%, copper complexes of chlorophyllins (E 141).

Pharmaceutical form. Capsules.

Main physicochemical characteristics: transparent soft gelatin capsules of dark green color with smooth surface and characteristic anise odor.

Pharmacotherapeutic group. Products used in cough and colds. ATC code R05C A.

Pharmacological Properties.

Pharmacodynamics.

Essential oil from anise fruits exerts expectorant, spasmolytic, and antibacterial effects.

Clinical characteristics.

Indications.

Respiratory tract infections of the upper airways accompanied by cough and viscous sputum.

Contraindications.

Hypersensitivity to star anise (oil), anise (oil), or other plants of the Umbelliferae family, anethole, or any other component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Do not use “Dr. Theiss Anise Oil Capsules” simultaneously with drugs having opposite pharmacological effects, or during treatment with hormonal medicinal products.

Special precautions for use.

Capsules should not be taken while lying down. Do not take a double dose of the medication if a previous dose has been missed.

Interruption or premature discontinuation of treatment is generally safe.

Use during pregnancy or breastfeeding.

Anise and anethole are widely used as flavoring agents, and there is no evidence indicating risk associated with their use during pregnancy or breastfeeding. However, there are no adequate experimental data on the use of this medicinal product during pregnancy or breastfeeding; therefore, the drug is not recommended for use during these periods.

Ability to affect reaction rate while driving or operating machinery.

No influence on the ability to drive or operate machinery is expected.

Dosage and Administration.

For adults and children aged 12 years and older, take orally 1 capsule 3 times daily after meals, without chewing, with plenty of fluid (preferably a full glass of water).

The duration of treatment should be determined by a physician depending on the nature and course of the disease. Do not take the medication continuously for more than 2 weeks.

If symptoms of the disease do not begin to improve within the first 3 days of treatment with this medicinal product, or if dyspnea, headache, fever, purulent/bloody sputum or nasal discharge occur, seek immediate medical advice.

Children.

Do not use in children under 12 years of age due to lack of data and because of the presence of the substance estragole.

Overdose.

Ingestion of doses exceeding the recommended amounts may intensify adverse reactions.

Ingestion of 1 to 5 ml of anise oil (corresponding to approximately 10–50 capsules) may cause nausea, vomiting, seizures, and pulmonary edema.

In cases of significant overdose, in addition to adverse reactions, increased stomach pain, nausea, and diarrhea may occur. In such cases, consult a physician immediately.

Adverse reactions.

In individuals with hypersensitivity to the drug, allergic reactions may occur, including skin rashes, itching, hyperemia, skin swelling, and bronchospasm. Gastrointestinal disturbances may also occasionally occur. The frequency of adverse reactions is not known.

If the first signs of hypersensitivity reactions of the skin or respiratory tract occur, the use of the drug should be discontinued.

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 in a blister pack. 2, 3, or 5 blisters per cardboard box.

Availability. Over-the-counter.

Manufacturer/Applicant.

Dr. Theiss Naturwaren GmbH.

Manufacturer's address and place of business.

Michelinstrasse 10, 66424 Homburg, Germany.