Doctor Theiss Anis oil (Capsules) Instructions for Use

Marketing Authorization Holder

Dr. Theiss Naturwaren GmbH (Germany)

ATC Code

R05CA10 (Expectorants in combination)

Active Substance

Anis oil (BP British Pharmacopoeia)

Dosage Form

Doctor Theiss Anis oil

Capsules 100 mg: 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Capsules are soft gelatin, size No. 5, transparent, dark green in color, oval in shape; the capsule contents are a slightly yellowish liquid with an anise odor.

Excipients: rapeseed oil – 170 mg.

Shell composition: gelatin – 89.06 mg, glycerol 85% – 37.64 mg, colorant (sodium copper chlorophyllin, E141) – 0.2 mg, water – 8.1 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with expectorant effect

Pharmacotherapeutic Group

Herbal expectorant

Pharmacological Action

A herbal remedy that has an expectorant, anti-inflammatory, laxative, and antispasmodic effect.

It stimulates the reticuloendothelial system, enhances phagocytosis, improves tissue respiration, and the motor activity of the ciliated epithelium of the respiratory tract.

It causes the death of microorganisms. It has deodorizing properties.

Indications

• Inflammatory diseases of the respiratory tract, accompanied by cough and difficult sputum discharge, as part of combination therapy.

Use for symptomatic relief of cough with difficult-to-expel mucus associated with conditions such as acute and chronic bronchitis, laryngitis, and tracheitis.

Employ as an adjunctive treatment to support standard mucolytic and expectorant regimens for respiratory inflammation.

ICD codes

Dosage Regimen

Administer orally. Swallow the capsules whole with a sufficient amount of liquid, such as a glass of water. Do not chew.

Adhere to the standard dosage for adults and children over 12 years: take one 100 mg capsule three times daily.

Adjust the frequency and duration of administration based on the clinical response and severity of symptoms. Do not exceed the recommended daily dose.

Adverse Reactions

Monitor for allergic reactions, which may include skin rash, pruritus, urticaria, or angioedema.

Observe for gastrointestinal disturbances such as nausea or abdominal discomfort. Discontinue use immediately upon the appearance of any hypersensitivity reactions.

Report any severe or persistent adverse effects to a healthcare professional.

Drug Interactions

Exercise caution with concurrent use of cough suppressants (antitussives), as this may counteract the expectorant effect and lead to secretion retention.

Be aware of potential interactions with other herbal products possessing estrogenic activity. No other specific, well-documented drug interactions are currently known.

Inform your physician about all concomitant medications, including over-the-counter products and herbal supplements.

Contraindications

• Hypersensitivity to the active substance (anis oil) or to any of the excipients listed in the composition.
• Known allergy to plants of the Apiaceae family (e.g., fennel, caraway, coriander, dill).

Do not use in cases of preexisting gastrointestinal inflammation or obstruction due to the potential for spasmolytic and secretory effects.

Avoid use in patients with a history of hormone-sensitive conditions due to the potential estrogenic activity of anethole, a key component of anis oil.

Overdose

Symptoms of overdose may include gastrointestinal irritation, nausea, vomiting, diarrhea, and seizures due to the neurotoxic potential of anethole in high doses.

In case of suspected overdose, discontinue the medication immediately and initiate symptomatic and supportive treatment.

Gastric lavage and administration of activated charcoal may be considered if ingestion was recent. Seek immediate medical attention and consult a poison control center.

Special Precautions

Used as part of combination preparations with mucolytic and expectorant agents.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.