Fixed Combinations of Anise oil, Fennel oil, Licorice root, and Thyme

Fixed combinations consisting of:

Anise oil corresponding to B.  Anz 122, July 6, 1988;
Fennel oil corresponding to B.  Anz 74, April 19, 1991;
Licorice root corresponding to B.  Anz 90, May 15, 1985;
Thyme according to B.  Anz 228, December 5, 1984;

and their preparations in effective dosage.  

Colds and diseases of the upper respiratory tract with viscous phlegm.  

For a daily dosage up to 100 mg glycyrrhizin:

• Oversensitivity to anise and anethole.  Pregnancy.  Not to be used for infants and small children.  

For a daily dosage of more than 100 mg glycyrrhizin:

• Cholestatic liver diseases, liver cirrhosis, hypertonia, hypokalemia, severe kidney insufficiency, pregnancy.  Allergies to anise and anethole.  Not to be used for infants and small children.  

For a daily dosage up to 100 mg glycyrrhizin:

• Occasionally, allergic reactions of the skin, respiratory tract, and gastrointestinal tract.  

For a daily dosage of more than 100 mg glycyrrhizin:

• Extended use and higher dosages may cause mineralocorticoid effects in the form of sodium and water retention, potassium loss with hypertonia, edema and hypokalemia with muscular asthenia, and, in rare cases, myoglobinuria.  Occasionally, allergic reactions of skin, respiratory tract, and gastrointestinal tract may occur.  

For a daily dosage up to 100 mg glycyrrhizin:

None known.  

For a dosage above 100 mg glycyrrhizin:

Loss of potassium can be increased through other drugs, e.g., thiazide and loop diuretics.  Sensitivity to digitalis glycosides increased through loss of potassium.  

Unless otherwise prescribed:

The individual four components of the combination must be present at 25 - 40 percent of the recommended daily dosage in the monographs for the individual herbs.  

Comminuted drug and essential oils, as well as galenical preparations for oral intake.  

Not longer than 4 - 6 weeks without medical advice.  

The following actions are documented: a secretolytic effect for licorice root and fennel oil; an expectorant effect for licorice root, thyme, and anise oil; a bronchospasmolytic and antibacterial effect for thyme and anise oil.  Pharmacological tests for the effectiveness of fixed combinations are not available.