Fixed Combinations of Anise seed, Ivy leaf, Fennel seed, and Licorice root

Fixed combinations consisting of:

Anise seed corresponding to B.  Anz. 122, July 6, 1988;
Ivy leaf corresponding to B.  Anz. 122, July 6, 1988;
Fennel seed corresponding to B.  Anz. 74, April 19, 1991;
Licorice root corresponding to B.  Anz. 90, May 15, 1985;

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: Preparations other than teas and preparations with essential oil contents comparable to those of teas.  

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.  

For a daily dosage up to 100 mg glycyrrhizin:

• Occasionally allergic reactions of the skin, respiratory tract, or 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 the skin, respiratory tract, or 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 components of the combination must be present at 25 - 40 percent of the amounts recommended as daily dosage in the monographs for the individual herbs.  

Preparations for oral intake.  

Not longer than 4 - 6 weeks without medical advice.  

Licorice root has a secretolytic and expectorant effect, fennel is secretolytic, anise and ivy leaves are expectorant and spasmolytic; anise also has an antibacterial action.  Pharmacological tests for the effectiveness of fixed combinations are not available.