Fixed Combinations of Anise seed, Marshmallow root, Eucalyptus oil, and Licorice root

Fixed combinations consisting of:

Anise seed corresponding to B.  Anz. 122, July 6, 1988;
Marshmallow root corresponding to B.  Anz. 43, March 2, 1989;
Eucalyptus oil corresponding to B.  Anz. 177a, September 24, 1986;
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 dry cough.  

For a daily dosage up to 100 mg glycyrrhizin:

• Oversensitivity to anise and anethole.  Inflammatory diseases of the gastrointestinal tract and biliary tract; severe liver diseases.  

For a daily dosage of more than 100 mg glycyrrhizin:

• Cholestatic liver diseases, liver cirrhosis and other severe liver diseases, hypertonia, hypokalemia, severe kidney insufficiency, pregnancy.  Allergies to anise and anethole.  Inflammatory diseases of the gastrointestinal tract and biliary tract.  

For a daily dosage up to 100 mg glycyrrhizin:

• Occasionally, allergic reactions of the skin, respiratory tract, and gastrointestinal tract.  In rare cases, gastric disturbances, nausea, and diarrhea may occur.  

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, and gastrointestinal tract may occur.  In rare cases, gastric disturbances, nausea, and diarrhea may occur.  

For a daily dosage up to 100 mg glycyrrhizin:

Eucalyptus oil causes the induction of the enzyme system in the liver responsible for the breakdown of foreign materials.  The effect of other medications may, therefore, be reduced and/or shortened.  

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 is increased through loss of potassium.  Eucalyptus oil causes the induction of the enzyme system in the liver responsible for the breakdown of foreign materials.  The effect of other medications may, therefore, be reduced and/or shortened.  

Warning:The absorption of other, simultaneously taken medications can be delayed.  

Unless otherwise prescribed:

Marshmallow must be at the concentration given in the monograph.  Licorice root, eucalyptus oil, and anise must be present at 30 - 50 percent of the amounts recommended as daily dosage in the monographs for the individual herbs.  

Comminuted drug and galenical preparations for oral intake.  

Not longer than 4 - 6 weeks without medical advice.  

An expectorant action is documented for preparations of licorice root, eucalyptus oil, and anise.  A secretolytic effect has been shown for licorice root, and a secretomotory action for eucalyptus oil.  Anise has also an antibacterial action.  Marshmallow has a soothing effect and inhibits in-vitro the mucociliary activity.  In addition, anise and eucalyptus oil have a mild spasmolytic action.  Pharmacological tests for the effectiveness of fixed combinations are not available.