Fixed Combinations of Licorice root, Primrose root, Marshmallow root, and Anise seed

Fixed combinations of licorice root, primrose root [ Primula , not Oenothera (evening primrose)], marshmallow root, and anise seed.  

Fixed combinations consisting of:

Licorice root corresponding to the monograph published May 6, 1985;
Primrose root corresponding to the monograph published April 11, 1988;
Marshmallow root corresponding to the monograph published January 5, 1989;
Anise seed corresponding to the monograph published April 11, 1988;

as well as their preparations in effective dosage.  

Catarrh of the upper respiratory tract and resulting dry cough.  

For daily dosages of less than 100 mg glycyrrhizin:

• Hypersensitivity to anise and anethole.  

For daily dosages of more than 100 mg glycyrrhizin:

• Cholestatic liver disorders, cirrhosis of the liver, hypertonia, hypokalemia, severe kidney insufficiency, pregnancy.  Hypersensitivity to anise and anethole.  

For daily dosages below 100 mg glycyrrhizin:

• Occasionally allergic reactions involving skin, respiratory tract and gastrointestinal tract.  Isolated stomach discomforts and nausea can occur.  

For daily dosages above 100 mg glycyrrhizin:

• Extended use and higher dosages can cause mineralocorticoid effects, such as sodium and water retention, loss of potassium coupled with high blood pressure, edema and hypokalemia with weakness of the muscles, and, in rare cases, myoglobinuria.  Occasionally allergic reactions involving skin, respiratory tract and gastrointestinal tract.  Isolated stomach discomforts and nausea can occur.  

For daily dosages below 100 mg glycyrrhizin:

• None known.  

For daily dosages above 100 mg glycyrrhizin:

• Loss of potassium due to other medications, e.g., thiazide and loop diuretics, can be increased.  Loss of potassium can increase the sensitivity to digitalis glycosides.  

Note:The absorption of other, simultaneously administered drugs can be delayed.  

Unless otherwise prescribed:

Marshmallow root must be present in the dosage given in its monograph.  

Licorice root, primrose root, and anise must be at the concentration of 30 - 50 percent of the daily dosage given in the individual monographs.  

Deviating dosages must be justified specifically for the preparation.  

Liquid and solid forms of preparations for oral use.  

Without medical advice, not longer than 4 - 6 weeks.  

An expectorant effect is documented for Licorice root, primrose root and anise seed.  In addition, a secretolytic action is shown for licorice root and primrose root.  Anise has an antibacterial and mild antispasmodic action; marshmallow root has a soothing action and inhibits ciliary activity in vitro.  Pharmacological experiments for the fixed combinations are not available.