Fixed Combinations of Pheasant's Eye herb and/or Lily-of-the-Valley herb and/or Squill and/or Oleander leaf with herbs that do not contain cardiac glycosides (Fixed combinations of Pheasant's Eye herb and/or Lily-of-the-valley herb and/or Squill and/or Ol

Published July 14, 1993.
List of German Commission E Monographs (Phytotherapy)

Name of Drug

Fixed combinations of Pheasant's Eye herb and/or Lily-of-the-valley herb and/or Squill and/or Oleander leaf with herbs which do not contain cardiac glycosides.

Components of Drug

Fixed combinations of Pheasant's Eye and/or Lily-of-the-valley herb and/or Squill and/or Oleander leaf are available with the following herbs not containing cardiac glycosides:

Elecampane root (B. Anz. No. 85 of May 5, 1988)
Anise seed (B. Anz. No. 122 of July 6, 1988)
Arnica flower (B. Anz. No. 228 of December 5, 1984)
Uva Ursi leaf (B. Anz. No. 228 of December 5, 1984)
Valerian root (B. Anz. No. 90 of May 15, 1985)
Blessed Thistle herb (B. Anz. No. 193a of October 15, 1987)
Scotch Broom herb (B. Anz. No. 11 of January 17, 1991)
Pimpinella root (B. Anz. No. 101 of June 1, 1990)
Birch leaf (B. Anz. No. 50 of March 13, 1986)
Bogbean leaf (B. Anz. No. 22a of February 1, 1990)
Mondshood (B. Anz. No. 193a of October 15, 1987)
Boldoleaf (B. Anz. No. 76 of April 23, 1987)
Stinging NEttle herb and leaf (B. Anz. No. 76 of April 23, 1987)
Blackberry leaf (B. Anz. No. 22a of February 1, 1990)
Rupturewort (B. Anz. No. 173 of September 18, 1986)
Cola nut (B. Anz. No. 127 of July 12, 1991)
Dill seed (B. Anz. No. 193a of October 15, 1987)
Verbena (B. Anz. No. 22a of February 1, 1990)
Ephedra (B. Anz. No. 11 of January 17, 1991)
Buckthorn bark (B. Anz. No. 228 of December 5, 1984)
Fennel seed (B. Anz. No. 74 of April 19, 1991)
Silverweed (B. Anz. No. 223 of November 30, 1985)
Yellow Jessamine root (B. Anz. No. 178 of September 21, 1991)
Ginseng root (B. Anz. No. 11 of January 17, 1991)
Goldenrod (B. Anz. No. 193a of October 15, 1987)
Guaiac wood (B. Anz. No. 76 of April 23, 1987)
Rose Hip (B. Anz. No. 164 of September 1, 1990)
Rose Hip seed (B. Anz. No. 164 of September 1, 1990)
Witch Hazel leaf and bark (B. Anz. No. 154 of August 21, 1985)
Spiny Restharrow root (B. Anz. No. 76 of April 23, 1987)
Motherwort herb (B. Anz. No. 50 of March 13, 1985)
Elder flower (B. Anz. No. 50 of March 13, 1985)
Hops (B. Anz. No. 228 of December 5, 1984)
St. John's Wort (B. Anz. No. 228 of December 5, 1984)
Chamomile flower, German (B. Anz. No. 228 of December 5, 1984)
Pine sprouts (B. Anz. No. 173 of September 18, 1986)
Night-blooming Cereus (B. Anz. No. 22a of February 1, 1990)
Cornflower (B. Anz. No. 43 of March 2, 1989)
Madder root (B. Anz. No. 173 of September 18, 1986)
Caraway seed (B. Anz. No. 22a of February 1, 1990)
Pumpkin seed (B. Anz. No. 223 of November 30, 1985)
Lavender flower (B. Anz. No. 228 of December 5, 1984)
Lovage root (B. Anz. No. 101 of June 1, 1990)
Dandelion root and herb (B. Anz. No. 228 of December 5, 1984)
Meadowsweet (B. Anz. No. 43 of March 2, 1989)
Marjoram (B. Anz. No. 226 of December 2, 1992)
Mallow flower (B. Anz. No. 43 of March 2, 1989)
Milk Thistle seed (B. Anz. No. 50 of March 13, 1986)
Maté (B. Anz. No. 85 of May 15, 1988)
Lemon Balm (B. Anz. No. 228 of December 5, 1984)
Mistletoe herb (B. Anz. No. 228 of December 5, 1984)
Java Tea (B. Anz. No. 50 of March 13, 1986)
Passionflower herb (B. Anz. No. 223 of November 30, 1985)
Parsley seed (B. Anz. No. 43 of March 2, 1989)
Parsley herb and root (B. Anz. No. 43 of March 2, 1989)
Peppermint leaf (B. Anz. No. 223 of November 30, 1985)
Primrose root (B. Anz. No. 122 of July 6, 1988)
Rue (B. Anz. No. 43 of March 2, 1989)
Serpent wood root (B. Anz. No. 173 of September 18, 1986)
Rosemary leaf (B. Anz. No. 223 of November 30, 1985)
Horse Chestnut seed (B. Anz. No. 228 of December 5, 1984)
Saw Palmetto berry (B. Anz. No. 43 of March 2, 1989)
Sage leaf (B. Anz. No. 90 of May 15, 1985)
Kidney bean pods (without seeds) (B. Anz. No. 50 of March 13, 1990)
Sandalwood, Red (B. Anz. No. 193a of October 15, 1987)
Horsetail herb (B. Anz. No. 22a of February 1, 1990)
Yarrow (B. Anz. No. 22a of February 1, 1990)
Celandine, herb (B. Anz. No. 90 of May 15, 1985)
Senna (B. Anz. No. 228 of December 5, 1984)
Echinacea Angustifolia root (B. Anz. No. 162 of August 29, 1992)
Asparagus root (B. Anz. No. 127 of July 12, 1991)
Heart's Ease herb (B. Anz. No. 50 of March 13, 1986)
Licorice root (B. Anz. No. 90 of May 15, 1985)
Kelp (B. Anz. No. 101 of June 1, 1990)
Tormentil root (B. Anz. No. 85 of May 5, 1988)
Juniper berry (B. Anz. No. 228 of December 5, 1984)
Walnut leaf (B. Anz. No. 101 of June 1, 1990)
White Willow bark (B. Anz. No. 228 of December 5, 1984)
Wormwood (B. Anz. No. 228 of December 5, 1984)
Bugleweed (B. Anz. No. 22a of February 1, 1990)

This list of components will be supplemented according to the progress of the Commission's work.

Pharmacological Properties, Pharmacokinetics, Toxicology

For pheasant's eye herb, lily-of-the-valleyherb, squill, oleander and the other herbs that do not contain cardiac glycosides, refer to the respective monographs.

Clinical Data 1. Uses The following indications are claimed for these combination preparations:

Mild forms of heart insufficiency, even with diminished kidney capacity, geriatric heart, athletic heart, cardiac dropsy, chronic cor pulmonale, myodegeneration of the heart, nervous heart, cardiac- and vasoneurosis, as a tonic for the heart during starvation (hunger) or fasting cures, as a tonic for the cardiac and circulatory system, for heart damage caused by tobacco, anginal discomforts, improvement of coronary blood supply, rhythmic disturbances, as a supplement to digitalis and strophanthin therapies, and for inflammation of the heart muscle and heart lining Feeling of ill health due to low blood pressure (dizziness, disturbances of sight, decrease in physical and mental capacity, vegetative dystonia, depression), hypotonic regulatory disorders, during and after infectious diseases, circulatory disturbances, and high blood pressure, especially during menopause Varicose symptoms, phlebectasia, angioneurosis, brachyalgia, endangiitis obliterans, ulcer of the leg, hemorrhoids Stimulation of kidney function, fluid removal during heart and kidney ailments, disturbances of the metabolism, e.g., high values of uric acid and overweight, dropsy, supporting treatment of catarrhs of the bladder and renal pelvis, cystitis, pyelonephritis, prevention of urinary gravel and urinary calculi, for renal, cardiac, hepatogenic or static edema, ascites, "bladder and kidney congestion," liver congestion, urine retention, reduction of residual urine, urination disorders, prostatitis, and hypertrophy of the prostate Supportive to treatment of obesity Arteriosclerosis Anxiety, sleeping disorders due to nervous palpitation, symptoms of "manager disease," vegetative dystonia Neuralgia, skin diseases, allergies, "disorders of secretions." No useful information is available pertaining to the claimed applications.

The effectiveness of the combinations for the claimed uses has not been documented.

2. Risks

The harmlessness of these combination preparations pertains to the herbs without cardiac glycosides, as specified by the data given in the individual monographs. Interactions between the herbs containing cardiac glycosides and the other herbs have not been investigated.

Pheasant's eye herb, lily-of-the-valley herb, squill, and oleander leaf contain cardiac glycosides.

The following risks apply:

Not to be used during therapy with digitalis glycosides, digitalis intoxication, hypercalcemia, potassium deficiency, bradycardia, ventricular tachycardia. Since studies regarding the use by children are not available, the administration is contraindicated. Caution in cases of conduction disturbances and during i.v. calcium therapy. Side effects that may occur: nausea, vomiting and cardiac dysrhythmia. Increased effectiveness, and thus also of side effects, occurs with simultaneous administration of quinidine, calcium, saluretics, laxatives, and, during long-term therapy, with glucocorticoids. Evaluation The indicated uses of the component herbs are listed in their respective monographs.

Concerning the combinations of pheasant's eye herb and/or lily-of-the-valley herb and/or squill and/or oleander leaf with herbs which do not contain cardiac glycosides, no data are available from which a positive contribution to the effectiveness of these drug combinations can be deduced. According to the evaluation results [of investigations] of the herbs not containing cardiac glycosides, these neither contribute to the effectiveness nor to the tolerance of pheasant's eye herb and/or lily-of-the-valley herb and/or squill and/or oleander leaf-containing medicines.

The combination of pheasant's eye herb and/or lily-of-the-valley herb and/or squill and/or oleander leaf, being drugs containing cardiac glycosides with narrow dosage ranges and high toxicity, with other compounds is not to be recommended.

Permission of such combination products cannot be recommended.