Draft Community Herbal Monograph On Glycyrrhiza Glabra L. And/Or Glycyrrhiza Inflata Bat. And/Or Glycyrrhiza Uralensis Fisch, Radix
o
EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
12 July 2011
EMA/HMPC/571119/2010
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch, radix
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch, radix; liquorice root
|
Discussion in Working Party on Community monographs and Community list (MLWP) |
September 2010 January 2011 March 2011 May 2011 |
|
Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
July 2011 |
|
End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 November 2011 |
|
Rediscussion in Working Party on Community monographs and Community list (MLWP) |
November 2011 |
|
Adoption by Committee on Herbal Medicinal Products (HMPC) |
Keywords
|
BG (balgarski): CnagHMK |
LT (lietuviq. kalba): |
|
CS (cestina): Lékoricovy koren |
LV (latviesu valoda): Lakricu saknes |
|
DA (dansk): Lakridsrod, uskrællet |
MT (malti): Gherq ta' Ghud is-Sus |
|
DE (Deutsch): Süßholzwurzel |
NL (nederlands): Zoethoutwortel |
|
EL (elliniká): TÀUKÙppiZa |
PL (polski): Korzen lukrecji |
|
EN (English): Liquorice, root |
PT (portugues): Alcaguz, raiz |
|
ES (espanol): Regaliz, raíz de |
RO (romånä): Rädäcinä de lemn dulce |
|
ET (eesti keel): Magusjuurejuur |
SK (slovencina): Sladkovkovy koren |
|
FI (suomi): |
SL (slovenScina): Korenina golostebelnega |
|
FR (français): Réglisse (racine de) |
sladkega korena |
|
HU (magyar): Édesgyôkér |
SV (svenska): Lakritsrot |
|
IT (italiano): Liquirizia, radice |
IS (islenska): NO (norsk): Lakrisrot, uskrelt |
7 Westferry Circus • Canary Wharf • London E14 4HB • United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7150 E-mail info@ema.europa.eu Website www.ema.europa.eu
© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.
An agency of the European Union
Community herbal monograph on Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch, radix
1. Name of the medicinal product
To be specified for the individual finished product.
2. Qualitative and quantitative composition1,2
|
Well-established use |
Traditional use |
|
With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch, radix (liquorice root) i) Herbal substance Not applicable. ii) Herbal preparations a) Comminuted herbal substance b) Soft extract (DER 1:0.4-0.5), extraction solvent water c) Soft extract (DER 3:1), extraction solvent water |
3. Pharmaceutical form
|
Well-established use |
Traditional use |
|
Comminuted herbal substance as a herbal tea for oral use. Herbal preparations in liquid dosage forms for oral use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term. |
1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
2. The material complies with the Ph. Eur. monograph (ref.: 01/2010: 0277).
4.1. Therapeutic indications
|
Well-established use |
Traditional use |
|
Indication 1 Traditional herbal medicinal product for the relief of digestive symptoms including burning sensation and dyspepsia. Indication 2 Traditional herbal medicinal product used as an expectorant in cough associated with cold. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use. |
4.2. Posology and method of administration
|
Well-established use |
Traditional use |
|
Posology Indication 1 Adults and elderly Single dose a) Comminuted herbal substance Herbal tea: 1.5 - 2 g of comminuted herbal substance in 150 ml of boiling water as a herbal infusion 2 to 4 times daily or 1.5 - 2 g of comminuted herbal substance in 150 ml of water as a decoction 2 to 4 times daily. Take one cup after meals. b) Soft extract (DER 1:0.4-0.5) 32 mg 2-3 times daily for oral use. Not more than 160 mg (32 mg 5 times) daily. Indication 2 Adults and elderly Single dose a) Comminuted herbal substance |
4.3. Contraindications
1.5 g of comminuted herbal substance in 150 ml of boiling water as a herbal infusion 2 times daily
or
1.5 g of comminuted herbal substance in 150 ml of water as a decoction 2 times daily.
c) Soft extract (DER 3:1)
1.2-1.5 g 3-4 times daily.
The use in children and adolescents under 18 years of age is not recommended (see section 4.4 'Special warnings and precautions for use').
Duration of use
Indication 1
Not to be used for more than 4 weeks.
If the symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
Indication 2
If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
Method of administration
Oral use.
|
Well-established use |
Traditional use |
|
Hypersensitivity to the active substance(s). |
4.4. Special warnings and precautions for use
|
Well-established use |
Traditional use |
|
The use in children and adolescents under 18 years of age has not been established due to lack of adequate data. Patients taking liquorice medication should not take other liquorice containing products as serious adverse events may occur such as hypokalemia, hypertension, cardiac rhythm disorders. |
|
Well-established use |
Traditional use |
|
Liquorice medication should be used with caution in patients affected by hypertension, kidney diseases, liver or cardiovascular disorders or hypokalemia, as they are more sensitive to the adverse effects of liquorice. If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. |
4.5. Interactions with other medicinal products and other forms of interaction
|
Well-established use |
Traditional use |
|
Liquorice root may counteract antihypertensive action of prescribed medications. Not to be used concomitantly with thiazide diuretics, cardiac glycosides, corticosteroids, stimulant laxatives or other medications which may aggravate electrolyte imbalance. |
4.6. Fertility, pregnancy and lactation
|
Well-established use |
Traditional use |
|
Studies in animals have shown reproductive toxicity (see section 5.3 'Preclinical safety data'). Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. No fertility data available. |
4.7. Effects on ability to drive and use machines
|
Well-established use |
Traditional use |
|
No studies on the effect on the ability to drive and use machines have been performed. |
4.8. Undesirable effects
|
Well-established use |
Traditional use |
|
Hypokalaemia, hypertension, cardiac rhythm disorders, hypertension encephalopathy may |
|
Well-established use |
Traditional use |
|
occur. The frequency is not known. If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted. |
4.9. Overdose
|
Well-established use |
Traditional use |
|
Cases of overdose have been reported with prolonged use and/or intake of high amount of liquorice, with symptoms similar than those reported in section 4.8 'Undesirable effects'. |
5. Pharmacological properties
5.1. Pharmacodynamic properties
|
Well-established use |
Traditional use |
|
Not required as per Article 16c (1)(a)(iii) of Directive 2001/83/EC as amended. |
5.2. Pharmacokinetic properties
|
Well-established use |
Traditional use |
|
Not required as per Article 16c (1)(a)(iii) of Directive 2001/83/EC as amended. |
5.3. Preclinical safety data1
|
Well-established use |
Traditional use |
|
Not required as per Article 16c (1)(a)(iii) of Directive 2001/83/EC as amended, unless necessary for the safe use of the product. Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed. |
|
Well-established use |
Traditional use |
|
Not applicable. |
7. Date of compilation/last revision
12 July 2011
Community herbal monograph on Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat.
and/or Glycyrrhiza uralensis Fisch, radix
EMA/HMPC/571119/2010
Page 7/7
Where herbal preparations from Liquiritiae radix are used, the total exposure to glycyrrhizic acid should be considered from a safety standpoint._