Draft European Union Herbal Monograph On Althaea Officinalis L., Radix
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
24 November 2015
EMA/HMPC/436679/2015
Committee on Herbal Medicinal Products (HMPC)
European Union herbal monograph on Althaea officinalis L., radix
Draft - revision
Herbal medicinal products; HMPC; European Union herbal monographs; traditional use; Althaea officinalis L., radix; Althaeae radix; Marshmallow root
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Discussion in Working Party on European Union monographs and European Union list (MLWP) |
March 2008 May 2008 July 2008 January 2009 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
17 July 2008 |
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End of consultation |
15 November 2008 |
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Re-discussion in MLWP |
January 2009 March 2009 |
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Adoption by HMPC Monograph (EMEA/HMPC/98717/2008) AR (EMEA/HMPC/98718/2008) List of references (EMEA/HMPC/98716/2008) Overview of comments received during the public consultation (EMEA/HMPC/2920/2009) HMPC Opinion (EMEA/HMPC/109223/2009) |
14 May 2009 |
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First systematic review | |
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Discussion in MLWP |
July 2015 September 2015 |
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Adoption by HMPC |
24 November 2015 |
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Start of public consultation |
11 December 2015 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 March 2016 |
Keywords
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© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.
BG (bulgarski): ^eneöHa pyxa, KopeH CS (cestina): proskumíkovy koren DA (dansk): Altæarod DE (Deutsch): Eibischwurzel EL (elliniká): piÇa aÀTaiaç- piÇa aÀ0aiaç EN (English): Marshmallow root ES (español): Altea, raíz de ET (eesti keel): alteejuur FI (suomi): rohtosalkoruusu, juuri FR (français): Guimauve (racine de)
HR (hrvatski): korijen obicnog bijelog sljeza HU (magyar): orvosi ziliz gyökér IT (italiano): Altea radice
LT (lietuviq. kalba): Svilaroziq. saknys LV (latviesu valoda): Altejas saknes MT (Malti): Gfterq tal-Hobbejza Medicinali NL (Nederlands): Echte Heemst PL (polski): Korzen prawoslazu PT (portugues): Alteia, raiz RO (romånä): rädäcinä de nalba mare SK (slovencina): Koren ibisa SL (slovenscina): korenina navadnega sleza SV (svenska): Läkemalva, rot IS (fslenska):
NO (norsk): Altearot
European Union herbal monograph on Althaea officinalis L., radix
1. Name of the medicinal product
To be specified for the individual finished product.
2. Qualitative and quantitative composition1, 2
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Well-established use |
Traditional use |
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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended Althaea officinalis L., radix (Marshmallow root) i) Herbal substance Not applicable. ii) Herbal preparations a) Comminuted herbal substance b) Liquid extract (DER 1:19.5-23.5), extraction solvent water c) Macerate for preparation of syrup1 2 d) Dry extract (DER 3-9:1), extraction solvent water e) Liquid extract (DER 1:1), extraction solvent ethanol 25% (V/V) |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Comminuted herbal substance as herbal tea for oral use. Herbal preparations in liquid or solid dosage forms for oral or oromucosal use. The pharmaceutical form should be described by |
1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
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Well-established use |
Traditional use |
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the European Pharmacopoeia full standard term. |
4. Clinical particulars
4.1. Therapeutic indications
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Well-established use |
Traditional use |
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Indication 1 Traditional herbal medicinal product used as a demulcent preparation for the symptomatic treatment of oral or pharyngeal irritation and associated dry cough. Indication 2 Traditional herbal medicinal product used as a demulcent preparation for the symptomatic relief of mild gastrointestinal discomfort. 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 administration4
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Well-established use |
Traditional use |
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Posology Oral use a) Comminuted herbal substance Indication 1) Adolescents, adults and elderly Herbal tea: 0.5 - 3 g of the comminuted herbal substance in 150 ml of water as a macerate several times daily Maximum daily dose: 15 g Children 6-12 years of age Herbal tea: 0.5 - 1.5 g of the comminuted herbal substance in 150 ml of water as a macerate 3 times daily Daily dose: 1.5 - 4.5 g |
4 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate preparation, please refer to the HMPC 'Glossary on herbal teas' (EMA/HMPC/5829/2010 Rev.1).
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Well-established use |
Traditional use |
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Children 3-5 years of age Herbal tea: 0.5 - 1.0 g of the comminuted herbal substance in 150 ml of water as a macerate 3 times daily Daily dose: 1.5 - 3.0 g The use in children under 3 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). Indication 2) Adolescents, adults and elderly Herbal tea: 3 - 5 g of the comminuted herbal substance in 150 ml of water as a macerate 3 times daily Maximum daily dose: 15 g The use in children under 12 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). b) Liquid extract (DER 1:19.5-23.5) Indication 1) Adolescents, adults and elderly Single dose: 4.6 g 3 - 6 times daily Daily dose: 13.8 - 27.6 g Children 6-12 years of age Single dose: 2.3 g 5 times daily Daily dose: 11.5 g Children 3-5 years of age Single dose: 1.9 g 4 times daily Daily dose: 7.6 g The use in children under 3 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). c) Macerate for preparation of syrup Indication 1) Adolescents, adults and elderly Single dose: macerate amount corresponding to 0.21 to 0.87 g of the herbal substance (10 - 15 ml of syrup) 3 - 5 times daily |
Daily dose: macerate amount corresponding to 0.63 to 2.9 g of the herbal substance (30 - 50 ml of syrup)
Children 6-12 years of age
Single dose: macerate amount corresponding to 0.1 to 0.29 g of the herbal substance (5 ml of syrup) 3 - 5 times daily
Daily dose: macerate amount corresponding to 0.32 to 1.45 g of the herbal substance (15 - 25 ml of syrup)
Children 3-5 years of age
Single dose: macerate amount corresponding to 0.1 to 0.29 g of the herbal substance (5 ml of syrup) up to 4 times daily Daily dose: macerate amount corresponding to 0.21 to 1.16 g of herbal substance (10 - 20 ml of syrup)
The use in children under 3 years of age is not recommended (see section 4.4 'Special warnings and precautions for use').
e) Liquid extract (DER 1:1)
Indication 1) and 2)
Adults and elderly
Single dose: 2 - 5 ml 3 times daily Daily dose: 6 - 15 ml
The use in children and adolescents under 18 years of age is not recommended (see section 4.4 'Special warnings and precautions for use').
Oromucosal use
d) Dry extract (DER 3-9:1)
Indication 1)
Adolescents, adults and elderly
Single dose: 160 mg several times daily Maximum daily dose: 1.6 g
Children 6-12 years of age
Single dose: 160 mg 3 times daily_
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Well-established use |
Traditional use |
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Daily dose: 480 mg The use in children under 6 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). Duration of use Indication 1) 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. Indication 2) 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. Method of administration Preparations a) b), c) and e) Oral use. Preparation d) Oromucosal use. The macerate should be used immediately after preparation. |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance. |
4.4. Special warnings and precautions for use
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Well-established use |
Traditional use |
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Indication 1) If dyspnoea, fever or purulent sputum occurs during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Preparations a), b) and c) The use in children under 3 years of age is not recommended because of concerns requiring |
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Well-established use |
Traditional use |
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medical advice. Preparation d) The use in children under 6 years of age is not recommended because of the pharmaceutical form (solid dosage form). Preparation e) The use in children and adolescents under 18 years of age has not been established due to lack of adequate data. For syrup the appropriate labelling for sucrose, taken from the 'Guideline on excipients in the label and package leaflet of medicinal products for human use', must be included. Indication 2) Preparation a) The use in children under 12 years of age has not been established due to lack of adequate data. Preparation e) The use in children and adolescents under 18 years of age has not been established due to lack of adequate data. Indications 1) and 2) Absorption of concomitantly administered medicines may be delayed. As a precautionary measure, the product should not be taken V to 1 hour before or after intake of other medicinal products. If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. For extracts containing ethanol, the appropriate labelling for ethanol, taken from the 'Guideline on excipients in the label and package leaflet of medicinal products for human use', must be included. |
4.5. Interactions with other medicinal products and other forms of interaction
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Well-established use |
Traditional use |
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None reported. |
4.6. Fertility, pregnancy and lactation
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Well-established use |
Traditional use |
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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
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Well-established use |
Traditional use |
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No studies on the effect on the ability to drive and use machines have been performed. |
4.8. Undesirable effects
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Well-established use |
Traditional use |
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None known. If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted. |
4.9. Overdose
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Well-established use |
Traditional use |
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No case of overdose has been reported. |
5. Pharmacological properties
5.1. Pharmacodynamic properties
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Well-established use |
Traditional use |
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Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended. |
5.2. Pharmacokinetic properties
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Well-established use |
Traditional use |
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Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended. |
5.3. Preclinical safety data
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Well-established use |
Traditional use |
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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 genotoxicity have not been performed. Tests on reproductive toxicity and carcinogenicity have not been performed. |
6. Pharmaceutical particulars
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Well-established use |
Traditional use |
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Not applicable. |
7. Date of compilation/last revision
24 November 2015
Page 10/10
European Union herbal monograph on Althaea officinalis L., radix
EMA/HMPC/436679/2015
The material complies with the Ph. Eur. monograph (ref.: 1126)
Prepared in accordance with the pharmacopoeial monographs for Sirupus althaeae in Österreichisches Arzneibuch 1981, Ceskoslovensky lekopis1954, Farmakopea Polska 1970 and 2002 or with the monograph Eibischsirup in Deutscher Arzneimittel-Codex 1979