Draft Community Herbal Monograph On Eucalyptus Globulus Labill., Eucalyptus Polybractea R.T. Baker And/Or Eucalyptus Smithii R.T. Baker, Aetheroleum
O
EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
15 June 2013
EMA/HMPC/307781/2012
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker, aetheroleum
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker, aetheroleum; Eucalypti aetheroleum; Eucalyptus oil
Draft
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Discussion in Working Party on Community monographs and Community list (MLWP) |
May 2012 September 2012 November 2012 March 2013 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
14 May 2013 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 November 2013 |
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Rediscussion in Working Party on Community monographs and Community list (MLWP) | |
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Adoption by Committee on Herbal Medicinal Products (HMPC) |
Keywords
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© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
BG (bälgarski): EBKa^wnTOBO Macm
CS (cestina): blahovicnikova silice
DA (dansk): Eucalyptusolie
DE (Deutsch): Eukalyptusöl
EL (ellinika): eÀaio euKaÀùnTOu- ai0épio eÀaio
euKaÀùnTOu
EN (English): Eucalyptus oil
ES (espanol): Eucalipto, aceite esentcial de
ET (eesti keel): eukalüptiôli
FI (suomi): eukalyptusöljy
FR (français): Eucalyptus (huile essentielle d')
HU (magyar): Eukaliptuszolaj
IT (italiano): Eucalipto essenza
LT (lietuviq. kalba): Eukaliptq. eterinis aliejus LV (latviesu valoda): Eikalipta eteriska ejja MT (malti): Zejt tal-Ewkaliptus NL (nederlands): Eucalyptusolie PL (polski): Olejek eteryczny eukaliptusowy PT (portugues): Oleo essencial de eucalipto RO (romånä): ueli volatil de eucalipt SK (slovencina): Eukalyptova silica SL (slovenscina): etericno olje evkalipta SV (svenska): Eukalyptusolja IS (fslenska):
NO (norsk): Eukalyptusolje
Community herbal monograph on Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and Eucalyptus smithii R.T. Baker, aetheroleum
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 Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and Eucalyptus smithii R.T. Baker, aetheroleum (Eucalyptus oil) i) Herbal substance Not applicable. ii) Herbal preparations Essential oil. |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Herbal preparation in solid or liquid dosage forms for oral use. Herbal preparations in liquid dosage forms for inhalation or as bath additives. Herbal preparations in liquid or semi-solid dosage forms for cutaneous 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.: 07/2012:0390).
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 for relief of cough associated with cold. Indication 2) Traditional herbal medicinal product for the symptomatic relief of localised muscle pain. 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
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Well-established use |
Traditional use |
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Posology Indication 1) Oral use Adolescents, adults and elderly Single dose: 100-200 mg, 2 to 5 times a day The use in children under 30 months of age is contraindicated (see section 4.3 'Contraindications'). The use in children under 12 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). Cutaneous use Children between 4 and 12 years of age, adolescents, adults and elderly Single dose for liquid dosage forms; a few drops on chest or back, 2 to 3 times a day Single dose for semi-solid dosage forms (10% Eucalyptus oil): apply a thin layer on chest and back, 2 to 3 times a day The use in children under 30 months of age is contraindicated (see section 4.3 |
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Well-established use |
Traditional use |
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'Contraindications'). The use is not recommended in children between 2.5 and 4 years of age (see section 4.4 'Special warnings and precautions for use'). Inhalation Adolescents, adults and elderly Single dose: up to 3-8 drops per 250 ml boiling water, 3 times a day Children between 4 and 12 years of age Single dose: up to 2-4 drops per 250 ml boiling water, 3 times a day The use in children under 30 months of age is contraindicated (see section 4.3 'Contraindications'). The use in children between 2.5 and 4 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). Use as bath additive Adolescents, adults and elderly Single dose: 1.5-6 g essential oil/100 l water, 3 to 4 times a week Children between 4 and 12 years of age Single dose: 0.5-3 g essential oil/100 l water, 3 to 4 times a week Recommended bath temperature is at 35-38°C for 10-20 minutes. The use in children under 30 months of age is contraindicated (see section 4.3 'Contraindications'). The use is not recommended in children between 2.5 and 4 years of age (see section 4.4 'Special warnings and precautions for use'). Indication 2) Cutaneous use Children between 4 and 12 years of age, adolescents, adults and elderly |
Single dose for liquid dosage forms: a few drops on the affected areas, 2 to 3 times a day
Single dose for semi-sold dosage forms (10% eucalyptus oil): apply a thin layer on affected areas, 2 to 3 times a day
The use in children under 30 months of age is contraindicated (see section 4.3 'Contraindications').
The use is not recommended in children between
2.5 and 4 years of age (see section 4.4 'Special warnings and precautions for use').
Use as bath additive
Children between 4 and 12 years of age, adolescents, adults and elderly
Single dose: 1.7-4 g essential oil/100 l water, 3 to 4 times a week
Recommended bath temperature is at 35-38°C for 10-20 minutes.
The use in children under 30 months of age is contraindicated (see section 4.3 'Contraindications').
The use is not recommended in children between
2.5 and 4 years of age (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)
Use as bath additive
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.
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Well-established use |
Traditional use |
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Cutaneous use 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 Oral use (indication 1). Cutaneous use (indications 1, 2). Inhalation (indication 1). Use as bath additive (indications 1, 2). |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to Eucalyptus oil or 1,8-cineol. Children with history of seizures (febrile or not). Children under 30 months of age, because there is a risk that 1,8-cineole containing preparations, like other essential oil can induce laryngospasm. Full hot baths are contraindicated in cases of large skin injuries and open wounds, acute skin diseases, high fever, severe infections, severe circulatory disturbances and cardiac failure. |
4.4. Special warnings and precautions for use
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Well-established use |
Traditional use |
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The use in children between 2.5 and 4 years of age has not been established due to lack of adequate data. Cutaneous use Eye contact with unwashed hands after the application of eucalyptus oil may potentially cause irritation. Eucalyptus oil should not be applied on broken or irritated skin. Oral use |
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Well-established use |
Traditional use |
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Eucalyptus oil should be used with caution in inflamed and ulcerated conditions of the gastrointestinal tract. Indication 1) When dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted. The oral use in children under 12 years of age has not been established due to lack of adequate data. Indication 2) When reddening or swelling of the aching parts occur a doctor or a qualified health care practitioner should be consulted. |
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 |
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Well-established use |
Traditional use |
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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 reproductive toxicity, genotoxicity 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
15 June 2013
Community herbal monograph on Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus
smithii R.T. Baker, aetheroleum
EMA/HMPC/307781/2012
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