Community herbal monograph on
Hedera helix
L
.
, folium
To be specified for the individual finished product.
Well-established use
Traditional use
With regard to the marketing authorisation
application of Article 10(a) of Directive
2001/83/EC as amended
With regard to the registration application of
Article 16d(1) of Directive 2001/83/EC as
amended
Hedera helix
L., folium (ivy leaf)
Hedera helix
L., folium (ivy leaf)
i) Herbal substance
i) Herbal substance
Not applicable.
Not applicable.
ii) Herbal preparations
ii) Herbal preparations
a)
Dry extract (DER 4-8:1), extraction solvent
ethanol 24-30% m/m
a)
Soft extract (DER 2.2-2.9:1), extraction
solvent ethanol 50% V/V: propylene glycol
(98:2)
b)
Dry extract (DER 6-7:1), extraction solvent
ethanol 40% m/m
c)
Dry extract (DER 3-6:1), extraction solvent
ethanol 60% m/m
d)
Liquid extract (DER 1:1), extraction solvent
ethanol 70% V/V
Well-established use
Traditional use
Herbal preparations in solid or liquid dosage forms
for oral use.
Herbal preparations in solid or liquid dosage forms
for oral use.
The pharmaceutical form should be described by
the European Pharmacopoeia full standard term.
The pharmaceutical form should be described by
the European Pharmacopoeia full standard term.
1 The material complies with the Ph. Eur. monograph (ref.: 01/2008:2148).
2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
Community herbal monograph on
Hedera helix
L., folium
EMA/HMPC/289430/2009
Page 2/6
4.1.
Therapeutic indications
Well-established use
Traditional use
Herbal medicinal product used as an expectorant
in case of productive cough.
Traditional herbal medicinal product used as an
expectorant in cough associated with cold.
The product is a traditional herbal medicinal
product for use in the specified indication
exclusively based upon long-standing use.
4.2.
Posology and method of administration
Well-established use
Traditional use
Posology
Posology
Adolescents, adults and elderly
Adolescents, adults and elderly
a)
Single dose: 15-65 mg, one to three times
daily up to a daily dose of 45-105 mg.
(Note: Maximum daily dose for ethanol-
containing finished products: 67 mg;
corresponding to 420 mg herbal substance).
a)
Single dose: 40 mg, three times daily.
Children between 5-12 years of age
a)
Single dose: 20-26 mg, three to four times
daily up to a maximum daily dose of 80 mg.
b)
Single dose: 14-18 mg, three times daily.
c)
Single dose: 33 mg, two times daily.
Children of 4 years of age
d)
Single dose: 100 mg, three times daily.
a)
Single dose: 20 mg, three times daily.
Children between 6-12 years of age
The use in children between 2-4 years of age is
not recommended (see section 4.4 ‘Special
warnings and precautions for use’).
a)
Single dose: 11-33 mg, two to three times
daily up to a daily dose of 33-70 mg.
(Note: Maximum daily dose for ethanol-
containing finished products: 34 mg;
corresponding to 210 mg herbal substance).
The use in children under 2 years of age is
contraindicated (see section 4.3
‘Contraindications’).
b)
Single dose: 9-18 mg, two to three times
daily up to a daily dose of 15-40 mg
Daily dose: 15-40 mg.
Duration of use
If the symptoms persist longer than one week
during the use of the medicinal product, a doctor
or a qualified health care practitioner should be
consulted.
c)
Single dose: 25 mg, two times daily.
d)
Single dose: 75 mg, three times daily.
Children between 2-5 years of age
Method of administration
a)
Single dose: 8-18 mg, two to three times
daily up to a daily dose of 24-36 mg.
(Note: Maximum daily dose for ethanol-
containing finished products: 24 mg;
corresponding to 150 mg herbal substance).
Oral use.
Community herbal monograph on
Hedera helix
L., folium
EMA/HMPC/289430/2009
Page 3/6
Well-established use
Traditional use
b)
Single dose: 7-9 mg, two to three times daily
up to a daily dose of 17-27 mg.
c)
Single dose: 17 mg, two times daily.
The use in children under 2 years of age is
contraindicated (see section 4.3
‘Contraindications’).
Duration of use
If the symptoms persist longer than one week
during the use of the medicinal product, a doctor
or a pharmacist should be consulted.
Method of administration
Oral use.
4.3.
Contraindications
Well-established use
Traditional use
Hypersensitivity to the active substance or to
plants of the Araliaceae family.
Hypersensitivity to the active substance or to
plants of the Araliaceae family.
Children under 2 years of age because of the risk
of aggravation of respiratory symptoms.
Children under 2 years of age because of the
risk of aggravation of respiratory symptoms.
4.4.
Special warnings and precautions for use
Well-established use
Traditional use
Persistent or recurrent cough in children between
2-4 years of age requires medical diagnosis before
treatment.
The use in children between 2-4 years of age is
not recommended because medical advice should
be sought.
When dyspnoea, fever or purulent sputum occurs,
a doctor or a pharmacist should be consulted.
When dyspnoea, fever or purulent sputum occurs,
a doctor or a qualified health care practitioner
should be consulted.
Concomitant use with antitussives such as codeine
or dextromethorphane is not recommended
without medical advice.
Concomitant use with antitussives such as codeine
or dextromethorphane is not recommended
without medical advice.
Caution is recommended in patients with gastritis
or gastric ulcer.
Caution is recommended in patients with gastritis
or gastric ulcer.
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.
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.
Preparation d) should not be administered to
Community herbal monograph on
Hedera helix
L., folium
EMA/HMPC/289430/2009
Page 4/6
Well-established use
Traditional use
children under 6 years of age because of the
alcohol content.
4.5.
Interactions with other medicinal products and other forms of
interaction
Well-established use
Traditional use
None reported.
None reported.
4.6.
Pregnancy and lactation
Well-established use
Traditional use
Safety during pregnancy and lactation has not
been established. In the absence of sufficient
data, the use during pregnancy and lactation is
not recommended.
Safety during pregnancy and lactation has not
been established. In the absence of sufficient
data, the use during pregnancy and lactation is
not recommended.
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.
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
Common: gastrointestinal reactions (nausea,
vomiting, diarrhoea) have been reported.
Uncommon: allergic reactions (urticaria, skin rash,
couperoses, dyspnoea) have been reported.
Allergic reactions (urticaria, skin rash, couperoses,
dyspnoea) and gastrointestinal reactions (nausea,
vomiting, diarrhoea) have been reported. The
frequency is not known.
If other adverse reactions not mentioned above
occur, a doctor or a pharmacist should be
consulted.
If other adverse reactions not mentioned above
occur, a doctor or a qualified health care
practitioner should be consulted.
Well-established use
Traditional use
Overdose can provoke nausea, vomiting,
diarrhoea and agitation.
Overdose can provoke nausea, vomiting,
diarrhoea and agitation.
One case of a 4-year old child who developed
aggressivity and diarrhoea after accidental intake
of an ivy extract corresponding 1.8 g herbal
One case of a 4-year old child who developed
aggressivity and diarrhoea after accidental intake
of an ivy extract corresponding 1.8 g herbal
Community herbal monograph on
Hedera helix
L., folium
EMA/HMPC/289430/2009
Page 5/6
Well-established use
Traditional use
substance has been reported.
substance has been reported.
5.1.
Pharmacodynamic properties
Well-established use
Traditional use
Pharmacotherapeutic group: respiratory system
Not required as per Article 16c(1)(a)(iii) of
Directive 2001/83/EC as amended.
Proposed ATC code: RO5 C
The mechanism of action is not known.
5.2.
Pharmacokinetic properties
Well-established use
Traditional use
No data available.
Not required as per Article 16c(1)(a)(iii) of
Directive 2001/83/EC as amended.
5.3.
Preclinical safety data
Well-established use
Traditional use
α-Hederin, ß-hederin and δ-hederin isolated from
ivy leaf showed no mutagenic potential in the
Ames test using
Salmonella typhimurium
strain TA
98, with or without S9 activation.
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.
α-Hederin, ß-hederin and δ-hederin isolated from
ivy leaf showed no mutagenic potential in the
Ames test using
Salmonella typhimurium
strain TA
98, with or without S9 activation.
Data on genotoxicity, carcinogenicity and
reproductive toxicity testing for ivy leaf
preparations are not available.
Data on genotoxicity, carcinogenicity and
reproductive toxicity testing for ivy leaf
preparations are not available.
Well-established use
Traditional use
Not applicable.
Not applicable.
31 March 2011
Community herbal monograph on
Hedera helix
L., folium
EMA/HMPC/289430/2009
Page 6/6
Source: European Medicines Agency
- Please bookmark this page (add it to your favorites).
- If you wish to link to this page, you can do so by referring to the URL address below this line.
https://theodora.com/drugs/eu/hederae_helicis_folium_herbal.html
Copyright © 1995-2021 ITA all rights reserved.