22 May 2012
EMA/HMPC/337066/2011
Committee on Herbal Medicinal Products (HMPC)

Community herbal monograph on Tilia cordata Miller, Tilia
platyphyllos Scop., Tilia x vulgaris Heyne or their
mixtures, flos
Final

Discussion in Working Party on Community monographs and Community

May 2011

list (MLWP)

July 2011

Adoption by Committee on Herbal Medicinal Products (HMPC) for release

13 September 2011

for consultation
End of consultation (deadline for comments). Comments should be

15 February 2012provided using this template to hmpc.secretariat@ema.europa.eu
Rediscussion in Working Party on Community monographs andMarch 2012

Community list (MLWP)
Adoption by Committee on Herbal Medicinal Products (HMPC)
Keywords

22 May 2012

Herbal medicinal products; HMPC; Community herbal monographs; traditionaluse; Tilia cordata Miller, Tila platyphyllos Scop., Tilia x vulgaris Heyne or their
mixtures, flos; Tiliae flos; Lime flower

BG (bălgarski): Липа, цвятLT (lietuvių kalba):CS (čeština): Lipový květLV (latviešu valoda): Liepu ziedi

DA (dansk): Lindeblomst

MT (malti):DE (Deutsch): Lindenblüten

NL (nederlands): Lindebloesem

EL (elliniká): Άνθος φιλλύραςPL (polski): Kwiat lipy

EN (English): Lime flower

PT (português): Tília, flor

ES (espanol): Tilo, flor deRO (română): Floare de tei

ET (eesti keel): PärnaõisSK (slovenčina): Lipový kvet

FI (suomi): Hopealehmus, kukka

SL (slovenščina): Cvet lipe

FR (français): Tilleul (fleur de)

SV (svenska): Lindblomma

HU (magyar): HársfavirágzatIS (íslenska):

IT (italiano): Tiglio fiore

NO (norsk): Lindeblomst

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Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7051
E-mail info@ema.europa.eu Website www.ema.europa.eu

An agency of the European Union© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

Community herbal monograph on Tilia cordata Miller, Tilia
platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures,flos
1. Name of the medicinal productTo be specified for the individual finished product.

2. Qualitative and quantitative composition 1,2Well-established use

Traditional use
With regard to the registration application of Article
16d(1) of Directive 2001/83/EC as amended
Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x
vulgaris Heyne or their mixtures, flos (lime flower)i) Herbal substanceNot applicable.

ii) Herbal preparationsa) Comminuted herbal substanceb) Liquid extract (DER 1:1), extraction
solvent ethanol 25% V/Vc)

Tincture (ratio of herbal substance to extraction
solvent 1:5), extraction solvent ethanol 45% V/V

3. Pharmaceutical form
Well-established use

Traditional use
Comminuted herbal substance as herbal tea for oral
use.
Herbal preparations in liquid dosage forms for oraluse.
The pharmaceutical form should be described by theEuropean 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.: 01/2008:0957).

Community herbal monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos
EMA/HMPC/337066/2011

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4. Clinical particulars
4.1. Therapeutic indications
Well-established use

Traditional use
Indication 1)
Traditional herbal medicinal product used for therelief of symptoms of common cold.
Indication 2)
Traditional herbal medicinal product for the reliefof mild symptoms of mental stress.
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 3
Well-established use

Traditional use
Posology
Adolescents, Adults and Elderly
Indications 1) and 2)a) Comminuted herbal substanceSingle doseHerbal tea: 1.5 g of the comminuted herbal
substance in 150 ml of boiling water as a herbal
infusion 2–4 times daily.
Daily dose: 3-6 gb) Liquid extract
Single dose: 2 ml, 1-2 times daily
Daily dose: 2-4 mlc) Tincture
Single dose: 1 ml, 1-2 times daily
Daily dose: 1-2 ml

3For 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).

Community herbal monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos
EMA/HMPC/337066/2011

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Well-established use

Traditional use
Indication 1)
Children between 4 and 12 years of agea) Comminuted herbal substanceSingle dose
Herbal tea: 1 g of the comminuted herbal
substance in 150 ml of boiling water as a herbal
infusion 2–4 times daily.
Daily dose: 2-4 g
The use in children under 4 years of age is notrecommended (see section 4.4 ‘Special warnings
and precautions for use’).
Indication 2)
The use in children under 12 years of age is notrecommended (see section 4.4 ‘Special warnings
and precautions for use’).

Duration of use
Indication 1)
The therapy should start at first signs of common
cold.
If the symptoms persist longer than 1 weekduring the use of the medicinal product, a doctor
or a qualified health care practitioner should beconsulted.
Indication 2)
If the symptoms persist during the use of themedicinal product, a doctor or a qualified healthcare practitioner should be consulted.
Method of administration
Oral use.

4.3. Contraindications
Well-established use

Traditional use
Hypersensitivity to the active substance.

Community herbal monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos
EMA/HMPC/337066/2011

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4.4. Special warnings and precautions for use
Well-established use

Traditional use
For tinctures and extracts containing ethanol, theappropriate labelling for ethanol, taken from the‘Guideline on excipients in the label and package
leaflet of medicinal products for human use’, must
be included.
Indication 1)
The use in children under 4 years of age has notbeen established due to lack of adequate data.
Indication 2)
The use in children under 12 years of age has notbeen established due to lack of adequate data.
Indication 1)
If the symptoms worsen during the use of the
medicinal product or if dyspnoea, high fever or
purulent sputum occurs, a doctor or a qualified
health care practitioner should be consulted.

4.5. Interactions with other medicinal products and other forms ofinteraction
Well-established use

Traditional use
None reported.

4.6. Fertility, pregnancy and lactation
Well-established use

Traditional use
No fertility data available.
Safety during pregnancy and lactation has notbeen established. In the absence of sufficientdata, 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 anduse machines have been performed.

Community herbal monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos
EMA/HMPC/337066/2011

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4.8. Undesirable effects
Well-established use

Traditional use
None known.
If adverse reactions occur, a doctor or a qualified
health care practitioner should be consulted.

4.9. Overdose
Well-established use

Traditional use
No case of overdose has been reported.

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 data
Well-established useTraditional use
Not required as per Article 16c(1)(a)(iii) of
Directive 2001/83/EC as amended, unlessnecessary for the safe use of the product.
Adequate tests on genotoxicity have not beenperformed.
Tests on reproductive toxicity and carcinogenicity
have not been performed.

6. Pharmaceutical particulars
Well-established use

Traditional use
Not applicable.

Community herbal monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos
EMA/HMPC/337066/2011

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7. Date of compilation/last revision
22 May 2012

Community herbal monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos
EMA/HMPC/337066/2011

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