Commission Decision
of 21 November 2008
establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
(notified under document number C(2008) 6933)
(Text with EEA relevance)
(2008/911/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, and in particular Article 16(f) thereof,
OJ L 311, 28.11.2001, p. 67.
Having regard to the opinions of the European Medicines Agency, formulated on 7 September 2007 by the Committee for Herbal Medicinal Products,
Whereas:
(1) Foeniculum vulgare Miller subsp. vulgare var. vulgare and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung comply with the requirements set out in Directive 2001/83/EC. Foeniculum vulgare Miller subsp. vulgare var. vulgare and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung can be considered as herbal substances, herbal preparations and/or combinations thereof.
(2) It is therefore appropriate to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products including the entry of Foeniculum vulgare Miller subsp. vulgare var. vulgare and the entry of Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung.
(3) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,
HAS ADOPTED THIS DECISION:

Article 1 A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products is established in Annex I.
Substituted by Commission Decision of 25 March 2010 on amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2010) 1867) (Text with EEA relevance) (2010/180/EU).
Article 2 The indications, the specified strengths and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product relevant for the herbal substances listed in Annex I are set out in Annex II.
Article 3 This Decision is addressed to the Member States.

ANNEX I List of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established in accordance with Article 16f of Directive 2001/83/EC as amended by Directive 2004/24/EC
Calendula officinalis L
Echinacea purpurea (L.) Moench
Eleutherococcus senticosus (Rupr. et Maxim.) Maxim
Foeniculum vulgare Miller subsp. vulgare var. vulgare (bitter fennel fruit)
Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung (sweet fennel fruit)
Hamamelis virginiana L., folium et cortex aut ramunculus destillatum
Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca , aetheroleum
Mentha x piperita L.
Pimpinella anisum L
Sideritis scardica Griseb., herba.
Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum
Valeriana officinalis L.
Vitis vinifera L., folium
Inserted by Commission Decision of 28 July 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2009) 5804) (Text with EEA relevance) (2010/28/EC).
Inserted by Commission Decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2009) 9703) (Text with EEA relevance) (2010/30/EU).
Inserted by Commission Implementing Decision of 28 November 2011 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2011) 7382) (Text with EEA relevance) (2011/785/EU).
Inserted by Commission Implementing Decision (EU) 2016/1659 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5748) (Text with EEA relevance).
Inserted by Commission Decision of 25 March 2010 on amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2010) 1867) (Text with EEA relevance) (2010/180/EU).
Inserted by Commission Implementing Decision (EU) 2018/134 of 24 January 2018 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2018) 218) (Text with EEA relevance).
Inserted by Commission Implementing Decision of 3 February 2012 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2012) 514) (Text with EEA relevance) (2012/67/EU).
Inserted by Commission Implementing Decision (EU) 2018/133 of 24 January 2018 amending Decision 2008/911/EC shing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2018) 213) (Text with EEA relevance).
Inserted by Commission Implementing Decision of 3 February 2012 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2012) 516) (Text with EEA relevance) (2012/68/EU).
ANNEX II

COMMUNITY LIST ENTRY ON CALENDULA OFFICINALIS L

Scientific name of the plant
Calendula officinalis L.

Botanical family
Asteraceae

Herbal substance
Calendula flower

Common name in all EU official languages of herbal substance
BG (bălgarski): Невен, цвят
CS (čeština): Měsíčkový květ
DA (dansk): Morgenfrueblomst
DE (Deutsch): Ringelblumenblüten
EL (elliniká): Άνθος καλέντουλας
EN (English): Calendula flower
ES (español): Flor de caléndula
ET (eesti keel): Saialilleõisik
FI (suomi): Tarhakehäkukan kukka
FR (français): Souci
HU (magyar): A körömvirág virága
IT (italiano): Calendula fiore
LT (lietuvių kalba): Medetkų žiedai
LV (latviešu valoda): Kliņģerītes ziedi
MT (malti): Fjura calendula
NL (nederlands): Goudsbloem
PL (polski): Kwiat nagietka
PT (português): Flor de calêndula
RO (română): Floare de gălbenele (calendula)
SK (slovenčina): Nechtíkový kvet
SL (slovenščina): Cvet vrtnega ognjiča
SV (svenska): Ringblomma, blomma
IS (íslenska): Morgunfrú, blóm
NO (norsk): Ringblomst

Herbal preparation(s)
A. Liquid extract (DER 1:1), extraction solvent ethanol 40-50 % (v/v).
B. Liquid extract (DER 1:1,8-2,2), extraction solvent ethanol 40-50 % (v/v).
C. Tincture (DER 1:5), extraction solvent ethanol 70-90 % (v/v).

European Pharmacopoeia monograph reference
Calendula flower – Calendulae flos (01/2005:1297)

Indication(s)
(a) Traditional herbal medicinal product for the symptomatic treatment of minor inflammations of the skin (such as sunburn) and as an aid in healing of minor wounds.
(b) Traditional herbal medicinal product for the symptomatic treatment of minor inflammations in the mouth or the throat.
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

Type of tradition
European

Specified strength
Please see ‘ Specified posology ’ .

Specified posology
Herbal preparations:
A. Liquid extract (DER 1:1)
In semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.
B. Liquid extract (DER 1:1,8-2,2)
In semi-solid dosage forms: amount equivalent to 2-5 % herbal substance.
C. Tincture (DER 1:5)
In compresses diluted at least 1:3 with freshly boiled water.
In semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.
As a gargle or mouth rinse in a 2 % solution.
2 to 4 times daily
Indication (a)
The use is not recommended in children under 6 years of age (see below ‘ Special warnings and precautions for use ’ ).
Indication (b)
The use in children under 12 years of age is not recommended because there is no experience available (see below ‘ Special warnings and precautions for use ’ ).

Route of administration
Cutaneous and oromucosal use.

Duration of use or any restrictions on the duration of use
Compresses: remove after 30-60 minutes
All herbal preparations: If the symptoms persist after 1 week during the use of the medicinal product a doctor or a qualified health care practitioner should be consulted.

Any other information necessary for the safe use

Contraindications
Hypersensitivity to members of the Asteraceae ( Compositae ) family.

Special warnings and precautions for use
Indication (a)
The use in children under 6 years of age is not recommended because there is no experience available.
Indication (b)
The use in children under 12 years of age is not recommended because there is no experience available.
If signs of skin infection are observed, a doctor or a qualified health care practitioner should be consulted.

Interactions with other medicinal products and other forms of interaction
None reported.

Pregnancy and lactation
Safety during pregnancy and lactation has not been established.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Effects on ability to drive and use machines
Not relevant.

Undesirable effects
Skin sensitisation. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

Overdose
None reported.

COMMUNITY LIST ENTRY ON ECHINACEA PURPUREA (L.) MOENCH, HERBA RECENS

Scientific name of the plant
Echinacea purpurea (L.) Moench

Botanical family
Asteraceae

Herbal substance
Purple coneflower herb

Common name in all EU official languages of herbal substance
BG (bălgarski): пурпурна ехинацея, пресен стрък
CS (čeština): čerstvá nať třapatky nachové
DA (dansk): Purpursolhat, frisk urt
DE (Deutsch): Purpursonnenhutkraut, frisch
EL (elliniká): Πόα Εχινάκεας της πορφυράς
EN (English): purple coneflower herb
ES (español): Equinácea purpúrea, partes aéreas incluidas sumidades floridas
ET (eesti keel): punane siilkübar
FI (suomi): kaunopunahattu, tuore verso
FR (français): parties aériennes fraîches d’échinacée pourpre
HU (magyar): bíbor kasvirág virágos hajtása
IT (italiano): Echinacea purpurea, pianta fresca
LT (lietuvių kalba): rausvažiedžių ežiuolių žolė
LV (latviešu valoda): purpursarkanās ehinacejas laksti
MT (malti): Echinacea Vjola
NL (nederlands): rood zonnehoedkruid
PL (polski): jeżówka purpurowa, świeże ziele
PT (português): Equinácea, partes aéreas floridas
RO (română): iarbã proaspãtã de Echinacea, pãlãria soarelui
SK (slovenčina): echinacea purpurová, čerstvá vňať
SL (slovenščina): sveža zel škrlatne ehinaceje
SV (svenska): röd solhatt, färsk ört
IS (íslenska): Sólhattur
NO (norsk): Rød solhatt

Herbal preparation(s)
Expressed juice and dried expressed juice from fresh flowering aerial parts.

European Pharmacopoeia monograph reference
N/A

Indication(s)
Traditional herbal medicinal product for treatment of small superficial wounds.
The product is a traditional herbal medicinal product for use in a specified indication exclusively based on long-standing use.

Type of tradition
European.

Specified strength
10 to 20 g/100 g of expressed juice or equivalent amount of dried expressed juice in liquid or semi-solid dosage forms.

Specified posology
Adolescents over the age of 12 years, adults, elderly
Small amount of ointment is applied on the affected area 2-3 times a day.
The use in children under 12 years of age is not recommended (see below ‘ Special warnings and precautions for use ’ ).

Route of administration
Cutaneous use.

Duration of use or any restrictions on the duration of use
Do not use the medicinal product for more than 1 week.
If the symptoms persist during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

Any other information necessary for the safe use

Contra-indications
Hypersensitivity to the active substance or to plants of the Asteraceae (Compositae) family.

Special warnings and precautions for use
If signs of skin infection are observed, medical advice should be sought.
The use in children below 12 years of age is not recommended because a safe use has not been sufficiently documented.

Interactions with other medicinal products and other forms of interaction
None reported.

Pregnancy and lactation
There are no data on cutaneous use during pregnancy or lactation.
Products containing Echinacea should not be applied to the breast of breastfeeding women.

Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects
Hypersensitive reactions (local rash, contact dermatitis, eczema and angioedema of the lips) may occur.
The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

Overdose
No case of overdose has been reported.

COMMUNITY LIST ENTRY ON ELEUTHEROCOCCUS SENTICOSUS (RUPR. ET MAXIM.) MAXIM., RADIX

Scientific name of the plant
Eleutherococcus senticosus (Rupr. et Maxim.) Maxim.

Botanical family
Araliaceae

Herbal substance
Eleutherococcus root

Common name in all EU official languages of herbal substance
BG (bălgarski): елеутерокок, корен
CS (čeština): eleuterokokový kořen
DA (dansk): Russisk rod
DE (Deutsch): Taigawurzel
EL (elliniká): Pίζα Eλευθεροκόκκου
EN (English): Eleutherococcus root
ES (español): Eleuterococo, raíz de
ET (eesti keel): eleuterokokijuur
FI (suomi): venäjänjuuren juuri
FR (français): racine d’éleuthérocoque (racine de ginseng sibérien)
HR (hrvatska): Korijen sibirskog ginsenga
HU (magyar): Szibériai ginszeng gyökér (tajga gyökér)
IT (italiano): Eleuterococco radice
LT (lietuvių kalba): Eleuterokokų šaknys
LV (latviešu valoda): Eleiterokoka sakne
MT (malti): Għerq ta’ l-elewterokokku
NL (nederlands): Russische ginsengwortel
PL (polski): korzeń eleuterokoka
PT (português): Raiz de Ginseng Siberiano
RO (română): Rădăcină de ginseng siberian
SK (slovenčina): Koreň eleuterokoka
SL (slovenščina): korenina elevterokoka
SV (svenska): Rysk rot
IS (íslenska): Síberíu ginseng, rót
NO (norsk): Russisk rot
Inserted by Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance).
Substituted by Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance).

Herbal preparation(s)
Comminuted herbal substance
Liquid extract (DER 1:1, extraction solvent ethanol 30-40 % v/v)
Dry extract (DER 13-25:1, extraction solvent ethanol 28-40 % v/v)
Dry extract (17-30: 1, ethanol 70 % v/v)
Dry aqueous extract (DER 15-17:1)
Tincture (ratio of herbal substance to extraction solvent 1:5, extraction solvent ethanol 40 % v/v)

European Pharmacopoeia monograph reference
Eleutherococcus — Eleutherococci radix (ref.: 01/2008: 1419 corrected 7.0 )

Indication(s)
Traditional herbal medicinal product for symptoms of asthenia such as fatigue and weakness.
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

Type of tradition
European, Chinese.

Specified strength
Please see ‘ Specified posology ’ .

Specified posology
Adolescents over 12 years of age , adults, elderly
Herbal preparations.
Average daily dose.
Comminuted herbal substance as herbal tea: 0,5-4 g.
Tea preparation: 0,5 to 4 g of comminuted herbal substance for infusion in 150 ml of boiling water.
Dosage frequency: 150 ml of tea infusion should be divided in one to three doses taken during the day.
Liquid extract: 2-3 ml.
Dry extracts (ethanol 28-70 % v/v) corresponding to 0,5-4 g dried root.
Dry aqueous extract (15-17:1): 90-180 mg.
Tincture: 10-15 ml.
The daily dose can be taken in one to three doses.
The use in children under 12 years of age is not recommended (see below ‘Special warnings and precautions for use’).
Deleted by Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance).

Route of administration
Oral use.

Duration of use or any restrictions on the duration of use
Not to be taken for more than 2 months.
If the symptoms persist for more than 2 weeks during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

Any other information necessary for the safe use

Contraindication
Hypersensitivity to the active substance.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Special warnings and precautions for use
The use in children under 12 years of age is not recommended due to lack of adequate data.
If the symptoms worsen during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted. For tinctures and 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.

Interactions with other medicinal products and other forms of interaction
None reported.

Fertility, pregnancy and lactation
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.

Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects
Insomnia, irritability, tachycardia and headaches may 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.

Overdose
No case of overdose has been reported.

Pharmaceutical particulars (if necessary)
Not applicable.

Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)
Not applicable.

A. COMMUNITY LIST ENTRY ON FOENICULUM VULGARE MILLER SUBSP. VULGARE VAR. VULGARE, FRUCTUS

Scientific name of the plant
Foeniculum vulgare Miller subsp. vulgare var. vulgare

Botanical family
Apiaceae

Herbal substance
Fennel, bitter

Common name in all EU official languages of herbal substance
BG (bălgarski): Горчиво резене, плод
CS (čeština): Plod fenyklu obecného pravého
DA (dansk): Fennikel, bitter
DE (Deutsch): Bitterer Fenchel
EL (elliniká): Μαραθόσπορος πικρός
EN (English): Bitter fennel, fruit
ES (español): Hinojo amargo, fruto de
ET (eesti keel): Mõru apteegitill, vili
FI (suomi): Karvasfenkoli, hedelmä
FR (français): Fruit de fenouil amer
HU (magyar): Keserűédeskömény-termés
IT (italiano): Finocchio amaro (o selvatico), frutto
LT (lietuvių kalba): Karčiųjų pankolių vaisiai
LV (latviešu valoda): Rūgtā fenheļa augļi
MT (malti): Bużbież morr, frotta
NL (nederlands): Venkelvrucht, bitter
PL (polski): Owoc kopru włoskiego (odmiana gorzka)
PT (português): Fruto de funcho amargo
RO (română): Fruct de fenicul amar
SK (slovenčina): Feniklový plod horký
SL (slovenščina): Plod grenkega navadnega komarčka
SV (svenska): Bitterfänkål, frukt
IS (íslenska): Bitur fennel aldin
NO (norsk): Fenikkel, bitter

Herbal preparation(s)
Fennel, bitter, dried comminuted fruit.
‘Comminuted fruit’ is intended to cover also ‘crushed fruit’.

European Pharmacopoeia monograph reference
Foeniculi amari fructus (01/2005:0824).

Indication(s)
(a) Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.
(b) Traditional herbal medicinal product for symptomatic treatment of minor spasm associated with menstrual periods.
(c) 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.

Type of tradition
European, Chinese.

Specified strength
Please see ‘Specified posology’.

Specified posology

Adults
Single dose
1,5 to 2,5 g of (freshly) comminuted fennel fruits with 0,25 l of boiling water (brew for 15 minutes) three times daily as a herbal tea.
For commercial preparation of comminuted fennel fruits the applicant must carry out appropriate stability testing related to the content of essential oil components.

Adolescents over 12 years of age, indication (a)
Adult dose

Children between four and 12 years of age, indication (a)
Average daily dose
3-5 g of (freshly) comminuted fruits as a herbal tea, in three divided doses, for short-term use in mild transitory symptoms only (less than one week).
The use in children under four years of age is not recommended (see section ‘Special warnings and precautions for use’).

Route of administration
Oral use.

Duration of use or any restrictions on the duration of use

Adults

Adolescents over 12 years of age, indication (a)
Not to be taken for more than two weeks.

Children between four and 12 years of age, indication (a)
For short-term use in mild transitory symptoms only (less than one week).
If the symptoms persist during the use of the medicinal product, a doctor or a qualified health-care practitioner should be consulted.

Any other information necessary for the safe use

Contraindications
Hypersensitivity to the active substance or to Apiaceae (Umbelliferae) (aniseed, caraway, celery, coriander and dill) or to anethole.

Special warnings and precautions for use
The use in children under four years of age is not recommended due to the lack of adequate data and a paediatrician’s advice should be sought.

Interactions with other medicinal products and other forms of interaction
None reported.

Pregnancy and lactation
There are no data from the use of fennel fruit in pregnant patients.
It is unknown if fennel constituents are excreted in human breast milk.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects
Allergic reactions to fennel, affecting the skin or the respiratory system may 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.

Overdose
No case of overdose has been reported.

Pharmaceutical particulars (if necessary)
Not applicable.

Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)
Not applicable.

B. COMMUNITY LIST ENTRY ON FOENICULUM VULGARE MILLER SUBSP. VULGARE VAR. DULCE (MILLER) THELLUNG, FRUCTUS

Scientific name of the plant
Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung

Botanical family
Apiaceae

Herbal substance
Fennel, sweet

Common name in all EU official languages of herbal substance
BG (bălgarski): Сладко резене, плод
CS (čeština): Plod fenyklu obecného sladkého
DA (dansk): Fennikel, sød
DE (Deutsch): Süßer Fenchel
EL (elliniká): Μαραθόσπορος γλυκύς
EN (English): Sweet fennel, fruit
ES (español): Hinojo dulce, fruto de
ET (eesti keel): Magus apteegitill, vili
FI (suomi): Makea fenkoli, hedelmä
FR (français): Fruit de fenouil doux
HU (magyar): Édesköménytermés
IT (italiano): Finocchio dolce (o romano), frutto
LT (lietuvių kalba): Saldžiųjų pankolių vaisiai
LV (latviešu valoda): Saldā fenheļa augļi
MT (malti): Bużbież ħelu, frotta
NL (nederlands): Venkelvrucht, zoet
PL (polski): Owoc kopru włoskiego (odmiana słodka)
PT (português): Fruto de funcho doce
RO (română): Fruct de fenicul dulce
SK (slovenčina): Feniklový plod sladký
SL (slovenščina): Plod sladkega navadnega komarčka
SV (svenska): Sötfänkål, frukt
IS (íslenska): Sæt fennel aldin
NO (norsk): Fenikkel, søt

Herbal preparation(s)
Fennel, sweet, dried comminuted or powdered fruit.
‘Comminuted fruit’ is intended to cover also ‘crushed fruit’.

European Pharmacopoeia monograph reference
Foeniculi dulcis fructus (01/2005:0825).

Indication(s)
(a) Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.
(b) Traditional herbal medicinal product for symptomatic treatment of minor spasm associated with menstrual periods.
(c) 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.

Type of tradition
European, Chinese.

Specified strength
Please see ‘Specified posology’.

Specified posology

Adults
Single dose
1,5 to 2,5 g of (freshly) comminuted fennel fruits with 0,25 l of boiling water (brew for 15 minutes) three times daily as a herbal tea.
For commercial preparation of comminuted or powdered fennel fruits the applicant must carry out appropriate stability testing related to the content of essential oil components.
Fennel powder: 400 mg three times a day (with a maximum of 2 g daily).

Adolescents over 12 years of age, indication (a)
Adult dose

Children between four and 12 years of age, indication (a)
Average daily dose
3-5 g of (freshly) comminuted fruits as a herbal tea, in three divided doses, for short-term use in mild transitory symptoms only (less than one week).
The use in children under four years of age is not recommended (see section ‘Special warnings and precautions for use’).

Route of administration
Oral use.

Duration of use or any restrictions on the duration of use

Adults

Adolescents over 12 years of age, indication (a)
Not to be taken for more than two weeks.

Children between four and 12 years of age, indication (a)
For short-term use in mild transitory symptoms only (less than one week).
If the symptoms persist during the use of the medicinal product, a doctor or a qualified health-care practitioner should be consulted.

Any other information necessary for the safe use

Contraindications
Hypersensitivity to the active substance or to Apiaceae (Umbelliferae) (aniseed, caraway, celery, coriander and dill) or to anethole.

Special warnings and precautions for use
The use in children under four years of age is not recommended due to the lack of adequate data and a paediatrician’s advice should be sought.

Interactions with other medicinal products and other forms of interaction
None reported.

Pregnancy and lactation
There are no data from the use of fennel fruit in pregnant patients.
It is unknown if fennel constituents are excreted in human breast milk.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects
Allergic reactions to fennel, affecting the skin or the respiratory system, may 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.

Overdose
No case of overdose has been reported.

Pharmaceutical particulars (if necessary)
Not applicable.

Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)
Not applicable.

COMMUNITY LIST ENTRY ON HAMAMELIS VIRGINIANA L., FOLIUM ET CORTEX AUT RAMUNCULUS DESTILLATUM

Scientific name of the plant
Hamamelis virginiana L.

Botanical family
Hamamelidaceae

Herbal preparation(s)
1. Distillate prepared from fresh leaves and bark (1:1.12 – 2.08; extraction solvent ethanol 6 % m/m)
2. Distillate prepared from dried twigs (1:2; extraction solvent ethanol 14-15 %)
According to USP (USP-31- NF 26, 2008 Vol 3:3526).

European pharmacopoeia monograph reference
Not applicable

Indication(s)

Indication (a)
Traditional herbal medicinal product for relief of minor skin inflammation and dryness of the skin.

Indication (b)
Traditional herbal medicinal product to be used for the temporary relief of eye discomfort due to dryness of the eye or to exposure to wind or sun.
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

Type of tradition
European

Specified strength
Please see ‘ Specified posology ’ .

Specified posology

Children over six years of age, adolescents, adults and elderly

Indication (a)
Distillate in a strength corresponding to 5-30 % in semi-solid preparations, several times daily.
The use in children under six years of age is not recommended (see section ‘ Special warnings and precautions for use ’ ).

Adolescents, adults and elderly

Indication (b)
Eye drops Distillate (2) diluted (1:10), 2 drops/each eye, 3-6 times daily.
The medicinal product complies with the Ph. Eur. monograph on eye preparations (01/2008:1163).
The use in children under 12 years of age is not recommended (see section ‘ Special warnings and precautions for use ’ ).

Route of administration
Cutaneous use.
Ocular use.

Duration of use or any restrictions on the duration of use

Children over six years of age, adolescents, adults and elderly

Indication (a)
If the symptoms persist longer than two weeks during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

Adolescents, adults and elderly

Indication (b)
The recommended duration of use is four days. If the symptoms persist longer than two days during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

Any other information necessary for the safe use

Contraindications
Hypersensitivity to the active substance.

Special warnings and precautions for use

Indication (a)
The use in children under six years of age has not been established due to lack of adequate data.

Indication (b)
If eye pain, changes in vision, continued redness, or irritation of the eye is experienced, or if the condition worsens or persists for more than 48 hours during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
The use in children under 12 years of age has not been established due to lack of adequate data.
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.

Interactions with other medicinal products and other forms of interaction
None reported.

Pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects

Indication (a)
Allergic contact dermatitis may occur in sensitive patients. The frequency is not known.

Indication (b)
Conjunctivitis cases have been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

Overdose
No case of overdose has been reported.

Pharmaceutical particulars [if necessary]
Not applicable.

Pharmacological effects or efficacy plausible on the basis of long-standing use and experience [if necessary for the safe use of the product]
Not applicable.

UNION LIST ENTRY ON MELALEUCA ALTERNIFOLIA (MAIDEN AND BETCH) CHEEL, M. LINARIIFOLIA SMITH, M. DISSITIFLORA F. MUELLER AND/OR OTHER SPECIES OF MELALEUCA , AETHEROLEUM

Scientific name of the plant
Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and other species of Melaleuca

Botanical family
Myrtaceae

Common name in all EU official languages of herbal preparation
BG (bălgarski): Чаено дърво, масло CS (čeština): silice kajeputu střídavolistého DA (dansk): Tetræolie DE (Deutsch): Teebaumöl EL (elliniká): Μελαλεύκης αιθέριο έλαιο EN (English): Tea tree oil ES (español): Melaleuca alternifolia, aceite esencial de ET (eesti keel): teepuuõli FI (suomi): teepuuöljy FR (français): Mélaleuca (arbre à thé) (huile essentielle de) HR (hrvatska): eteričnog ulje australijskog čajevca HU (magyar): Teafa-olaj	IT (italiano): Melaleuca essenza LT (lietuvių kalba): Arbatmedžių eterinis aliejus LV (latviešu valoda): Tējaskoka ēteriskā eļļa MT (Malti): Żejt tal-Melaleucae NL (Nederlands): Theeboomolie PL (polski): Olejek eteryczny drzewa herbacianego PT (português): Óleo esencial de melaleuca RO (română): Melaleuca (arbore de ceai) (ulei esențial) SK (slovenčina): Silica melaleuky SL (slovenščina): eterično olje melalevke SV (svenska): Teträdsolja NO (norsk): Tetreolje

Herbal preparation
Essential oil

European Pharmacopoeia monograph reference
01/2008:1837

Indications

Indication (a)
Traditional herbal medicinal product for treatment of small superficial wounds and insect bites.

Indication (b)
Traditional herbal medicinal product for treatment of small boils (furuncles and mild acne).

Indication (c)
Traditional herbal medicinal product for the relief of itching and irritation in cases of mild athlete's foot.

Indication (d)
Traditional herbal medicinal product for symptomatic treatment of minor inflammation of the oral mucosa.
The product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use.

Type of tradition
European.

Specified strength
Please see ‘ Specified posology ’ .

Specified posology

Indication (a)

Adolescents, adults and elderly

Single dose
0,03-0,07 ml of undiluted essential oil to be applied to the affected area using a cotton bud 1-3 times daily.
Liquid preparations containing 0,5 % to 10 % of essential oil to be applied to the affected area 1-3 times daily.

Indication (b)

Adolescents, adults and elderly

Single dose
Oily liquid or semi-solid preparations containing 10 % of essential oil to be applied to the affected area 1-3 times daily, or
0,7-1 ml of essential oil stirred into 100 ml of lukewarm water to be applied as an impregnated dressing to the affected areas of skin. Undiluted essential oil to be applied to the boil using a cotton bud 2-3 times daily.

Indication (c)

Adolescents, adults and elderly

Single dose
Oily liquid or semi-solid preparations containing 10 % of essential oil to be applied on the affected area 1-3 times daily. 0,17-0,33 ml of essential oil in an appropriate volume of warm water to cover the feet. Soak feet for 5-10 minutes daily.
Undiluted essential oil to be applied to the affected area using a cotton bud 2-3 times daily.

Indication (d)

Adolescents, adults and elderly
0,17-0,33 ml of essential oil to be mixed in 100 ml of water for rinse or gargle several times daily.
The use in children under 12 years of age is not recommended (see section ‘ Special warnings and precautions for use ’ ).

Route of administration

Indications (a), (b) and (c)
Cutaneous use

Indication (d)
Oromucosal use.

Duration of use or any restrictions on the duration of use

Indication (a)
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.

Indications (b) and (c)
Not to be used for more than 1 month.
If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Indication (d)
If the symptoms persist longer than 5 days during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Any other information necessary for the safe use

Contraindications
Hypersensitivity to the active substance or to colophony.

Special warnings and precautions for use
The use in children under 12 years of age has not been established due to lack of adequate data.
If a rash develops, discontinue use.
Not to be used orally or as inhalation.
Not to be used in eyes or ears.
If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Indication (a)
If fever or signs of exacerbating skin infection are observed, a doctor or a qualified health care practitioner should be consulted.

Indication (b)
In cases of severe acne a doctor or a qualified health care practitioner shall be consulted.

Indication (c)
For the eradication of fungal infection a doctor or a qualified health care practitioner shall be consulted.

Indication (d)
Not to be swallowed.

Interactions with other medicinal products and other forms of interaction
None reported.

Fertility, pregnancy and lactation
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.

Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects
Adverse skin reactions including smarting pain, mild pruritus, burning sensation, irritation, itching, stinging, erythema, oedema (contact dermatitis) or other allergic reactions have been reported. The frequency is not known.
Burn-like skin reactions have been reported. The frequency is rare (< 1/ 1 000 ).
If other adverse reactions not mentioned occur, a doctor or a qualified health care practitioner should be consulted.

Overdose
Cutaneous use:
None reported.
Oromucosal use:
Accidental overdose may cause central nervous system depression and muscle weakness. However, in adults these symptoms generally resolve within 36 hours.
If ingestion occurs, the patient should be monitored and standard supportive treatment applied as required.
In children, ingestion of tea tree oil is a medical emergency requiring immediate hospital treatment and respiratory support.

Pharmaceutical particulars (if necessary)
Store in air-tight containers, protected from light and heat.
Proper storage and handling are needed to avoid the formation of oxidation products which have greater potential for skin sensitisation.

Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)
Not applicable.

COMMUNITY LIST ENTRY ON MENTHA x PIPERITA L., AETHEROLEUM

Scientific name of the plant
Mentha x piperita L.

Botanical family
Lamiaceae (Labiatae)

Herbal preparation(s)

Peppermint oil
essential oil obtained by steam distillation from the fresh aerial parts of the flowering plant

European Pharmacopoeia monograph reference
Peppermint oil — Menthae piperitae aetheroleum (01/2008:0405)

Indication(s)
Herbal medicinal product traditionally used:
1. for the relief of symptoms in coughs and colds;
2. for the symptomatic relief of localised muscle pain;
3. for the symptomatic relief of localised pruritic conditions in intact skin.
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

Type of tradition
European

Specified strength

Indications 1, 2 and 3
Single dose

Children between 4 to 10 years of age
Semi-solid preparations 2-10 %
Hydroethanolic preparations 2-4 %

Children between 10 to 12 years of age, adolescents between 12 to 16 years of age
Semi-solid preparations 5-15 %
Hydroethanolic preparations 3-6 %

Adolescents over 16 years of age, adults
Semi-solid and oily preparations 5-20 %
In aqueous-ethanol preparations 5-10 %
In nasal ointments 1-5 % essential oil.

Specified posology
Up to three times daily
The use in children under 2 years of age is contraindicated (see ‘ Contraindications ’ ).
The use is not recommended in children between 2 to 4 years of age (see ‘ Special warnings and precautions for use ’ ).

Route of administration
Cutaneous and transdermal.

Duration of use or any restrictions on the duration of use

Indication 1
Not to be used for more than 2 weeks.

Indications 2 and 3
It is not recommended to use the medicinal product continuously for more than 3 months.
If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Any other information necessary for the safe use

Contraindications
Children under 2 years of age, because menthol can induce reflex apnoea and laryngospasm.
Children with history of seizures (febrile or not).
Hypersensitivity to peppermint oil or menthol.

Special warnings and precautions for use
Eye contact with unwashed hands after the application of peppermint oil may potentially cause irritation.
Peppermint oil should not be applied on broken or irritated skin.
The use is not recommended in children between 2 to 4 years of age, as there is no sufficient experience available.

Interactions with other medicinal products and other forms of interaction
None reported.

Pregnancy and lactation
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects
Hypersensitivity reactions such as skin rash, contact dermatitis, and eye irritation have been reported. These reactions are most of the time mild and transient. The frequency is not known.
Irritation of the skin and mucosa of the nose is possible, after local application. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

Overdose
No case of overdose has been reported.

COMMUNITY LIST ENTRY ON PIMPINELLA ANISUM L

Scientific name of the plant
Pimpinella anisum L.

Botanical family
Apiaceae

Herbal substance
Aniseed

Common name in all EU official languages of herbal substance
BG (bălgarski): Анасон, плод
CS (čeština): Anýzový plod
DA (dansk): Anisfrø
DE (Deutsch): Anis
EL (elliniká): Γλυκάνισο
EN (English): Aniseed
ES (español): Fruto de anís
ET (eesti keel): Aniis
FI (suomi): Anis
FR (français): Anis (fruit d)
HU (magyar): Ánizsmag
IT (italiano): Anice (Anice verde), frutto
LT (lietuvių kalba): Anyžių sėklos
LV (latviešu valoda): Anīsa sēklas
MT (malti): Frotta tal-Anisi
NL (nederlands): Anijsvrucht
PL (polski): Owoc anyżu
PT (português): Anis
RO (română): Fruct de anason
SK (slovenčina): Anízový plod
SL (slovenščina): Plod vrtnega janeža
SV (svenska): Anis
IS (íslenska): Anís
NO (norsk): Anis

Herbal preparation(s)
Dried aniseed, comminuted or crushed

European Pharmacopoeia monograph reference
Anisi fructus (01/2005:0262)

Indication(s)
(a) Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.
(b) 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.

Type of tradition
European

Specified strength
Please see ‘ Specified posology ’

Specified posology
Adolescents over 12 years of age, adults, elderly :
Indications (a) and (b)
1 to 3,5 g of whole or (freshly ) comminuted or crushed aniseed in 150 ml of boiling water as a herbal tea
For commercial preparations of comminuted or crushed aniseed the applicant must carry out appropriate stability testing related to the content of essential oil components.
3 times daily
The use in children under 12 years is not recommended of age (see below ‘ Special warnings and precautions for use ’ ).

Route of administration
Oral use

Duration of use or any restrictions on the duration of use
Not to be taken for more than 2 weeks.
If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Any other information necessary for the safe use

Contraindications
Hypersensitivity to the active substance or to Apiaceae ( Umbelliferae ) (caraway, celery, coriander, dill and fennel) or to anethole.

Special warnings and precautions for use
The use is not recommended in children under 12 years of age due to the lack of adequate data for safety assessment.

Interactions with other medicinal products and other forms of interaction
None reported.

Pregnancy and lactation
There are no data from the use of aniseed in pregnant patients.
It is unknown if aniseed constituents are excreted in human breast milk.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects
Allergic reactions to aniseed affecting the skin or the respiratory system may occur. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitionerf should be consulted.

Overdose
No case of overdose has been reported.

UNION LIST ENTRY ON SIDERITIS SCARDIA GRISEB., HERBA
Scientific name of the plant	
Sideritis scardica Griseb.	
Botanical family	
Lamiaceae (Labiatae)	
Herbal substance	
Ironwort ( Sideritis herba )	
Common name in all EU official languages of herbal preparation	
BG (bălgarski): Мурсалски чай, стрък CS (čeština): nať hojníku DA (dansk): Kortkroneurt DE (Deutsch): Balkan-Gliedkraut EL (elliniká): Πόα σιδηρίτου EN (English): Ironwort ES (español): Siderita, partes aéreas de ET (eesti keel): haavarohuürt FI (suomi): raudakki, verso FR (français): Crapaudine (parties aériennes de) HR (hrvatska): očistova zelen HU (magyar): sármányvirág virágos hajtása IT (italiano): Stregonia parti aeree fiorite	LT (lietuvių kalba): Timsrų žolė LV (latviešu valoda): Siderītu laksts MT (Malti): ħaxixa tas-Sideritis NL (Nederlands): (Griekse) bergthee, kruid PL (polski): Ziele gojnika PT (português): Siderite, partes aéreas RO (română): iarba de ceaiul muntelui cretan SK (slovenčina): Vňať ránhoja SL (slovenščina): zel sklepnjaka SV (svenska): Sårmynta, ört IS (íslenska): NO (norsk): Gresk fjellte
Herbal preparations	
Comminuted herbal substance	
European Pharmacopoeia monograph reference	
Not applicable	
Indications	
Indication (1) Traditional herbal medicinal product used for the relief of cough associated with cold. Indication (2) Traditional herbal medicinal product used for the relief of mild gastrointestinal discomfort. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.	
Type of tradition	
European	
Specified strength	
Please see ‘Specified posology’.	
Specified posology	
Adults and elderly Indication (1) and (2) Single dose: Herbal tea: 2-4 g of the comminuted herbal substance in 150-200 ml of water as a herbal infusion 2-3 times daily Daily dose: up to 12 g The use in children and adolescents under 18 years of age is not recommended (see section ‘ Special warnings and precautions for use ’ )	
Route of administration	
Oral use	
Duration of use or any restrictions on the duration of use	
Indication (1) If 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 symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.	
Any other information necessary for the safe use	
Contraindications Hypersensitivity to the active substance and to other plants of the Lamiaceae (Labiatae) family. Special warnings and precautions for use The use in children and adolescents under 18 years of age has not been established due to lack of adequate data. If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Interactions with other medicinal products and other forms of interaction None reported Fertility, pregnancy and lactation Safety during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended. No fertility data available. Effects on ability to drive and use machines No studies on the effect on the ability to drive and use machines have been performed. Undesirable effects None known If adverse reactions occur, a doctor or qualified health care practitioner should be consulted. Overdose No case of overdose has been reported. Pharmaceutical particulars (if necessary) Not applicable Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product) Not applicable.	

COMMUNITY LIST ENTRY ON THYMUS VULGARIS L., THYMUS ZYGIS LOEFL. EX L., AETHEROLEUM

Scientific name of the plant
Thymus vulgaris L., Thymus zygis Loefl. ex L.

Botanical family
Lamiaceae

Herbal preparation(s)
Essential oil obtained by steam distillation from the fresh flowering aerial parts of Thymus vulgaris L., Thymus zygis Loefl. ex L. or a mixture of both species

European Pharmacopoeia monograph reference
01/2008:1374

Indication(s)
Traditional herbal medicinal product for the relief of symptoms in coughs and colds.
The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.

Type of tradition
European

Specified strength
Please see ‘ Specified posology ’

Specified posology

Adults and elderly
Cutaneous use: in liquid and semi-solid dosage forms in concentrations up to 10 %; apply up to 3 times daily.
Use as bath additive: 0,007-0,025 g per litre.

Adolescents
Use as bath additive: 0,007-0,025 g per litre

Children 6-12 years
Use as bath additive: 0,0035-0,017 g per litre

Children 3-6 years
Use as bath additive: 0,0017-0,0082 g per litre
One bath every day or every second day.
The cutaneous use in children and adolescents under 18 years of age is not recommended (see section ‘ Special warnings and precaution for use ’ ).
The use as bath additive in children under 3 years of age is not recommended (see section ‘ Special warnings and precaution for use ’ ).

Route of administration
Cutaneous use: apply to the chest and the back.
Use as a bath additive: recommended temperature of bath: 35-38 °C.

Duration of use or any restrictions on the duration of use
Duration of a bath: 10-20 minutes.
If the symptoms persist longer than 1 week, a doctor or a qualified health care practitioner should be consulted.

Any other information necessary for the safe use

Contraindications
Hypersensitivity to the active substance.

Use as bath additive:
Full baths are contraindicated in cases of open wounds, large skin injuries, acute skin diseases, high fever, severe infections, severe circulatory disturbances and cardiac insufficiency.

Special warnings and precautions for use

Cutaneous use:
Like other essential oils Thyme oil should not be applied to the face particularly in the nasal area of babies and infants under the age of 2 years because of the risk of a laryngospasm.
When dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.
The use in children and adolescents under 18 years of age is not recommended due to lack of adequate data.

Use as bath additive:
When dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.
The use in children under 3 years of age is not recommended because medical advice should be sought and due to lack of adequate data.
In cases of hypertension, a full bath should be used with caution.

Interactions with other medicinal products and other forms of interaction
None reported.

Pregnancy and lactation
Safety during pregnancy and lactation has not been established.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects
Hypersensitivity reactions and skin irritation have been observed. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

Overdose
No case of overdose has been reported.

Pharmaceutical particulars [If necessary]
Not applicable.

Pharmacological effects or efficacy plausible on the basis of long-standing use and experience [If necessary for the safe use of the product]
Not applicable.

UNION LIST ENTRY ON VALERIANA OFFICINALIS L.
Scientific name of the plant	
Valeriana officinalis L.	
Botanical family	
Valerianaceae	
Common name in all EU official languages of herbal preparation	
BG (bălgarski): Валериана, корен CS (čeština): kozlíkový kořen DA (dansk): Baldrianrod DE (Deutsch): Baldrianwurzel EL (elliniká): Ρίζα βαλεριανής EN (English): Valerian root ES (español): Valeriana, raíz de ET (eesti keel): palderjanijuur FI (suomi): rohtovirmajuuri, juuri FR (français): Valériane (racine de) HR (hrvatska): odoljenov korijen HU (magyar): Macskagyökér IT (italiano): Valeriana radice	LT (lietuvių kalba): Valerijonų šaknys LV (latviešu valoda): Baldriāna saknes MT (Malti): Għerq tal-Valerjana NL (Nederlands): Valeriaanwortel PL (polski): Korzeń kozłka PT (português): Valeriana, raiz RO (română): rădăcină de valeriană SK (slovenčina): Koreň valeriány SL (slovenščina): korenina zdravilne špajke SV (svenska): Vänderot, rot IS (íslenska): NO (norsk): Valerianarot
Herbal preparation(s)	
(a) Comminuted herbal substance (b) Powdered herbal substance (c) Expressed juice from fresh root (1:0,60-0,85) (d) Dry extract (DER 4-6:1), extraction solvent: water (e) Liquid extract (DER 1:4-6), extraction solvent: water (f) Dry extract (DER 4-7:1), extraction solvent: methanol 45 % (V/V) (g) Dry extract (DER 5,3-6,6:1), extraction solvent: methanol 45 % (m/m) (h) Liquid extract (DER 1:7-9), extraction solvent: sweet wine (i) Liquid extract (DER 1:1), extraction solvent: ethanol 60 % (V/V) (j) Tincture (ratio of herbal substance to extraction solvent 1:8), extraction solvent: ethanol 60 % (V/V) (k) Tincture (ratio of herbal substance to extraction solvent 1:10), extraction solvent: ethanol 56 % (l) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent: ethanol 70 % (V/V) (m) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent: ethanol 60-80 % (V/V) (n) Dry extract (DER 5,5-7,4:1), extraction solvent: ethanol 85 % (m/m)	
European Pharmacopoeia monograph reference	
04:2017:0453	
Indications	
Traditional herbal medicinal product for relief of mild symptoms of mental stress and to aid sleep. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.	
Type of tradition	
European.	
Specified strength	
Please see ‘Specified posology’.	
Specified posology	
Adolescents, adults and elderly Oral use (a) single dose: 0,3-3 g For relief of mild symptoms of mental stress up to 3 times daily. To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary. Herbal tea: 0,3-3 g of the comminuted herbal substance in 150 ml of boiling water as a herbal infusion (b) single dose: 0,3-2,0 g For relief of mild symptoms of mental stress up to 3 times daily. To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary. (c) single dose: 10 ml For relief of mild symptoms of mental stress up to 3 times daily. To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary. (d) single dose: 420 mg For relief of mild symptoms of mental stress up to 3 times daily. To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary. (e) single dose: 20 ml For relief of mild symptoms of mental stress up to 3 times daily. To aid sleep, a single dose half to one hour before bedtime. (f) single dose: 144-288 mg For relief of mild symptoms of mental stress up to 4 times daily. To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary. (g) single dose: 450 mg For relief of mild symptoms of mental stress up to 3 times daily. To aid sleep, a single dose half to one hour before bedtime with an earlier dose during the evening if necessary. (h) single dose: 10 ml, up to 3 times daily (i) single dose: 0,3-1,0 ml, up to 3 times daily (j) single dose: 4-8 ml, up to 3 times daily (k) single dose: 0,84 ml For relief of mild symptoms of mental stress 3-5 times daily. To aid sleep, a single dose half an hour before bedtime. (l) single dose: 1,5 ml (mental stress), 3 ml (to aid sleep) For relief of mild symptoms of mental stress up to 3 times daily. To aid sleep, a single dose half an hour before bedtime. (m) single dose: 10 ml, up to 3 times daily (n) single dose: 322 mg, up to 3 times daily Use as bath additive single dose: 100 g for a full bath, up to 1 bath daily	
Route of administration	
Oral use Use as bath additive. Temperature: 34-37 °C, duration of bath 10-20 minutes.	
Duration of use or any restrictions on the duration of use	
If symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.	
Any other information necessary for the safe use	
Contraindications Hypersensitivity to the active substance. Use as bath additive Full baths are contraindicated in cases of open wounds, large skin injuries, acute skin diseases, high fever, severe infections, severe circulatory disturbances and cardiac insufficiency. Special warnings and precautions for use The use in children under 12 years of age has not been established due to lack of adequate data. If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. For tinctures and 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. Interactions with other medicinal products and other forms of interaction None reported Fertility, pregnancy and lactation Safety during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended. No fertility data available. Effects on ability to drive and use machines May impair ability to drive and use machines. Affected patients should not drive or operate machinery. Undesirable effects Oral use Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of valerian root preparations. The frequency is not known. If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted. Use as bath additive None known If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted. Overdose Oral use Valerian root at a dose of approximately 20 g caused symptoms, such as fatigue, abdominal cramp, chest tightness, light-headedness, hand tremor and mydriasis, which disappeared within 24 hours. If symptoms arise, treatment should be supportive. Use as bath additive No case of overdose has been reported. Pharmaceutical particulars [If necessary] Not applicable Pharmacological effects or efficacy plausible on the basis of long-standing use and experience [If necessary for the safe use of the product] Not applicable.	

COMMUNITY LIST ENTRY ON VITIS VINIFERA L., FOLIUM

Scientific name of the plant
Vitis vinifera L.

Botanical family
Vitaceae

Herbal substance
Grapevine leaf
The material complies with the monograph of the Pharmacopée Française X., 1996.

Common name of herbal substance in all EU official languages
BG (bălgarski): лоза, лист
CS (čeština): Červený list vinné révy
DA (dansk): Vinblad
DE (Deutsch): Rote Weinrebenblätter
EL (elliniká): Φύλλο Αμπέλου
EN (English): Grapevine leaf
ES (español): Vid, hoja de
ET (eesti keel): Viinapuu lehed
FI (suomi): Aitoviiniköynnös, lehti
FR (français): Feuille de vigne rouge
HU (magyar): Bortermő szőlő levél
IT (italiano): Vite, foglia
LT (lietuvių kalba): Tikrųjų vynmedžių lapai
LV (latviešu valoda): Īstā vīnkoka lapas
MT (malti): Werqa tad-dielja
NL (nederlands): Wijnstokblad
PL (polski): Liść winorośli właściwej
PT (português): Folha de videira
RO (română): Frunze de viță-de-vie
SK (slovenčina): List viniča
SL (slovenščina): List vinske trte
SV (svenska): Blad från vinranka
IS (íslenska): Vínviðarlauf
NO (norsk): Rød vinranke, blad

Herbal preparation(s)
Soft extract (2.5-4:1; extraction solvent water)

European Pharmacopoeia monograph reference
Not applicable

Indication(s)
Traditional herbal medicinal product to relieve symptoms of discomfort and heaviness of legs related to minor venous circulatory disturbances.
The product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use.

Type of tradition
European

Specified strength
Please see ‘ Specified posology ’ .

Specified posology

Adults and elderly
Soft extract (2.5-4:1; extraction solvent water) in a cream base (10 g contain 282 mg soft extract).
Apply a thin layer on the affected area 1-3 times daily.
The use in children and adolescents under 18 years of age is not recommended (see section ‘ Special warnings and precautions for use ’ ).

Route of administration
Cutaneous use.

Duration of use or any restrictions on the duration of use

Adults and elderly
The recommended duration of use is 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.

Any other information necessary for the safe use

Contraindications
Hypersensitivity to the active substance.

Special warnings and precautions for use
If there is inflammation of the skin, thrombophlebitis or subcutaneous induration, severe pain, ulcers, sudden swelling of one or both legs, cardiac or renal insufficiency, a doctor should be consulted.
The product should not be used on broken skin, around the eyes or on mucous membranes.
In the absence of sufficient safety data, the use in children and adolescents below 18 years of age is not recommended.

Interactions with other medicinal products and other forms of interaction
None reported.

Pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects
Contact allergy and/or hypersensitivity reactions of the skin (itching and erythema, urticaria) have been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

Overdose
No case of overdose has been reported.

Pharmaceutical particulars (if necessary)
Not applicable.

Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)
Not applicable.