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)

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(1), and in particular Article 16(f) thereof,

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:

[F1Article 1 U.K.

A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products is established in Annex I.

Textual Amendments

Article 2 U.K.

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.]

Textual Amendments

Article 3U.K.

This Decision is addressed to the Member States.

ANNEX IU.K.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

  • [F2Calendula officinalis L]

  • [F3Echinacea 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)

  • [F4Hamamelis virginiana L., folium et cortex aut ramunculus destillatum]

  • [F5Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca , aetheroleum]

  • [F6Mentha x piperita L.]

  • [F2Pimpinella anisum L]

  • [F7Sideritis scardica Griseb., herba.]

  • [F8Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum]

  • [F9Valeriana officinalis L.]

  • [F10Vitis vinifera L., folium]

Textual Amendments

ANNEX IIU.K.

[F2COMMUNITY LIST ENTRY ON CALENDULA OFFICINALIS L U.K.

Scientific name of the plant U.K.

Calendula officinalis L.

Botanical family U.K.

Asteraceae

Herbal substance U.K.

Calendula flower

Common name in all EU official languages of herbal substance U.K.

  • 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) U.K.

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

European Pharmacopoeia monograph reference U.K.

Calendula flower – Calendulae flos (01/2005:1297)

Indication(s) U.K.

(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. U.K.
(b) Traditional herbal medicinal product for the symptomatic treatment of minor inflammations in the mouth or the throat. U.K.

The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

Type of tradition U.K.

European

Specified strength U.K.

Please see ‘ Specified posology ’ .

Specified posology U.K.

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 U.K.

Cutaneous and oromucosal use.

Duration of use or any restrictions on the duration of use U.K.

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 U.K.

Contraindications U.K.

Hypersensitivity to members of the Asteraceae ( Compositae ) family.

Special warnings and precautions for use U.K.

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 U.K.

None reported.

Pregnancy and lactation U.K.

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 U.K.

Not relevant.

Undesirable effects U.K.

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 U.K.

None reported.]

[F3COMMUNITY LIST ENTRY ON ECHINACEA PURPUREA (L.) MOENCH, HERBA RECENS U.K.

Scientific name of the plant U.K.

Echinacea purpurea (L.) Moench

Botanical family U.K.

Asteraceae

Herbal substance U.K.

Purple coneflower herb

Common name in all EU official languages of herbal substance U.K.

  • 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) U.K.

Expressed juice and dried expressed juice from fresh flowering aerial parts.

European Pharmacopoeia monograph reference U.K.

N/A

Indication(s) U.K.

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 U.K.

European.

Specified strength U.K.

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 U.K.

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 U.K.

Cutaneous use.

Duration of use or any restrictions on the duration of use U.K.

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 U.K.

Contra-indications U.K.

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

Special warnings and precautions for use U.K.

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 U.K.

None reported.

Pregnancy and lactation U.K.

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 U.K.

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

Undesirable effects U.K.

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 U.K.

No case of overdose has been reported.

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

Scientific name of the plant U.K.

Eleutherococcus senticosus (Rupr. et Maxim.) Maxim.

Botanical family U.K.

Araliaceae

Herbal substance U.K.

Eleutherococcus root

Common name in all EU official languages of herbal substance U.K.

  • 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)

  • [F11HR (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): [F12Koreň eleuterokoka]

  • SL (slovenščina): korenina elevterokoka

  • SV (svenska): Rysk rot

  • IS (íslenska): Síberíu ginseng, rót

  • NO (norsk): Russisk rot

Textual Amendments

Herbal preparation(s) U.K.

[F12Comminuted herbal substance]

[F12Liquid extract (DER 1:1, extraction solvent ethanol 30-40 % v/v)]

[F12Dry extract (DER 13-25:1, extraction solvent ethanol 28-40 % v/v)]

Dry extract (17-30: 1, ethanol 70 % v/v)

[F12Dry aqueous extract (DER 15-17:1)]

[F12Tincture (ratio of herbal substance to extraction solvent 1:5, extraction solvent ethanol 40 % v/v)]

European Pharmacopoeia monograph reference U.K.

Eleutherococcus — Eleutherococci radix (ref.: 01/2008: 1419 corrected [F127.0] )

Indication(s) U.K.

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 U.K.

[F12European, Chinese.]

Specified strength U.K.

[F12Please see ‘ Specified posology ’ .]

Specified posology U.K.

Adolescents [F13over 12 years of age] , adults, elderly

Textual Amendments

Herbal preparations.

[F12Average 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.

[F12The use in children under 12 years of age is not recommended] (see below ‘Special warnings and precautions for use’).

Route of administration U.K.

Oral use.

Duration of use or any restrictions on the duration of use U.K.

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 U.K.

[F12Contraindication] U.K.

Hypersensitivity to the active substance.

[ F13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Special warnings and precautions for use U.K.

[F12The 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. [F11For 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 U.K.

None reported.

[F12Fertility, pregnancy and lactation] U.K.

Safety during pregnancy and lactation has not been established.

In the absence of sufficient data, the use during pregnancy and lactation is not recommended. [F11No fertility data available.]

Effects on ability to drive and use machines U.K.

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

Undesirable effects U.K.

Insomnia, irritability, tachycardia and headaches may occur. The frequency is not known. [F11If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.]

Overdose U.K.

No case of overdose has been reported.

[F11Pharmaceutical particulars (if necessary) U.K.

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) U.K.

Not applicable.] ]

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

Scientific name of the plantU.K.

Foeniculum vulgare Miller subsp. vulgare var. vulgare

Botanical familyU.K.

Apiaceae

Herbal substanceU.K.

Fennel, bitter

Common name in all EU official languages of herbal substanceU.K.

  • 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)U.K.

Fennel, bitter, dried comminuted(2) fruit.

European Pharmacopoeia monograph referenceU.K.

Foeniculi amari fructus (01/2005:0824).

Indication(s)U.K.

(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 traditionU.K.

European, Chinese.

Specified strengthU.K.

Please see ‘Specified posology’.

Specified posologyU.K.

AdultsU.K.

Single dose

1,5 to 2,5 g of (freshly(3)) comminuted fennel fruits with 0,25 l of boiling water (brew for 15 minutes) three times daily as a herbal tea.

Adolescents over 12 years of age, indication (a)U.K.

Adult dose

Children between four and 12 years of age, indication (a)U.K.

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 administrationU.K.

Oral use.

Duration of use or any restrictions on the duration of useU.K.

AdultsU.K.
Adolescents over 12 years of age, indication (a)U.K.

Not to be taken for more than two weeks.

Children between four and 12 years of age, indication (a)U.K.

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 useU.K.

ContraindicationsU.K.

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

Special warnings and precautions for useU.K.

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 interactionU.K.

None reported.

Pregnancy and lactationU.K.

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 machinesU.K.

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

Undesirable effectsU.K.

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.

OverdoseU.K.

No case of overdose has been reported.

Pharmaceutical particulars (if necessary)U.K.

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)U.K.

Not applicable.

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

Scientific name of the plantU.K.

Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung

Botanical familyU.K.

Apiaceae

Herbal substanceU.K.

Fennel, sweet

Common name in all EU official languages of herbal substanceU.K.

  • 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)U.K.

Fennel, sweet, dried comminuted(4) or powdered fruit.

European Pharmacopoeia monograph referenceU.K.

Foeniculi dulcis fructus (01/2005:0825).

Indication(s)U.K.

(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 traditionU.K.

European, Chinese.

Specified strengthU.K.

Please see ‘Specified posology’.

Specified posologyU.K.

AdultsU.K.

Single dose

1,5 to 2,5 g of (freshly(5)) comminuted fennel fruits with 0,25 l of boiling water (brew for 15 minutes) three times daily as a herbal tea.

Fennel powder: 400 mg three times a day (with a maximum of 2 g daily).

Adolescents over 12 years of age, indication (a)U.K.

Adult dose

Children between four and 12 years of age, indication (a)U.K.

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 administrationU.K.

Oral use.

Duration of use or any restrictions on the duration of useU.K.

AdultsU.K.
Adolescents over 12 years of age, indication (a)U.K.

Not to be taken for more than two weeks.

Children between four and 12 years of age, indication (a)U.K.

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 useU.K.

ContraindicationsU.K.

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

Special warnings and precautions for useU.K.

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 interactionU.K.

None reported.

Pregnancy and lactationU.K.

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 machinesU.K.

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

Undesirable effectsU.K.

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.

OverdoseU.K.

No case of overdose has been reported.

Pharmaceutical particulars (if necessary)U.K.

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)U.K.

Not applicable.

[F4COMMUNITY LIST ENTRY ON HAMAMELIS VIRGINIANA L., FOLIUM ET CORTEX AUT RAMUNCULUS DESTILLATUM U.K.

Scientific name of the plant U.K.

Hamamelis virginiana L.

Botanical family U.K.

Hamamelidaceae

Herbal preparation(s) U.K.

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 %) (6)

European pharmacopoeia monograph reference U.K.

Not applicable

Indication(s) U.K.

Indication (a) U.K.

Traditional herbal medicinal product for relief of minor skin inflammation and dryness of the skin.

Indication (b) U.K.

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 U.K.

European

Specified strength U.K.

Please see ‘ Specified posology ’ .

Specified posology U.K.

Children over six years of age, adolescents, adults and elderly U.K.
Indication (a) U.K.

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 U.K.
Indication (b) U.K.

Eye drops (7) Distillate (2) diluted (1:10), 2 drops/each eye, 3-6 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 U.K.

  • Cutaneous use.

  • Ocular use.

Duration of use or any restrictions on the duration of use U.K.

Children over six years of age, adolescents, adults and elderly U.K.
Indication (a) U.K.

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 U.K.
Indication (b) U.K.

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 U.K.

Contraindications U.K.

Hypersensitivity to the active substance.

Special warnings and precautions for use U.K.
Indication (a) U.K.

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

Indication (b) U.K.

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 U.K.

None reported.

Pregnancy and lactation U.K.

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 U.K.

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

Undesirable effects U.K.
Indication (a) U.K.

Allergic contact dermatitis may occur in sensitive patients. The frequency is not known.

Indication (b) U.K.

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 U.K.

No case of overdose has been reported.

Pharmaceutical particulars [if necessary] U.K.

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] U.K.

Not applicable.]

[F5UNION LIST ENTRY ON MELALEUCA ALTERNIFOLIA (MAIDEN AND BETCH) CHEEL, M. LINARIIFOLIA SMITH, M. DISSITIFLORA F. MUELLER AND/OR OTHER SPECIES OF MELALEUCA , AETHEROLEUM U.K.

Scientific name of the plant U.K.

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

Botanical family U.K.

Myrtaceae

Common name in all EU official languages of herbal preparation U.K.

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 U.K.

Essential oil

European Pharmacopoeia monograph reference U.K.

01/2008:1837

Indications U.K.

Indication (a) U.K.

Traditional herbal medicinal product for treatment of small superficial wounds and insect bites.

Indication (b) U.K.

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

Indication (c) U.K.

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

Indication (d) U.K.

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 U.K.

European.

Specified strength U.K.

Please see ‘ Specified posology ’ .

Specified posology U.K.

Indication (a) U.K.
Adolescents, adults and elderly U.K.
Single dose U.K.

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) U.K.
Adolescents, adults and elderly U.K.
Single dose U.K.

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) U.K.
Adolescents, adults and elderly U.K.
Single dose U.K.

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) U.K.
Adolescents, adults and elderly U.K.

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 U.K.

Indications (a), (b) and (c) U.K.

Cutaneous use

Indication (d) U.K.

Oromucosal use.

Duration of use or any restrictions on the duration of use U.K.

Indication (a) U.K.

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) U.K.

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) U.K.

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 U.K.

Contraindications U.K.

Hypersensitivity to the active substance or to colophony.

Special warnings and precautions for use U.K.

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) U.K.

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

Indication (b) U.K.

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

Indication (c) U.K.

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

Indication (d) U.K.

Not to be swallowed.

Interactions with other medicinal products and other forms of interaction U.K.

None reported.

Fertility, pregnancy and lactation U.K.

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 U.K.

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

Undesirable effects U.K.

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 U.K.

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) U.K.

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) U.K.

Not applicable.]

[F6COMMUNITY LIST ENTRY ON MENTHA x PIPERITA L., AETHEROLEUM U.K.

Scientific name of the plant U.K.

Mentha x piperita L.

Botanical family U.K.

Lamiaceae (Labiatae)

Herbal preparation(s) U.K.

Peppermint oil

:

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

European Pharmacopoeia monograph reference U.K.

Peppermint oil — Menthae piperitae aetheroleum (01/2008:0405)

Indication(s) U.K.

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 U.K.

European

Specified strength U.K.

Indications 1, 2 and 3 U.K.

Single dose

Children between 4 to 10 years of age U.K.

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 U.K.

Semi-solid preparations 5-15 %

Hydroethanolic preparations 3-6 %

Adolescents over 16 years of age, adults U.K.

Semi-solid and oily preparations 5-20 %

In aqueous-ethanol preparations 5-10 %

In nasal ointments 1-5 % essential oil.

Specified posology U.K.

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 U.K.

Cutaneous and transdermal.

Duration of use or any restrictions on the duration of use U.K.

Indication 1 U.K.

Not to be used for more than 2 weeks.

Indications 2 and 3 U.K.

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 U.K.

Contraindications U.K.

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 U.K.

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 U.K.

None reported.

Pregnancy and lactation U.K.

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

Effects on ability to drive and use machines U.K.

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

Undesirable effects U.K.

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 U.K.

No case of overdose has been reported.]

[F2COMMUNITY LIST ENTRY ON PIMPINELLA ANISUM L U.K.

Scientific name of the plant U.K.

Pimpinella anisum L.

Botanical family U.K.

Apiaceae

Herbal substance U.K.

Aniseed

Common name in all EU official languages of herbal substance U.K.

  • 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) U.K.

Dried aniseed, comminuted or crushed

European Pharmacopoeia monograph reference U.K.

Anisi fructus (01/2005:0262)

Indication(s) U.K.

(a) Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence. U.K.
(b) Traditional herbal medicinal product used as an expectorant in cough associated with cold. U.K.

The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

Type of tradition U.K.

European

Specified strength U.K.

Please see ‘ Specified posology ’

Specified posology U.K.

Adolescents over 12 years of age, adults, elderly :

Indications (a) and (b)

1 to 3,5 g of whole or (freshly (8) ) comminuted or crushed aniseed in 150 ml of boiling water as a herbal tea

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 U.K.

Oral use

Duration of use or any restrictions on the duration of use U.K.

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 U.K.

Contraindications U.K.

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

Special warnings and precautions for use U.K.

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 U.K.

None reported.

Pregnancy and lactation U.K.

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 U.K.

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

Undesirable effects U.K.

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 U.K.

No case of overdose has been reported.]

[F7UNION LIST ENTRY ON SIDERITIS SCARDIA GRISEB., HERBA U.K.

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.]

[F8COMMUNITY LIST ENTRY ON THYMUS VULGARIS L., THYMUS ZYGIS LOEFL. EX L., AETHEROLEUM U.K.

Scientific name of the plant U.K.

Thymus vulgaris L., Thymus zygis Loefl. ex L.

Botanical family U.K.

Lamiaceae

Herbal preparation(s) U.K.

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 U.K.

01/2008:1374

Indication(s) U.K.

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 U.K.

European

Specified strength U.K.

Please see ‘ Specified posology ’

Specified posology U.K.

Adults and elderly U.K.

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 U.K.

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

Children 6-12 years U.K.

Use as bath additive: 0,0035-0,017 g per litre

Children 3-6 years U.K.

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 U.K.

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 U.K.

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 U.K.

Contraindications U.K.

Hypersensitivity to the active substance.

Use as bath additive: U.K.

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 U.K.
Cutaneous use: U.K.

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: U.K.

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 U.K.

None reported.

Pregnancy and lactation U.K.

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 U.K.

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

Undesirable effects U.K.

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 U.K.

No case of overdose has been reported.

Pharmaceutical particulars [If necessary] U.K.

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] U.K.

Not applicable.]

[F9UNION LIST ENTRY ON VALERIANA OFFICINALIS L. U.K.

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.]

[F10COMMUNITY LIST ENTRY ON VITIS VINIFERA L., FOLIUM U.K.

Scientific name of the plant U.K.

Vitis vinifera L.

Botanical family U.K.

Vitaceae

Herbal substance U.K.

Grapevine leaf (9)

Common name of herbal substance in all EU official languages U.K.

  • 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) U.K.

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

European Pharmacopoeia monograph reference U.K.

Not applicable

Indication(s) U.K.

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 U.K.

European

Specified strength U.K.

Please see ‘ Specified posology ’ .

Specified posology U.K.

Adults and elderly U.K.

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 U.K.

Cutaneous use.

Duration of use or any restrictions on the duration of use U.K.

Adults and elderly U.K.

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 U.K.

Contraindications U.K.

Hypersensitivity to the active substance.

Special warnings and precautions for use U.K.

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 U.K.

None reported.

Pregnancy and lactation U.K.

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 U.K.

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

Undesirable effects U.K.

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 U.K.

No case of overdose has been reported.

Pharmaceutical particulars (if necessary) U.K.

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) U.K.

Not applicable.]

(2)

‘Comminuted fruit’ is intended to cover also ‘crushed fruit’.

(3)

For commercial preparation of comminuted fennel fruits the applicant must carry out appropriate stability testing related to the content of essential oil components.

(4)

‘Comminuted fruit’ is intended to cover also ‘crushed fruit’.

(5)

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.

(6)

[F4According to USP (USP-31- NF 26, 2008 Vol 3:3526).]

(7)

[F4The medicinal product complies with the Ph. Eur. monograph on eye preparations (01/2008:1163).]

(8)

[F2For commercial preparations of comminuted or crushed aniseed the applicant must carry out appropriate stability testing related to the content of essential oil components.]

(9)

[F10The material complies with the monograph of the Pharmacopée Française X., 1996.]

Textual Amendments