
Article 1 
A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products is established in Annex I.
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


 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

ANNEX II
Calendula officinalis L.

Asteraceae

Calendula flower


 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
 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).

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

European

Please see ‘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’).

Cutaneous and oromucosal 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.

Hypersensitivity to members of the Asteraceae (Compositae) family.

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.

None reported.

Safety during pregnancy and lactation has not been established.

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

Not relevant.

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.

None reported.

Echinacea purpurea (L.) Moench

Asteraceae

Purple coneflower herb


 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

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

N/A

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.

European.

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

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’).

Cutaneous 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.

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

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.

None reported.

There are no data on cutaneous use during pregnancy or lactation.

Products containing Echinacea should not be applied to the breast of breastfeeding women.

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

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.

No case of overdose has been reported.

Eleutherococcus senticosus (Rupr. et Maxim.) Maxim.

Araliaceae

Eleutherococcus root


 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

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)

Eleutherococcus — Eleutherococci radix (ref.: 01/2008: 1419 corrected 7.0)

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.

European, Chinese.

Please see ‘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’).

Oral 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.

Hypersensitivity to the active substance.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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.

None reported.

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.

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

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.

No case of overdose has been reported.

Not applicable.

Not applicable.

A. 
Foeniculum vulgare Miller subsp. vulgare var. vulgare

Apiaceae

Fennel, bitter


 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

Fennel, bitter, dried comminuted fruit.

Foeniculi amari fructus (01/2005:0824).


((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.

European, Chinese.

Please see ‘Specified posology’.

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.

Adult dose

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’).

Oral use.

Not to be taken for more than two weeks.

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.

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

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.

None reported.

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.

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

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.

No case of overdose has been reported.

Not applicable.

Not applicable.

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

Apiaceae

Fennel, sweet


 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

Fennel, sweet, dried comminuted or powdered fruit.

Foeniculi dulcis fructus (01/2005:0825).


((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.

European, Chinese.

Please see ‘Specified posology’.

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.

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

Adult dose

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’).

Oral use.

Not to be taken for more than two weeks.

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.

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

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.

None reported.

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.

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

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.

No case of overdose has been reported.

Not applicable.

Not applicable.

Hamamelis virginiana L.

Hamamelidaceae


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 %)

Not applicable

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

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.

European

Please see ‘Specified posology’.

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’).

Eye drops 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’).


 Cutaneous use.
 Ocular use.

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.

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.

Hypersensitivity to the active substance.

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

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.

None reported.

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 studies on the effect on the ability to drive and use machines have been performed.

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

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.

No case of overdose has been reported.

Not applicable.

Not applicable.

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

Myrtaceae


BG (bălgarski): Чаено дърво, маслоCS (čeština): silice kajeputu střídavolistéhoDA (dansk): TetræolieDE (Deutsch): TeebaumölEL (elliniká): Μελαλεύκης αιθέριο έλαιοEN (English): Tea tree oilES (español): Melaleuca alternifolia, aceite esencial deET (eesti keel): teepuuõliFI (suomi): teepuuöljyFR (français): Mélaleuca (arbre à thé) (huile essentielle de)HR (hrvatska): eteričnog ulje australijskog čajevcaHU (magyar): Teafa-olaj IT (italiano): Melaleuca essenzaLT (lietuvių kalba): Arbatmedžių eterinis aliejusLV (latviešu valoda): Tējaskoka ēteriskā eļļaMT (Malti): Żejt tal-MelaleucaeNL (Nederlands): TheeboomoliePL (polski): Olejek eteryczny drzewa herbacianegoPT (português): Óleo esencial de melaleucaRO (română): Melaleuca (arbore de ceai) (ulei esențial)SK (slovenčina): Silica melaleukySL (slovenščina): eterično olje melalevkeSV (svenska): TeträdsoljaNO (norsk): Tetreolje

Essential oil

01/2008:1837

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

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

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

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.

European.

Please see ‘Specified posology’.

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.

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.

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.

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’).

Cutaneous use

Oromucosal use.

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.

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.

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.

Hypersensitivity to the active substance or to colophony.

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.

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

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

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

Not to be swallowed.

None reported.

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.

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

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.

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.

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.

Not applicable.

Mentha x piperita L.

Lamiaceae (Labiatae)

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

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

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.

European

Single dose

Semi-solid preparations 2-10 %

Hydroethanolic preparations 2-4 %

Semi-solid preparations 5-15 %

Hydroethanolic preparations 3-6 %

Semi-solid and oily preparations 5-20 %

In aqueous-ethanol preparations 5-10 %

In nasal ointments 1-5 % essential oil.

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’).

Cutaneous and transdermal.

Not to be used for more than 2 weeks.

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.

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.

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.

None reported.

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

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

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.

No case of overdose has been reported.

Pimpinella anisum L.

Apiaceae

Aniseed


 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

Dried aniseed, comminuted or crushed

Anisi fructus (01/2005:0262)
 (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.

European

Please see ‘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

3 times daily

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

Oral 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.

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

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

None reported.

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.

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

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.

No case of overdose has been reported.


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, стръкCS (čeština): nať hojníkuDA (dansk): KortkroneurtDE (Deutsch): Balkan-GliedkrautEL (elliniká): Πόα σιδηρίτουEN (English): IronwortES (español): Siderita, partes aéreas deET (eesti keel): haavarohuürtFI (suomi): raudakki, versoFR (français): Crapaudine (parties aériennes de)HR (hrvatska): očistova zelenHU (magyar): sármányvirág virágos hajtásaIT (italiano): Stregonia parti aeree fiorite LT (lietuvių kalba): Timsrų žolėLV (latviešu valoda): Siderītu lakstsMT (Malti): ħaxixa tas-SideritisNL (Nederlands): (Griekse) bergthee, kruidPL (polski): Ziele gojnikaPT (português): Siderite, partes aéreasRO (română): iarba de ceaiul muntelui cretanSK (slovenčina): Vňať ránhojaSL (slovenščina): zel sklepnjakaSV (svenska): Sårmynta, örtIS (íslenska):NO (norsk): Gresk fjellte
Herbal preparations
Comminuted herbal substance
European Pharmacopoeia monograph reference
Not applicable
Indications

Traditional herbal medicinal product used for the relief of cough associated with cold.

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

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

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.

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

Hypersensitivity to the active substance and to other plants of the Lamiaceae (Labiatae) family.

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.

None reported

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.

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

None known

If adverse reactions occur, a doctor or qualified health care practitioner should be consulted.

No case of overdose has been reported.

Not applicable

Not applicable.


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

Lamiaceae

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

01/2008:1374

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.

European

Please see ‘Specified posology’

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.

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

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

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’).

Cutaneous use: apply to the chest and the back.

Use as a bath additive: recommended temperature of bath: 35-38 °C.

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.

Hypersensitivity to the active substance.

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.

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.

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.

None reported.

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 studies on the effect on the ability to drive and use machines have been performed.

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.

No case of overdose has been reported.

Not applicable.

Not applicable.


Scientific name of the plant
Valeriana officinalis L.
Botanical family
Valerianaceae
Common name in all EU official languages of herbal preparation
BG (bălgarski): Валериана, коренCS (čeština): kozlíkový kořenDA (dansk): BaldrianrodDE (Deutsch): BaldrianwurzelEL (elliniká): Ρίζα βαλεριανήςEN (English): Valerian rootES (español): Valeriana, raíz deET (eesti keel): palderjanijuurFI (suomi): rohtovirmajuuri, juuriFR (français): Valériane (racine de)HR (hrvatska): odoljenov korijenHU (magyar): MacskagyökérIT (italiano): Valeriana radice LT (lietuvių kalba): Valerijonų šaknysLV (latviešu valoda): Baldriāna saknesMT (Malti): Għerq tal-ValerjanaNL (Nederlands): ValeriaanwortelPL (polski): Korzeń kozłkaPT (português): Valeriana, raizRO (română): rădăcină de valerianăSK (slovenčina): Koreň valeriánySL (slovenščina): korenina zdravilne špajkeSV (svenska): Vänderot, rotIS (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

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

single dose: 100 g for a full bath, up to 1 bath daily

Route of administration
Oral useUse 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

Hypersensitivity to the active substance.

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.

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.

None reported

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.

May impair ability to drive and use machines. Affected patients should not drive or operate machinery.

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.

None known

If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted.

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.

No case of overdose has been reported.

Not applicable

Not applicable.


Vitis vinifera L.

Vitaceae

Grapevine leaf


 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

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

Not applicable

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.

European

Please see ‘Specified posology’.

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’).

Cutaneous use.

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.

Hypersensitivity to the active substance.

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.

None reported.

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 studies on the effect on the ability to drive and use machines have been performed.

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.

No case of overdose has been reported.

Not applicable.

Not applicable.
