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)

[F1 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)

• [F2 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): [F3 Koreň eleuterokoka]

• SL (slovenščina): korenina elevterokoka

• SV (svenska): Rysk rot

• IS (íslenska): Síberíu ginseng, rót

• NO (norsk): Russisk rot

Textual Amendments

F2 Inserted by Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance).

F3 Substituted by Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance).

Herbal preparation(s) U.K.

[F3 Comminuted herbal substance]

[F3 Liquid extract (DER 1:1, extraction solvent ethanol 30-40 % v/v)]

[F3 Dry extract (DER 13-25:1, extraction solvent ethanol 28-40 % v/v)]

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

[F3 Dry aqueous extract (DER 15-17:1)]

[F3 Tincture (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 [F3 7.0] )

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.

[F3 European, Chinese.]

Specified strength U.K.

[F3 Please see ‘ Specified posology ’ .]

Specified posology U.K.

Adolescents [F4 over 12 years of age] , adults, elderly

Textual Amendments

F4 Deleted by Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance).

Herbal preparations.

[F3 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.

[F3 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.

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.

[F3 Contraindication] U.K.

Hypersensitivity to the active substance.

[ F4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Special warnings and precautions for use U.K.

[F3 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. [F2 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 U.K.

None reported.

[F3 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. [F2 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.

Insomnia, irritability, tachycardia and headaches may occur. The frequency is not known. [F2 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.

[F2 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.] ]

Textual Amendments

F1 Inserted by Commission Decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2009) 9703) (Text with EEA relevance) (2010/30/EU).