Pflanzenwissen.
Mit Herkunft.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 2, 3
    Well-established use                                             Traditional use

    With regard to the marketing authorisation                       With regard to the registration application of
    application of Article 10(a) of Directive                        Article 16d(1) of Directive 2001/83/EC as
    2001/83/EC as amended                                            amended

    Valeriana officinalis L., radix (Valerian root)                  Valeriana officinalis L., radix (Valerian root)

    i) Herbal substance                                              i) Herbal substance
    Not applicable                                                   Not applicable

    ii) Herbal preparations                                          ii) Herbal preparations
    Dry extract (DER 3-7.4:1), extraction solvent:                   a)   Comminuted herbal substance
    ethanol 40-70% (V/V)                                             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)


2
 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
3
    The material complies with the Ph. Eur. monograph (ref.: 0453).


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 Well-established use                                                Traditional use

                                                                     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)



3. Pharmaceutical form
 Well-established use                                                Traditional use

 Herbal preparations in solid dosage forms for                       Comminuted herbal substance as herbal tea for
 oral use.                                                           oral use.

 The pharmaceutical form should be described by                      Herbal preparation in liquid or solid dosage forms
 the European Pharmacopoeia full standard term.                      for oral use.

                                                                     Comminuted herbal substance for use as bath
                                                                     additive.

                                                                     The pharmaceutical form should be described by
                                                                     the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                                Traditional use

 Herbal medicinal product for the relief of mild                     Traditional herbal medicinal product for relief of
 nervous tension and sleep disorders.                                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.


4.2. Posology and method of administration 4

 Well-established use                                                Traditional use

 Posology                                                            Posology

 Adolescents, adults and elderly                                     Adolescents, adults and elderly

 Oral use                                                            Oral use

 Single dose: 400-600 mg dry extract;                                a)   single dose: 0.3-3 g
 For relief of mild nervous tension up to 3 times                         For relief of mild symptoms of mental stress
 daily.                                                                   up to 3 times daily.
                                                                          To aid sleep, a single dose half to one hour

4
  For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).


European Union herbal monograph on Valeriana officinalis L., radix
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 Well-established use                                                Traditional use

 For relief of sleep disorders, a single dose half to                     before bedtime with an earlier dose during
 one hour before bedtime with an earlier dose                             the evening if necessary.
 during the evening if necessary.                                         Herbal tea: 0.3-3 g of the comminuted

 Maximum daily dose: 4 single doses                                       herbal substance in 150 ml of boiling water
                                                                          as a herbal infusion
 The use in children under 12 years of age is not
                                                                     b)   single dose: 0.3-2.0 g
 recommended (see section 4.4 ‘Special warnings
                                                                          For relief of mild symptoms of mental stress
 and precautions for use’).
                                                                          up to 3 times daily.
 Duration of use                                                          To aid sleep, a single dose half to one hour
                                                                          before bedtime with an earlier dose during
 Because of its gradual onset of efficacy valerian
                                                                          the evening if necessary.
 root is not suitable for acute interventional
 treatment of mild nervous tension or sleep                          c)   single dose: 10 ml
 disorders. To achieve an optimal treatment                               For relief of mild symptoms of mental stress
 effect, continued use over 2-4 weeks is                                  up to 3 times daily.
 recommended.                                                             To aid sleep, a single dose half to one hour
                                                                          before bedtime with an earlier dose during
 If the symptoms persist or worsen after 2 weeks
                                                                          the evening if necessary.
 of continued use, a doctor or a pharmacist
 should be consulted.                                                d)   single dose: 420 mg
                                                                          For relief of mild symptoms of mental stress
 Method of administration
                                                                          up to 3 times daily.
 Oral use                                                                 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



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 Well-established use                                                Traditional use


                                                                     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

                                                                     The use in children under 12 years of age is not
                                                                     recommended (see section 4.4 ‘Special warnings
                                                                     and precautions for use’).

                                                                     Use as bath additive

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

                                                                     The use in children under 12 years of age is not
                                                                     recommended (see section 4.4 ‘Special warnings
                                                                     and precautions for use’).

                                                                     Duration of use
                                                                     If symptoms persist during the use of the
                                                                     medicinal product, a doctor or a qualified health
                                                                     care practitioner should be consulted.

                                                                     Method of administration
                                                                     Oral use

                                                                     Use as bath additive. Temperature: 34-37°C,
                                                                     duration of bath 10-20 minutes.

Contraindications

4.3. Contraindications

 Well-established use                                                Traditional use

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

                                                                     Use as bath additive

                                                                     Full baths are contraindicated in cases of open
                                                                     wounds, large skin injuries, acute skin diseases,


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 Well-established use                                                Traditional use

                                                                     high fever, severe infections, severe circulatory
                                                                     disturbances and cardiac insufficiency.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                                Traditional use

 The use is not recommended in children below                        The use in children under 12 years of age has not
 12 years of age due to a lack of data on safety                     been established due to lack of adequate data.
 and efficacy.
                                                                     If the symptoms worsen during the use of the
 If the symptoms worsen during the use of the                        medicinal product, a doctor or a qualified health
 medicinal product, a doctor or a pharmacist                         care practitioner should be consulted.
 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

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                                Traditional use

 None reported                                                       None reported

Undesirable effects

4.8. Undesirable effects

 Well-established use                                                Traditional use

 Gastrointestinal symptoms (e.g. nausea,                             Oral use
 abdominal cramps) may occur after ingestion of
                                                                     Gastrointestinal symptoms (e.g. nausea,
 valerian root preparations. The frequency is not
                                                                     abdominal cramps) may occur after ingestion of
 known.
                                                                     valerian root preparations. The frequency is not
 If other adverse reactions not mentioned above                      known.
 occur, a doctor or a pharmacist should be
                                                                     If other adverse reactions not mentioned above
 consulted.
                                                                     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.