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 1,2
 Well-established use                                            Traditional use

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

                                                                 Matricaria recutita L., aetheroleum (matricaria
                                                                 oil)

                                                                 i) Herbal substance

                                                                 Not applicable.

                                                                 ii) Herbal preparation

                                                                 Essential oil



3. Pharmaceutical form
 Well-established use                                            Traditional use

                                                                 Herbal preparations in liquid dosage forms for
                                                                 use as a 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

                                                                 Traditional herbal medicinal product used for
                                                                 adjuvant therapy of irritations of skin and
                                                                 mucosae in the anal and genital region, after
                                                                 serious conditions have been excluded by a
                                                                 medical doctor.

                                                                 The product is a traditional herbal medicinal

1
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
  The material complies with the Ph. Eur. monograph (ref.: 1836).


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 Well-established use                                            Traditional use

                                                                 product for use in the specified indication
                                                                 exclusively based upon long-standing use.


4.2. Posology and method of administration

 Well-established use                                            Traditional use

                                                                 Posology

                                                                 Adolescents, adults and elderly

                                                                 Single dose

                                                                 Use as bath additive: 0.5 – 1 mg per litre
                                                                 Full bath: approximately 100 litre
                                                                 Partial bath: 20 – 50 litre

                                                                 Average daily dose

                                                                 Full bath: one bath per day or every other day
                                                                 Partial bath: one or two times per day

                                                                 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

                                                                 Duration of bath: 10 – 20 minutes

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

                                                                 Method of administration

                                                                 Cutaneous use.

                                                                 Use as bath additive. Recommended temperature
                                                                 of bath: 35 – 38 °C

Contraindications

4.3. Contraindications

 Well-established use                                           Traditional use

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

                                                                Full baths are contraindicated in cases of open
                                                                wounds, large skin injuries, acute skin diseases,
                                                                high fever, severe infections, severe circulatory
                                                                disturbances and cardiac insufficency.



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 Well-established use                                           Traditional use

                                                                Partial baths are contraindicated in cases of open
                                                                wounds, large skin injuries, acute skin diseases,
                                                                high fever and severe infections.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                            Traditional use

                                                                 The use in children under 12 years of age has not
                                                                 been established due to lack of adequate data.

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.

Undesirable effects

4.8. Undesirable effects

 Well-established use                                            Traditional use

                                                                 Hypersensitivity reactions including severe
                                                                 allergic reaction (dyspnoea, Quincke’s disease,
                                                                 vascular collapse, anaphylactic shock) following
                                                                 mucosal contact with liquid chamomile
                                                                 preparations have been reported. The frequency
                                                                 is not known.

                                                                 If other adverse reactions not mentioned above


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 Well-established use                                            Traditional use

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