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.

                                                                Cinnamomum verum J. S. Presl, corticis
                                                                aetheroleum (cinnamon bark oil)

                                                                i) Herbal substance

                                                                   Not applicable.

                                                                ii) Herbal preparations

                                                                   Essential oil obtained by steam distillation from
                                                                   the cortex.


3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Herbal preparation in liquid dosage forms for oral
                                                                use.

                                                                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 for
                                                                symptomatic treatment of mild, spasmodic gastro-
                                                                intestinal complaints including bloating and
                                                                flatulence.

                                                                The product is a traditional herbal medicinal
                                                                product for use in a specified indication

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.: 04/2011:1501).

Community herbal monograph on Cinnamomum verum J.S. Presl, corticis aetheroleum
EMA/HMPC/706229/2009                                                                                                Page 2/5
Well-established use                                          Traditional use

                                                              exclusively based upon long-standing use.


4.2. Posology and method of administration

Well-established use                                          Traditional use

                                                              Posology

                                                              Adults and elderly

                                                              Essential oil: 50 to 200 mg daily, in 2 to 3 doses.

                                                              In order to avoid local irritation, the use of the
                                                              undiluted oil is not recommended.

                                                              The use in children and adolescents under 18
                                                              years of age is not recommended (see section 4.4
                                                              ‘Special warnings and precautions for use’).

                                                              Duration of use

                                                              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.

                                                              Method of administration

                                                              Oral use.

Contraindications

4.3. Contraindications

Well-established use                                         Traditional use

                                                             Hypersensitivity to the active substance or to
                                                             Peru balsam.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                          Traditional 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 professional should be consulted.




Community herbal monograph on Cinnamomum verum J.S. Presl, corticis aetheroleum
EMA/HMPC/706229/2009                                                                                       Page 3/5

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

                                                              Local irritation of the oral mucosa has 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.