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, cortex
                                                                (cinnamon)i) Herbal substance

                                                                Not applicable.

                                                                ii) Herbal preparations

                                                                a) Comminuted herbal substance

                                                                b) Liquid extract (DER 1:1), extraction solvent
                                                                   ethanol 70% V/V

                                                                c) Tincture (ratio of herbal substance to extraction
                                                                   solvent 1:5), extraction solvent ethanol 70%
                                                                   V/V



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Comminuted herbal substance as herbal tea for
                                                                oral use.

                                                                Herbal preparation in liquid dosage forms for oral
                                                                use.

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




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.: 04/2011:0387).

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4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                         Traditional use

                                                              Indication 1

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

                                                             Indication 2
                                                             Traditional herbal medicinal product for
                                                             symptomatic treatment of mild diarrhoea.

                                                             The product is a traditional herbal medicinal
                                                             product for use in a specified indications
                                                             exclusively based upon long-standing use.


4.2. Posology and method of administration 3

Well-established use                                         Traditional use

                                                             Posology

                                                             Adults and elderly


                                                             Indications 1) and 2)

                                                              a) Herbal tea:
                                                              0.5-1 g comminuted herbal substance as an
                                                              infusion, up to 4 times daily

                                                             Indication 1)

                                                              b) Liquid extract:
                                                              Single dose: 0.5-1 ml, 3 times daily

                                                              c) Tincture:
                                                              Daily dose: 2-4 ml

                                                             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

                                                             Indication 1)
                                                             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

3
 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).


Community herbal monograph on Cinnamomum verum J.S. Presl, cortex
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                                                            consulted.

                                                            Indication 2)
                                                            If the symptoms persist longer than two days, 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

                                                            Indications 1) and 2)

                                                            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.

                                                            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.

                                                            Indication 2)
                                                            In case of diarrhoea, rehydration should be the
                                                            first measure.

                                                            If recurrent diarrhoea or bloody stools occur, a
                                                            doctor or a qualified health care practitioner
                                                            should be consulted.

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.




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Undesirable effects

4.8. Undesirable effects

Well-established use                                        Traditional use

                                                            None known.

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