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 Curcuma
                                                               longa L., rhizoma (turmeric root)

                                                               i) Herbal substance

                                                               Not applicable

                                                               ii) Herbal preparations

                                                               a) Powdered herbal substance

                                                               b) Comminuted herbal substance

                                                               c)    Tincture (ratio of herbal substance to
                                                                     extraction solvent 1:10), extraction solvent
                                                                     ethanol 70% (V/V)

                                                               d) Dry extract (DER 13-25:1), extraction solvent
                                                                     ethanol 96% (V/V)

                                                               e) Dry extract (DER 5.5-6.5:1), extraction
                                                                     solvent ethanol 50% (V/V)

                                                               f)    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 preparations in liquid or solid dosage forms
                                                               for oral use.

                                                               The pharmaceutical form should be described by

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. 2543).



European Union herbal monograph on Curcuma longa L., rhizoma
EMA/HMPC/329755/2017                                                                                                Page 3/7
Well-established use                                           Traditional use

                                                               the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                           Traditional use

                                                               Traditional herbal medicinal product used for the
                                                               relief of digestive disturbances, such as feelings of
                                                               fullness, slow digestion and flatulence.

                                                               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 3

Well-established use                                           Traditional use

                                                               Posology

                                                               Adults and Elderly

                                                               a) Powdered herbal substance: 0.5-1 g, 2-3 times
                                                               daily;

                                                               b) Herbal tea: 0.5-1.0 g comminuted herbal
                                                               substance in 150 ml of boiling water as an
                                                               infusion, 2-3 times daily;

                                                               c) Tincture (1:10): 0.5-1 ml, 3 times daily;

                                                               d) Dry extract (DER 13-25:1): 90-162 mg, divided
                                                               in 2-5 doses daily;

                                                               e) Dry extract (DER 5.5-6.5:1): 100-200 mg, 2
                                                               times daily;

                                                               f) Tincture (1:5): 10 ml once daily or 5 ml in 60
                                                               ml water, 3 times daily;

                                                               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

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).


European Union herbal monograph on Curcuma longa L., rhizoma
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Well-established use                                           Traditional use

                                                               consulted.

                                                               Method of administration

                                                               Oral use

Contraindications

4.3. Contraindications

Well-established use                                           Traditional use

                                                               Hypersensitivity to the active substance.

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.

                                                               Due to possible stimulation on bile secretion
                                                               Curcuma longa is not recommended in case of
                                                               obstruction of the bile duct, cholangitis, liver
                                                               disease, gallstones and any other biliary diseases.

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

                                                               For tinctures 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

Undesirable effects

4.8. Undesirable effects

Well-established use                                           Traditional use

                                                               Mild symptoms of dry mouth, flatulence and
                                                               gastric irritation may occur. The frequency is not
                                                               known.

                                                               If other adverse reactions not mentioned above
                                                               occur, a doctor or a qualified health care
                                                               practitioner should be consulted.