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 registration application of
                                                                Article 16d(1) of Directive 2001/83/EC.

                                                                Taraxacum officinale F.H. Wigg., radix
                                                                (dandelion root).

                                                                i) Herbal substance

                                                                Not applicable

                                                                ii) Herbal preparations

                                                                a) Comminuted dried root

                                                                b) Expressed juice (DER 1:1) from fresh root
                                                                     subjected to a steam of ethanol

                                                                c) Juice from fresh root

                                                                d) Liquid extract (DER 1:1), extraction solvent
                                                                     ethanol 30% V/V

                                                                e) Tincture (ratio of herbal substance to
                                                                     extraction solvent 1:5), extraction solvent
                                                                     ethanol 45% V/V



3. Pharmaceutical form
    Well-established use                                        Traditional use

                                                                Comminuted herbal substance as herbal tea for
                                                                oral use.

                                                                Herbal preparations in liquid dosage form for
                                                                oral use.

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


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.: 1852).



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EMA/HMPC/475726/2020                                                                                          Page 3/8
4. Clinical particulars

4.1. Therapeutic indications

    Well-established use                                        Traditional use

                                                                Indication 1)

                                                                Traditional herbal medicinal product used for the
                                                                relief of symptoms related to mild digestive
                                                                disorders (such as feeling of abdominal fullness,
                                                                flatulence, and slow digestion).

                                                                Indication 2)

                                                                Traditional herbal medicinal product for
                                                                temporary loss of appetite.

                                                                Indication 3)

                                                                Traditional herbal medicinal product to increase
                                                                the amount of urine to achieve flushing of the
                                                                urinary tract as an adjuvant in minor urinary
                                                                complaints.

                                                                The product is a traditional herbal medicinal
                                                                product for use in the specified indications
                                                                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

                                                                Indications 1), 2) and 3)

                                                                a) Comminuted herbal substance for
                                                                     decoction: single dose of 1-5 g in 150 ml of
                                                                     water, 2-3 times daily

                                                                b) Expressed juice (DER 1:1) from fresh root
                                                                     subjected to a steam of ethanol: single dose
                                                                     5 ml, diluted in small volume of water, 3
                                                                     times daily

                                                                Indication 1) and 3)

                                                                c)   Juice from fresh root: single dose 4-8 ml, 3
                                                                     times daily


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 Taraxacum officinale F.H. Wigg., radix
EMA/HMPC/475726/2020                                                                                           Page 4/8
 Well-established use                                           Traditional use



                                                                d) Liquid extract (DER 1:1), extraction solvent
                                                                     ethanol 30% V/V: single dose 2-8 ml, 3
                                                                     times daily

                                                                e) Tincture (ratio of herbal substance to
                                                                     extraction solvent 1:5), extraction solvent
                                                                     ethanol 45% V/V: single dose 5-10 ml, 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’).

                                                                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.

                                                                Indication 2)

                                                                Preparations are to be taken ½ hour before
                                                                meal.

                                                                Indication 3)

                                                                To ensure an increase of the amount of urine,
                                                                adequate fluid intake is required during
                                                                treatment (see section 4.4. Special warnings
                                                                and precautions for use).

Contraindications

4.3. Contraindications

 Well-established use                                           Traditional use

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

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                           Traditional use

                                                                Indication 1), 2) and 3)

                                                                Due to possible stimulation on bile secretion,
                                                                dandelion root is not recommended in case of


European Union herbal monograph on Taraxacum officinale F.H. Wigg., radix
EMA/HMPC/475726/2020                                                                                         Page 5/8
 Well-established use                                           Traditional use

                                                                obstruction of the bile duct, cholangitis, liver
                                                                disease, gallstones and any other biliary
                                                                diseases.

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

                                                                Indication 3)

                                                                If complaints or symptoms such as fever,
                                                                dysuria, spasms or blood in urine occur during
                                                                the use of the medicinal product, a doctor or a
                                                                qualified health care practitioner should be
                                                                consulted.

                                                                Because adequate fluid intake is required during
                                                                treatment (see section 4.2. Posology and
                                                                method of administration), dandelion root is not
                                                                recommended for patients with conditions
                                                                where reduced fluid intake is advised by a
                                                                medical doctor.

                                                                For preparations 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

                                                                Allergic reactions 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.