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
Well-established use                                            Traditional use

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


                                                                Taraxacum officinale Weber ex Wigg., folium
                                                                (dandelion leaf)


                                                                i) Herbal substance

                                                                    Not applicable.


                                                                ii) Herbal preparations


                                                                a) Dried leaves, comminuted
                                                                b) Liquid extract (DER 1:1),
                                                                   extraction solvent ethanol 25% (V/V)
                                                                c) Expressed juice 2 from fresh leaves



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Herbal preparations in liquid dosage forms for oral
                                                                use.

                                                                Comminuted herbal substance as herbal tea 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, when dried, with Ph. Eur. monograph on herbal drugs.

Community herbal monograph on Taraxacum officinale Weber ex Wigg., folium
EMA/HMPC/579636/2008                                                                                                 Page 2/6
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                           Traditional use

                                                               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 indication
                                                               exclusively based upon long-standing use.


4.2. Posology and method of administration

Well-established use                                           Traditional use

                                                               Posology

                                                               Adolescents, adults and elderly
                                                               a) Comminuted herbal substance:
                                                                  Single dose 4-10 g as an infusion,
                                                                  3 times daily

                                                               b) Liquid extract:
                                                                  Single dose 4-10 ml,
                                                                  3 times daily

                                                               c)   Expressed juice from fresh leaves:
                                                                    Single dose 5-10 ml,
                                                                    2 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.

                                                               To ensure an increase of the amount of urine,
                                                               adequate fluid intake is required during treatment.




Community herbal monograph on Taraxacum officinale Weber ex Wigg., folium
EMA/HMPC/579636/2008                                                                                         Page 3/6

Contraindications

4.3. Contraindications

Well-established use                                          Traditional use

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

                                                              Obstructions of bile ducts, cholangitis, liver
                                                              diseases, gallstones, active peptic ulcer and any
                                                              other biliary diseases.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                           Traditional use

                                                               The use in patients with renal failure and/or
                                                               diabetes, and/or heart failure should be avoided
                                                               because of possible risks due to hyperkalemia.

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

                                                               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.

                                                               For 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.

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.