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

                                                                Silybum marianum (L.) Gaertn., dried fruit
                                                                (milk thistle)

                                                                i) Herbal substance

                                                                Not applicable.

                                                                ii) Herbal preparations

                                                                a) Comminuted herbal substance for herbal tea

                                                                b) Powdered herbal substance

                                                                c)    Dry extract (DER 20-70:1), extraction
                                                                      solvent acetone

                                                                d) Dry extract (DER 30-40:1), extraction
                                                                      solvent ethanol 96% (V/V)

                                                                e) Dry extract (DER 20-35:1), extraction
                                                                      solvent ethyl acetate

                                                                f)    Dry extract (DER 26-45:1), extraction
                                                                      solvent ethyl acetate

                                                                g) Dry extract (DER 36-44:1), extraction
                                                                      solvent ethyl acetate

                                                                h) Dry extract (DER 20-34:1), extraction
                                                                      solvent methanol 90% (V/V)

                                                                i)    Soft extract (DER 10-17:1), extraction
                                                                      solvent ethanol 60% (V/V)



3. Pharmaceutical form
    Well-established use                                        Traditional use


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.: 1860).



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 Well-established use                                          Traditional use

                                                               Comminuted herbal substance as herbal tea for
                                                               oral use.

                                                               Herbal preparations in solid or 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 the
                                                               symptomatic relief of digestive disorders,
                                                               sensation of fullness and indigestion and to
                                                               support the liver function, after serious
                                                               conditions have been excluded by a medical
                                                               doctor.

                                                               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) Comminuted herbal substance for herbal tea
                                                               Single dose: 3-5 g in 100 ml of boiling water, 2-
                                                               3 times daily, before meals
                                                               b) Powdered herbal substance
                                                               Single dose: 300 mg–600 mg, 2-3 times daily
                                                               Daily dose: up to 1800 mg, before meals

                                                               c) Dry extract (DER 20-70:1), extraction solvent
                                                               acetone
                                                               Single dose: 82-239 mg, 2-3 times daily
                                                               Daily dose: up to 478 mg, before meals

                                                               d) Dry extract (DER 30-40:1), extraction solvent
                                                               ethanol 96% (V/V)
                                                               Single dose: 200 mg
                                                               Daily dose: 200 mg

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).


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 Well-established use                                          Traditional use

                                                               e) Dry extract (DER 20-35:1), extraction solvent
                                                               ethyl acetate
                                                               Single dose: 162.5-250 mg, 3-4 times daily

                                                               f) Dry extract (DER 26-45:1), extraction solvent
                                                               ethyl acetate
                                                               Single dose: 123-208.3 mg, 3-4 times daily

                                                               g) Dry extract (DER 36-44:1), extraction solvent
                                                               ethyl acetate
                                                               Single dose: 173.0-186.7 mg, 3 times daily

                                                               h) Dry extract (DER 20-34:1), extraction solvent
                                                               methanol 90% (V/V)
                                                               Single dose: 70 mg, 3 times daily

                                                               i) Soft extract
                                                               Single dose: 392 mg 2 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
                                                               consulted.

                                                               Method of administration

                                                               Oral use

Contraindications

4.3. Contraindications

 Well-established use                                          Traditional use

                                                               Hypersensitivity to the active substance and 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

                                                               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 practitioner should be consulted. If icterus
                                                               or a change in colour of urine or stool appears,



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 Well-established use                                          Traditional use

                                                               the medical doctor should be consulted
                                                               immediately.

                                                               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.

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 gastrointestinal symptoms such as dry
                                                               mouth, nausea, upset stomach, gastric irritation
                                                               and diarrhoea may occur; headache; allergic
                                                               reactions (dermatitis, urticaria, skin rash,
                                                               pruritus, anaphylaxis, asthma) 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.




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