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

                                                                Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x
                                                                vulgaris Heyne or their mixtures, flos (lime flower)

                                                                i) Herbal substance

                                                                Not applicable.



                                                                ii) Herbal preparations

                                                               a) Comminuted herbal substance

                                                               b) Liquid extract (DER 1:1), extraction
                                                                     solvent ethanol 25% V/V

                                                                c)   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 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.: 01/2008:0957).

Community herbal monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos
EMA/HMPC/337066/2011                                                                                                           Page 2/7
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                                 Traditional use

                                                                     Indication 1)

                                                                     Traditional herbal medicinal product used for the
                                                                     relief of symptoms of common cold.

                                                                     Indication 2)

                                                                     Traditional herbal medicinal product for the relief
                                                                     of mild symptoms of mental stress.

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


4.2. Posology and method of administration 3

Well-established use                                                 Traditional use

                                                                     Posology

                                                                     Adolescents, Adults and Elderly

                                                                     Indications 1) and 2)

                                                                     a) Comminuted herbal substance

                                                                     Single dose

                                                                     Herbal tea: 1.5 g of the comminuted herbal
                                                                     substance in 150 ml of boiling water as a herbal
                                                                     infusion 2–4 times daily.
                                                                     Daily dose: 3-6 g



                                                                     b) Liquid extract

                                                                     Single dose: 2 ml, 1-2 times daily

                                                                     Daily dose: 2-4 ml



                                                                     c) Tincture

                                                                     Single dose: 1 ml, 1-2 times daily

                                                                     Daily dose: 1-2 ml




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 Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos
EMA/HMPC/337066/2011                                                                                                           Page 3/7
Well-established use                                                 Traditional use

                                                                     Indication 1)

                                                                     Children between 4 and 12 years of age


                                                                     a) Comminuted herbal substance

                                                                     Single dose

                                                                     Herbal tea: 1 g of the comminuted herbal
                                                                     substance in 150 ml of boiling water as a herbal
                                                                     infusion 2–4 times daily.

                                                                     Daily dose: 2-4 g

                                                                     The use in children under 4 years of age is not
                                                                     recommended (see section 4.4 ‘Special warnings
                                                                     and precautions for use’).

                                                                     Indication 2)

                                                                     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

                                                                     Indication 1)

                                                                     The therapy should start at first signs of common
                                                                     cold.

                                                                     If the symptoms persist longer than 1 week
                                                                     during the use of the medicinal product, a doctor
                                                                     or a qualified health care practitioner should be
                                                                     consulted.

                                                                     Indication 2)

                                                                     If the symptoms persist 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.




Community herbal monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos
EMA/HMPC/337066/2011                                                                                                           Page 4/7

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                                 Traditional use

                                                                     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 1)

                                                                     The use in children under 4 years of age has not
                                                                     been established due to lack of adequate data.

                                                                     Indication 2)

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

                                                                     Indication 1)

                                                                     If the symptoms worsen during the use of the
                                                                     medicinal product or if dyspnoea, high fever or
                                                                     purulent sputum occurs, 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.

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.