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


                                                                Thymus vulgaris L. and Thymus zygis L., or a
                                                                mixture of both species, herba (thyme)


                                                                i) Herbal substance
                                                                Not applicable.


                                                                ii) Herbal preparations

                                                                a) Liquid extract (DER 1:1), extraction solvent
                                                                     ethanol 24% (V/V)
                                                                b) Liquid extract (DER 1:1.16), extraction
                                                                     solvent glycerol 85% (m/m): ethanol 25%
                                                                     (m/m) (0.1:2)
                                                                c)   Liquid extract (DER 1:2-2.5), extraction
                                                                     solvent ammonia solution 10% (m/m) :
                                                                     glycerol 85% (m/m) : ethanol 90% (V/V) :
                                                                     water (1:20:70:109)
                                                                d) Tincture (1:10), extraction solvent ethanol
                                                                     70% (V/V)
                                                                e) Tincture (1:5), extraction solvent ethanol
                                                                     70% (V/V)
                                                                f)   Soft extract (DER 5-8:1), extraction solvent
                                                                     ethanol 25% - 30% (V/V)
                                                                g) Liquid extract fresh herb 3 (DER 1:1.5-2.4),
                                                                     extraction solvent water (often referred as
                                                                     ‘expressed juice’)
                                                                h) Dry extract (DER 6-10:1), extraction solvent
                                                                     ethanol 70% (v/v)
                                                                i)   Dry extract (DER 1.6-2.4:1), extraction
                                                                     solvent ethanol 96% (V/V)


1 The material complies with the Ph. Eur. monograph (ref.: 04/2009:0865).
2 The declaration of the active substance for an individual finished product should be in accordance with relevant herbal
quality guidance.
3
  The fresh material complies with the Ph. Eur. monograph (ref.: 04/2009:0865) when dried


Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba
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Well-established use                                          Traditional use


                                                              j)   Liquid extract (DER 1:4.5), extraction solvent
                                                                   ammonia solution 10% (m/m) : glycerol 85%
                                                                   (m/m) : ethanol 96% (V/V) : water
                                                                   (1.2:25:112:113)
                                                              k) Dry extract (DER 7-13:1), extraction solvent
                                                                   water
                                                              l)   Comminuted herbal substance


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
                                                              the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                          Traditional use

                                                              Traditional herbal medicinal product used in
                                                              productive cough associated with cold.

                                                              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) Liquid extract (DER 1:1):
                                                                   Single dose: 1-2 ml, 3-4 times daily
                                                              b) Liquid extract (DER 1:1.16):
                                                                   Single dose 1.2-2.4 ml, 3-4 times daily
                                                              c)   Liquid extract (DER 1:2-2.5):
                                                                   Single dose 1-4 g, 1-7 times daily, maximum
                                                                   daily dose 14 g



Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba
EMA/HMPC/342332/2013                                                                                         Page 4/8
Well-established use                                          Traditional use

                                                              d) Tincture (1:10):
                                                                   Single dose 40 drops, 3 times daily
                                                              e) Tincture (1:5):
                                                                   Single dose 2-6 ml, 3 times daily
                                                              f)   Soft extract:
                                                                   Single dose 50 mg, 6 times daily
                                                              g) Liquid extract (DER 1:1.5-2.4)
                                                                   Single dose 10 ml, 3-4 times daily
                                                              h) Dry extract (DER 6-10:1):
                                                                   Single dose 75-200 mg, 3 times daily
                                                              i)   Dry extract (DER 1.6-2.4:1)
                                                                   Single dose 135 mg, 1-3 times daily
                                                              j)   Liquid extract (1:4.5)
                                                                   Single dose 480 – 960 mg, 3-4 times daily
                                                              k) Dry extract (DER 7-13:1)
                                                                   Single dose 100 – 200 mg, 3-4 times daily
                                                              l)   Comminuted herbal substance
                                                                   Herbal tea: 1-2 g of the comminuted herbal
                                                                   substance in 150 ml of boiling water as a
                                                                   herbal infusion 3-4 times daily
                                                              Children between 4 and 12 years of age:

                                                              c) Liquid extract (DER 1:2-2.5):
                                                                    Single dose 0.5-0.9 ml, 3-5 times daily
                                                              g) Liquid extract (DER 1:1.5-2.4):
                                                                    Single dose 7-10 ml, 2-3 times daily


                                                              Herbal preparations a, b, d, e, f, h, i, j, k, l:
                                                              The use in children under 12 years of age is not
                                                              recommended (see 4.4 Special warnings and
                                                              precaution for use).


                                                              Herbal preparations c, g:
                                                              The use in children under 4 years of age is
                                                              not recommended (see 4.4 Special warnings
                                                              and precaution for use).



                                                              Duration of use

                                                              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.

                                                              Method of administration

                                                              Oral use.




Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba
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Contraindications

4.3. Contraindications

Well-established use                                          Traditional use

                                                              Hypersensitivity to the active substance or to
                                                              other plants of the Lamiaceae (Labiatae) family.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                          Traditional use

                                                              If dyspnoea, fever or purulent sputum occurs, a
                                                              doctor or a qualified health care practitioner
                                                              should be consulted.

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

                                                              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.

                                                              Herbal preparations a, b, d, e, f, h, i, j, k, l
                                                              The use in children under 12 years of age has not
                                                              been established due to lack of adequate data.

                                                              Herbal preparations c, g
                                                              The use in children under 4 years of age has not
                                                              been established because medical advice should
                                                              be sought.

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

                                                              Gastric disorders 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.