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

                                                                 Matricaria recutita L., aetheroleum (matricaria
                                                                 oil)

                                                                 i) Herbal substance

                                                                 Not applicable.

                                                                 ii) Herbal preparation

                                                                 Essential oil



3. Pharmaceutical form
 Well-established use                                            Traditional use

                                                                 Herbal preparations in liquid dosage forms for
                                                                 use as a bath additive.

                                                                 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 for
                                                                 adjuvant therapy of irritations of skin and
                                                                 mucosae in the anal and genital region, after
                                                                 serious conditions have been excluded by a
                                                                 medical doctor.

                                                                 The product is a traditional herbal medicinal

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.: 1836).


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 Well-established use                                            Traditional use

                                                                 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

                                                                 Single dose

                                                                 Use as bath additive: 0.5 – 1 mg per litre
                                                                 Full bath: approximately 100 litre
                                                                 Partial bath: 20 – 50 litre

                                                                 Average daily dose

                                                                 Full bath: one bath per day or every other day
                                                                 Partial bath: one or two times per day

                                                                 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

                                                                 Duration of bath: 10 – 20 minutes

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

                                                                 Method of administration

                                                                 Cutaneous use.

                                                                 Use as bath additive. Recommended temperature
                                                                 of bath: 35 – 38 °C

Contraindications

4.3. Contraindications

 Well-established use                                           Traditional use

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

                                                                Full baths are contraindicated in cases of open
                                                                wounds, large skin injuries, acute skin diseases,
                                                                high fever, severe infections, severe circulatory
                                                                disturbances and cardiac insufficency.



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 Well-established use                                           Traditional use

                                                                Partial baths are contraindicated in cases of open
                                                                wounds, large skin injuries, acute skin diseases,
                                                                high fever and severe infections.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                            Traditional use

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

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

                                                                 Hypersensitivity reactions including severe
                                                                 allergic reaction (dyspnoea, Quincke’s disease,
                                                                 vascular collapse, anaphylactic shock) following
                                                                 mucosal contact with liquid chamomile
                                                                 preparations have been reported. The frequency
                                                                 is not known.

                                                                 If other adverse reactions not mentioned above


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 Well-established use                                            Traditional use

                                                                 occur, a doctor or a qualified health care
                                                                 practitioner should be consulted.

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
                                                                  Matricaria recutita L., flos (matricaria flower)
                                                                  i) Herbal substance

                                                                  As defined in the Ph. Eur. monograph.
                                                                  ii) Herbal preparations

                                                                  a)   Comminuted herbal substance
                                                                  b)   Liquid extract (DER 1:1), extraction solvent:
                                                                       ethanol 96% V/V:water:ammonia solution
                                                                       10% m/m (50:47.5:2.5) 3
                                                                  c)   Liquid extract (DER 1:4.3-5.7), extraction
                                                                       solvent: ethanol 96% V/V:water:ammonia
                                                                       solution 10% m/m (50:47.5:2.5)3

                                                                  d)   Liquid extract (DER 1:1), extraction solvent:
                                                                       ethanol 48% V/V:ammonia solution 10% m/m
                                                                       (39:1)3

                                                                  e)   Liquid extract (DER 1:1), extraction solvent:
                                                                       ethanol 45% V/V:ammonia solution 10% m/m
                                                                       (14.7:1)
                                                                  f)   Dry extract (DER 4-7:1), extraction solvent:
                                                                       ethanol 50% m/m
                                                                  g)   Liquid extract (DER 1:1.7-2.6), extraction
                                                                       solvent: ethanol 48% V/V

                                                                  h)   Liquid extract (DER 1:1), extraction solvent:
                                                                       ethanol 55% V/V
                                                                  i)   Liquid extract (DER 1:2), extraction solvent:
                                                                       ethanol 70% V/V

                                                                  j)   Liquid extract (DER 1:4.1-4.6), extraction
                                                                       solvent: ethanol 55% V/V:Poloxamer 188
                                                                       (993:3)

                                                                  k)   Liquid extract (DER 1:1.8-2.1), extraction
                                                                       solvent: ethanol 52% V/V:macrogol
                                                                       hydroxystearate (99.5:0.5)

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.: 0404).
3
  The material complies with the Ph. Eur. monograph (ref.: 1544).


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 Well-established use                                             Traditional use

                                                                  l)   Liquid extract (DER 1:4-4.5) extraction
                                                                       solvent: ethanol 38.5% m/m (containing
                                                                       1.36% sodium acetate trihydrate, 0.45%
                                                                       sodium ascorbate and 0.41% sodium
                                                                       hydroxide)
                                                                  m) Liquid extract (DER 2.7-5.5:1), extraction
                                                                     solvent: ethanol 95.4% V/V (containing
                                                                     0.22% sodium acetate, 0.12% sodium
                                                                     hydroxide)
                                                                  n)   Dry extract (DER 11-16:1), extraction solvent:
                                                                       ethanol 95.4% V/V (containing 0.22% sodium
                                                                       acetate, 0.12% sodium hydroxide)
                                                                  o)   Liquid extract (DER 1:2-2.8), extraction
                                                                       solvent: propan-2-ol 48% V/V



3. Pharmaceutical form
 Well-established use                                             Traditional use

                                                                  Herbal substance or comminuted herbal substance
                                                                  as herbal tea for oral use and inhalation.

                                                                  Herbal preparations in liquid dosage forms for oral
                                                                  use.

                                                                  Herbal substance or comminuted herbal substance
                                                                  for infusion preparation for oromucosal or
                                                                  cutaneous use.
                                                                  Herbal preparations in liquid dosage forms for
                                                                  preparation of dilutions for oromucosal or
                                                                  cutaneous use.
                                                                  Herbal preparations in liquid dosage forms for
                                                                  preparation of dilutions for steam inhalation.

                                                                  Herbal preparations in semi-solid dosage forms for
                                                                  cutaneous use.
                                                                  Herbal preparations in liquid dosage forms for use
                                                                  as bath additives.
                                                                  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

                                                                  Indication 1)
                                                                  Traditional herbal medicinal product used for the
                                                                  symptomatic treatment of minor gastro-intestinal
                                                                  complaints such as bloating and minor spasms.




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 Well-established use                                             Traditional use

                                                                  Indication 2)
                                                                  Traditional herbal medicinal product used for the
                                                                  relief of symptoms of common cold.

                                                                  Indication 3)
                                                                  Traditional herbal medicinal product for the
                                                                  treatment of minor ulcers and inflammations of the
                                                                  mouth and throat.

                                                                  Indication 4)
                                                                  Traditional herbal medicinal product used for
                                                                  adjuvant therapy of irritations of skin and mucosae
                                                                  in the anal and genital region, after serious
                                                                  conditions have been excluded by a medical
                                                                  doctor.

                                                                  Indication 5)
                                                                  Traditional herbal medicinal product used for the
                                                                  treatment of minor inflammation of the skin
                                                                  (sunburn), superficial wounds and small boils
                                                                  (furuncles).
                                                                  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 4

 Well-established use                                             Traditional use

                                                                  Posology
                                                                  Preparation a)
                                                                  Indication 1)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 1.5-4 g of the herbal substance or
                                                                  comminuted herbal substance in 150 ml of boiling
                                                                  water as a herbal infusion
                                                                  Daily dose: 3-4 times
                                                                  Children (6 months - 2 years)
                                                                  Single dose: 0.5-1.0 g
                                                                  Daily dose: 2-4 times

                                                                  Children (2-6 years)
                                                                  Single dose: 1.0-1.5 g
                                                                  Daily dose: 2-4 times

                                                                  Children (6-12 years)
                                                                  Single dose: 1.5-3.0 g
                                                                  Daily dose: 2-4 times

                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 3-10 g of herbal substance
                                                                  or comminuted herbal substance in 100 ml hot
                                                                  water for inhalation

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).


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 Well-established use                                             Traditional use

                                                                  Daily dose: several times
                                                                  Children (6-12 years)
                                                                  Single dose: 2-5 g of herbal substance
                                                                  or comminuted herbal substance in 100 ml hot
                                                                  water for inhalation
                                                                  Daily dose: 1-2 times

                                                                  Indication 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: Herbal substance or comminuted
                                                                  herbal substance for infusion preparation for
                                                                  oromucosal use: 1-5 g in 100 ml water, for rinsing
                                                                  and gargling
                                                                  Daily dose: several times

                                                                  Indication 4)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 4.5-5 g herbal substance or
                                                                  comminuted herbal substance per 1 l water for
                                                                  infusion preparation for irrigation
                                                                  Daily dose: several times

                                                                  Indication 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 3-10 g herbal substance or
                                                                  comminuted herbal substance in 100 ml water for
                                                                  infusion preparation for washings and impregnated
                                                                  dressings
                                                                  Daily dose: several times
                                                                  Preparation b)
                                                                  Indication 1)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 2 g in 150 ml warm water
                                                                  Daily dose: 3-4 times
                                                                  Preparation c)
                                                                  Indication 3) (for gargling or rinsing)

                                                                  Indication 5) (for washing or impregnated
                                                                  dressings)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 10 ml in 150 ml warm water
                                                                  Daily dose: 3-4 times
                                                                  Preparation d)
                                                                  Indication 1)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 3 ml in 150 ml water
                                                                  Daily dose: 3-4 times

                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 1 ml in 100 ml hot water for
                                                                  inhalation
                                                                  Daily dose: 1-2 times




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 Well-established use                                             Traditional use

                                                                  Indication 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 1 ml in 100 ml waterfor gargling or
                                                                  rinsing
                                                                  Daily dose: several times

                                                                  Indication 4)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 1 ml in 100 ml water for irrigations
                                                                  Single dose: 5 ml per 1 l water for partial baths
                                                                  Daily dose: several times

                                                                  Indication 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 1.5 ml in 150 ml water for
                                                                  compresses and irrigation
                                                                  Daily dose: several times
                                                                  Preparation e)
                                                                  Indication 1)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 5 ml in 150 ml water
                                                                  Daily dose: up to 4 times

                                                                  Children (6-12 years)
                                                                  Single dose: 2.5 ml in 150 ml water
                                                                  Daily dose: up to 4 times

                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 5 ml in 150 ml hot water for
                                                                  inhalation
                                                                  Daily dose: several times

                                                                  Indication 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 2.5 ml in 125 ml water for gargling or
                                                                  rinsing
                                                                  Daily dose: 3-4 times

                                                                  Indication 4)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 20 ml per 1 l water for compresses
                                                                  and irrigation
                                                                  Single dose: 10 ml per 1 l water for partial baths
                                                                  Daily dose: several times

                                                                  Indication 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 20 ml per 1 l water for compresses
                                                                  and irrigation
                                                                  Single dose: 10 ml per 1 l water for partial baths
                                                                  Daily dose: several times
                                                                  Preparation f) (in diluted liquid dosage forms
                                                                  containing approximately 0.47% dry extract)
                                                                  Indication 5) (sun burn)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: apply few drops in a thin layer on the


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 Well-established use                                             Traditional use

                                                                  affected area
                                                                  Daily dose: several times

                                                                  Preparation g)
                                                                  Indication 1) and 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose 1.5 ml in 150 ml water for oral use and
                                                                  mouth rinsing or gargling
                                                                  Daily dose: 3-4 times

                                                                  Children (6-12 years)
                                                                  Single dose: 0.7–1 ml in 150 ml water for oral use
                                                                  and mouth rinsing or gargling
                                                                  Daily dose: 3-4 times

                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 15 ml per 1 l hot water for inhalation
                                                                  Daily dose: 1-2 times

                                                                  Indication 4) and 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 15 ml per 1 l hot water for
                                                                  compresses and irrigation or partial baths
                                                                  Daily dose: several times

                                                                  Preparation h)
                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 15 ml per 1 l hot water for inhalation
                                                                  Daily dose: 1-3 times

                                                                  Indication 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 1-2 ml in 150 ml warm water for
                                                                  mouth rinsing or gargling
                                                                  Daily dose: up to 4 times

                                                                  Children (6-12 years)
                                                                  Single dose: 0.5-1 ml in 150 ml warm water mouth
                                                                  rinsing or gargling
                                                                  Daily dose: up to 4 times
                                                                  Indication 4) and 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 15 ml per 1 l warm water for
                                                                  compresses and irrigation
                                                                  Single dose: 15-30 ml per 5 l warm water for
                                                                  partial baths
                                                                  Daily dose: one to several times

                                                                  Preparation i)
                                                                  Indication 1) and 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 2.5-5 ml in 50-100 ml water
                                                                  Daily dose: 3-4 times




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 Well-established use                                             Traditional use

                                                                  Indication 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 5-10 ml in 100 ml water for washings
                                                                  and compresses
                                                                  Daily dose: several times

                                                                  Preparation j)
                                                                  Indication 1)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 5 ml in 150 ml warm water
                                                                  Daily dose: 3-4 times

                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 40 ml per 1 l hot water for inhalation
                                                                  Daily dose: 1-2 times

                                                                  Indication 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 5 ml in 100 ml water for rinsing or
                                                                  gargling
                                                                  Daily dose: 3 times

                                                                  Indication 4)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 20 ml per 1 l water for hip baths
                                                                  Single dose: 40 ml per 1 l water for washings and
                                                                  impregnated dressings
                                                                  Daily dose: one to several times

                                                                  Indication 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 40 ml per 1 l water for irrigations and
                                                                  impregnated dressings
                                                                  Daily dose: one to several times

                                                                  Preparation k)
                                                                  Indication 1)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 1 g in 150 ml water
                                                                  Daily dose: up to 4 times
                                                                  Children (6-12 years)
                                                                  Single dose: 0.7 g in 150 ml water
                                                                  Daily dose: up to 4 times

                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 10-20 ml per 1 l hot water for
                                                                  inhalation
                                                                  Daily dose: one to several times

                                                                  Indication 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 0.7-1.0 ml in 75 ml water for rinsing
                                                                  or gargling
                                                                  Daily dose: one to several times




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 Well-established use                                             Traditional use

                                                                  Indication 4)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 7.5-15 ml per 1 l water for partial
                                                                  baths and irrigations
                                                                  Daily dose: one to several times daily

                                                                  Indication 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 10-20 ml per 1 l water for washing,
                                                                  impregnated dressings and partial baths
                                                                  Daily dose: one to several times daily
                                                                  Preparation l)
                                                                  Indication 1)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 5 ml in 100 ml water
                                                                  Daily dose: up to 4 times

                                                                  Children from (6-12 years)
                                                                  Single dose: 2-3 ml in 100 ml water
                                                                  Daily dose: up to 4 times

                                                                  Indication 2)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 20 ml per 1 l hot water for inhalation
                                                                  Daily dose: 1-2 times

                                                                  Indication 3)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 5 ml per 100 ml warm water for
                                                                  rinsing or garglingDaily dose: 3 to several times

                                                                  Indication 4) and 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 45 ml per 1 l water for washings,
                                                                  impregnated dressings and irrigations
                                                                  Daily dose: 1-2 times
                                                                  Single dose: 30 ml per 1 l water for partial bath or
                                                                  hip bath
                                                                  Daily dose: 1-2 times

                                                                  Preparation m) in semi-solid dosage forms
                                                                  (corresponding to app. 8% herbal substance)
                                                                  Indication 4) and 5)
                                                                  Children (4 weeks - 12 years), adolescents, adults
                                                                  and elderly
                                                                  Single dose: apply a thin layer on the affected
                                                                  area.
                                                                  Daily dose: 2-3 times

                                                                  Preparation n) in semi-solid dosage forms
                                                                  (corresponding to app. 5.5% herbal substance).
                                                                  Indication 4) and 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: apply a thin layer on the affected
                                                                  area.



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 Well-established use                                             Traditional use

                                                                  Daily dose: several times

                                                                  Preparation o)
                                                                  Indication 4) and 5)
                                                                  Adolescents, adults and elderly
                                                                  Single dose: 20 ml per 1 l for compresses and
                                                                  irrigation
                                                                  Daily dose: one to several times
                                                                  Single dose: 20-40 ml in 20-40 l water for partial
                                                                  baths
                                                                  Daily dose: one time
                                                                  Single dose: 30 ml in 150 l water for full baths
                                                                  Daily dose: one time

                                                                  Children (4 weeks - 12 years)
                                                                  Single dose: 10-20 ml in 10-20 l water for baths
                                                                  Daily dose: one time

                                                                  For all herbal preparations
                                                                  The use is not recommended in specific age groups
                                                                  as specified in 4.4 ‘special warnings and
                                                                  precautions for use‘.

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

                                                                  Method of administration

                                                                  Indication 1) Oral use.

                                                                  Indication 2) Inhalation.

                                                                  Indication 3) Oromucosal use.

                                                                  Indication 4) and 5) Cutaneous use, Use as bath
                                                                  additive

Contraindications

4.3. Contraindications

 Well-established use                                             Traditional use

                                                                  Hypersensitivity to the active substance and to
                                                                  other plants of the Asteraceae (Compositae)
                                                                  family.
                                                                  Use as bath additive:

                                                                  Full baths are contraindicated in cases of open
                                                                  wounds, large skin injuries, acute skin diseases,
                                                                  high fever, severe infections, severe circulatory
                                                                  disturbances and cardiac insufficency.

                                                                  Partial baths or hip baths are contraindicated in
                                                                  cases of open wounds, large skin injuries, acute
                                                                  skin diseases, high fever and severe infections.


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Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                             Traditional use

                                                                  All methods of administration
                                                                  The use of the herbal preparations b, c, d, f, i, j,
                                                                  and n in children under 12 years of age has not
                                                                  been established due to lack of adequate data.

                                                                  Indication 1)
                                                                  The oral use of the herbal tea for children below 6
                                                                  months of age has not been established due to
                                                                  general considerations of nutrition and fluid intake.

                                                                  The oral use of herbal preparations e, g, k, l in
                                                                  children under 6 years of age has not been
                                                                  established due to lack of adequate data.

                                                                  The oral use of herbal preparations b, d, i, j in
                                                                  children under 12 years of age has not been
                                                                  established due to lack of adequate data.
                                                                  Indication 2)
                                                                  The use of herbal preparations d, e, g, h, j, k, l as
                                                                  steam inhalation in children under 12 years of age
                                                                  has not been established due to lack of adequate
                                                                  data.
                                                                  The use of herbal preparation a as steam
                                                                  inhalation in children under 6 years of age has not
                                                                  been established due to lack of adequate data.
                                                                  Indication 3)
                                                                  The use of herbal preparation h, for mouth washes
                                                                  or gargling in children under 6 years of age has
                                                                  not been established due to lack of adequate data.
                                                                  The use of herbal preparations a, c, d, e, i, j, k, l,
                                                                  for mouth washes or gargling in children under 12
                                                                  years of age has not been established due to lack
                                                                  of adequate data.
                                                                  Indication 4)
                                                                  The use of herbal preparation o, m for partial
                                                                  baths or local cutenous use in children under 4
                                                                  weeks of age has not been established due to lack
                                                                  of adequate data.
                                                                  The use of herbal preparations a, d, e, g, h, j k, l,
                                                                  n for partial baths or local cutaneous use in
                                                                  children under 12 years of age has not been
                                                                  established due to lack of adequate data.
                                                                  Indication 5)
                                                                  The use of herbal preparation m, o, for partial
                                                                  baths or local cutaneous use in children under 4
                                                                  weeks of age has not been established due to lack
                                                                  of adequate data.
                                                                  The use of herbal preparations a, c, d, e, f, g, i, j,
                                                                  k, l, n (partially) for partial baths or local cutenous
                                                                  use in children under 12 years of age has not been
                                                                  established due to lack of adequate data.
                                                                  If the symptoms worsen during the use of the


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                                                                  medicinal product, a doctor or a qualified health
                                                                  care practitioner should be consulted.

                                                                  For tinctures and 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

                                                                  Oral use: For patients after renal transplantation
                                                                  taking high dosages for longer periods (about two
                                                                  months) interactions based on effects on CYP450
                                                                  have been reported.
                                                                  Cutaneous, oromucosal use, inhalation, or as
                                                                  bath additive:
                                                                  None reported.

Undesirable effects

4.8. Undesirable effects

 Well-established use                                             Traditional use

                                                                  Hypersensitivity reactions including severe allergic
                                                                  reaction (dyspnoea, Quincke’s disease, vascular


European Union herbal monograph on Matricaria recutita L., flos
EMA/HMPC/55843/2011                                                                                            Page 12/13
 Well-established use                                             Traditional use

                                                                  collapse, anaphylactic shock) following mucosal
                                                                  contact with liquid chamomile preparations have
                                                                  been reported. The frequency is not known .
                                                                  If other adverse reactions not mentioned above
                                                                  occur, a doctor or a qualified health care
                                                                  practitioner should be consulted.