Well-established use

Traditional use

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

Taraxacum officinale Weber ex Wigg., radix cum herba (dandelion root with herb)

i) Herbal substance Not applicable

ii) Herbal preparations

a) Dry extract (5.6-8.4:1), extraction solvent ethanol 60% (v/v)

b) Liquid extract (1:0.9-1.1) extraction solvent ethanol 30% (v/v)

c) Liquid extract (0.75:1) extraction solvent ethanol 30% (v/v)

d) Expressed juice^{1 2} from fresh flowering Taraxaci radix cum herba (1 : 0.6 - 0.8).

e) Expressed juice² from fresh flowering Taraxaci radix cum herba (1.75:1)

f) Dried root with herb, comminuted

Well-established use

Traditional use

Herbal preparations in solid or liquid dosage forms or as herbal tea for oral use.

The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

Well-established use

Traditional use Indication a)

Traditional herbal medicinal product used in mild dyspeptic/gastrointestinal disorders.

Indication b)

Traditional herbal medicinal product to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary complaints.

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

Well-established use

Traditional use Posology Indication a)

Adolescents over 12 years of age and adults

a)    2 times daily 1 coated tablet containing 300 mg dry extract or 3 times daily 1 - 2 coated tablets containing 150 mg dry extract each

b)    3 times daily 90 drops liquid containing 100 % liquid extract, (90 drops = 3.15 ml = 3.31g)

c)    3 times daily 35 drops liquid containing 0.266 g liquid extract, (35 drops = ca. 1 ml = 1g)

d)    3 times daily 10 - 15 ml liquid containing 100 % expressed juice

e)    3 times daily 10 - 15 ml liquid containing 100 % expressed juice

f)    Dried root with herb, comminuted:

up to four times daily (750 mg to 4000 mg/daily) for tea preparation

Indication b)

Adolescents over 12 years of age and adults

f) Dried root with herb, comminuted:

up to four times daily (750 mg to 4000 mg/daily)

The use is not recommended in children under 12 years of age (see also 4.4 ‘Special warnings and precautions for use’).

Duration of use

If the symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Method of administration

Oral use.

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

Well-established use

Traditional use

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

Obstructions of the biliary or intestinal tract, acute gallbladder inflammation, or in case of active peptic ulcer.

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.

The use in adolescents over 12 years of age and adults all with renal failure and/or diabetes, and/or heart failure should be avoided because of possible complications due to hyperkalaemia.

The use in children under 12 years of age is not recommended because of the lack of available experience.

If complaints or symptoms such as fever, dysuria, spasms or blood in urine occur during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Well-established use

Traditional use None reported.

Well-established use

Traditional use

Safety during pregnancy and lactation has not been established.

In the absence of sufficient data, use during pregnancy and lactation is not recommended.

Well-established use

Traditional use

No studies on the effect on the ability to drive and use machines have been performed.

Well-established use

Traditional use

Epigastric pain and hyperacidity may occur. The frequency is not known.

Allergic reactions. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified health care professional should be consulted.

Well-established use

Traditional use

No case of overdose has been reported.

Well-established use

Traditional use

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Well-established use

Traditional use

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Well-established use

Traditional use

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended, unless necessary for the safe use of the product.

Adequate tests on genotoxicity have not been performed.

Tests on reproductive toxicity and carcinogenicity have not been performed.

Well-established use

Traditional use

Not applicable.