Discussion in Working Party on Community monographs and Community

March 2010

list (MLWP)

May 2010

Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation

6 May 2010

End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu

15 September 2010

Rediscussion in Working Party on Community monographs and Community list (MLWP)

Adoption by Committee on Herbal Medicinal Products (HMPC)

BG (balgarski):

LT (lietuviq. kalba):

CS (cestina): semeno piskavice reckého sena

LV (latviesu valoda):

DA (dansk):

MT (malti):

DE (Deutsch):

NL (nederlands):

EL (ellinika):

PL (polski):

EN (English): Fenugreek

PT (português):

ES (espanol):

RO (romàna):

ET (eesti keel):

SK (slovencina):

FI (suomi):

SL (slovenscina):

FR (français): Fenugrec

SV (svenska):

HU (magyar): Gorogszéna

IS (íslenska):

IT (italiano):

NO (norsk):

Well-established use

Traditional use

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

Trigonella foenumgraecum L., semen (fenugreek)

i)    Herbal substance Dried seed

ii)    Herbal preparations

a)    Dry extract (DER 4 : 1), extraction solvent ethanol 20 % V/V

b)    Soft extract (DER 5-6 : 1), extraction solvent ethanol 60 %V/V

Well-established use

Traditional use

Herbal substance or herbal preparation in solid dosage forms or as herbal tea for oral use.

Herbal substance for infusion for cutaneous use.

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

Well-established use

Traditional use

Indication 1)

Traditional herbal medicinal product used in temporary loss of appetite.

Well-established use

Traditional use

Indication 2)

Traditional herbal medicinal product for the symptomatic treatment of minor inflammations of the skin.

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

Adults Oral use

i)    Herbal substance

Herbal substance for tea preparation : 1 to 6 g daily in divided doses

ii)    Herbal preparations

a)    Dry extract (4 : 1 ethanol 20 %V/V) : 295 mg 2 times daily

b)    Soft extract (5-6 : 1 ethanol 60 % V/V) : 500 mg 2 times daily

Cutaneous use

i) Herbal substance

Infusion for cutaneous use: 50 g / 250 ml of water. The still warm infusion is used in cataplasm.

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

Indication 1)

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

Indication 2)

Well-established use

Traditional 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

Oral use.

Cutaneous use.

Well-established use

Traditional use

Hypersensitivity to the active substance(s).

Well-established use

Traditional use

The use in children and adolescents under 18 years of age is not recommended because of incomplete data on safety.

Oral use

Due to a possible hypoglycaemic effect of fenugreek, close monitoring of glycaemic control should be considered in patients treated for diabetes mellitus.

Well-established use

Traditional use

No reported interactions of clinical relevance.

Well-established use

Traditional use

There are no or limited data from use during pregnancy and lactation.

Studies in animals have shown reproductive toxicity (see section 5.3 'Preclinical safety data').

The use should be avoided during pregnancy and lactation.

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

Oral use

Gastrointestinal disorders: flatulence, diarrhoea Nervous system disorders: dizziness The frequency is not known.

Cutaneous use

Allergic reactions have been observed after local application (facial angioedema, wheezing) or ingestion (asthma, allergic rhinitis). The frequency is not known.

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

Well-established use

Traditional use

High doses (between 25 g and 100 g daily of debitterized powder of fenugreek seeds divided into two equal doses) have been reported to cause minor gastrointestinal symptoms such as diarrhoea and flatulence in 4 out of 10 cases.

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.

Tests on genotoxicity have not been performed with preparations of fenugreek covered by this monograph.

Decreased thyroid hormone levels (T3, tri iodothyronine) were reported in rodents treated with hydro-ethanolic extracts at 110 mg/kg/day and above; a NOAEL was not determined.

Testicular toxicity (altered sperm parameters, decreased testis weight, lowered / arrest of spermatogenesis, and degenerating seminiferous tubules) was reported in rats treated for 2 to 3 months with either fenugreek seed powder or the steroidal fraction of seeds. These effects are attributed to the treatment-related decrease in testosterone, and a NOAEL was not determined.

Conventional embryo-fetal and peri-post-natal toxicity studies were not performed. Limited studies showed conflicting results regarding the occurrence of malformations in rats.

Well-established use

Traditional use

Not applicable.