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

May 2012 September 2012 November 12 January 2013 March 2013

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

14 May 2013

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

15 November 2013

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

Adoption by Committee on Herbal Medicinal Products (HMPC)

BG (bulgarski): OyKyc Be3MKyno3yc

LT (lietuviq kalba): Puslétqjq guveiniq gniuzulai

CS (cestina): chaluha

LV (latviesu valoda): Fuka laponis

DA (dansk): Blæretang

MT (Malti): Fukus

DE (Deutsch): Blasentang

NL (Nederlands): blaaswier

EL (elliniká): Oùkoç to kuotùôeç

PL (polski): morszczyn pçcherzykowaty

EN (English): bladderwrack

PT (portugués): bodelha

ES (español): fucus

RO (româna):

ET (eesti keel): poisadru

SK (slovencina): chaluha

FI (suomi): rakkoleva

SL (slovenscina): zel mehurjastega bracica

FR (français): Fucus (thalle de)

SV (svenska): blåstång

HR (hrvatski):

IS (íslenska):

HU (magyar): barnamoszattelep

NO (norsk): blæretang

IT (italiano): Quercia marina tallo

Well-established use

Traditional use

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

Fucus vesiculosus L., thallus (bladderwrack)

i)    Herbal substance Not applicable.

ii)    Herbal preparations Powdered herbal substance

Well-established use

Traditional use

Herbal preparations in solid dosage forms for oral use.

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

Well-established use

Traditional use

Traditional herbal medicinal product used as an adjuvant to reduced calorie diet to help weight loss in overweight adults, after serious conditions have been excluded by a medical doctor.

The product is a traditional herbal medicinal product for use in the specified indication

Well-established use

Traditional use

exclusively based upon long-standing use.

Well-established use

Traditional use

Posology

Adults and elderly Single dose

Powdered herbal substance: 130 mg,

twice daily with a glass of water, 2 hours before

meals.

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

If patients taking Fucus vesiculosus have been unable to lose weight after 10 weeks, they should consult a doctor or a qualified health care practitioner.

Method of administration

Oral 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 concerns requiring medical advice.

Other herbal preparations containing Fucus vesiculosus, preparations containing iodine or medicines for the thyroid gland should not be taken concomitantly.

Intake of Fucus vesiculosus can change the TSH levels.

Well-established use

Traditional use

One case report of hyperthyroidism was published in a patient diagnosed with bipolar disorder and under treatment with lithium.

Well-established use

Traditional use

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

No fertility data available.

Well-established use

Traditional use

Not relevant.

Well-established use

Traditional use

None known.

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

Well-established use

Traditional use

The daily intake of 700 or 1,400 mg (n=3) for several weeks indicated an influence on the menstrual cycle length.

Exceeding doses may cause aggravation of acne, heart palpitation, increased heart rate, trembling, changes in blood pressure, and increased basal metabolism.

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 reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

Well-established use

Traditional use

The upper daily limit of 400 pg total iodine per day following intake of Fucus vesiculosus containing medicinal products should not be exceeded.

According to the European Pharmacopoeia monograph, the iodine content of Fucus vesiculosus powder should contain a minimum of 0.03% and a maximum of 0.2% of iodine. Batches of herbal preparations should be mixed in order to respect the specified upper daily limit of iodine when taking the therapeutic doses mentioned under section 4.2.