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25 November 2010 EMA/HMPC/600717/2007 Corr. 1 Committee on Herbal Medicinal Products (HMPC)

Community herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma Final

Discussion in Working Party on Community monographs and Community

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list (MLWP)

January 2008

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

July 2009 September 2009

17 September 2009

End of consultation (deadline for comments). Comments should be

Su pe rs

March 2008

January 2009

provided using this template to [email protected]

15 February 2010

Rediscussion in Working Party on Community monographs and

July 2010

Community list (MLWP)

November 2010

Adoption by Committee on Herbal Medicinal Products (HMPC) Keywords

25 November 2010

Herbal medicinal products; HMPC; Community herbal monographs; wellestablished medicinal use; Cimicifuga racemosa (L.) Nutt., rhizoma;

Cimicifugae rhizoma; black cohosh

BG (bălgarski): Цимицифуга, коренище

LT (lietuvių kalba):

CS (čeština): ploštičníkový kořen

LV (latviešu valoda): Sudrabsveces saknenis

DA (dansk): Sølvlysrhizom

MT (malti): Riżoma tal-Koħox

DE (Deutsch): Cimicifugawurzelstock

NL (nederlands): Zilverkaars

EL (elliniká):

PL (polski): Kłącze pluskwicy groniastej

EN (English): black cohosh

PT (português): Cimicifuga, rizoma

ES (espanol): Cimicifuga, rizoma de

RO (română): rizom de cimicifuga

ET (eesti keel): lursslillejuurikas

SK (slovenčina): Podzemok ploštičníka

FI (suomi):

SL (slovenščina):

FR (français):

SV (svenska): Läkesilverax, jordstam

HU (magyar): Fürtös poloskavész gyökértörzs

IS (íslenska): NO (norsk): Klaseormedruerot

IT (italiano): Cimicifuga rizoma

1

Changes introduced in substance names in EU languages and sections 4.8 and 5.1

7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7051 E-mail [email protected] Website www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

Community herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma 1. Name of the medicinal product To be specified for the individual finished product.

Well-established use

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2. Qualitative and quantitative composition 2 Traditional use

With regard to the marketing authorisation application of Article 10(a) of Directive 2001/83/EC as amended

(black cohosh) i) Herbal substance Not applicable.

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ii) Herbal preparations

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Cimicifuga racemosa (L.) Nutt., rhizoma

a) Dry extract (DER 5-10:1), extraction solvent ethanol 58% (V/V)

b) Dry extract (DER 4.5-8.5:1), extraction solvent ethanol 60% (V/V)

c) Dry extract (DER 6-11:1), extraction solvent propan-2-ol 40% (V/V)

3. Pharmaceutical form Well-established use

Traditional use

Herbal preparation in solid dosage forms for oral use.

The pharmaceutical form should be described by

the European Pharmacopoeia full standard term.

2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance. Community herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma EMA/HMPC/600717/2007

Page 2/6

4. Clinical particulars 4.1. Therapeutic indications Traditional use

Well-established use Herbal medicinal product for the relief of menopausal complaints such as hot flushes and

4.2. Posology and method of administration

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profuse sweating.

Traditional use

Well-established use Posology Female adults in the menopause

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Daily dose (divided into 1 or 2 single doses):

Dry extracts corresponding to 40 mg of the herbal substance. Duration of use

If the symptoms persist during the use of the medicinal product, a doctor or a pharmacist

Su pe rs

should be consulted.

Cimicifuga should not be taken for more than 6 months without medical advice. Method of administration Oral use.

4.3. Contraindications Well-established use

Traditional use

Hypersensitivity to the active substance.

4.4. Special warnings and precautions for use Well-established use

Traditional use

Patients with a history of liver disorder should

take Cimicifuga preparations with caution (see section 4.8 ‘Undesirable effects’).

Patients should stop taking Cimicifuga preparations and consult their doctor immediately if they develop signs and symptoms suggestive of liver injury (tiredness, loss of appetite, yellowing of skin and eyes or severe upper stomach pain

Community herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma EMA/HMPC/600717/2007

Page 3/6

Traditional use

Well-established use with nausea and vomiting or dark urine). If vaginal bleeding occurs or other symptoms occur, a doctor should be consulted. Cimicifuga preparations should not be used together with oestrogens unless advised by a doctor.

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Patients who have been treated or who are undergoing treatment for breast cancer or other hormone-dependent tumours should not use Cimicifuga preparations without medical advice. Please see section 5.3. ‘Preclinical safety data’. If the symptoms worsen during the use of the should be consulted.

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medicinal product, a doctor or a pharmacist

4.5. Interactions with other medicinal products and other forms of interaction Well-established use

Su pe rs

None reported.

Traditional use

4.6. Pregnancy and lactation 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.

Women of childbearing potential should consider using effective contraception during treatment.

4.7. Effects on ability to drive and use machines Well-established use

Traditional use

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

4.8. Undesirable effects Well-established use

Traditional use

Liver toxicity (including hepatitis, jaundice, disturbances in the liver function tests) is Community herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma EMA/HMPC/600717/2007

Page 4/6

Traditional use

Well-established use associated with the use of Cimicifuga containing products. The frequency is not known. Skin reactions (urticaria, itching, exanthema), facial oedema, peripheral oedema and gastrointestinal symptoms (i.e. dyspeptic disorders, diarrhoea) have been reported. The frequency is not known.

ed

If other adverse reactions not mentioned above occur, a doctor or a pharmacist should be consulted.

4.9. Overdose

Traditional use

No case of overdose has been reported.

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Well-established use

5. Pharmacological properties

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5.1. Pharmacodynamic properties Well-established use

Traditional use

Pharmacotherapeutic group: other gynaecologicals

ATC code: G02C

Neither the mode of action nor the constituents relevant for the improvement of menopausal complaints are known.

Clinical pharmacological studies indicate that

menopausal complaints (such as hot flushes and profuse sweating) can improve under treatment

with medicinal products from Cimicifuga racemosa root.

5.2. Pharmacokinetic properties Well-established use

Traditional use

No data available.

Community herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma EMA/HMPC/600717/2007

Page 5/6

5.3. Preclinical safety data Well-established use

Traditional use

In a six-month study in rats the no-observedeffect-level (NOEL) for the isopropanolic extract (Granulate) was defined with 21.06 mg native extract/kg bodyweight. Evidence from in-vitro and in-vivo

ed

pharmacological studies suggests that Cimicifuga extracts do not influence the latency or development of breast cancer. However, contradictory results have been obtained in other in-vitro experiments. In Cimicifuga-treated (isopropanolic black cohosh extract equivalent to 40 mg of root and rhizome),

ed

tumour-bearing, female transgenic mice, the

percentage of mice with detectable metastatic lung tumours at necropsy was increased compared to those on the control diet.

However, in the same experimental model, no increase in primary breast tumour was seen.

Influence on breast cancer or other hormone-

Su pe rs

depending tumours cannot be completely excluded.

A genotoxicity study (AMES-test) of the ethanolic extract (4.5-8.5:1, ethanol 60% (V/V)) was

performed to a concentration of 1 mg/plate. The test does not fulfil the recent criteria of such testing and therefore the relevance of these results for safety assessment is doubtful.

There are no conclusive studies on carcinogenicity and reproductive toxicity.

6. Pharmaceutical particulars Well-established use

Traditional use

Not applicable.

7. Date of compilation/last revision 25 November 2010

Community herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma EMA/HMPC/600717/2007

Page 6/6

Community herbal monograph on Cimicifuga racemosa - European ...

Nov 25, 2010 - LT (lietuvių kalba):. LV (latvieÅ¡u valoda): Sudrabsveces saknenis. MT (malti): Riżoma tal-Koħox. NL (nederlands): Zilverkaars. PL (polski): ...

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