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ENGLISH HERBAL MEDICINES BLACK COHOSH RUMATIX

Active substance(s): BLACK COHOSH LIQUID EXTRACT 1:1 82% ALCOHOL / BLACK COHOSH LIQUID EXTRACT 1:1 82% ALCOHOL / BLACK COHOSH LIQUID EXTRACT 1:1 82% ALCOHOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
English Herbal Medicines Black Cohosh Rumatix

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of oral liquid contains 1 ml of liquid extract from dried Black
Cohosh rhizome and root (Cimicifuga racemosa (L.) Nutt.) (1:1). Extraction
solvent: ethanol 82 % v/v.
1 ml of oral liquid also contains approximately 647 mg of ethanol (alcohol).
(See section 4.4 'Special warnings and precautions for use'.
For a full list of excipients see section 6.1.

3

PHARMACEUTICAL FORM
Oral Liquid.
Medium brown liquid.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of
backache and muscular and rheumatic aches and pains, based on traditional
use only.
Women of childbearing potential should use effective contraception.

4.2

Posology and method of administration
For oral use only
Adults and the elderly
Take 0.2ml (six drops) three times a day in water or fruit juice if desired.

Children and adolescents less than 18 years
This product is not indicated in children and adolescents less than 18 years
(see section 4.4).

Hepatic and renal impairment
The safety of Black Cohosh extract has not been studied in patients with
hepatic and/or renal impairment. This product should not be taken by patients
who have hepatic impairment or renal impairment.
If symptoms persist or do not improve after 4 weeks, a doctor or qualified
healthcare practitioner should be consulted.

4.3

Contraindications
Hypersensitivity to Black Cohosh or any of the excipients.
Children and adolescents under 18 years.
Pregnancy and lactation.
Patients with active liver disease or a history of liver damage.
Patients currently receiving treatment for or with a history of an oestrogen
dependent tumour.

4.4

Special warnings and precautions for use
Do not exceed the stated dose.
There have been rare cases of hepatic reactions associated with the use of
Black Cohosh. Patients taking this product should immediately stop the use of
the product and consult their doctor if they develop signs and symptoms that
suggest liver dysfunction (fatigue, anorexia, yellowing of the skin and eyes or
severe upper stomach pain with nausea and vomiting or dark urine).
Advice should be sought from a doctor if the patient has a family history of an
oestrogen dependent tumour.
Oestrogens may only be taken simultaneously with this product under medical
supervision, as their effect may be intensified by Black Cohosh.
The use in children and adolescents under 18 years of age is not recommended
because data are not sufficient and medical advice should be sought.
Contains alcohol – up to 129 mg ethanol per dose (equivalent to 3.2 ml of beer
or 1.4 ml of wine). Harmful for those suffering from alcoholism. To be taken

into account in pregnant or breast-feeding women, children and high-risk
groups such as patients with liver-disease, or epilepsy.

4.5

Interaction with other medicinal products and other forms of interaction
No studies have been carried out to determine if drug interactions occur with
this product.
Contains alcohol, and should therefore be avoided in patients taking other
medication known to interact with alcohol (e.g. Metronidazole).

4.6

Pregnancy and lactation
The safety of the product during pregnancy and lactation has not been
established, therefore it should not be used during pregnancy or lactation or by
women attempting to become pregnant.

4.7

Effects on ability to drive and use machines
No studies on the effect of this product on the ability to drive or use machinery
have been performed.
This product contains alcohol (see Section 2).

4.8

Undesirable effects
Very rarely (less than 1 in 1000, but more than 1 in 10000 treated patients),
there may be gastrointestinal symptoms (dyspeptic symptoms, diarrhoea),
allergic skin reactions (nettle rash, itching of the skin, skin rash), facial
oedema and peripheral oedema, and weight gain.

In rare cases, Black cohosh may cause liver reactions (including hepatitis,
jaundice and disturbances) in liver function tests.
If other adverse reactions not mentioned above occur, a doctor or qualified
healthcare practitioner should be consulted.

4.9

Overdose
In the event of an overdose, patients should contact a doctor, pharmacist or
qualified healthcare practitioner. Treatment should be symptomatic and
supportive.
Overdose of this product may result in alcohol intoxication and should be
treated accordingly. Amount of ethanol in a full bottle – 32.3 g in 50 ml
equivalent to 2 large glasses of wine and 161.7 g in 250ml equivalent to 10
large glasses of wine.
Older herbal texts state that doses of over 5g unprocessed drug (equivalent to
5ml of this product or 25 individual doses) daily may produce symptoms of
nausea, vomiting, dizziness, visual and nervous disturbances, reduced pulse
rate and increased perspiration.

5

PHARMACOLOGICAL PROPERTIES

5.1

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

5.2

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

5.3

Preclinical safety data
The preclinical toxicology data available are limited. Tests on reproductive
toxicity, genotoxicity and carcinogenicity have not been performed.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Ethanol
Water

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
Three years.

6.4

Special precautions for storage
This medicinal product does not require any special storage conditions.

6.5

Nature and contents of container
Glass bottle with polyethylene dropper cap: 50ml
Glass bottle with butyl-rubber bulb and HDPE plastic cap: 50ml

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Rutland Biodynamics Ltd, Town Park Farm, Brooke, Rutland, LE15 8DG.

8

MARKETING AUTHORISATION NUMBER(S)
THR 28255/0018

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
08/02/2011

10

DATE OF REVISION OF THE TEXT
08/02/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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