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