SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Holland & Barrett Black Cohosh Menopause Relief Tablets GNC Live Well Black Cohosh Menopause Relief Tablets Lifecycle Black Cohosh Menopause Relief Tablets Nature’s Garden Black Cohosh Menopause Relief Tablets Nature’s Bounty Black Cohosh Menopause Relief Tablet

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Each tablet contains 5mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L) Nutt.) (equivalent to 25mg -40mg of Black Cohosh rhizome and root). Extraction solvent: Ethanol 75%v/v.

For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Tablets

Speckled brown, round tablets, plain on both sides.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the    relief of symptoms of the

menopause, such as hot flushes, night sweats, and temporary changes in mood. This is based on traditional use only.

As there is evidence that Black cohosh may have hormone-like actions, it should only be used by women of childbearing potential if contraception is used.

4.2    Posology and method of administration

For oral use only.

For women experiencing menopausal symptoms

Take 1 tablet daily. The tablet should be taken at the same time of the day if possible (morning or evening) Swallow the tablet whole with water.

Do not exceed the stated dose.

Duration of use:

If symptoms worsen or do not improve after 12 weeks of taking this product, a Doctor or a qualified Healthcare Practitioner should be consulted.

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 or renal impairment.

Not recommended for use in children, adolescents under 18 years of age (see Section 4.4, Special Warnings and Precautions for Use.)

4.3 Contraindications

Hypersensitivity to Black Cohosh or any of the excipients

Women who are pregnant or breastfeeding or women of child bearing potential and not using contraception

Patients who have or who have ever had liver disease or history of liver damage

Patients who have been treated or who are undergoing treatment for breast cancer or other hormone-dependent tumours

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

There have been rare reports of hepatic reactions associated with the use of Black Cohosh. Patients should stop taking this product immediately and consult their doctor if they develop signs and symptoms that suggest liver dysfunction (fatigue, anorexia, yellowing of the skin and eyes or severe 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 effects may be intensified by Black Cohosh.

If menstrual disorders occur or menstruation re-appears and if the symptoms are persistent, of unknown origin, or have recently occurred, a doctor should be consulted as this may indicate the presence of other conditions which need to be medically diagnosed.

If symptoms worsen or do not improve after 12 weeks of taking this product, a Doctor or a qualified Healthcare Practitioner should be consulted.

The use in children or adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.

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.

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and lactation is not recommended.

Due to the potential for Black Cohosh to have hormone-like actions, the product should not be used by women who could become pregnant unless contraception is used.

Studies on the effects on fertility have not been carried out.

4.7    Effects on ability to drive and use machines

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

4.8    Undesirable effects

Possible side effects are:

•    Allergic skin reactions (such as nettle rash, itching of the skin and skin rash)

•    Digestive upsets (such as indigestion and/or diarrhoea)

•    Facial oedema and peripheral oedema

•    Weight gain

The frequency is not known.

In rare cases, Black cohosh may cause liver reactions (including hepatitis, jaundice and disturbances in liver function tests).

The frequency is not known.

If other adverse reactions not mentioned above occur, a Doctor or qualified Healthcare Practitioner should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9    Overdose

No case of overdose has been reported

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

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

In a six-month study in rats the no-observed- effect-level (NOEL) for the isopropanolic extract (Granulate) was defined with 21.06 mg native extract/kg bodyweight.

Evidence from in-vitro and in-vivo 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), 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-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.

6.1    List of excipients

Microcrystalline cellulose Croscarmellose sodium Magnesium stearate Colloidal hydrated silica

Excipients in the extract:

Maltodextrin

Colloidal anhydrous    silica

6.2    Incompatibilities

Not applicable

6.3    Shelf life

18 months

6.4    Special precautions    for storage

Do not store above 25°C Keep in the original packaging Keep the bottle tightly closed

6.5 Nature and contents of container

Green Polyethylene terephthalate (PET) bottles with a chiffon green hinge cap (Polypropylene), with an inner seal liner designed to lift ‘n’ peel. The inner seal acts as a tamper evident seal under the cap. The inner seal liner is made up of polyester film, polymer adhesive layer, polyester tab, polyolefin foam, aluminium foil and sealable polyester film.

Pack size: 50 and 100 tablets

6.6 Special precautions for disposal

No special requirements

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