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Holland & Barrett Black Cohosh Joint And Muscle Relief

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Holland & Barrett Black Cohosh Joint and Muscle Relief GNC Live Well Black Cohosh Joint and Muscle Relief Lifecycle Black Cohosh Joint and Muscle Relief Nature’s Garden Black Cohosh Joint and Muscle Relief Nature’s Bounty Black Cohosh Joint and Muscle Relief

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains 19mg extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L) Nutt.) (equivalent to 97mg -155mg of Black Cohosh rhizome and root). Extraction solvent: Ethanol 75%v/v.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Capsule, hard

Two piece clear hard capsules with brown fill.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used for symptomatic relief of backache, muscular and rheumatic aches and pains. 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.

Adults and the elderly

Take 1 capsule 3 times daily. Swallow the whole capsule with water.

Do not exceed the stated dose.

Duration of use:

If symptoms worsen or do not improve after 4 weeks, 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 under 18 years (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

Patients currently receiving treatment for or who have ever had an oestrogen dependent tumour

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 productimmediately 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 symptoms worsen or do not improve after 4 weeks, a Doctor or a qualified Healthcare Practitioner should be consulted.

If joint pain is experienced accompanied by swelling of the joints, redness or fever, a Doctor or 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.

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 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Microcrystalline cellulose Magnesium stearate Colloidal hydrated silica

Excipients in the extract:

Maltodextrin

Colloidal anhydrous silica

Capsule Shell:

Hypromellose

6.2 Incompatibilities

Not applicable

6.3 Shelf life

36 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 capsules

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

NBTY Europe Limited Samuel Ryder House Barling Way Nuneaton Warwickshire CV10 7RH United Kingdom

Medine.co.uk