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Holland & Barrett Black Cohosh Menopause Relief Tablets

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PATIENT INFORMATION LEAFLET


LIFECYCLE BLACK COHOSH MENOPAUSE RELIEF TABLETS Black Cohosh Root Extract 5mg


Important notes

U Please read this leaflet carefully before you use this product because it contains important information

U Keep this leaflet; you may need to read it again

U Seek professional advice if you need more information

U Please tell a Doctor or a qualified Healthcare Practitioner if your symptoms worsen or do not improve after 12 weeks of taking this product

U Please tell a Doctor or a qualified Healthcare Practitioner if you suffer from side effects not listed in this leaflet and/or if any of the side effects become serious


Do not take this product if you have or have ever had treatment for breast cancer or any other hormone-dependent tumours.

Consult a Doctor or a qualified Healthcare Practitioner if you:

U Are currently taking medicine containing oestrogen

U Have a family history of oestrogen dependent tumours

U Have a persistent history of menstrual disorders

If menstrual disorders occur or menstruation re-appears and if the symptoms are persistent, of unknown origin, or have recently occurred, a Doctor or a qualified Healthcare Practitioner should be consulted.


In this leaflet

1    What this product is and what it is used for

2    Before you take this product

3    How to take this product

4    Possible side effects

5    How to store this product

6    Further information


1 - What this product is and what it is used for

This product contains Black Cohosh rhizome and root extract. It is 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.


3 - How to take this product

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.

If you take too much of the product (overdose): Speak to a Doctor or a qualified Healthcare Practitioner immediately and take this leaflet and bottle with you.

If you forget to take this product: Do not take a double dose to make up for the missed dose(s). Continue to take your usual dose at the usual time. It does not matter if you have missed a dose.

Duration of use: If symptoms worsen, or do not improve after 12 weeks of taking this product, or if any of the side effects listed in the leaflet become serious or if side effects not listed occur; or if you notice any re-appearance or changes in menstrual bleeding, a Doctor; Pharmacist or a qualified Healthcare Practitioner should be consulted.


2 - Before you take this product

Do not take this product if you are:

U Under 18 years of age U Pregnant or breastfeeding U Of childbearing age and not using contraception U Allergic to Black Cohosh or any of the ingredients in this product (see section 6 of this leaflet)

U Suffering from, or have had liver or kidney problems (e.g. hepatitis, jaundice or cirrhosis)


4 - Possible side effects

Like all medicines, this product can have side effects, although not everybody gets them. Possible side effects are:

U Allergic skin reactions (such as nettle rash and/or itching of the skin)

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

U Swelling of the face or extremities U Weight gain

More information on back panel


If these symptoms persist or become troublesome, stop taking this product. If you experience any other side effects not listed above, consult a Doctor, Pharmacist or a qualified Healthcare Practitioner.

If you experience any allergic reactions, stop taking this product and consult a Doctor.

Black Cohosh may rarely cause liver problems.

If you notice symptoms such as yellowing of the skin/eyes, nausea, vomiting, dark urine, abdominal pain or unusual tiredness, stop taking the product immediately and consult a Doctor, Pharmacist or a qualified Healthcare Practitioner.

Reporting of side effects

If you get any side effects, talk to your doctor; pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.


5 - How to store this product

♦    Keep the tablets in the bottle until it is time to take them

♦    Do not take the tablets after the expiry date (see outer label). The expiry date refers to the last day of the month

♦    Do not store above 25°C

♦    Store in the original packaging

♦    Keep the bottle tightly closed

♦    Keep the tablets out of sight and reach of children


THR 21710/0025

Traditional Herbal Registration Holder

NBTY Europe Limited Samuel Ryder House Barling Way Nuneaton

Warwickshire, CVI0 7RH United Kingdom

Manufacturer

NBTY Europe Limited Vitality House Sixth Avenue Centrum I00 Burton-on-Trent Staffordshire, DEI4 2WP United Kingdom

If you would like further information about this product, please contact:

NBTY Europe Limited Regulatory Services Department Samuel Ryder House Barling Way Nuneaton

Warwickshire, CVI0 7RH United Kingdom

Is this leaflet hard to see or read?

Contact us on:

Telephone: +44 (0) 2476 215 400

Fax: +44 (0) 2476 215 452

Email: customerservices@NBTYeurope.com

This leaflet was prepared on: 11/11/2014

6 - Further information

About this product: Each tablet contains 5mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemose (L.) Nutt.) (equivalent to 25mg-40mg of Black Cohosh rhizome and root).

Extraction solvent: Ethanol 75% v/v.

This product also contains the following inactive (excipient) ingredients: Microcrystalline cellulose, Croscarmellose sodium, Magnesium stearate,

Silica colloidal hydrated.

Excipients in the extract: Maltodextrin, Silica colloidal anhydrous.

Each bottle contains 50 or 100 speckled, brown biconvex round shaped tablets, plain on both sides.


THR"


BMXXX-000 00A IXXXXX-000


CERTIFICATION MARK