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NATURES GARDEN BLACK COHOSH MENOPAUSE RELIEF TABLETS

Active substance(s): BLACK COHOSH DRY EXTRACT

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PATIENT INFORMATION LEAFLET
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
In this leaflet
1
2
3
4
5
6

What this product is and what it is used for
Before you take this product
How to take this product
Possible side effects
How to store this product
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.
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)

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.
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.
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
u Keep the tablets in the bottle until it is
time to take them
u Do not take the tablets after the
expiry date (see outer label). The expiry
date refers to the last day of the month
u Do not store above 25ÂșC
u Store in the original packaging
u Keep the bottle tightly closed
u 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, CV10 7RH
United Kingdom
Manufacturer
NBTY Europe Limited
Vitality House
Sixth Avenue
Centrum 100
Burton-on-Trent
Staffordshire, DE14 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, CV10 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 racemosa (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.

BMXXX-000 00A IXXXXX-000

CERTIFICATION MARK

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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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