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BIOPLANTA BLACK COHOSH MENOPAUSE RELIEF TABLETS

Active substance(s): BLACK COHOSH ROOT EXTRACT

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Bioplanta Black Cohosh PIL 2014 5940-01 12/03/2014 09:30 Page 1

PATIENT INFORMATION LEAFLET
Information for the User

Bioplanta Black Cohosh Menopause Relief tablets
The active substance is Black Cohosh root extract 6.5mg
Please read this leaflet carefully before you start taking these tablets.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or qualified healthcare practitioner.
• You must contact a qualified healthcare practitioner if your symptoms worsen or if they do not
improve after twelve weeks, if any of the side-effects get serious, or if you notice any side-effects
not listed in this leaflet.
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 is a traditional herbal medicinal
product containing Black Cohosh root. Each filmcoated tablet of this product contains 6.5mg of
extract (as dry extract) from Black Cohosh
rhizome and root (Cimicifuga racemosa (L.) Nutt.)
(4.5-8.5:1) (equivalent to 29.25 – 55.25mg of
Black Cohosh).
Extraction solvent: Ethanol 60% v/v.
Bioplanta Black Cohosh Menopause Relief 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 (such as nervous irritability and restlessness).
This usage is based on traditional use only.
As there is evidence that Black Cohosh may have
hormone-like actions, it should therefore only be
used by women of child-bearing potential if
contraception is used.
2. Before you take this product
DO NOT TAKE this product if you:
• have ever had or are suffering from liver or kidney
disease (eg. Hepatitis, jaundice or cirrhosis)
• have ever had or are suffering from an oestrogen
dependent tumour
• are of childbearing potential and do not
use contraception

• are lactose intolerant (react badly to
lactose or milk)
• are under 18 years of age
• are allergic to any of the ingredients
(listed in section 6)
• are pregnant or breastfeeding
Tell your doctor before taking this product if you:
• have a persistent history of menstrual disorders
• are currently taking a medicine containing
oestrogen
3. How to take this product
You should speak to your doctor, pharmacist or
qualified healthcare practitioner if you are not sure
if this product is suitable for you.
Adults and the elderly
Take one tablet daily.
Swallow the tablets whole with some water
or other liquid.
Do not chew the tablets.
Don’t take more than the recommended dose.
If you take too much of this product
If you take too much and feel ill, talk to your
doctor. Taking too much is unlikely to be harmful.
If you forget to take this product
Don’t worry about the missed dose. Take the next
tablet as usual.
If you have any questions, or are unsure about
anything, please ask your doctor, pharmacist or
qualified healthcare practitioner.
You must speak to a qualified healthcare
practitioner if your symptoms worsen, if they do
not improve after twelve weeks, if side-effects not
mentioned in this leaflet occur or if you notice any
re-appearance or changes in menstrual bleeding.

Bioplanta Black Cohosh PIL 2014 5940-01 12/03/2014 09:30 Page 2

4. Possible Side Effects

6. Further Information

Like all medicines, this product can cause
side-effects, although not everybody gets them.

Each film-coated tablet of this product contains
6.5mg of extract (as dry extract) from Black Cohosh
rhizome and root (Cimicifuga racemosa (L.) Nutt.)
(4.5-8.5:1) (equivalent to 29.25 – 55.25mg of
Black Cohosh).
Extraction solvent: Ethanol 60% v/v.

Minor effects
The following minor side-effects can occur when
using this product.
These are very rare and affect less than 1 in every
1,000 people.
• Digestive upsets such as indigestion or
diarrhoea
• Facial swelling
• Weight gain
These are often short-lived and should go away by
themselves. However, if they are troubling you,
talk to your doctor or pharmacist.

This product also contains the following
ingredients:
Tablet core: Cellulose powdered, lactose
monohydrate, silica colloidal anhydrous,
magnesium stearate, maize starch, cellulose
microcrystalline, sodium starch glycolate (type A).
Film-coating: Hypromellose, Macrogol 4000,
titanium dioxide (E171).

• Allergic skin reactions such as nettle rash and
itching of the skin
Stop taking the product if allergic skin reactions
occur.

If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this product.
Each film-coated tablet contains 142 mg of lactose.

Other side-effects:
Black Cohosh may rarely cause liver problems.
If you become unwell (yellowing eyes/skin,
nausea, vomiting, dark urine, abdominal pain,
unusual tiredness) stop taking immediately and
seek medical advice.
If you are concerned about any side-effect or if
you notice any side-effects not listed in this leaflet,
please tell your doctor or pharmacist.
You can help to make medicines safer by reporting
any side-effects to the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
Alternatively you can get a paper Yellow Card form
from your GP’s surgery or pharmacy, or call Freephone 0808 100 3352 (available 10am–2pm
Monday – Friday).
5. How to store this product
Do not use your tablets after the expiry date.
Return any out-of-date tablets to your pharmacist
who will dispose of them for you. The expiry date
is printed on the box and the blister pack.
Store the tablets in a cool dry place.
Keep the tablets out of the reach and sight
of children.
Keep your tablets in the blister pack until it
is time to take them.

Each pack contains 30, 60 or 90 tablets.
Not all pack sizes may be marketed.
Traditional Registration holder for this product
Bioplanta UK Ltd
Alexander House, Mere Park, Dedmere Road
Marlow, Bucks SL7 1FX
Manufacturer of this product
Hälsa Pharma GmbH
Immermannstrasse 9,
33619, Bielefeld, Germany.
Traditional herbal registration number:
THR 34768/0002.
If you would like further information about this
product, contact the local representative of the
Traditional Herbal Registration Holder:
Bioplanta UK Ltd
Alexander House
Mere Park, Dedmere Road
Marlow, Bucks SL7 1FX
Telephone: 01628 401980
Email: info@bioplanta.co.uk
This leaflet was revised in 03/2014.

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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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