Bioplanta Black Cohosh PIL 2014 5940-01 12/03/2014-0®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.    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 is a traditional herbal medicinal product containing Black Cohosh root. 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.

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.

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

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

Stop taking the product if allergic skin reactions occur.

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.

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.

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).

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. 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

Halsa Pharma GmbH Immermannstrasse 9,

33619, Bielefeld, Germany.

Traditional herbal registration number: THR 34768/0002.

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.

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.