LEAFLET SPEC

PATIENT INFORMATION LEAFLET

HOLLAND fr BARRETT

MENOCOOL BLACK COHOSH TABLETS Black Cohosh root extract 6.5mg

Important notes

U Please read this leaflet carefully before you start taking these tablets; It contains some important information about MenoCool Black Cohosh tablets.

U Keep this leaflet with the tablets; you may want to read it again or show it to your doctor; pharmacist or qualified healthcare practitioner.

U Are pregnant or breast-feeding

U Are allergic to any of the ingredients (see section 6)

U Are under 18 years of age

Tell your doctor before taking this product if you:

U Have a persistent history of menstrual disorders

U Are currently taking a medicine containing oestrogen

What is 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. 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 (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 only be used by women of child- bearing potential if contraception is used.

3 - How to take this product

Adults

For women experiencing menopausal symptoms: Take 1 tablet daily: Tablets should be taken at the same time of day if possible (morning or evening): Swallow the tablet whole with some water or other liquid. Do not chew the tablets.

Do not exceed the stated dose.

If you take too much of this product (overdose): If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you.

If you forget to take this product: Continue to take your usual dose at the usual time, it does not matter if you have missed a dose. 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 12 weeks, or if you notice any re-appearance or changes in menstrual bleeding.

Stop taking this product immediately if you experience any allergic skin reaction.

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 notice any other side-effect not mentioned above, or if any side-effect becomes serious, 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

U Do not use your tablets after the expiry date U 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 U Store the tablets in a cool dry place U Do not store above 30°C U Keep the tablets out of the reach and sight of children

U Keep your tablets in the blister pack until it is time to take them

2 - Before you take this product

Do not take this product if you:

U Have ever had or are suffering from liver or kidney disease (e.g. hepatitis, jaundice or cirrhosis)

U Have ever had or are suffering from an oestrogen dependent tumour

U Are of childbearing potential and do not use contraception

U Are lactose-intolerant (react badly to lactose or milk)

4 - Possible side effects

Like all medicines, this product can have side-effects. These are listed below.

U Digestive upsets such as indigestion or diarrhoea U Facial swelling

U Allergic skin reactions such as nettle rash, itching of the skin

If these persist for more than a few days, or become troublesome, stop taking this product. These uncommon side-effects are often only temporary.

6 - Further information

Each film-coated tablet contains 6.5mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemose (L.) Nutt.) (4.5-8.5:l) (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 (El7l).

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 l42mg of lactose.

Each pack contains 30 or 60 film-coated tablets.

Registration holder for this product

Schwabe Pharma (UK) Ltd,

Alexander House, Mere Park, Dedmere Road, Marlow, Bucks, SL7 lFX

Manufactured for:

NBTY Europe Limited by:

Wiewelhove GmbH,

Gildestrasse 39, 49477 Ibbenburen, Germany

Traditional herbal registration number:

THR 23056/0003

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

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

Warwickshire, CVl0 7RH United Kingdom

Is this leaflet hard to see or read?

Contact us on:

Telephone: +44 (0) 2476 2l5 400

Fax: +44 (0) 2476 2l5 452

Email: customerservices@NBTYeurope.com

This leaflet was prepared on: 0l/04/20l4

THR"

BMXXX-000 00A IXXXXX-000    cermficamon mark

HB BLACK COHOSH LEAFLET

LEAFLET SIZE: 140mm x 180mm (flat)

45mm x 140mm (folded)

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