Patient Information Leaflet

DiaBlack Cohosh Tablets

film-coated tablets

Black Cohosh root extract 6.5mg

Please read this leaflet carefully before you start taking these tablets.

•    It contains some important information about DiaBlack Cohosh Tablets.

•    Keep this leaflet with the tablets.

•    You may wantto read it again or show it to your doctor, pharmacist or healthcare practitioner.

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: Side-effects 5: After taking this product 6: Product description

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 (Cirmafuga racemose {L.) Nutt.) (4.5-B.5:1) (equivalent to 29.25-SS,25mg of Black Cohosh). Extraction solvent: Ethanol 60 % v/v.

DiaBlack Cohosh Tablets 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 ori traditional use only.

As there is evidence that Black Cohosh may have hormone-like actions, it should only be used by woman of children hearing 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 (e.g. hepatitis, jaundice or cirrhosis)

•    have ever had or are suffering from an oestrogen dependenttumour

•    are of childbearing potential or do not use contraception

•    are lactose-intolerant (react badly to lactose or milk)

•    are pregnant or breastfeeding

•    are allergic to any of the ingredients (see section 6)

•    are under IByears of age

Tell your doctor before taking this product if you:

•    have a persistent history of menstrual disorders

•    are currently taking a medicine containing¹ oestrogen

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 tablets 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 doc I or. pharmacist or healthcare practitioner and take this leaflet with you.

If you forgetto take this product

Continue to take you usual dose at the usual time, it

does not matter if you have missed a dose.

If you have any guestions, or are unsure about anything, please ask your doctor, pharmacist or healthcare practitioner.

4: Side-effects

Like ail medicines, this product can have side-effects. They are listed below.

Uncommon side-effects (affecting fewer than 1 in 1 GOG people)

•    digestive upsets such as indigestion or diarrhoea.

•    facial swelling

•    weight gam

•    allergic skin reactions such as nettle rash, itching of the skin

If these persistfor more than a few days, or become troublesome, stop taking tins product. These common side-effects are often only temporary.

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 tired ness) stop taking immediately and seek medicinal advice. Tell your doctor or pharmacist, if you notice any other side-effect.

5: After taking this product

You must speak to a healthcare practitioner if you symptoms worsen, if they do not improve after 12 weeks, or if you notice any re-appearance or changes in menstrual bleeding.

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 piace. Do not store the tablets in a place where the temperature goes above 30^C,C.

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.

6: Product description

Each film-coated tablet of this product contains 6.5mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimiafuga racemosa (L.) Nutt.) (4.5-8.5:1) (equivalentto 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 microcrystallme, sodium starch glycolate (type A).

Film-coating:

Hypromellose, macrogo14000,titanium dioxide (E 171)

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

Each pack contains 30, 60, 90 or 100 film-coated tablets.

Registration holder and manufacturer of this product

Diapharm GmbH & Co. KG llafenweg 18-20 48155 Munster Germany

Traditional herbal registration number:

THR 42340/0006

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

Diapharm GmbH & Co. KG

Wiirzburger Str. 3 26121 Oldenburg Germany

Telephone: +49 (0)441 98344-0 Email: mfo@diapharm.de

This leaflet was prepared in June 2009.