a company of

KLOSTERFRAU

HEALTHCARE GROUP

Certification Mark

THR~

Patient Information Leaflet

Kira ®

Menopause relief

tablets

Black Cohosh root extract 6.5 mg

Please read this leaflet carefully before you start §! taking these tablets. It contains some important information about Kira® Menopause relief.

“ Keep this leaflet with the tablets. You may want to read it again or show it to your doctor, pharmacist or qualified healthcare practitioner. m 0

_m What is in this leaflet

1. What this product is and what it is used for S 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

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1.    What this product is and what it is used for

Kira^® Menopause relief is a traditional herbal medicinal product containing Black Cohosh root. Each film-coated tablet of this product contains 6.5 mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L.) Nutt.) (4.5-8.5:1) (equivalent to 29.25-55.25 mg of Black Cohosh). Extraction solvent: Ethanol 60 % v/v.

Kira^® Menopause relief is a traditional herbal medicinal product 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.

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 dependant tumour

-    Are of child-bearing potential and do not use contraception

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

-    Are pregnant or breast-feeding

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

-    Are under the age of 18 years

Tell your doctor before taking this product if you:

-    Have persistent history of menstrual disorders

-    Are currently taking a medicine containing 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 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.

4. Possible side effects

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

-    Digestive upsets such as indigestion or diarrhoea

-    Facial swelling

-    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 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,

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vomiting, dark urine, abdominal pain, unusual tiredness) stop taking the product immediately and seek medical advice.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: 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

You must speak to a healthcare practitioner

-    if your symptoms worsen

-    if they do not improve after 12 weeks

-    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 place.

Do not store the tablets in a place where the temperature goes above 30 °C.

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Keep your tablets out of the reach and sight of children.

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

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6. Further information

Each film-coated tablet contains 6.5 mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L.) Nutt. (4.5-8.5:1) (equivalent to 29.25-55.25 mg 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 glycollate (type A)

Film-coating:

Hypromellose, macrogol 4000, titanium dioxide (E171).

If you think 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 film-coated tablets.

Registration holder for this product

Cassella-med GmbH & Co.KG Gereonsmuehlengasse 1 50567 Cologne Germany

Manufacturer of this product

Klosterfrau Berlin GmbH Motzener Strasse 41 12277 Berlin Germany

Traditional herbal registration number:

THR 29860/0002

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

Ceuta Healthcare Ltd.,

41 Richmond Hill,

BOURNEMOUTH BH26HS,

United Kingdom.

Telephone: 01202 780558

Fax: 01202 780559

Email.: info@ceutahealthcare.com

This leaflet was last revised May 2015.

For a large print, Braille or audio version of this leaflet, call Ceuta Healthcare Ltd.

Cassella-med GmbH is a company of the

KLOSTERFRAU

HEALTHCARE CROUP

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