film-coated tablets

Black Cohosh root extract 6.5 mg

Please read this leaflet carefully before you start taking this product. It contains some important information about this medicine.

1. What Menopret is and what it is used for

This product is a traditional medicinal product containing black cohosh root extract. 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.

Menopret is a traditional medicinal product used for the relief of symptoms associated with the menopause, such as hot flushes, night sweats, poor sleep, mood changes and irritability, 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 childbearing potential if contraception is used.

2. Before you take Menopret

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x Do not take this product if you:

•    have or ever have had liver or kidney disease (e.g. hepatitis, jaundice or cirrhosis)

•    have or ever have had an oestrogen-dependent tumour

•    are of childbearing potential and do not use contraception

•    are attempting to become pregnant

•    are pregnant or breastfeeding

•    are under 18 years of age

•    are allergic to any of the ingredients

(see section 6 for list of ingredients.

This product contains lactose.)

Tell your doctor before taking

this product if you:

•    are currently using any medicine containing oestrogen

•    have an intolerance to some sugars (see section 6)

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Tell your doctor while taking

this product if you:

•    notice any re-appearance or change in menstrual bleeding

•    develop any new menstrual symptom(s)

3. How to take Menopret

Directions

Women experiencing menopausal symptoms: Take 1 tablet daily.

Not suitable for children or adolescents under 18 years of age.

Swallow the tablets whole with some water or other liquid. Menopret should be taken at the same time each day if possible (preferably in the evening).

Do not exceed the stated dose.

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if your symptoms persist or worsen

You must speak to a doctor if your symptoms worsen or do not improve after 3 months. if you take too much of this product (overdose)

Speak to a doctor, pharmacist or healthcare practitioner and take this leaflet with you. if you forget to take a dose

Continue to take your next usual dose at the usual time. It does not matter if you miss a dose. If you have any questions or are unsure about anything, please ask your doctor, pharmacist

or healthcare practitioner.

Bionorica

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30.03.10 17:25

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Rare side-effects (affecting fewer than 1 in 1,000 people):

digestive upsets such as indigestion or diarrhoea

swelling of the face and/or extremities weight gain

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

allergic skin reactions such as nettle rash or itching of the skin

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

breast tenderness

^Other side-effects:

Black cohosh may rarely cause liver problems. Signs and symptoms of a l iver problem incl ude:

•    yellowing of the eyes and/or skin

•    nausea

•    vomiting

•    dark urine

•    abdominal pain

•    unusual tiredness

•    loss of appetite

Stop taking this product immediately and seek medical advice if you become unwell with any of these signs/ symptoms.

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