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Menolieve Film-Coated Tablets

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Boots Menolieve Black Cosh leaflet 2014 21/03/2014 15:31 Page 1

148 mm



Information for the user


Menolieve Tablets


Black Cohosh root extract 6.5 mg

Read all of this leaflet carefully because it contains important information for you.


210 mm


This medicine is a traditional herbal medicinal product available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

•    Keep this leaflet, you may need to read it again

•    Ask your pharmacist if you need more information or advice

What this medicine is for

This traditional herbal medicinal product contains Black Cohosh root extract 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 medicine is recommended for these conditions 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 age if contraception is used.


f Talk to your pharmacist or doctor:

•    If you have a family history of oestrogen dependent tumour

Other important information

If you get menstrual problems or your period starts again and continues talk to! a doctor.

If you take other medicines

Before you take these tablets, make sure that you tell your pharmacist if you are taking the following:

•    Medicines containing the hormone oestrogen

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine; you have bought for yourself.


Before you take this medicine

This medicine can be taken by women aged 18 years and over. However, some women should not take this medicine or should seek the advice of their pharmacist or doctor first.

^Do not take:

•    If you are under 18 years

•    If you are allergic to any of the

ingredients (see “What is in this medicine”)

•    If you have, or have ever had, liver or kidney problems

•    If you have, or have ever had, an

oestrogen dependent tumour

•    If you are of child-bearing age and

you do not use contraception

•    if you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains lactose)

•    If you are pregnant, trying to get pregnant or breastfeeding


/How to take this medicine

Check the foil is not broken before use.

If it is, do not take that tablet.

Age

How many to take

How often to take

Women aged 18 years and over

experiencing

menopausal

symptoms

One

Once daily, at the same time of day, if possible (morning or evening)

Swallow the ta

blet whole with water or

liquid. Do not chew the tablet.


Do not give to children or adolescents under 18 years.


Do not take more than the amount recommended above.


If symptoms worsen, do not improve after 12 weeks, or you notice any re-appearance or changes in menstrual bleeding, talkToyour doctor.________


If you take too many tablets: Talk to a doctor, pharmacist or qualified healthcare professional.

Possible side effects

Most people will not have problems, but some may get some.

f If you get any of these side effects, stop taking the tablets. See a doctor at once:

•    Yellowing of the skin and eyes, tiredness, severe stomach pain, feeling sick, being sick, dark urine (these are signs of liver problems)

If you get any of these side effects, stop taking the tablets:

•    Allergic reactions (skin rash, red itchy skin)

These other effects may happen.

If they bother you talk to a pharmacist:

•    Digestive upsets such as heartburn or diarrhoea

•    Swollen face, legs or hands

•    Weight gain

If any side effect becomes severe, lasts more than a few days, or you notice any side effect not listed here, please tell your pharmacist or doctor.

You can also help to make medicines safer by reporting any side effects to the Yellow Card Scheme at www.yellowcard.gov.uk. 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).

How to store this medicine

Do not store above 30°C.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the base of the carton. After this date return any unused product to your nearest pharmacy for safe disposal.


What is in this medicine

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). This is equivalent to 29.25 - 55.25 mg of Black Cohosh. The extraction solvent is ethanol 60% v/v.

As well as the active ingredient, the extract also contains lactose monohydrate, cellulose, colloidal anhydrous silica.

The tablet core contains colloidal anhydrous silica, magnesium stearate, maize starch, microcrystalline cellulose, sodium starch glycolate (type A).

The tablet coating contains hypromellose, macrogol 4000, titanium dioxide (E171).

The pack contains 30 or 90 white round convex, scored film-coated tablets.

Who makes this medicine

Manufactured for The Boots Company PLC by Wiewelhove GmbH Gildestrasse 39 49477 Ibbenburen Germany. Traditional Herbal Registration held by Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow Buckinghamshire SL7 1FX

Leaflet revised 03/2014

If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Menolieve Tablets Reference number: THR 23056/0003

This is a service provided by the Royal National Institute of Blind People.

3889/01