What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: THR 23056/0003 .


Boots Menolieve Tablets

Information for the user

Boots Menolieve Tablets

Black Cohosh root extract 6.5mg

Please read this leaflet carefully because it contains important information for you.

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 potential if contraception is used.

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 childbearing 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
  • If you are taking a medicine containing estrogen unless your doctor advises it is safe to do so

Talk to your pharmacist or doctor:

  • If are currently taking a medicine containing oestrogen
  • If you have a family history of oestrogen dependant 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 other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought yourself.

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

How to take this medicine

Check the foil is not broken before use. If it is, do not take that tablet.

Women aged 18 years and over experiencing menopausal symptoms:

Take one tablet daily, at the same time of the day, if possible (morning or evening)

Swallow the tablet 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 worse, do not improve after 12 weeks, or you notice any re-appearance or changes in the menstrual bleeding, talk to your 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.

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

Reporting of side-effects

If you get any side-effects talk to your doctor, pharmacist or nurse. This includes any possible side-effects not mentioned in this leaflet. You can also report side-effects directly via the the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side-effects you can help provide more information on the safety of this medicine.

How to store this medicine

Do not store above 30°C.Store in the original packaging.

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 6.5mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L.) Nutt.) (4.5-8.5:1). This is equivalent to 29.25-55.25mg 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 (E 171).

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

Who makes this medicine

Manufactured for

The Boots Company PLC
Nottingham
NG2 3AA

by

Wiewelhove GmbH
Gildestrasse 39
49477 Ibbenbűren
Germany

Traditional Herbal Registration held by

Schwabe Pharma (UK) Ltd
Alexander House
Mere Park
Dedmere Road
Marlow
Buckinghamshire
SL7 1FX

Leaflet prepared October 2020

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.

Artwork reference; WBAG380753