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Simply Supplements Black Cohosh Menopause Relief tablets, Healthspan Black Cohosh Menopause Relief tablets, Boots Menolieve film-coated tablets, Higher Nature Black Cohosh Menopause Relief film-coated tablets, Holland & Barrett Menocool Black Cohosh table – patient leaflet, side effects, dosage

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Patient leaflet - Simply Supplements Black Cohosh Menopause Relief tablets, Healthspan Black Cohosh Menopause Relief tablets, Boots Menolieve film-coated tablets, Higher Nature Black Cohosh Menopause Relief film-coated tablets, Holland & Barrett Menocool Black Cohosh table

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 (Cimicifuga racemosa (L.) Nutt.) (4.5-8.5:1) (equivalent to 29.25-55.25mg of Black Cohosh). Extraction solvent: ethanol 60% v/v.

Higher Nature Black Cohosh Menopause Relief 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), 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 problems (e.g. hepatitis, jaundice or cirrhosis)
  • have or have ever had treatment for breast cancer or any other hormone dependent tumour
  • are of childbearing potential and 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 taking a medicine containing estrogen unless your doctor advises it is safe to do so
  • are under 18 years of age

Tell your doctor before taking this product if you:

  • have a persistent history of menstrual disorders
  • are currently taking a medicine containing estrogen

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 menstrual bleeding.

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. You must not take Black Cohosh for more than 6 months without medical advice.

Do not take more than the label / leaflet tells you to.

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.

Uncommon side-effects (affecting fewer than 1 in 1000 people)

  • digestive upsets such as indigestion

    or diarrhoea

  • facial swelling, swelling in legs and arms, weight gain
  • 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 uncommon 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 tiredness) stop taking immediately and seek medical advice.

If you notice any other side-effect not mentioned above, or if any side-effect becomes serious, tell your doctor or pharmacist.

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 Yellow Card Scheme at 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.

5. How to store this product

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.

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

Store in the original packaging.

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

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

210mm

6. Further information

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) (equivalent to 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 microcrystalline, sodium starch glycolate (type A). Film-coating:

Hypromellose, macrogol 4000, titanium dioxide (E171).

If 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 142mg of lactose.

Each pack contains 30 film-coated tablets.

Registration holder for this product

Schwabe Pharma (UK) Ltd

Alexander House, Mere Park,

Dedmere Road, Marlow, Bucks, SL7 1FX

Manufacturer of this product

Wiewelhove GmbH,

Dörnebrink 19, 49479 Ibbenbüren, Germany

Traditional herbal registration number:

THR 23056/0003

If you would like further information on this product or if the leaflet is hard to see or read please contact:

Higher Nature Ltd,

10 Discovery Way, Horam, East Sussex TN21 0GE, UK

Telephone: 0800 458 4747

Email: nutritionsupport@highernature.com

Leaflet last revised 11/2020

certification mark THR 23056/0003

About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk)

Last revision stated in the text: November 2020

What the sections and the side effect frequencies mean: How to read a patient leaflet

Found a mistake? Tell us on the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Simply Supplements Black Cohosh Menopause Relief tablets, Healthspan Black Cohosh Menopause Relief tablets, Boots Menolieve film-coated tablets, Higher Nature Black Cohosh Menopause Relief film-coated tablets, Holland & Barrett Menocool Black Cohosh table

What these facts mean

Marketing authorisation? THR 23056/0003

Sources: the MHRA product information (products.mhra.gov.uk). Contains public sector information licensed under the Open Government Licence v3.0.