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Black Cohosh for menopause symptom relief

image descriptionMenoHerb Black Cohosh Menopause Relief Tablets

Black Cohosh root extract 6.5mg

30 tablets

Traditionally used for:

  • Symptoms of the Menopause
  • Hot Flushes
  • Night Sweats
  • Temporary mood changes
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A traditional herbal medicinal product used for the relief of symptoms of the menopause exclusively based upon long-standing use as a traditional remedy. Always read the label.

  • Vegetarian
  • Vegan
  • Lactose free
  • Gluten free
  • Wheat free
  • Soya free
  • Corn free
  • Sugar free
  • GM free
Herbal active
Black Cohosh (Cimicifuga racemosa ( L.) Nutt.
Strength
6.5mg of dried rhizome and root extract (equivalent to 29.25-55.25mg of Black Cohosh)
Dose
One tablet daily

A licensed herbal medicine means a safe, high quality product

MenoHerb Black Cohosh Menopause Relief Tablets have been registered under the Traditional Herbal Registration Scheme (THRS), a regulatory approval process for herbal treatments in the EU. Registration under this scheme primarily means that:

  • MenoHerb is a regulated herbal product and meets specific standards of safety and quality
  • MenoHerb is of pharmaceutical quality and has been manufactured to European Good Manufacturing Practice (GMP) Guidelines

The quality of many herbal products on the UK market at present is unknown and there are no independent quality and safety checks available to offer you reassurance about these products. MenoHerb’s registration under the THRS scheme provides you with the reassurance that it has been assessed by the MHRA and meets the required standard of safety and quality, as well as providing reliable patient information. The THR number on product packaging provides the proof of evidence that MenoHerb has met the MHRA’s agreed level of safety and quality, and that the on-pack consumer information has been approved by the MHRA.

Each pharmaceutical grade coated tablet is foiled blister packed to retain its freshness and maintain its potency.

We are committed to improving people’s health and wellbeing and do so using only the finest plant based, natural healthcare products. Please click Trust Schwabe to see why we’re the leaders in traditional herbal medicine, worldwide.

MenoHerb contains Black Cohosh, a perennial plant native to North America. Also known as Squaw root or Black snakeroot, the herb has been used for centuries by native Americans for a wide range of female conditions.

Also available from…

Boots, Holland & Barrett, Ocado and other leading independent pharmacies and health food stores nationwide.

About Black Cohosh

Black Cohosh is a perennial plant native to North America and has been used for centuries by native Americans.

Visit Herbfacts.co.uk

About Menopause

The menopause is the name given to the end of menstruation (periods) and is commonly referred to as “the change of life”.

Menoherb Guide

Download ‘Managing your menopause naturally’ as a PDF.

Take a health check

Check your menopause status using this simple questionnaire and get some useful tips on what might help.

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.

MenoHerb 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). 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.

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 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 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 oestrogen

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 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 healthcare practitioner.

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 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 (yellowingeyes/skin, nausea, vomiting, dark urine, abdominal pain, unusual tiredness) stoptaking immediately and seek medical advice.

If you notice any other side-effect not mentioned above, or if any side-effectbecomes 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 www.mhra.gov.uk/yellowcard. By reporting side-effects you can help provide more information on the safety of this medicine.

After taking this product

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.

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.

Store the tablets in a cool dry place.

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

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

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

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, 60 or 90 film-coated tablets.

Registration holder for this product

Schwabe Pharma (UK) Ltd
Alexander House, Mere Park,
Dedmere Road, Marlow, Bucks SL7 1PD

Manufacturer of this product

Wiewelhove GmbH, Gildestrasse 39, 49477 Ibbenbüren, Germany

Traditional herbal registration number: THR 23056/0003

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

Schwabe Pharma (UK) Ltd,
Alexander house, Mere Park, Dedmere Road, Marlow, Bucks, SL7 1PD

Telephone: 01628 401980. Email: info@schwabepharma.co.uk

This information was revised in 11/2014

1 Name of the medicinal product

  • Menoherb® Black Cohosh Menopause Relief Tablets
  • Menolieve Film-coated Tablets
  • Higher Nature Black Cohosh Menopause Relief Film-coated Tablets
  • Healthspan Black Cohosh Menopause Relief Tablets
  • Tesco Menopause Relief Black Cohosh Tablets
  • Holland & Barrett MenoCool Black Cohosh Tablets
  • Simply Supplements Black Cohosh Menopause Relief Tablets

2 Qualitative and quantitative composition

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. One film-coated tablet contains 142 mg lactose monohydrate. (See Section 4.4.’Special warnings and precautions for use’).

3 Pharmaceutical form

Film-coated tablet. White, round, convex curved and with a score mark on one side.

4 Clinical particulars

4.1 Therapeutic indications

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 childbearing potential if contraception is used.

4.2 Posology and method of administration

For oral use only. For women experiencing menopausal symptoms, take 1 tablet daily. Tablets should be taken at the same time of day if possible (morning or evening) and swallowed whole with plenty of liquid. Do not chew the tablets. Children and adolescents less than 18 years old. This product is not indicated in patients less than 18 years. Hepatic and renal impairment. The safety of cimicifuga rhizome extract has not been studied in patients with hepatic and/or renal impairment. This product should not be taken by patients who have hepatic impairment or renal impairment.

4.3 Contraindications

  • Hypersensitivity to the active ingredient or to any of the excipients
  • In patients under 18 years old.
  • Women who are pregnant or breast feeding or in women who could become pregnant (unless contraception is used).
  • In patients who have active liver disease or a history of liver damage.
  • In patients who have been treated or who are undergoing treatment for breast cancer or other hormone dependent tumours.

4.4 Special warnings and precautions for use

There have been rare cases of hepatic reactions associated with the use of black cohosh. Patients taking Menoherb should be informed to immediately stop the use of the product and consult their doctor if they develop signs and symptoms suggestive of liver dysfunction. (Fatigue, anorexia, yellowing of the skin and eyes or severe upper stomach pain with nausea and vomiting or dark urine). Patients who have been treated or who are undergoing treatment for breast cancer or other hormone-dependent tumours should not use Cimicifuga preparations without medical advice. Please see section 5.3 “Preclinical safety data”. Oestrogens may only be taken simultaneously with Menoherb® under medical supervision, as their effect may be intensified by Black cohosh. If menstrual disorders occur or menstruation re-appears and if the symptoms are persistent, of unknown origin, or have recently occurred, a doctor should be consulted as this may indicate the presence of other conditions which need to be medically diagnosed. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

None reported.

4.6 Fertility, pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy or lactation is not recommended. Additionally, because of the potential for the product to have hormone-like actions the product should also be avoided by women who could become pregnant unless contraception is used. No studies on the effects on fertility have been performed.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive or use machines have been performed.

4.8 Undesirable effects

Very rarely (less than 1 in 1000, but more than 1 in 10000 treated patients), there may be gastrointestinal symptoms (dyspeptic symptoms, diarrhoea), allergic skin reactions (nettle rash, itching of the skin, skin rash), facial oedema and peripheral oedema, and weight gain. In rare cases, Black cohosh may cause liver reactions (including hepatitis, jaundice and disturbances in liver function tests). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard.

4.9 Overdose

In the event of an overdose, patients are advised to contact a doctor, pharmacist or qualified healthcare professional. A small overdose (up to 4 tablets) is unlikely to cause any symptoms. In the event of a larger overdose (more than 4 tablets), advice should be sought from a doctor. Management of a large overdose should be symptomatic and supportive in nature. Older herbal texts state that doses of over 5 g unprocessed drug daily may produce symptoms of nausea, vomiting, dizziness, visual and nervous disturbances, reduced pulse rate and increased perspiration.

5 Pharmacological properties

5.1 Pharmacodynamic properties

ATC Code:G02CP03 ATC Group: G02CP It is not possible to make conclusive statements about the oestrogen-like stimulating or inhibiting effect of Black cohosh, because the literature data are contradictory.

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation. In a six-month study in rats the no-observed- effect-level (NOEL) for the isopropanolic extract (Granulate) was defined with 21.06 mg native extract/kg bodyweight. Evidence from in-vitro and in-vivo pharmacological studies suggests that Cimicifuga extracts do not influence the latency or development of breast cancer. However, contradictory results have been obtained in other in-vitro experiments. In Cimicifuga-treated (isopropanolic black cohosh extract equivalent to 40 mg of root and rhizome), tumour-bearing, female transgenic mice, the percentage of mice with detectable metastatic lung tumours at necropsy was increased compared to those on the control diet. However, in the same experimental model, no increase in primary breast tumour was seen. Influence on breast cancer or other hormone-depending tumours cannot be completely excluded. Tests on reproductive toxicity and carcinogenicity have not been performed.

6 Pharmaceutical particulars

6.1 List of excipients

Excipients of the herbal preparation:

  • Lactose monohydrate
  • Cellulose powdered
  • Silica, colloidal anhydrous

Excipients of the tablet:

  • Silica, colloidal anhydrous
  • Magnesium stearate
  • Maize starch
  • Cellulose, microcrystalline
  • Sodium starch glycolate (type A)

Excipients of the film-coating:

  • Hypromellose
  • Macrogol 4000
  • Titanium dioxide E 171

6.2 Incompatibilities

Not applicable

6.3 Shelf life

4 years

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Original packages containing 30, 60 or 90 Menoherb Black Cohosh Menopause Relief film-coated tablets. Not all pack sizes may be marketed. Also original packages containing 30 (Menolieve Film-coated Tablets, Higher Nature Black Cohosh Menopause Relief Film-coated Tablets, Tesco Menopause Relief Black Cohosh Tablets, Holland & Barrett MenoCool Black Cohosh Tablets) or 60 (Healthspan Black Cohosh Menopause Relief Tablets, Holland & Barrett MenoCool Black Cohosh Tablets, Simply Supplements Black Cohosh Menopause Relief Tablets) film-coated tablets. The film-coated tablets are packed in PVC/PVDC aluminium blisters and inserted into a carton together with the package leaflet.

6.6 Special precautions for disposal

No special requirements

7 Marketing authorisation holder

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

8 Marketing authorisation number(s)

THR 23056/0003

9 Date of first authorisation/renewal of the authorisation

02/06/2017

10 Date of revision of the text

02/06/2017

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