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Menopause mood relief

image descriptionMenoMood Menopause Mood Relief Tablets

St John’s Wort extract 300mg and
Black Cohosh root extract 6.4mg

30 tablets

Traditionally used for:

  • Hot flushes
  • Night sweats
  • Slightly low mood
  • Mild anxiety
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MenoMood Menopause Relief – Black Cohosh root extract and St John’s Wort. 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
St John’s Wort (Hypericum perforatum L.) and Black Cohosh (Cimicifuga racemosa L. Nutt)
Strength
300 mg of dried aerial parts extract (equivalent to 1050-1800mg of St John’s Wort) and 6.4 mg of dried rhizome and root extract (equivalent to 28.8-54.4mg of Black Cohosh)
Dose
One tablet daily

A licensed herbal medicine means a safe, high quality product

MenoMood Menopause Mood 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:

  • MenoMood is a regulated herbal product and meets specific standards of safety and quality
  • MenoMood 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. MenoMood’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 MenoMood 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 foil 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 leaders in traditional herbal medicine, worldwide.

MenoMood contains St John’s Wort, a wild flowering herb with distinctive yellow blooms. The petals and leaves of the St John’s Wort plant contain a number of unique substances such as hypericin and hyperforin. This is also combined with 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.

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 St John's Wort

St John’s Wort, a wild flowering herb, has been used by herbalists for centuries.

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”.

MenoMood 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 St John’s wort and Black cohosh root. Each coated tablet of this product contains 300 mg of extract (as dry extract) from St John’s wort aerial parts (Hypericum perforatum L.) (3.5­6:1) (equivalent to 1050–1800 mg of St John’s wort). Extraction solvent ethanol 60% m/m; and 6.4 mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L.) Nutt.) (4.5­8.5:1) (equivalent to 28.80–54.40 mg of Black Cohosh). Extraction solvent ethanol 60% v/v.

MenoMood Menopause Mood Relief is a traditional herbal medicinal product used for the relief of symptoms of the menopause including hot flushes, nightsweats, slightly low mood and mild anxiety. This usage is based on traditional use only.

As there is evidence that Black cohosh may have hormone-like actions, this product should only be used by women of childbearing potential if contraception is used.

Before you take this product

DO NOT TAKE this product if:

  • you are under 18 years of age
  • you are pregnant or breast­feeding
  • you are of childbearing potential and do not use adequate contraception
  • you are allergic to any of the ingredients (listed in section 6)
  • your skin is exceptionally sensitive to sunlight (photosensitive)
  • you are having light treatment (phototherapy) for any condition
  • you are suffering from depression (see below)
  • you are taking a medicine containing estrogen unless your doctor advises it is safe to do so
  • you have or have ever had liver or kidney problems (e.g. hepatitis, jaundice or cirrhosis)
  • you have or have ever had treatment for breast cancer or any other hormone-dependent tumour

Tell your doctor before using this product if you:

  • think you may be suffering from depression (see below)
  • have a persistent history of menstrual disorders
  • have been told by your doctor that you have an intolerance to some sugars. This product contains lactose monohydrate, sucrose and glucose – see section 6.
  • are currently taking a medicine containing oestrogen

While you are taking this product:

  • avoid excessive sunbathing or the use of sunbeds/ solariums
  • stop using it at least 10 days prior to undergoing any surgery.

Suffering from depression?

Symptoms of depression include feelings of helplessness and hopelessness, loss of interest in daily activities, appetite or weight changes, sleep changes, loss of energy and difficulty concentrating. If your doctor has told you that you are suffering from depression do not use this product. If you think that you may be suffering from depression you should tell your doctor.

Driving and using machines

In rare cases St John’s wort may make you feel dizzy or sleepy. If affected do not drive or operate machines.

Taking other medicines

St John’s wort can affect the way some medicines work and reduce their effectiveness. Medicines that can be affected by St John’s wort include prescription medicines and those that you may have bought yourself without a prescription.

Therefore it is important that you do not take MenoMood if you are using any of the medicines listed in the table.

DO NOT TAKE THIS PRODUCT IF YOU ARE TAKING ANY OF THE FOLLOWING MEDICINES
All hormonal contraceptives The birth control ‘Pill’, emergency contraception, hormonal implants, creams, patches, intra­uterine devices with hormones.
All medicines for depression/anxiety Amitriptyline, clomipramine, moclobemide, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine.
All hormonal replacement therapy (HRT) treatments HRT tablets, patches, gels, vaginal rings
All medicines for thinning the blood (anticoagulants) Warfarin, acenocoumarol
All medicines for epilepsy Carbamazepine, phenobarbitone, phenytoin, primidone, sodium valproate
All immunosuppressant medicines Ciclosporin, tacrolimus
All medicines for HIV infections Amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir, efavirenz, nevirapine, delavirdine
Some medicines for cholesterol Simvastatin, atorvastatin
Some medicines for cancer Irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib, etoposide, mitotane
Some medicines for heart disease Digoxin, ivabradine, amiodarone
Some medicines for migraines Almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
Some medicines for high blood pressure Amlodipine, nifedipine, felodipine, verapamil
A medicine for regulating mood Lithium
A thyroid hormone Thyroxine

St John’s Wort may also affect the following medicines. Therefore do not take this product with these medicines unless a doctor has said it is safe to do so:

  • fentanyl, propofol, sevoflurane, and midazolam (anaesthetics/pre­operative medicines)
  • tramadol (an analgesic)
  • erythromycin, clarithromycin and telithromycin (antibiotics)
  • itraconazole and voriconazole (antifungals)
  • artemether and lumefantrine (antimalarials)
  • rasagiline (an anti­parkinson’s medicine)
  • aripiprazole (an antipsychotic medicine)
  • buspirone (an anxiolytic)
  • aprepitant (used to treat post­operative vomiting)
  • butobarbital and phenobarbital (barbiturates)
  • methyl phenidate (a central nervous system or CNS stimulant)
  • exemestane (a hormone antagonist)
  • eplerenone (a diuretic)
  • lansoprazole and omeprazole (proton pump inhibitors)
  • theophylline (a bronchodilator)
  • gliclazide (an antidiabetic medicine).

How to take this product

Adults and the elderly

Take 1 tablet daily. Swallow the tablets whole with some water or other liquid. Do not chew the tablets. The tablets should be taken at the same time of day if possible (morning or evening). You must not take products containing 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.

You must speak to a qualified healthcare practitioner if your symptoms worsen, if they do not improve after six weeks, or if you notice any re-appearance or changes in menstrual bleeding.

Possible side­-effects

Like all medicines this product can have side­-effects, although these are uncommon. These are listed below.

  • gastrointestinal disorders e.g indigestion, loss of appetite, nausea, diarrhoea, constipation
  • fatigue and restlessness
  • facial swelling, swelling of the feet, ankles or lower leg
  • weight gain
If these persist for more than a few days, or become troublesome, stop taking this product. These sideeffects
are often only temporary.
  • allergic skin reactions such as nettle rash, itching of the skin, hives
Stop taking this product immediately if you experience an allergic reaction.
Other side-effects
These include headaches, nerve pain or tingling, anxiety, dizziness, mania.Also, sunburn like reactions in skin exposed to strong sunlight or strong ultraviolet (UV) irradiation, e.g solarium, have been reported, particularly in fairskinned individuals, when taking St John’s Wort.

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.

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 or search MHRA Yellow Car 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 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 the original packaging. Do not store the tablets in a place where the temperature goes above 25°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 coated tablet of this product contains 300 mg of extract (as dry extract) from St John’s wort aerial parts (Hypericum perforatum L.) (3.5­6:1) (equivalent to 1050­1800 mg of St John’s wort). Extraction solvent ethanol 60% m/m; and 6.4 mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L.) Nutt.) (4.5­8.5:1) (equivalent to 28.80­54.40 mg of Black Cohosh). Extraction solvent ethanol 60% v/v.

This product also contains the following ingredients:

Extract: Maltodextrin, silica colloidal anhydrous, lactose monohydrate
cellulose powdered.

Tablet core: Silica, colloidal anhydrous, cellulose microcrystalline,
croscarmellose sodium, sodium starch glycolate (type A), magnesium stearate.

Coating: Hypromellose, sucrose, talc, calcium carbonate E170, tragacanth,
acacia, liquid glucose, titanium dioxide E171, iron oxide hydrate E172
(= yellow iron oxide), vanillin, beeswax white, carnauba wax, shellac.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. Each coated tablet contains 234 mg of sucrose, 19 mg of lactose monohydrate and 6 mg glucose.

Each pack contains 28, 30, 56 or 60 coated tablets.
Not all pack sizes may be marketed.

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, Gildestrasse 39, 49477 Ibbenbüren, Germany

Traditional Herbal Registration number: THR 23056/0013

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

Schwabe Pharma (UK) Ltd, Alexander House, Mere Park, Dedmere Road, Marlow, Bucks, SL7 1FX
Telephone: 01628 401980. Email: info@menomood.co.uk

This leaflet was revised in 11/2020.

1 Name of the medicinal product

Menomood Menoparuse Relief tablets Holland & Barrett Menopause Mood Relief tablets

2 Qualitative and quantitative composition

Each coated tablet contains: 300 mg of extract (as dry extract) from St John’s wort aerial parts (Hypericum perforatum L.) (3.5-6:1) (equivalent to 1050 – 1800 mg of St John’s wort). Extraction solvent: Ethanol 60% m/m, and 6.4 mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L.) Nutt.) (4.5-8.5:1) (equivalent to 28.80-54.40 mg of Black Cohosh). Extraction solvent: Ethanol 60% v/v. Each coated tablet contains 234 mg of sucrose, 19 mg of lactose monohydrate and 6 mg glucose. (See Section 4.4.’Special warnings and precautions for use’). For full list of excipients, see section 6.1

3 Pharmaceutical form

Coated tablet. Light-yellow, round, biconvex, smooth glossy surface.

4 Clinical particulars

4.1 Therapeutic indications

A traditional herbal medicinal product used for the relief of symptoms of the menopause, including hot flushes, night sweats, slightly low mood and mild anxiety, based on traditional use only.

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. If symptoms worsen or do not improve after 6 weeks a doctor or qualified healthcare practitioner should be consulted. The use in children or adolescents under 18 years of age is not recommended (See Section 4.4 Special warnings and precautions for use).

4.3 Contraindications

Hypersensitivity to the active ingredients or to any of the excipients. Patients with known dermal photosensitivity or patients undergoing phototherapy or any photodiagnostic procedures. Concomitant use with the medicines included in Section 4.5. This is because St John’s wort (Hypericum perforatum) has been shown to induce the cytochrome P450 isoenzymes CYP1A2, CYP2C9, CYP2C19 and CYP3A4 as well as transport protein P-glycoprotein. This results in pharmacokinetic interactions with a large number of medicines including leading to a possible decrease in the effectiveness of those medicines. In addition, pharmacodynamic interactions have also been identified with antidepressants, particularly the SSRI antidepressants and with the triptan group of medicine. Patients who have hepatic and/or renal impairment since the safety of Black cohosh extract has not been studied in patients with hepatic andor renal impairment. Patients who have active liver disease or a history of liver damage. Patients who have been treated or who are undergoing treatment for breast cancer or other hormone dependent tumours. 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.

4.4 Special warnings and precautions for use

Do not exceed the stated dose. If the condition worsens, or if symptoms persist for more than six weeks a doctor or qualified healthcare practitioner should be consulted. The use of this product in children and adolescents under 18 years of age is not recommended since there is no relevant use. This product is intended for relief of menopausal symptoms including slightly low mood and mild anxiety. Patients with signs and symptoms of depression should consult a doctor for appropriate treatment. In very rare cases, particularly in light-skinned persons, sun burn type reactions on skin areas exposed to strong sunlight may occur due to photosensitisation by St John’s wort. Persons using this product should avoid excessive sunbathing or the use of sunbeds or solariums. This product should be discontinued at least 10 days prior to elective surgery due to the potential for interactions with medicinal products used during general and regional anaesthesia (see Section 4.5) There have been rare cases of hepatic reactions associated with the use of Black cohosh. Patients taking Menomood should be advised 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 Menomood under supervision of a doctor, 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. This product contains sucrose, lactose and glucose. Patients with rare hereditary problems of galactose intolerance and/or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine

4.5 Interaction with other medicinal products and other forms of interaction

There are no reported studies for Black Cohosh. Substances in St John’s wort (Hypericum perforatum) have been shown to induce the cytochrome P450 isoenzymes CYP1A2, CYP2C19, CYP2C9 and CYP3A4 as well as the transport protein P-glycoprotein. This results in pharmacokinetic interactions with a large number of medicines leading to a potential decrease in the effectiveness of those medicines. The concomitant use of ciclosporin, tacrolimus for systemic use, Amprenavir, indinavir and other protease inhibitors, irinotecan and warfarin is contraindicated. Special care should be taken in the case of the concomitant use of all drug substances the metabolism of which is influenced by CYP1A2, CYP3A4, CYP2C9, CYP2C19 or P-glycoprotein (e.g. amitriptyline, fexofanadine, benzodiazepines, methadone, simvastatin, digoxin, finasteride) because a reduction of plasma concentration is possible. Users of oral contraceptives taking St John’s wort may experience intracyclic menstrual bleeding and risk of contraception failure is increased. Clinically significant pharmacodynamic interactions have also been identified with the SSRI antidepressants, and the triptan group of medicines used to treat migraines. Due to the increased risk of undesirable effects associated with these interactions this product should not be used concomitantly with these types of medicines. Therefore this product should not be taken concomitantly with the medicines included in table below.

Co-administered drug Interaction Recommendations concerning co­administration

Anaesthetics /pre-operative medicines

Fentanyl, propofol, sevoflurane, midazolam Reduced blood levels with risk of therapeutic failure. Based on the elimination half-lives of hypericin and hyperforin this product should be discontinued at least 10 days prior to elective surgery.

Analgesics

Tramadol Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Antianginals

Ivabradine Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Anti-arrhythmics

Amiodarone Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Antibacterials

Erythromycin, clarithromycin, telithromycin Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Anticoagulants

warfarin, acenocoumarol Reduced anticoagulant effect and need for increased dose Do not take with this product.

Antidepressants

Tricyclics eg. amitriptyline, clomipramine MAOIs eg. moclobemide SSRIs eg. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline Others eg. duloxetine, venlafaxine Increased serotonergic effects with increased incidence of adverse reactions. Do not take with this product.

Antiepileptics

All drugs in this class including: carbamazepine phenobarbitone phenytoin primidone sodium valproate Reduced blood levels with increased risk of frequency and severity of seizures. Do not take with this product.

Antifungals

itraconazole, voriconazole Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Antimalarials

artemether lumefantrine Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Anti-parkinsons

rasagiline Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Antipsychotics

aripiprazole Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Antivirals

HIV protease inhibitors: amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir Reduced blood levels with possible loss of HIV suppression. Do not take with this product.
HIV non-nucleoside reverse transcriptase inhibitors: efavirenz, nevirapine, delavirdine Reduced blood levels with possible loss of HIV suppression Do not take with this product.

Anxiolytics

buspirone Increased serotonergic effects with increased incidence of adverse reactions. Do not take with this product.

Aprepitant

Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Barbiturates

butobarbital, phenobarbital Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Calcium channel blockers

amlodipine,nifedipine verapamil, felodipine Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Cardiac glycosides

digoxin Reduced blood levels and loss of control of heart rhythm or heart failure. Do not take with this product.

CNS Stimulants

methyl phenidate Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Cytotoxics

irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib, etoposide, mitotane Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Hormonal contraceptives

Oral contraceptives Emergency Hormonal Contraception Hormonal implants, injections Transdermal patches, creams etc. Intra-uterine devices with hormones Reduced blood levels with risk of unintended pregnancy and breakthrough bleeding. Do not take with this product.

Hormone Replacement Therapy

Hormone Replacement Therapy: Oral Trandermal patches, gels Vaginal rings Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Hormone antagonists

exemestane Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Diuretics

eplerenone Reduced blood levels with risk of therapeutic failure. Do not take with this product.

5HT agonists

almotriptan,eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan and zolmitriptan Increased serotonergic effects with increased incidence of adverse reactions. Do not take with this product.

Immunosuppressants

ciclosporin, tacrolimus Reduced blood levels with risk of transplant rejection. Do not take with this product.

Lipid regulating drugs

simvastatin, atorvastatin Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Lithium

Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Proton pump inhibitors

lansoprazole, omeprazole Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Theophylline

Reduced blood levels and loss of control of asthma or chronic airflow limitation. Do not take with this product.

Thyroid hormones

thyroxine Reduced blood levels with risk of therapeutic failure. Do not take with this product.

Oral hypoglycaemic drugs

gliclazide Reduced blood levels with risk of therapeutic failure. Do not take with this product.

4.6 Fertility, pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established. In the absence of sufficient data the use during pregnancy and lactation is not recommended. Additionally because of the potential for Black cohosh to have hormone-like actions, the use by women who could become pregnant is not recommended 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 effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Gastrointestinal disorders (e.g. dyspepsia, anorexia, nausea, diarrhea, constipation); allergic skin reactions (e.g. rash, urticaria, pruritis); fatigue and restlessness may occur. The frequency is not known. Fair-skinned individuals may react with intensified sunburn-like symptoms under intense sunlight or strong ultra-violet (UV) irradiation. Other adverse reactions that have been reported in the literature with products containing Black cohosh include facial oedema, and peripheral oedema, and weight gain. Other adverse reactions that have been reported in the literature with products containing St John’s wort include headaches, neuropathy, anxiety, dizziness and mania. In rare cases, Black cohosh containing products may cause liver reactions (including hepatitis, jaundice and disturbances in liver function tests). If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continual monitoring of the benefit/risk of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at www.mhra.gov.uk/yellowcard

4.9 Overdose

There are no data on human overdose with St John’s wort. After the intake of up to 4.5 g dry extract per day for 2 weeks and additionally 15 g dry extract just before hospitalization, seizures and confusion have been reported. Where a large overdose has occurred, phototoxic reactions may occur. The skin of the patient should be protected for one to two weeks from UV irradiation and sunlight. Outdoor activities should be restricted and clothes and/or sun block preparations used to protect the skin from sunlight. Symptomatic and supportive measures should be taken as appropriate. Older herbal texts state that doses of over 5 g of unprocessed Black Cohosh 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

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

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. Adequate tests on reproductive toxicity have not been performed. Tests on carcinogenicity have not been performed. 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. A genotoxicity study (AMES-test) of the ethanolic extract (4.5-8.5:1, ethanol 60% (V/V)) was performed to a concentration of 1 mg/plate. The test does not fulfil the recent criteria of such testing and therefore the relevance of these results for safety assessment is doubtful. There are no conclusive studies on carcinogenicity and reproductive toxicity.

6 Pharmaceutical particulars

6.1 List of excipients

Extract excipients

Maltodextrin Silica colloidal anhydrous Lactose monohydrate Cellulose, powdered

Tablet core

Silica, colloidal anhydrous Cellulose, microcrystalline Croscarmellose sodium Sodium starch glycolate (type A) Magnesium stearate

Tablet coating

Hypromellose Sucrose Talc Calcium carbonate E170 Tragacanth Acacia Liquid glucose (dry substance) Titanium dioxide E171 Iron oxide hydrate E172 (= yellow iron oxide) Vanillin Capol 600 solids

consist of Beeswax, white Carnauba wax Shellac

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C. Store in the original packaging

6.5 Nature and contents of container

Original packages contain 28, 30, 56 and 60 Menomood Menopause Mood Relief coated tablets. Not all pack sizes may be marketed. Also original packages containing 30 Holland & Barrett Menopause Mood Relief coated tablets. The 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 Registration holder

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

8 Marketing authorisation number

THR 23056/0013

9 Date of first authorisation/renewal of the authorisation

05/06/2017

10 Date of Revision of the text

05/06/2017

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