SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Menomood Menopause Mood 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 max. 234 mg of sucrose, 19 mg of lactose monohydrate and 6 mg glucose.

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 ingredient(s)

Patients with known dermal photosensitivity or patients undergoing phototherapy or any photodiagnostic procedures.

This product should not be taken concomitantly with the medicines included in Section 4.5. This is because St John’s wort (Hypericumperforatum) 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 and or 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

Substances in St John’s wort (Hypericumperforatum) 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	Increased serotonergic effects with increased incidence of adverse reactions.	Do not take with this product.
MAOIs eg.

moclobemide SSRIs eg. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, Others eg. duloxetine, venlafaxine
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 nonnucleoside 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	Reduced blood levels with risk of unintended pregnancy and breakthrough bleeding.	Do not take with this product.
Hormonal implants, injections
Transdermal patches, creams etc.
Intra-uterine devices with hormones
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,	Increased serotonergic effects with increased incidence of adverse	Do not take with this product.

rizatriptan, sumatriptan and zolmitriptan	reactions.
Immunosuppressants
ciclosporin, tacrolimus	Reduced blood levels with risk of transplant rejection.	Do not take with this product.
Lipid regulating dru	gs_
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 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.

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 ADRs reported in the literature with products containing Black cohosh include facial oedema, and peripheral oedema, and weight gain.

Other ADRs 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.

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.

PHARMACOLOGICAL PROPERTIES

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

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

Special precautions for storage

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

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    MARKETING AUTHORISATION HOLDER

Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow

Buckinghamshire SL7 1FX

8    MARKETING AUTHORISATION NUMBER(S)

THR 23056/0013

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

20/01/2011

10    DATE OF REVISION OF THE TEXT

17/03/2015