MENOMOOD MENOPAUSE MOOD RELIEF TABLETS

Active substance: ST JOHNS WORT DRY EXTRACT

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MenoMood PIL 2012 (5804-02)

26/6/12

17:05

Page 1

Patient Information Leaflet
®

MenoMood

2: Before you take this product

Menopause Mood Relief Tablets

St John's wort extract 300 mg and Black cohosh root extract 6.4 mg
Please read this leaflet carefully before you start taking these tablets.
It contains some important information about MenoMood Menopause Mood
Relief Tablets.
Keep this leaflet with the tablets.
You may want to read it again or show it to your doctor, pharmacist or
qualified healthcare practitioner.

What is in this leaflet
1: What this product is and what it is used for ............................page 1
2: Before you take this product ..........................................pages 2-4
3: How to take this product....................................................page 4
4: Possible side-effects ........................................................page 5
5: How to store this product ..................................................page 5
6: Further information..........................................................page 6

1: 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.) (3.5-6:1) (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.
MenoMood Menpause Mood Relief is 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. 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.
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DO NOT TAKE THIS PRODUCT IF YOU ARE TAKING ANY OF THE
FOLLOWING MEDICINES

DO NOT TAKE this product if:
• you are under 18 years of age
• you are pregnant or breast-feeding
• 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)
• have ever had or are suffering from liver or kidney disease (eg. hepatitis,
jaundice or cirrhosis)
• have ever had or are suffering from an oestrogen dependent tumour

All hormonal contraceptives

The birth control ‘Pill’, emergency
contraception (also known as the
morning after pill), hormonal implants,
creams, patches, intra-uterine 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

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.

Some medicines for migraines

Almotriptan, eletriptan, frovatriptan,
naratriptan, rizatriptan, sumatriptan,
zolmitriptan

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 opposite.

Some medicines for high blood
pressure

Amlodipine, nifedipine, felodipine,
verapamil

A medicine for regulating mood

Lithium

A thyroid hormone

Thyroxine

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.

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MenoMood PIL 2012 (5804-02)

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Taking other medicines (continued)
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/pre-operative medicines)
• tramadol (an analgesic)
• erythromycin, clarithromycin and telithromycin (antibiotics)
• itraconazole and voriconazole (antifungals)
• artemether and lumefantrine (antimalarials)
• rasagiline (an anti-parkinson’s medicine)
• aripiprazole (an antipsychotic medicine)
• buspirone (an anxiolytic)
• aprepitant (used to treat post-operative 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).

Store the tablets in a cool dry place. 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.

4: 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 side-effects 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.

6: 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.) (3.5-6:1) (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.
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 1PD
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 1PD
Telephone: 01628 401980. Email: info@menomood.co.uk
This leaflet was prepared in May 2012.
For a large print, Braille or audio version of this leaflet, call 01628 401980

Other side-effects

3: 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). 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
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.
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These include headaches, nerve pain or tingling, anxiety, dizziness, mania.
Also, sun-burn like reactions in skin exposed to strong sunlight or strong
ultra-violet (UV) irradiation, e.g solarium, have been reported, particularly in
fair-skinned 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.
If you notice any other side-effect not mentioned above, or if any side-effect
become serious, tell your doctor or pharmacist.
You can help to make medicines safer by reporting any side-effects to the
Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Alternatively you can
get a paper Yellow Card from your G.P.’s surgery or pharmacy, or call
Freephone 0808 1003352 (available 10am–2pm Monday–Friday).

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.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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