MENOMOOD MENOPAUSE MOOD RELIEF TABLETS

Active substance: ST JOHNS WORT DRY EXTRACT

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LEAFLET SPEC
HB MENOPAUSE MOOD RELIEF LEAFLET

PATIENT INFORMATION LEAFLET
MENOPAUSE MOOD RELIEF TABLETS
St John's wort extract 300 mg and
Black cohosh root extract 6.4 mg
Important notes
Please read this leaflet carefully before you start taking these
tablets; It contains some important information about Holland &
Barrett Menopause Mood Relief tablets.
u Keep this leaflet with the tablets; you may want to read it again
or show it to your doctor, pharmacist or qualified healthcare
practitioner.
u

What is in this leaflet
1
2
3
4
5
6

What this product is and what it is used for
Before you take this product
How to take this product
Possible side-effects
How to store this product
Further information

1 - What this product is and what it is used for
This product 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.

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:
u Fentanyl, propofol, sevoflurane, and midazolam (anaesthetics/pre-operative
medicines)
u Tramadol (an analgesic)
u Erythromycin, clarithromycin and telithromycin (antibiotics)
u Itraconazole and voriconazole (antifungals)
u Artemether and lumefantrine (antimalarials)
u Rasagiline (an anti-parkinson’s medicine)
u Aripiprazole (an antipsychotic medicine)
u Buspirone (an anxiolytic)
u Aprepitant (used to treat post-operative vomiting)
u Butobarbital and phenobarbital (barbiturates)
u Methyl phenidate (a central nervous system or CNS stimulant)
u Exemestane (a hormone antagonist)
u Eplerenone (a diuretic)
u Lansoprazole and omeprazole (proton pump inhibitors)
u Theophylline (a bronchodilator)
u Gliclazide (an antidiabetic medicine)
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.

2 - Before you take this product
Do not take this product if:
u You are under 18 years of age
u You are pregnant or breastfeeding
u You are of childbearing potential and do not use adequate contraception
u You are allergic to any of the ingredients (listed in section 6)
u Your skin is exceptionally sensitive to sunlight (photosensitive)
u You are having light treatment (phototherapy) for any condition
u You are suffering from depression (see below)
u You have ever had or are suffering from liver or kidney disease (eg. hepatitis,
jaundice or cirrhosis)
u You have ever had or are suffering from an oestrogen dependent tumour
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.
Tell your doctor before using this product if you:
u Think you may be suffering from depression (see below)
u Have a persistent history of menstrual disorders
u 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.
u Are currently taking a medicine containing oestrogen
While you are taking this product:
u Avoid excessive sunbathing or the use of sunbeds/solariums
u 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

Do not take this product if you are taking any of the following medicines:
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 medicines for thinning the blood (anticoagulants):
Warfarin, acenocoumarol
All medicines for epilepsy:
Carbamazepine, phenobarbitone, phenytoin, primidone, sodium valproate

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

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 this product 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

6 - Further information

Like all medicines this product can have side-effects, although these are
uncommon. These are listed below.
u Gastrointestinal disorders e.g indigestion, loss of appetite, nausea,
diarrhoea, constipation
u Fatigue and restlessness
u Facial swelling, swelling of the feet, ankles or lower leg
u Weight gain
u Allergic skin reactions such as nettle rash, itching of the skin, hives
Stop taking this product immediately if you experience an allergic reaction.
If these persist for more than a few days, or become troublesome, stop taking
this product. These side-effects are often only temporary.

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 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.) (4.5-8.5:1) (equivalent to 28.80-54.40 mg of Black Cohosh). Extraction
solvent ethanol 60% v/v.

Other side-effects
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 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.

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

Manufactured for
NBTY Europe Limited by:
Wiewelhove GmbH,
Gildestrasse 39, 49477 Ibbenbüren, Germany

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
u Do not use your tablets after the expiry date
u 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
u Store the tablets in a cool dry place
u Do not store above 25°C
u Keep the tablets out of the reach and sight of children
u Keep your tablets in the blister pack until it is time to take them

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.

Each pack contains 30 coated tablets.
Registration holder for this product
Schwabe Pharma (UK) Ltd,
Alexander House, Mere Park, Dedmere Road,
Marlow, Bucks, SL7 1FX

Traditional Herbal Registration number: THR 23056/0013
If you would like further information about this product, please contact:
NBTY Europe Limited,
Regulatory Services Department,
Samuel Ryder House, Barling Way,
Nuneaton, Warwickshire, CV10 7RH,
United Kingdom
Is this leaflet hard to see or read? Contact us on:
Telephone: +44 (0) 2476 215 400
Fax: +44 (0) 2476 215 452
Email: customerservices@NBTYeurope.com
This leaflet was prepared on: 17/03/2014

FONTS:
Gil Sans
Times New Roman
FINISH:

All immunosuppressant medicines:
Ciclosporin, tacrolimus

Some medicines for migraines:
Almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

4 - Possible side-effects

CHANGES FROM LAST PRINT: None
COLOURS:
K
P364

All hormonal replacement therapy (HRT) treatments:
HRT tablets, patches, gels, vaginal rings

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

LEAFLET SIZE: 315mm x 145mm (flat)
? (folded)
BLEED: N/A
BULK:
ISSUE:
BARCODE:

CERTIFICATION MARK

BMXXX-000 00A IXXXXX-000

LPI:
SCREEN ANGLES:
CAUTION: It is the vendors responsibility to print a
scannable UPC code from either our artwork or
your alternative UPC method
COLOUR MATCH:

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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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