LEAFLET SPEC

PATIENT INFORMATION LEAFLET

HOLLAND & BARRETT

MOODEASE ST JOHN’S WORT ONE-A-DAY TABLETS St John's Wort extract 425 mg

Important notes

♦    Please read this leaflet carefully before you start taking these tablets: It contains some important information about Holland & Barrett Moodease St John's Wort one-a-day 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

2    Before you take this product

3    How to take this product

4    Possible side-effects

5    How to store this product

6    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 slightly low mood and mild anxiety This usage is based on traditional use only.

2 - Before you take this product

Do not take this product if:

♦    You are under 18 years of age

♦    You are pregnant or breastfeeding

♦    You    ;ic 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)

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.

Tell your doctor before using this product if you:

♦    Think you may be suffering from depression (see below)

♦    Have been told by your doctor that you have an intolerance to some sugars

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

Driving and operating machinery

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 this product if you are using any of the medicines listed in the table opposite.

HB35291 MOODEASE LEAFLET

LEAFLET SIZE: 295mm x 145mm (flat)

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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)

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.

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, if any side-effect becomes serious or if side-effects not mentioned in this leaflet occur

4 - Possible side-effects

Like all medicines, this product can have side-effects, although the frequency is not known. These are listed below.

♦    Digestive upsets e.g indigestion, loss of appetite, nausea, diarrhoea, constipation

♦    Fatigue and restlessness

♦    Allergic skin reactions such as rash, hives or itching

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

Other side-effects

These include headaches, nerve pain or tingling (neuropathy), anxiety, dizziness and mania. Also sunburn-like reactions in skin exposed to strong ultra-violet (UV) irradiation (e.g. sun, solarium) have been reported, particularly in fair-skinned individuals.

If you notice any other side-effects not mentioned above, or if any side-effect becomes 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 paperYellow Card form from your GP's surgery or pharmacy, or call Freephone 0808 100 3352 (available 10am - 2pm Monday - Friday).

6 - Further information

Each coated tablet of this product contains 425mg of extract (as dry extract) from St John's Wort aerial parts (Hypericum perforatum L.) (35-6:1) (equivalent to 1490- 2550mg of St John's Wort). Extraction solvent: Ethanol 60% v/v.

This product also contains the following ingredients:

Tablet core: Maltodextrin, silica colloidal anhydrous, microcrystalline cellulose, croscarmellose sodium, sodium starch glycolate (Type A), magnesium stearate. Coating: Hypromellose, sucrose, talc, calcium carbonate EI70, tragacanth, acacia, liquid glucose (dry substance), titanium dioxide EI7I, iron oxide hydrate EI72 (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 tablet contains 6mg of glucose and 234mg of sucrose.

Each pack contains 30 coated tablets.

Registration holder for this product

Schwabe Pharma (UK) Ltd,

Alexander House, Mere Park, Dedmere Road,

Marlow, Bucks, SL7 IFX

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

♦    Store the tablets in a cool dry place

♦    Do not store 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

Manufactured for

NBTY Europe Limited by:

Wiewelhove GmbH,

Gildestrasse 39, 49477 Ibbenburen, Germany Traditional Herbal Registration number: tHr 23056/0007

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

NBTY Europe Limited,

Regulatory Services Department,

Samuel Ryder House, Barling Way Nuneaton, Warwickshire, CVI0 7RH,

United Kingdom

Is this leaflet hard to see or read? Contact us on: Telephone: +44 (0) 2476 2I5 400 Fax: +44 (0) 2476 2I5 452 Email: customerservices@NBTYeurope.com

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