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Goldshield Moodease PIL (2014) 28/04/2014 15:07 Page 1

Patient Information Leaflet

Moodease" film-coated tablets

St John’s Wort Extract 250mg

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

What this product is and what it is used for........................................page 1

Before you take this product............................................................page 2-4

How to take this product......................................................................page    4

Possible side-effects............................................................................page    5

How to store this product....................................................................page    5

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. Each film-coated tablet of this product contains 250mg of extract (as dry extract) from St John’s Wort aerial parts (Hypericum perforatum L.) (3.5-6:1) (equivalent to 875-1500mg of St John’s Wort). Extraction solvent: Ethanol 60% v/v.

Moodease™ St John’s Wort 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 are allergic to any of the ingredients (listed in section 6)

•    you are lactose intolerant (react badly to lactose or milk)

•    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 have an intolerance to some sugars (see section 6).

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 use machines.

Taking this product with 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 St John’s Wort if you are using any of the medicines listed in the table opposite.

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.

•    digestive upsets such as indigestion, loss of appetite, nausea, diarrhoea, constipation

•    fatigue and restlessness

•    allergic skin reactions    Stop taking this product immediately if you

such as rash, hives or itching    experience an allergic reaction.

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-effect not mentioned above or 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.yellowcard.gov.uk. Alternatively you can get a paper Yellow Card form from your GP’s surgery or pharmacy, or call Freephone 0808 100 3352 (available 10am-2pm Monday -Friday).

After taking this product

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.

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 the tablets in a place where the temperature goes above 25^oC.

Each film-coated tablet of this product contains 250mg of extract (as dry extract) from St John’s Wort aerial parts (Hypericum perforatum L.) (3.5-6:1) (equivalent to 8751500mg of St John’s Wort). Extraction solvent: Ethanol 60% v/v.

This product also contains the following ingredients:

Extract: Lactose monohydrate, calcium hydrogen phosphate dihydrate, cellulose powdered, silica colloidal anhydrous.

Tablet core: Cellulose powdered, stearic acid, sodium starch glycolate (type A), silica colloidal anhydrous, magnesium stearate.

Film-coating: Eudragit E 100, hypromellose, Macrogol 6000, talc, titanium dioxide (E171), iron oxide hydrate (E172) (yellow iron oxide).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

Each film-coated tablet contains 11 mg of lactose monohydrate.

Each pack contains 30 film-coated tablets.

Registration holder for this product

Schwabe Pharma (UK) Ltd, Alexander House, Mere Park, Dedmere Road, Marlow, Bucks, SL71FX

Manufacturer of this product

Wiewelhove GmbH, Gildestrasse 39, 49477 Ibbenburen, Germany

Certification Mark. Traditional Herbal Registration number: THR 23056/0011

If you would like further information about this product, please contact: Goldshield Limited (Reg No: 3561477)

No.1 Croydon (NLA Tower), 12-16 Addiscombe Road, Croydon CR0 0XT

Telephone: 080 8168 0712. Email: info@goldshield.co.uk This leaflet was revised in 04/ 2012

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.