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Patient Information Leaflet

Higher Nature St John’s Wort Mood Uplift

Coated tablets

St John’s Wort extract 425mg

Please read this leaflet carefully before you start taking these tablets.

It contains some important information about Higher Nature St John’s Wort Mood Uplift.

Keep this leaflet with the tablets.

You may want to read it again or show it to your doctor, pharmacist or qualified healthcare practitioner.

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. Each coated tablet of this product contains 425mg of extract (as dry extract) from St John’s Wort aerial parts (Hypericum perforatum L.) (3.5-6:1) (equivalent to 1490-2550mg of St John’s Wort). Extraction solvent: ethanol 60% v/v.

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)

•    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.

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 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.
Some medicines for migraines	Almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan.
Some medicines for high blood pressure	Amlodipine, nifedipine, felodipine, verapamil.
A medicine for regulating mood	Lithium.
A thyroid hormone	Thyroxine.

St John’s Wort may also affect the following medicines. Therefore do not take this product with these medicines unless a doctor or pharmacist 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

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.

4. Possible side-effects

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

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 product in a cool dry place.

Do not store the tablets in a place where the temperature goes above 25°c.

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.) (3.5-6:1) (equivalent to 14902550mg 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 E170, tragacanth, acacia, liquid glucose (dry substance), 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 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 1FX

Manufacturer of this product

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:

Higher Nature Burwash Common East Sussex, TN19 7LX Telephone: 0870 0664478 Email: nutrition@higher-nature.co.uk

Leaflet last revised 11/201 5.

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