Also sunburn-like reactions on skin exposed to strong sunlight or strong ultraviolet (UV) irradiation e.g. solarium have been reported, particularly in fair skinned individuals. Other side effects that have been reported include headaches, nerve pain or tingling, anxiety, dizziness and mania. The frequency of these effects occurring is not known.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yeiiow Card Scheme website www.mhra.gov.uk/yeiiowcard.

5: How to store this product

Do not use your film-coated 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 Return any out-of-date tablets to your pharmacist who will dispose of them for you.The expiry date is printed on the box and the blister pack.

Do not store above 25°C. Store in original packaging.

Keep the tablets out of the reach and the sight of children.

Keep your tablets in the blister pack until it is time to take them.

6: Further information

Each film-coated tablet contains: 370mg of extract (as dry extract) from St John's Wort aerial parts (Hypericumperforatum L.) (5-7:1) (equivalent to 1,850mg to 2,590mg of St John's Wort.) Extraction solvent: Ethanoi 60% v/v.

This product also contains the following ingredients:

Excipients in the extract: Maltodextrin, coiioidai anhydrous silica.

Tablet core: Maltodextrin, microcrystalline ceiiuiose, croscarmeiiose sodium, stearic acid, magnesium stearate, coiioidai anhydrous silica.

Tablet coating: Hypromeiiose, giyceroi.

What Healthspan St John's Wort Mood Relief looks like and contents of the pack:

Each pack contains 60 fiim-coated tablets.

You must speak to a qualified healthcare practitioner if your symptoms worsen, if they do not improve after six weeks, or if side effects not mentioned in this leaflet occur.

Registration holder and manufacturer of this product:

Traditional herbal registration holder and manufacturer for this product:

Thompson & Capper Ltd. Hardwick Road.Astmoor, Runcorn, Cheshire, WA7 1PH Traditional herbal registration number:THR 01359/0001 If you would like further information about this product please contact:

Healthspan Ltd, PO Box 64, Guernsey, GY1 1BT    L-fe

Telephone: 0800 73 123 77 Email: herbaiinfo@heaithspan.co.uk    THR

This leaflet was prepared in August 2016.    certification mark

LK182-2

Patient Information Leaflet

Healthspan St John's Wort Mood Relief

tablets

St John's Wort Extract 370mg

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

It contains some important information about Healthspan St John's Wort Mood Relief. 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 ................................................................................page 1-3

3: How to take this product ........................................................................................page 3

4: Possible side-effects ..............................................................................................page 3-4

5: How to store this product ........................................................................................page 4

6: Further information......................................................................................................page 4

1: What this product is and what it is used for

This product is a traditional herbal medicinal product containing St John's Wort extract. Each film-coated tablet contains: 370mg of extract (as dry extract) from St John's Wort aerial parts [Hypericumperforatum L.) (5-7:1) (equivalent to 1,850mg to 2,590mg of St John's Wort.) Extraction solvent: Ethanol 60% v/v.

This product is a traditional herbal medicinal product used to relieve the symptoms of slightly low mood and mild anxiety.This is based on traditional use only.

2: Before you take this product

DO NOT TAKE this product if:

•    Your skin is exceptionally sensitive to sunlight (photosensitive)

•    You are having light treatment (phototherapy) for any condition

•    You are suffering from depression (see below)

•    You are pregnant or breastfeeding

•    You are allergic to any of the ingredients (see section 6)

•    You are under the age of 18 years Suffering from depression?

Symptoms of depression include feelings of helplessness and hopelessness, loss of interest in daily activities, appetite or weight changes, changes in sleep pattern, 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 before taking this product.

2: Before you take this product (continued)

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

St John's Wort may make you feel dizzy or sleepy. If affected do not drive or use machines. Taking other medicines

Healthspan St John's Wort Mood Relief 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 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.

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 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 tablet whole with some water or other liquid.

Do not chew the tablet.

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.

If your symptoms worsen, if they do not improve after six weeks, or If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or qualified healthcare practitioner.

4: Possible side-effects

Heaithspan St John's Wort Mood Relief can cause side effects, although not everybody gets them. Stop taking Heaithspan St John's Wort Mood Relief and check with your doctor, pharmacist or qualified healthcare practitioner immediately if any of the following side effects occur:

•    Gastrointestinal disorders such as indigestion, loss of appetite, nausea, diarrhoea and constipation.

•    Fatigue and restlessness.

•    Allergic skin reactions such as rash, hives or itching of the skin. If you experience allergic skin reactions, stop taking the product and consult your doctor.

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