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VITABIOTICS

st john’s wort

^J    tablets

Patient Information Leaflet St John’s Wort Extract 425mg

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 is a traditional herbal medicinal product containing St John’s Wort extract. It is 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 breast-feeding

•    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.

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 or operating machines:

St John's Wort may make you feel dizzy or sleepy.

If affected do not drive or use machinery.

Taking this product with other medicines

St John's Wort can affect the way some medicines work and

Please read this information carefully before you start taking these tablets. It contains some important information about this product. Keep this leaflet with the tablets. You may want to read it again or show it to your doctor, pharmacist or refer to a qualified healthcare practitioner.

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 in the table below.

Taking this product with 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. 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.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, this product can have side effects. The following side effects have been reported:

•    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.

Also sunburn-like reactions on skin exposed to strong sunlight or strong ultra-violet (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.

You must speak to a doctor or qualfied healthcare practitioner if your symptoms worsen, if they do not improve after six weeks, or if any of the side effects become serious or if you notice any side effects not mentioned in the leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE THIS PRODUCT

Do not use your tablets after the expiry date. The expiry date is printed on the box and the blister pack. The expiry date refers to the last day of that month.

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

Keep the tablets out of sight and reach of children.

Keep your tablets in the packaging until it is time to take them. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6.    FURTHER INFORMATION

Each film coated tablet contains 425mg of extract (as dry extract) from St John's Wort aerial parts (Hypericum perforatum L.) (5-7:1) (equivalent to 2125mg - 2975mg of St John’s Wort). Extraction Solvent: Ethanol 60% V/V.

This product also contains the following ingredients:

Excipients in the extract Maltodextrin, Silica Colloidal Anhydrous Tablet Core

Maltodextrin, Microcrystalline cellulose, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Silica Colloidal Anhydrous Tablet Coating

Hypromellose, Red Iron Oxide (E172), Titanium Dioxide (E171), Glycerol

The tablets are red coated and oval shaped.

This product is available in 30, 60 and 90 tablets. Not all pack sizes are marketed.

If you would like further information about this product or for large print, Braille or audio version please contact:

Traditional Herbal Registration Holder: Vitabiotics Ltd, 1 Apsley Way, London NW2 7HF. Telephone: 020 8955 2662

Manufacturer: Thompson & Capper Ltd, Hardwick Road, Astmoor, Runcorn, Cheshire WA7 1PH. Traditional Herbal Registration Number: THR 00387/0055

This leaflet was revised in September 2016.

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VITABIOTICS