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6. FURTHER INFORMATION Each 5 ml of oral liquid contains:

0.812 ml liquid extract of Vervain herb (Verbena officinalis L.) (1:1) (equivalent to 812 mg of Vervain). Extraction Solvent: Ethanol 21% v/v. 0.188 ml liquid extract of Scullcap herb (Scutellaria lateriflora L) (1:1)

(equivalent to 188 mg of Scullcap). Extraction Solvent: Ethanol 21% v/v 0.4 ml tincture from dried Scullcap herb (Scutellaria lateriflora L) (1:5)

(equivalent to 80 mg of Scullcap). Extraction Solvent: Ethanol 41% v/v

0.425 ml liquid extract of Passion Flower herb (Passiflora incarnatal.) (1:1) (equivalent to 425 mg of Passion Flower). Extraction Solvent: Ethanol 21% v/v

0.213 ml liquid extract of Oat Seed (Avenasatival.) (1:1) (equivalent to 213 mg of Oat Seed). Extraction Solvent: Ethanol 21% v/v

Traditional Herbal Registration Holder

Rickard Lane's &WH Box Ltd,

24 Tennant Street, Edinburgh EH6 5ND

Traditional Herbal Registration Manufacturer

Potters, Wigan WN5 0JZ

Traditional Herbal Registration Number

THR 15670/0026

THR"

Certification mark

This leaflet was revised on 02/12/2013 ILX5238 0

This product also contains:

Liquid extract wild thyme, orange oil, lemon oil, coriander oil, aniseed oil, 90% ethanol, water.

This product comes in a glass bottle of 100 ml with a child-resistant safety cap. It contains a brown liquid.

PATIENT INFORMATION LEAFLET

NEAL’S YARD REMEDIES STRESS AND SLEEP HERBAL RELIEF

Please read this leaflet carefully before you start taking this product.

It contains important information for you about this product that may affect you.

Keep this leaflet. You may wish to read it again.

You must contact a doctor or qualified healthcare practitioner if your symptoms worsen or do not improve after 4 weeks.

If any side effects become serious, or if you notice side effects not listed in here, please tell your doctor 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.    Howto store this product

6.    Further information

1.    WHAT THIS PRODUCT IS AND WHAT IT IS USED FOR

Neal's Yard Remedies Stress and Sleep Herbal Relief is a traditional herbal medicinal product containing extracts from Vervain, Scullcap, Passion Flower and Oat Seed. For full details see Section 6.

Neal's Yard Remedies Stress and Sleep Herbal Relief is a traditional herbal medicinal product used for the relief of symptoms associated with stress, such as mild anxiety and to aid sleep, based on traditional use only.

2.    BEFORE YOU TAKE THIS PRODUCT Do not take this product If you are:

•    under 18 years old

•    allergic to any of the ingredients or oat preparations

•    pregnant or breast-feeding

•    already taking a medicine for sleep or anxiety

•    taking medicines known to interact with alcohol i.e. metronidazole

•    suffering from depression-this product is intended for the relief

of symptoms associated with stress such as mild anxiety. If you have symptoms of depression such as low mood you should seek medical advice for appropiate treatment.

If you suffer from coeliac disease, consult your doctor before taking this product.

Important Information about some of the Ingredients In this medicine

This product contains 14% v/v ethanol (alcohol), i.e. up to 560 mg per dose, equivalent to 14 ml beer, 5.8 ml wine per dose. Harmful for those suffering from alcoholism, liver disease or epilepsy.

This product also contains Oat Seed (Avena). There is no information about the gluten content of this product so patients suffering from coeliac disease should consult their doctor.

Driving and using machines

This product contains alcohol and therefore may impair ability to drive or operate machines. If affected, do not drive or operate machines.

3. HOW TO TAKE THIS PRODUCT

For oral use only. For adults and the elderly and adolescents over 18 years of age.

For temporary relief of mild anxiety:

One 5 ml teaspoonful in water three times a day.

To aid sleep: One 5 ml teaspoonful in water at bedtime. An extra 5 ml (one teaspoonful) in water can be taken during the night if needed.

Do not exceed the recommended dose.

If symptoms worsen or do not improve after taking the product for 4 weeks, consult your doctor or a qualified healthcare practitioner.

If you take too much (overdose)

If you take more than the recommended dose, speak to a qualified healthcare practitioner and take this leaflet with you.

Overdose of this product may result in alcohol intoxication and should be treated accordingly.

If you forget to take this product

Continue to take your usual dose at the usual time. Do not take a double dose.

It does not matter if you miss a dose.

If you have any questions, or are unsure of anything, please speak to a qualified healthcare practitioner.

4.    POSSIBLE SIDE EFFECTS

Anaphylactic shock has been reported with Burdock root. This is rare and the frequency is not known.

If this adverse effect or reactions not mentioned above occur, stop taking this product and contact your doctor or qualified healthcare practitioner.

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 this 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 this product after the expiry date. The expiry date is printed on the label and on the bottom of the carton. This product does not require special storage conditions.

Return any unused medicine to a pharmacist for safe disposal.

Keep this product out of the sight and reach of children.