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Neals Yard Remedies Stress & Sleep Herbal Relief

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Document: leaflet MAH BRAND_THR 15670-0026 change

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

0.425ml liquid extract of Passion Flower herb (Passiflora incarnata L.)

(1:1) (equivalent to 425 mg of Passion Flower). Extraction Solvent: Ethanol 21% v/v

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

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 or 200 ml with a child-resistant safety cap. It contains a brown liquid.

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

Certification mark

This leaflet was revised 01/11/2012 NAP14LEA

Making medicines safer

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.mhra.gov.uk/ yellowcard

Alternatively you can get a paper Yellow Card form from your doctor's surgery or a pharmacy, or call freephone 0808 100 3352 (available 10am-2pm Monday to Friday).

PATIENT INFORMATION LEAFLET

NAPIERS HERBAL STRESS AND SLEEP AID

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.    How to store this product

6. Further information

NIAPUIRS

EDINBURGH 1860 HERB & PLANT REMEDIES

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

Napiers Herbal Stress and Sleep Aid is a traditional herbal medicinal product containing extracts from Vervain, Scullcap, Passion Flower and Oat Seed. For full details see Section 6.

Napiers Herbal Stress and Sleep Aid is a traditional herbal medicinal product used for the relief of symptoms associated with stress, such as mild axaiety 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

•    pregnant or breastfeeding

•    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 mid anxiety. If you have symtoms of depression such as low mood

you shoud seek medical advice for appropiate treatment.

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 caution is advised for patients suffering from coeliac disease.

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 anaxiety:

One 5 ml teaspoonful in water three times day.

To aid sleep: One 5 ml teaspoonful in water at bed time. 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

Like all medicines, this product can have side effects.

There have been one report of nausea and increased heart beat and one report of hypersensitivity with Passion flower herb.

Other possible side effects are: allergic skin reactions such as itching, redness or blistering of the skin.

The frecuency is not known.

If you notice any other side effect with this medicine, speak to a qualified healthcare practitioner.

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 any special storage conditions.

Return any unused medicine to a pharmacist for safe disposal.

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