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Napiers Sweet Dreams Sleep Remedy

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You can also get a Yellow Card form at your doctor's surgery, any pharmacy, or call freephone 0808 100 3352 (available 10am-2pm Monday to Friday).

5.    HOW TO STORE THIS PRODUCT

Do not use this product after the expiry date printed on the label and on the bottom of the carton.

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

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

Return any unused medicine to a pharmacist for safe disposal.

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

0.5 ml liquid extract Passion Flower

herb (Passiflora incarnata L.) (1:1) (equivalent to 500 mg of Passion Flower herb). Extraction solvent: Water

0.5 ml liquid extract Jamaica Dogwood

bark (Piscidia erythrina L.) (1:1) (equivalent to 500 mg of Jamaica Dogwood bark). Extraction solvent: Ethanol 60% v/v

0.4 ml liquid extract Hop Strobile

(Humulus lupulus L.) (1:1) (equivalent

to 400 mg of Hop Strobile). Extraction solvent: Ethanol 45% v/v

0.25ml liquid extract Valerian root (Valeriana officinalis L.) (1:1) (equivalent to 250mg of Valerian root. Extraction solvent: Ethanol 45% v/v

This product also contains:

Ethanol, glucose liquid, syrup (sucrose), glycerol, compound cardamom tincture (cochineal E120, cardamom oil, caraway oil, cinnamon bark oil, glycerol, water), nutmeg oil, clove oil, cinnamon oil, liquorice liquid extract (liquorice root, sorbitol, glucose liquid, caramel (E150), ethanol, water), caramel (E150), water.

This product comes in a glass bottle of 150 ml with a child-resistant safety cap. It contains a dark brown liquid.

Traditional herbal registration holder and manufacturer:

Potters, Wigan WN5 0JZ Traditional herbal registration number:

THR 33656/0075

Certification mark

This leaflet was revised 17/03/2014

NAP03LEA

Further Enquiries

If you would like more information about this product, or a leaflet version in large format print for the blind or partially sighted, please contact:

Napiers the Herbalists

24 Tennant Street, Edinburgh EH6 5ND

Telephone: 0845 002 1860

What is Passion Flower?

Passion flower is a herb and wildflower that is native to the southern states of America. The part used is the herb.

What is Jamaica Dogwood?

Jamaica dogwood is a tree that is native to the West Indies. The part used is sustainably harvested bark.

What is Hop?

The Common Hop is a flowering herb native to Europe and the British Isles.

The part used is the flower (strobile).

What is Valerian?

Valerian is a wildflower, native to the British Isles. The part used is the herb.

PATIENT INFORMATION LEAFLET

NAPIERS SWEET DREAMS SLEEP REMEDY

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

ESTQ EDINBURGH 1860 HERB & PLANT REMEDIES

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

Napiers Sweet Dreams Sleep Remedy is a traditional herbal medicinal product containing extracts of Passion Flower (Passiflora), Jamaica Dogwood, Hops & Valerian. For full details see Section 6.

Napiers Sweet Dreams Sleep Remedy is a traditional herbal medicinal product used 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 of age

•    pregnant or breastfeeding

•    allergic to any of the ingredients

•    already taking medicines for sleep or anxiety

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

Important information about some of the ingredients in this medicine

The effect of this product may be increased by alcohol. Excessive consumption of alcohol whilst taking this product should therefore be avoided.

This medicinal product contains sucrose (syrup) and glucose (dextrose).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicinal product contains 16.5% v/v ethanol (alcohol), i.e. up to 660 mg per dose (5 ml), equivalent to 16.5 ml beer, 6.9 ml wine per dose. It may be harmful for those suffering from alcoholism and high-risk groups such as pregnant or breastfeeding women, children and patients with liver disease or epilepsy.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding, due to a lack of safety data.

Driving and using machines

This product may cause drowsiness and contains ethanol (alcohol) which may impair your ability to drive or operate machines. If affected, do not drive or operate machines.

Taking other medicines

Please ask your doctor or pharmacist for advice if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

3. HOW TO TAKE THIS PRODUCT

It is important that you follow these instructions carefully.

Shake the bottle well before use.

For oral use. Adults and the elderly:

Take one 5ml teaspoonful after the last meal of the day, and two 5ml teaspoonful at bedtime.

The use in children and adolescents under 18 years is not recommended.

For the best results, you may need to take this product for 2 - 4 weeks continuously.

If your symptoms worsen, or persist after 4 weeks, speak to your doctor, pharmacist or 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. (See section 2 for more information.)

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 cause side effects, but not everyone gets them. If you get any of the following side effects, stop taking the medicine and tell your doctor, pharmacist or a qualified healthcare practitioner:

Gastrointestinal symptoms such as nausea and abdominal cramps have been reported with Valerian root. The frequency is not known.

One case of hypersensitivity (vasculitis) and one case of increased heart beat (tachycardia) has been reported in a patient using Passion Flower herb. The frequency is not known.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 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 medicines.