THR 14010/0042 Herbal Quiet Nights

PATIENT INFORMATION LEAFLET Important Notes

•    Please read this leaflet carefully before you use this product as it contains important information

•    Keep this leaflet; you may need to read it again

•    Seek professional advice if you need more information

•    Please tell a Doctor or a qualified Healthcare Practitioner if your symptoms worsen or do not improve after 4 weeks of taking this product

•    Please tell a Doctor or a qualified Healthcare Practitioner if you suffer from side effects not listed in this leaflet and/or if any of the side effects become serious

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 product contains extracts of Hops, Wild Lettuce, Passion Flower and Valerian Root. It is a traditional herbal medicinal product used for the temporary relief of sleep disturbances, 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 in this product

•    Already taking a medicine for sleep or anxiety

The effects of this product may be increased with alcohol. Therefore excessive alcohol consumption should be avoided.

Driving and using machines:

If you feel sleepy do not drive or use machines.

Taking other medicines.

Tell your doctor about any other medicines you are taking, including any bought without a prescription.

3. How to take this product

Adults and the elderly: Two or three tablets to be taken at night, preferably with a little liquid.

Duration of use: As it may not improve your symptoms immediately, this medicine should be taken for at least 2 - 4 weeks continuously.

If symptoms worsen or persist after 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.

If you take too much of the product (overdose): Speak to a Doctor or a qualified Healthcare Practitioner immediately and take this leaflet and bottle with you.

If you forget to take this product: Do not take a double dose to make up for the missed dose(s). Continue to take your usual dose at the usual time. It does not matter if you have missed a dose.

4. Possible side effects

Like all medicines Herbal Quiet Nights can have side effects. Possible side effects are:

•    Gastrointestinal disorders such as stomach discomfort, nausea, vomiting, diarrhoea

•    Racing heart beat (tachycardia) and hypersensitivity (vasculitis).

If these persist for more than a few days, or become troublesome, stop taking this product.

Tell a Doctor or a qualified Healthcare Practitioner if you notice any other side effects.

You can help 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 GP’s surgery or pharmacy, or call Freephone 0808 100 4252

5.    How to store this product

•    Keep the tablets in the bottle until it is time to take them

•    Do not take the tablets after the expiry date (see outer label)

• Store the tablets below 25 ⁰C

•    Keep the bottle tightly closed

•    Keep the tablets out of sight and reach of children

6.    Further information

About this product: This is a traditional herbal medicinal product that contains extracts of Hops, Passion Flower, Wild lettuce and Valerian root.

Each tablet contains:

15 mg (as dry extract) from Hops strobiles (Humulus lupulus L.) (4-6:1)

Extraction solvent: Methanol 30 % v/v

10 mg extract (as dry extract) from Wild Lettuce leaf (Lactuca virosa L.) (4:1) Extraction solvent: Methanol 50 % v/v

10 mg extract (as dry extract) from Passion Flower herb (Passiflora incarnata L.) (4-6:1) Extraction solvent: Ethanol 70% v/v

30 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (5-6:1) Extraction solvent: Ethanol 70% v/v

This product also contains the following inactive (excipient) ingredients: Colloidal anhydrous silica

Maltodextrin, Cellulose, Gum Arabic, Calcium Phosphate Dibasic, Sago Flour, Stearic Acid, Ethylcellulose N100

After taking this product: You must speak to a Doctor or a qualified Healthcare Practitioner:

•    If your symptoms get worse

•    If your symptoms do not improve after 4 weeks

•    If side effects not listed in this leaflet occur

Registration Holder:

Nutrition Warehouse Limited

Samuel Ryder House Barling Way Eliot Park Nuneaton Warwickshire CV10 7RH UK

Manufacturer of this product:

Nutrition Warehouse Limited

Samuel Ryder House Barling Way Eliot Park Nuneaton Warwickshire CV10 7RH UK

If you would like further information about this product, please contact:

Nutrition Warehouse Limited

Regulatory Services Samuel Ryder House Barling Way Nuneaton

Warwickshire CV10 7RH UK

Is this leaflet hard to see or read?

Contact us on:

Telephone: +44 (0) 2476 215 400

Fax: +44 (0) 2476 215 452

Email: customerservices@nbtyeurope.com

You can help 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 GP’s surgery or pharmacy, or call Freephone 0808 100 4252

This leaflet was prepared on March 2013

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