SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Nutrition Warehouse Herbal Quiet Nights Holland & Barrett Herbal Quiet Nights

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

15 mg extract (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.) (46:1)

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

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Tablet

Brown oval biconvex tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of sleep disturbances, based on traditional use only.

4.2 Posology and method of administration

For oral short term use only.

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

As treatment effects may not be apparent 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.

The use in children or adolescents under 18 years of age is not recommended (see section 4.4 Special warnings and precautions for use.’)

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

The use in children and adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought..

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

4.5 Interaction with other medicinal products and other forms of interaction

Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interactions with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP1A2 or CYP 2E1 pathway has not been observed.

Additive effects with hypnotics and other sedatives cannot be excluded and therefore co-medication is not recommended as a general precaution.

The effect of this product may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

May impair ability to drive and use machines. If affected patients should not drive or operate machines.

4.8 Undesirable effects

Gastrointestinal symptoms (e.g nausea, abdominal cramps) may occur after ingestion of Valerian root preparations. The frequency is not known.

One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported with Passion flower. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted

4.9 Overdose

Valerian root at a dose of approximately 20g (equivalent to 100 tablets) caused benign symptoms (fatigue, abdominal cramp, chest tightness, light headedness, hand tremor and mydriasis) which disappeared within 24 hours.

If symptoms arise, treatment should be supportive.

After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30 g of the drug) withdrawal symptoms (delirium) have been reported.

Symptomatic and supportive measures should be taken as appropriate.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Extract excipients: Colloidal anhydrous silica Maltodextrin Cellulose Gum Arabic

Core excipients Calcium Phosphate Dibasic Sago Flour Stearic Acid Ethylcellulose N100

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original package.

6.5 Nature and contents of container

High density polyethylene tampertainers. Pack size: 100 tablets.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Nutrition Warehouse Limited

Samuel Ryder House

Barling Way

Eliot Park

Nuneaton

Warwickshire

CV10 7RH

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

THR 14010/0042

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

28/03/2013

10    DATE OF REVISION OF THE TEXT

28/03/2013