SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Holland & Barrett Valerian Capsules GNC Live Well Valerian Capsules Lifecycle Valerian Capsules Nature’s Garden Valerian Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 337mg of extract (as dry extract) from Valerian root (Valeriana officinalis L) (equivalent to 1683mg - 2020mg of Valerian root). Extraction solvent: ethanol 70%v/v.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Capsules, hard

Two piece clear hard capsules with grey/brown fill.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of symptoms of mild anxiety and to aid sleep, based on traditional use only.

4.2 Posology and method of administration

For oral use only

Adults and elderly:

For the temporary relief of symptoms of mild anxiety: take 1 capsule 3 times daily.

To aid sleep: take one capsule 30 minutes to one hour before bedtime with an earlier dose during the evening if necessary.

Swallow capsule with water

As the effects of this product may not occur immediately, the capsules should be taken continuously for 2 - 4 weeks.

Do not exceed the stated dose.

Maximum dose: 4 capsules per day.

Duration of use:

If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.

Not for children or adolescents under 18 years (see Section 4.4. Special warnings and precautions for use)

4.3 Contraindications

Hypersensitivity to Valerian or any of the excipients

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

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 sedative drugs cannot be

excluded and therefore co-medication is not recommended as a general precaution.

The effect of Valerian 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. Due to the lack of data, 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 the ability to drive and use machines. If affected, patients should not drive or operate machinery.

4.8 Undesirable effects

Gastrointestinal symptoms, such as nausea, abdominal cramps, may occur. The frequency is not known. If other adverse reactions not mentioned above occur, a doctor or qualified health care practitioner should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Valerian root at a dose of approximately 20g (equivalent to approximately 7 capsules of Valerian root 450mg) 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 30g of the drug) withdrawal symptoms (delirium) have been reported

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

Valerian Root was not mutagenic in a bacterial mutagenicity assay in the presence and absence of metabolic activation.

Tests on reproductive toxicity and carcinogenicity have not been performed

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Magnesium stearate

Excipients in the extract:

Maltodextrin

Silica colloidal anhydrous

Capsule shell:

Hypromellose

Incompatibilities

Not applicable

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C. Keep the bottle tightly closed

6.5 Nature and contents of container

Green Polyethylene terephthalate (PET) bottles with a chiffon green hinge cap (Polypropylene), with an inner seal liner designed to lift ‘n’ peel. The inner seal acts as a tamper evident seal under the cap. The inner seal liner is made up of polyester film, polymer adhesive layer, polyester tab, polyolefin foam, aluminium foil and sealable polyester film

Pack size: 30 capsules and 60 capsules

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

Holland & Barrett International Ltd

Samuel Ryder House

Barling Way

Nuneaton

Warwickshire

CV10 7RH

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

THR 21710/0001

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

03/07/2015

10    DATE OF REVISION OF THE TEXT

03/07/2015