SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Napiers Valerian Tincture,

Neal’s Yard Remedies Valerian Herbal Tincture

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml of oral liquid contains 1g of Valerian root (Valeriana officinalis L.)

5ml of oral liquid contains approximately 1.05 ml of ethanol. (See section 4.4 ‘Special warnings and precautions for use’.)

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Oral liquid.

A medium brown liquid.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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

4.2    Posology and method of administration

For oral use only. Adults and the elderly.

To aid sleep: Take one 5ml teaspoonful in water or fruit juice half to one hour before bedtime, with an earlier dose during the evening if necessary.

For the temporaryrelief of mild anxiety: Take one 5ml teaspoonful in water or fruit juice when necessary, up to three times a day.

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

Maximum daily dose: 4 single doses

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

The use in children and adolescents under the age of 18 is not recommended. (See section 4.4 ‘Special warnings and precautions for use’).

4.3 Contraindications

Patients with known hypersensitivity to Valerian should not use Valerian root preparations.

Patients already taking medicines for sleep or anxiety should not use Valerian root preparations.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

This medicinal product contains 21 % v/v ethanol (alcohol), i.e. up to 840 mg per dose, equivalent to 21 ml beer, 8.75 ml wine per dose.

Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

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 interaction with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway has not been observed.

Combination with synthetic sedatives is not recommended.

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

Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole).

4.6 Fertility, Pregnancy and lactation

Safety during pregnancy and lactation has not been established. Due to lack of data, the use of this product during pregnancy and lactation is not recommended.

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 machinery.

In addition, this product contains alcohol, which may also impair your ability to drive and use machines. (See Section 4.4 “Special warnings and precautions for use”.)

4.8 Undesirable effects

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

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

Overdose

Valerian root at a dose of approximately 20 g (equivalent to 20 doses of Napiers Valerian Tincture) caused benign symptoms (fatigue, abdominal cramp, chest tightness, lightheadedness, 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.

Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle of the product (21 g in 100 ml; 42 g in 200 ml: equivalent to 0.4 and 0.8 large glasses of wine, respectively) may result in intoxication and should be treated accordingly.

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

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

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

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Rectified Spirit (96% ethanol) Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

6.6 Special precautions for disposal

Glass bottle with child-resistant safety cap packed in a cardboard carton: 100ml and 200ml.

7    MARKETING AUTHORISATION HOLDER

Highland Herbs Limited 10 Payne Street

Glasgow G4 0LF

8    MARKETING AUTHORISATION NUMBER(S)

THR 43751/0027

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14/09/2010

10    DATE OF REVISION OF THE TEXT

03/07/2015