Nytol Herbal

English Herbal Medicines Valerian Relaxisleep

Herbs Hands Healing ValRelax

Brooke Green Valerian Elixir

Swiss Herbal Remedies Valerian Elixir

Nytol Herbal Simply Sleep & Calm Elixir

Each 5ml of oral liquid contains 1.5 ml of tincture from dried Valerian (Valeriana officinalis L.) root (1:8). Extraction solvent: Ethanol 57% v/v.5 ml of oral liquid contains approximately 1.25g Ethanol (alcohol), equivalent to 32 ml of beer or 13 ml of wine and 734 mg sucrose.For list of excipients see Section 6.1.

Oral Liquid. Dark brown liquid.

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

For oral short term use only.

Adults and Elderly

For the symptomatic relief of symptoms of mild anxiety take two 5ml spoonfuls three times a day with water or fruit juice if desired.To aid sleep take two 5ml spoonfuls 30 minutes before bedtime with an earlier dose during the evening if necessary.As treatment effects may not be apparent immediately, this product should be taken 2-4 weeks continuously.Maximum daily dose:- 4 single dosesDuration of use:-If symptoms persist, worsen or do not improve after 4 weeks during the use of this product, a doctor or qualified healthcare practitioner should be consulted. The use of this product is not recommended in children and adolescents below the age of 18 years (see also 4.4 Special warnings and precautions for use).

Patients with known hypersensitivity to Valerian root or any of the excipients.

Do not exceed the stated dose.Contains alcohol – up to 2.5g ethanol per dose (equivalent to 64 ml of beer or 26 ml of wine).Harmful for those suffering from alcoholism. To be taken into account in high-risk groups such as patients with liver-disease or epilepsy.Contains sucrose – if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the teeth.The use of this product is not recommended in children and adolescents below the age of 18 years because data are insufficient and medical advice should be sought.

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, CYP 1A2 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.Contains alcohol, and should therefore be avoided in patients taking other medication known to interact with alcohol (e.g. metronidazole).The effect of Valerian may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

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

This product may impair ability to drive or use machinery. Affected patients should not drive or operate machinery. This product contains alcohol (see Section 2).

Gastrointestinal symptoms (eg nausea, abdominal cramps) may occur after ingesting Valerian root. The frequency is not known.If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.

No case of overdose has been reported.Valerian root at a dose of approximately 20g (equivalent to 533 ml of this product) 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.Overdose of this product may result in alcohol intoxication: the amount in a full bottle: (25.2g in 100ml, 37.9g in 150ml, 50.5g in 200ml and 75.6g in 300ml: equivalent to 1.5, 2.3, 3 and 4.5 large glasses of wine respectively) may result in intoxication and should be treated accordingly.

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

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.

Liquorice Liquid Extract

Orange Oil

Lemon Oil

Coriander Oil

Anise Oil

Ethanol (90%)

Sucrose

Water

Not applicable.

Three years.

This medicinal product does not require any special storage conditions.

Glass bottle with polypropylene screwcap: 100ml, 150ml, 200ml and 300ml. Not all pack sizes may be marketed.

No special requirements.

Rutland Biodynamics Ltd, Town Park Farm, Brooke, Rutland, LE15 8DG.

THR 28255/0017

29/06/2010

15^th September 2014