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Napiers Stress Relief Herbal Remedy

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

English Herbal Medicines Stress Relief

Napiers Stress Relief Herbal Remedy

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of oral liquid contains:

0.25 ml of extract (as liquid extract) from Hops strobile (Humulus lupulus L.) (1:1).

Extraction solvent: ethanol 45 % v/v.

0.4 ml of extract (as liquid extract) from Vervain herb* (Verbena officinalis L.) (1:1).

Extraction solvent: ethanol 25% v/v.

0.15 ml of extract (as liquid extract) from Scullcap herb* (Scutellaria lateriflora L.) (1:1)

Extraction solvent: ethanol 25% v/v.

0.5 ml of extract (as liquid extract) from Jamaica Dogwood root bark (Piscidia erythrina L.) (1:1)

Extraction solvent: ethanol 60% v/v.

0.25 ml of extract (as liquid extract) from Passiflora herb* (Passiflora incarnata L.)( (1:1).

Extraction solvent: ethanol 25% v/v.

0.5 ml of extract (as liquid extract) from Oat seed* (Avena sativa L.) (1:1).

Extraction solvent: ethanol 25% v/v.

0.25 ml of extract (as liquid extract) from Valerian root* (Valerian officinalis L.) (1:5). Extraction solvent: ethanol 25% v/v.

* Certified organically produced herbal ingredient.

5 ml of oral liquid contains approximately 1.25 ml ethanol (alcohol). (See Section 4.4. special warnings and precautions for use.)

For full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Oral Liquid.

Dark brown liquid.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of symptoms associated with stress, tension and irritability, based on traditional use only.

4.2 Posology and method of administration

For oral use only

Adults and the elderly

Take one 5ml spoonful three times a day. Can be taken with water or fruit juice if desired.

Maximum daily dose: 15mls (3 doses)

Use is not recommended for children and adolescents under 18 years. (see Section

4.4. Special warnings and precautions for use)

The effects of this treatment may not occur immediately therefore this product should be taken continuously for 2 to 4 weeks.

If symptoms worsen or do not improve after 4 weeks during the use of the medicinal product, a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to any of the active ingredients, or oat preparations or plants of the Asteraceae(Compositae) family or to 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.

Caution is advised when used in patients with coeliac disease because data on the protein content are not available.

Contains alcohol - up to 1 g ethanol per dose (equivalent to 25 ml of beer or 10.4 ml of wine).

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.

Contains Lucerne (Alfalfa). Potentially harmful for individuals with a history of systematic lupus erythematosus.

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.

Although no clinical data about interactions with synthetic sedatives are available, concomitant use with synthetic sedatives (such as benzodiazepines) is not recommended unless advised by a doctor.

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

Contains alcohol, and should therefore be avoided in patients taking other medication 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 sufficient 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 ability to drive and operate machines. Affected patients should not drive or operate machines.

Contains alcohol (see section 2)

4.8    Undesirable effects

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

Gastrointestinal symptoms (eg nausea, abdominal cramps) may occur after ingesting Valerian root. The frequency is not known.

Other possible side effects include allergic skin reactions, such as itching, redness or blistering.

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

4.9 Overdose

No case of overdose has been reported.

Valerian root at a dose of approximately 20g (equivalent to 2 litres 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 (delerium) have been reported.

Jamaica dogwood has been reported to cause numbness, tremors, salivation and sweating.

Overdose of this product may result in alcohol intoxication and should be treated accordingly. Amount of ethanol in a full bottle:

40 g in 200ml equivalent to 1.7 large glasses of wine;

50 g in 250ml equivalent to 2.1 large glasses of wine;

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

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Compound Cardamon Tincture (Cardamom oil, Caraway oil, Cinnamon oil, Cochineal E120, glycerol and ethanol)Liquid Extract Lucerne (Medicago sativa)

Caramel E150 Glycerol Ethanol Water

6.2    Incompatibilities

None known

6.3    Shelf life

3 years

6.4    Special precautions for storage

Do not store above 25oC. Store in the original container

6.5 Nature and contents of container

Glass bottle with hard plastic or polypropylene wadded screw-cap: 100ml, 150ml and 200ml

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

Rutland Biodynamics Ltd,

Town Park Farm,

Brooke, Rutland,

LE15 8DG

8    MARKETING AUTHORISATION NUMBER(S)

THR 28255/0026

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16/04/2013

10    DATE OF REVISION OF THE TEXT

12/03/2014