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Napiers Herbal Sleep Aid

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

English Herbal Medicines Passionflower Sleep Aid Complex Napiers Herbal Sleep Aid

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of oral liquid contains:-

0.5 ml of liquid extract from Passiflora herb * (Passiflora incarnata L.) (1:1). Extraction solvent: ethanol 21% v/v.

0.125 ml of liquid extract from Wild Lettuce leaf * (Lactuca virosa L.) (1:1). Extraction solvent: ethanol 21% v/v.

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

Extraction solvent: ethanol 56% v/v.

0.27 ml of liquid extract from White Willow bark * (Salix alba L.) (1:1). Extraction solvent: ethanol 21% v/v.

*Certified organically produced herbal ingredient

Each 5 ml of oral liquid also contains approximately:

1.2 g Ethanol (alcohol) equivalent to 30 ml of beer or 13 ml of wine (See Section 4.4 ‘Special warnings and precautions for use’.)

For list of excipients see Section 6.1.

3    PHARMACEUTICAL FORM

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

Take one 5ml teaspoonful in the early evening and take two 5ml teaspoonfuls at bedtime. Take with water. or other liquids.

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

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

4.3 Contraindications

Hypersensitivity to any of the active ingredients or to plants of the Asteraceae (Compositae) family or to any of the excipients.

Hypersensitivity to salicylates (e.g. history of angiodema, bronchial spasm, chronic urticaria in response to salicylates or to other NSAIDs).

Asthma

Active peptic ulcer disease

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Contains alcohol - up to 1.2 g ethanol per 5ml dose (equivalent to 30 ml of beer or 13 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.

Not recommended for use in children or adolescents under 18 years because data are not sufficient and medical advice should be sought.

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

Concomitant use with salicylates and other NSAIDs is not recommended without medical advice.

In case of severe liver or renal dysfunction, coagulation disorders, gastric/duodenal ulcer and glucose-6-phosphate dehydrogenase deficiency, the product should only be taken under medical supervision.

4.5 Interaction with other medicinal products and other forms of interaction

No studies have been carried out to determine if drug interactions occur with this product.

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.

Willow bark may increase the effects of anticoagulants such as heparin and coumarin derivatives.

Contains alcohol, and should therefore be avoided in patients taking other medication known to interact with alcohol (eg metronidazole).

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. Salicylates cross the placenta and appear in breast milk.

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 affect ability to drive or operate machines. If affected do not drive or operate machines.

This product contains alcohol (see Section 2).

4.8 Undesirable effects

One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported in patients taking Passiflora. The frequency is not known.

Willow bark may cause allergic reactions such as puritus, urticaria, asthma and gastrointestinal symptoms such as nausea, vomiting, abdominal pain, dyspepsia, heartburn, diarrhoea. 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

No case of overdose has 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:

36 g in 150 ml equivalent to 1.5 large glasses of wine;

48 g in 200 ml equivalent to 2 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

Ethanol Orange Oil

Quillaia Bark Liquid Extract

Glycerol

Water.

6.2    Incompatibilities

None

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 polypropylene screw-cap: 100ml 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 28255/0029

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15/04/2013

10    DATE OF REVISION OF THE TEXT

15/04/2013