SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Nodoff Plus Mixture Napiers Sweet Dreams Sleep Remedy

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml of oral liquid contains: -

0.5 ml of extract (as liquid extract) from Passion Flower herb (Passiflora incarnata L.) (1:1) (equivalent to 500 mg of Passion Flower herb)

Extraction solvent: Water

0.5 ml of extract (as liquid extract) from Jamaica Dogwood bark (Piscidia erythrina L.) (1:1) (equivalent to 500 mg of Jamaica Dogwood bark) Extraction solvent: Ethanol 60% v/v

0.4 ml of extract (as liquid extract) from Hop strobile (Humulus lupulus L.) (1:1) (equivalent to 400 mg of Hop strobile)

Extraction solvent: Ethanol 45% v/v

0.25 ml of extract (as liquid extract) from Valerian root (Valeriana officinalis L.) (1:1) (equivalent to 250 mg of Valerian root)

Extraction solvent: Ethanol 45% v/v

Excipients:

5 ml of oral liquid contains 0. 825 ml ethanol, 0.37 mg sucrose and 0.03 mg glucose. (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 dark brown liquid.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to aid sleep, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults and the elderly: Take one 5ml teaspoonful after the last meal of the day, and two 5ml teaspoonfuls at bedtime.

The use in children and adolescents under the age of 18 years is not recommended. (See section 4.4 ‘Special warnings and precautions for use’). As treatment effects may not be apparent immediately, the product should be taken for 2-4 weeks continuously.

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 any of the excipients.

4.4    Special warnings and precautions for use

Do not exceed the stated dose.

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

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 16.5% v/v ethanol (alcohol), i.e. up to 660mg per 5 ml dose, equivalent to 16.5ml beer, 6.9ml 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.

This medicinal product contains sucrose and glucose.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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 such as benzodiazepines is not recommended.

The effect of the product 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.

Studies on fertility have not been performed.

4.7    Effects on ability to drive and use machines

May impair ability to drive and use machines. If affected do 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

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

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.

4.9 Overdose

No cases of overdose have been reported for this product.

Valerian root at a dose of approximately 20 g (equivalent to 5 doses of the product) 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: and should be treated accordingly. The amount of alcohol in a full bottle of the product is

13.2 g in 100 ml; 19.8 g in 150 ml and 26.4 g in 200 ml: equivalent to 0.6. 0.9 and 1.2 large glasses of wine, respectively.

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

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

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Ethanol

Glucose Liquid Syrup (sucrose)

Glycerol

Compound Cardamom Tincture (cochineal (E120), cardamom oil, caraway oil, cinnamon bark oil, glycerol, water)

Nutmeg Oil Clove Oil Cinnamon Oil

Liquorice Liquid Extract (liquorice root, sorbitol, glucose liquid, caramel (E150), ethanol, water)

Caramel (E150)

Water

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years.

11/04/2013