SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

•    Nutrition Warehouse Ginseng Tablets

•    Holland & Barrett Ginseng Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

500mg Ginseng Root (Panax ginseng C. A. Meyer)

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Tablet

Brown oval biconvex tablets.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Traditional herbal medicinal product used for the temporary relief of fatigue, weakness and exhaustion, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

The tablets should be swallowed whole with 1-2 glasses of water. Do not chew the tablets.

Adults and the elderly:

One tablet to be taken three times a day.

Children and adolescents under 18 years of age:

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

Duration of use

Not to be taken continuously for more than 2 months.

If the symptoms worsen or do not improve after 2 weeks, a doctor or qualified health care practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

The use in children and adolescents under 18 years of age is not recommended due to the lack of data on safety and efficacy.

If the symptoms worsen or do not improve after 2 weeks, a doctor or qualified health care practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. 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

No studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Hypersensitivity reactions (urticaria, itching) insomnia and gastrointestinal disorders such as stomach discomfort, nausea, vomiting, diarrhoea, and constipation have been reported.

The frequency is not known.

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

4.9 Overdose

No cases of overdose have not been reported.

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

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

6.1 List of excipients

Mannitol

Calcium Phosphate Tribasic Calcium Sulphate Dihydrate Sago Flour Low Fat Soya Flour Vegetable Fatty Acid Gum Acacia Ethylcellulose N100

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original package.

6.5 Nature and contents of container

Polystyrene tampertainer.

Pack size: 60 tablets.

6.6 Special precautions for disposal

No special requirements.

MARKETING AUTHORISATION HOLDER

Nutrition Warehouse Limited Samuel Ryder House Barling Way Eliot Park Nuneaton Warwickshire CV10 7RH United Kingdom

19/03/2013