SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Holland & Barrett Horse Chestnut Tablets GNC Live Well Horse Chestnut Tablets Lifecycle Horse Chestnut Tablets Nature’s Garden Horse Chestnut Tablets Nature’s Bounty Horse Chestnut Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gastro resistant tablet contains 272mg - 332mg of extract (as dry extract) from Horse chestnut seeds (Aesculus hippocastanum L. semen) corresponding to 60mg of Triterpene glycosides calculated as aescin.

Extraction solvent: Ethanol 80% v/v For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Gastro-resistant tablet

Speckled, light brown, clear coated, bi-convex, oval shaped tablet, plain on both sides.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the relief of symptoms associated with minor venous insufficiency and varicose veins, such as tired heavy legs, pain, cramps and swelling. This is based on traditional use only.

Posology and method of administration

For oral use only.

Adults and the elderly

Take 1 tablet 2 times daily immediately after food. Swallow the whole tablet with water.

Do not exceed the stated dose.

Duration of use:

If symptoms worsen or do not improve after 2 weeks, a Doctor or a qualified Healthcare Practitioner should be consulted.

Not for use in children or adolescents under 18 years (see section 4.4 Special warning and precautions for use)

4.3 Contraindications

Hypersensitivity to Horse Chestnut seed or any of the excipients

4.4 Special warnings and precautions for use

Do not exceed the stated dose

Patients who have developed ulcers on their lower limbs due to chronic venous insufficiency should not use this product if they are receiving medical care for their venous ulcers. If a patient develops a venous ulcer while using this product they should seek medical advice for advice for the ulceration immediately

If there is inflammation of the skin, thrombophlebitis or subcutaneous induration, severe pain, ulcers, sudden swelling of one or both legs particularly associated with redness and heat, cardiac or renal insufficiency, a doctor should be consulted immediately.

The use in children and adolescents under 18 years if age has not been established due to the need for medical supervision.

If symptoms worsen or do not improve after 2 weeks, a Doctor or a qualified Healthcare Practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

There are limited data available on drug interactions with extracts of horse chestnut seed. The data indicates that horse chestnut seeds extracts are unlikely to interact with other medicinal products.

Fertility, Pregnancy and lactation

Safety during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and lactation is not recommended.

Studies 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

Undesirable effects associated with the use of horse chestnut seed extracts are generally mild.

The following undesirable effects have been reported in clinical studies:

Gastrointestinal disorders:

Nausea

Abdominal Pain or discomfort

Diarrhoea

Vomiting

Allergic reactions (hypersensitivity of the skin, itching, rash, erythema, eczema) Headache and vertigo

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.

In the event of an overdose, patients may expect an increased likelihood of experiencing an undesirable effect.

Management of an overdose should include appropriate symptomatic and supportive treatment.

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

Excipients in the extract Silica colloidal anhydrous

Tablet core

Calcium hydrogen phosphate dihydrate Microcrystalline cellulose Maize starch Croscarmellose sodium Magnesium Stearate

Tablet Coating:

Hypromellose

Triacetin

Talc

Sodium Alginate Stearic acid Ethylcellulose Ammonium hydroxide Medium chain triglycerides Oleic acid

Purified water (volatile)

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

35 months

6.4    Special precautions for storage

Store below 25°C.

Store in the original container Keep the bottle tightly closed

6.5    Nature and contents    of container

Container.

Green Polyethylene terephthalate (PET) bottles with a green hinge cap (polypropylene), with an inner seal liner designed to lift ‘n’ peel. The inner seal acts as a tamper evident seal under the cap. The inner seal liner is made up of polyester film, polymer adhesive layer, polyester tab, polyolefin form, aluminium foil and sealable polyester film

Pack size. 30 tablets

Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

NBTY Europe Limited Samuel Ryder House Barling Way Nuneaton Warwickshire CV10 7RH United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

THR 21710/0012

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

20/12/2011

10    DATE OF REVISION OF THE TEXT

04/04/2013