SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Holland & Barrett Burdock Capsules GNC Live Well Burdock Capsules Lifecycle Burdock Capsules Nature’s Garden Burdock Capsules Nature’s Bounty Burdock Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 399mg of extract (as dry extract) from Burdock Root (Arctium lappa L.) (equivalent to 798mg - 1596mg of Burdock Root). Extraction solvent: Ethanol 70% v/v.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Capsule, hard

Two piece clear hard capsules with brown fill.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to increase the amount of urine for the purpose of flushing the urinary tract to assist in minor urinary complaints. This is based on traditional use only

4.2 Posology and method of administration

For oral use only.

Adults and elderly:

Take 2 capsules 3 times daily. Swallow the whole capsule 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 and adolescents under 18 years (see section 4.4 Special warning and precautions for use)

4.3 Contraindications

Hypersensitivity to Burdock or to plants of the Asteraceae (Compositae) family 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 lack of adequate data

If the symptoms worsen during the use of the medicinal product a doctor or qualified healthcare practitioner should be consulted

If complaints of symptoms such as fever, dysuria, spasms or blood in the urine occur during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted

Concomitant treatment with diuretics is not recommended

4.5 Interaction with other medicinal products and other forms of interaction

None reported.

4.6 Pregnancy and lactation

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

Anaphylactic shock and mild gastrointestinal effects may be experienced. The frequency is not known.

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

4.9 Overdose

No cases of overdose have 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

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended, unless necessary for the safe use of the product.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Microcrystalline cellulose

Magnesium stearate Silica colloidal hydrated

Excipients in the extract:

Maltodextrin

Silica colloidal anhydrous

Capsule Shell:

Hypromellose

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Do not store above 25°C.

Keep in the original container.

6.5 Nature and contents of container

Container.

Green Polyethylene terephthalate (PET) bottles with a chiffon 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 foam, aluminium foil and sealable polyester film

Pack size. 30 capsules

6.6 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 21710/0016

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21/07/2011

10    DATE OF REVISION OF THE TEXT

19/08/2013