SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

•    Holland & Barrett Milk Thistle Capsules

•    GNC Live Well Milk Thistle Capsules

•    Lifecycle Milk Thistle Capsules

•    Nature’s Garden Milk Thistle Capsules

•    Nature’s Bounty Milk Thistle Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains 133mg-324mg of standardised extract (as dry extract) from Milk Thistle Fruits (Silybum marianum (L.) Gaertner) (equivalent to 3325mg - 9720mg of Milk Thistle Fruits) corresponding to 108mg of silymarin calculated as silibinin.

Extraction solvent: Acetone 99.9% v/v.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Capsule, hard

Two piece clear hard capsules with light beige fill.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product to relieve the symptoms associated with occasional over indulgence of food and drink such as indigestion and upset stomach. This is based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults and the elderly

Take 1 capsule 2 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 1 week, 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 Milk Thistle or to plants of the Asteraceae (Compositae) family or to any of the excipients

4.4 Special warnings and precautions for use

•    Do not exceed the stated dose

•    Patients suffering from active liver disease should consult their doctor before taking the product

•    Milk Thistle may alter the way that certain drugs are broken down by the liver (se Section 4.5 Interaction with other medicinal products and other forms of interaction).

•    The use in children and adolescents under 18 years of age has not been established due to lack of adequate data

4.5 Interaction with other medicinal products and other forms of interaction

In vitro, Milk Thistle extract resulted in inhibition of CYP isoenzymes. However, the clinical relevance of these findings is not established.

4.6 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 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

Gastrointestinal reactions (nausea, upset stomach, diarrhoea), headache, allergic reactions (urticarial, skin rash, pruritus, anaphylaxis).

The frequency is not known

If other adverse reactions not mentioned above occur, a Doctor or qualified Healthcare practitioner should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at www.mhra.gov.uk/yellowcard

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

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

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Microcrystalline cellulose Magnesium stearate Silica colloidal hydrated Excipients in the extract:

Maltodextrin

Capsule Shell:

Hypromellose

6.2 Incompatibilities

Not applicable.

6.3    Shelf life

36 months

6.4    Special precautions for storage

Do not store above 25°C.

Keep the bottle tightly closed.

Nature and contents of 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 sizes. 30 capsules, 50 capsules, 100 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 21710/0024

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21/12/2012

10    DATE OF REVISION OF THE TEXT

31/10/2014