SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Gerard House Milk Thistle Tablets Herbalstore Milk Thistle Tablets Wilko Milk Thistle Tablets Superdrug Milk Thistle Tablets HealthAid Milk Thistle Tablets Sainsbury’s Healthcare Milk Thistle Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains: 125 mg of standardised extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertner) (equivalent to 2.5 - 5.0 g of Milk Thistle fruits) corresponding to 62.5 - 75 mg of silymarin, calculated as silibinin.

Extract solvent: Ethyl acetate 100 % v/v

For full list of excipients, see 6.1

3 PHARMACEUTICAL FORM Film coated tablet.

Yellow circular biconvex

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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

4.2 Posology and method of administration For oral use only.

Swallow the tablets whole with water. Do not chew.

Adults and the elderly: The recommended dosage is 1 - 2 tablets twice daily, before a meal.

Children and adolescents under 18 years old: This medicine is not recommended for children and adolescents under 18 years of age (see Section 4.4 Special warnings 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 this product.

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

The use in children and adolescents under 18 years of age is not recommended as there is no relevant indication.

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

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

The safety of this product during pregnancy and lactation has not been established. In the absence of sufficient data the use in 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 effects on the ability to drive and use machines have been performed.

4.8. Undesirable effects

Gastrointestinal reactions (nausea, upset stomach, diarrhoea), headache, allergic reactions (urticaria, skin rash, puritis anaphylaxis). The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor, pharmacist 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 case of overdose has been reported.

Supportive and symptomatic treatment should be provided as appropriate.

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 on carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Tablet core:

Calcium Carbonate Maltodextrin Croscarmellose Sodium Microcrystalline Cellulose Colloidal Anhydrous Silica Magnesium Stearate

Film Coating:

Hypromellose Purified Talc

6.2 Incompatibilities None applicable.

6.3    Shelf life 36 months

6.4    Special precautions for storage

Do not store above 25^oC. Store in the original package.

Not all pack sizes may be marketed

6.6 Special precautions for disposal No special requirements.

7 MARKETING AUTHORISATION HOLDER

Brunei Healthcare Manufacturing Limited

William Nadin Way

Swadlincote

Derbyshire

DE11 0BB

8 MARKETING AUTHORISATION NUMBER(S) THR 20894/0072

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

14/03/2012

10 DATE OF REVISION OF THE TEXT

10/06/2015