SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Silygalon Milk Thistle capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains:

173.0 mg - 186.7 mg of standardised extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertner) (equivalent to 6,228 mg - 8,215 mg of Milk Thistle fruits) corresponding to 108 mg of silymarin, calculated as silibinin.

Extraction solvent: Ethyl acetate

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Hard capsules

Brown, opaque hard gelatin capsule.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to relieve 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

Posology

Adults and the elderly Take one capsule 3 times daily.

Children or adolescents under 18 years

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

Method of administration

Swallow the capsule whole with water or other liquid.

Duration of use:

If symptoms worsen, or do not improve after 1 week, a doctor or a qualified healthcare practitioner should be consulted.

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 has not been established due to lack of adequate data.

If symptoms worsen, or do not improve after 1 week, a doctor or a 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

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

Mild gastrointestinal disorders (such as dry mouth, nausea, upset stomach, gastric irritation, diarrhoea), headache, hypersensitivity reactions (such as dermatitis, urticaria, skin rash, pruritus, asthma and 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 balance 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

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.

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

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Capsule contents:

Microcrystalline cellulose Sodium starch glycolate Maize starch Magnesium stearate Sodium lauryl sulphate

Capsule shell:

Gelatin

Iron oxide, Red E 172 Titanium dioxide E 171 Iron oxide, Black E 172

6.2    Incompatibilities

Not applicable

6.3    Shelf life

3 years

6.4    Special precautions for    storage

Store in the original package.

6.5 Nature and contents of container

PVC film / aluminium foil blister strips. Pack sizes: 30, 60 and 100 capsules

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Tenlec Pharma Ltd.

Hailsham,

East Sussex BN271PQ United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

THR 19053/0100

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

26/07/2016

10    DATE OF REVISION OF THE TEXT

26/07/2016