1 NAME OF THE MEDICINAL PRODUCT

Thisilyn Maximum Strength Milk Thistle capsules

Higher Nature Milk Thistle capsules

Boots Max Strength Digestion Relief Milk Thistle capsules

Healthspan Milk Thistle capsules

Zipvit Milk Thistle Digestion Relief capsules

Holland & Barrett Over Indulgence Milk Thistle capsules

Simply Supplements Milk Thistle Max Strength capsules

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains:

193 mg - 261 mg of standardized extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertner)(equivalent to 3.725 g - 10.818 g of Milk Thistle fruits) corresponding to 108 mg of silymarin, calculated as silibinin.

Extraction solvent: Acetone 95% v/v.

For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Hard capsule.

Red, opaque, hard gelatin capsule.

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.

Adults and the elderly

Take 1 capsule up to twice daily. The capsules should be swallowed whole with some water or other liquid. The capsules should not be chewed.

Children and adolescents under 18 years of age

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 the 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 for more than one week 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 the product during pregnancy and lactation has not been established.

In the absence of sufficient data the 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 of 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 (urticaria, skin rash, pruritis, anaphylaxis).

The frequency is not known.

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

4.9    Overdose

No cases of overdose have 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

Milk Thistle extract was not mutagenic in the mammalian murine micronucleus test. Tests on reproductive toxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Extract excipients Mannitol

Capsule contents:

Capsule filling mass:

Mannitol

Cellulose microcrystalline

Croscarmellose sodium Silica, colloidal anhydrous Magnesium Stearate

Capsule shell:

Gelatin

Purified water

Titanium dioxide E171

Sodium lauryl sulphate

Iron (III)-oxide E172 (= red iron oxide)

Iron oxide hydrate E172 (= yellow iron oxide)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C.

6.5    Nature and contents of container

Original packages containing 21, 28, 30, 56, 60 or 90 hard capsules (Thisilyn Maximum Strength Milk Thistle).

Original packages containing 30 hard capsules (Boots Max Strength Digestion Relief Milk Thistle capsules, Higher Nature Milk Thistle capsules, Healthspan Milk Thistle capsules, Holland & Barrett Over Indulgence Milk Thistle capsules) or 60 hard capsules (ZipVit Milk Thistle Digestion Relief capsules, Simply Supplements Milk Thistle Max Strength capsules).

The capsules are packed in PVC/ PVDC aluminium blisters and inserted into a carton together with the package leaflet.

Not all pack sizes are marketed.

6.6 Special precautions for disposal

No special requirements

7. REGISTRATION HOLDER

Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow

Buckinghamshire SL7 1FX

8    MARKETING AUTHORISATION NUMBER(S)

THR 23056/0010

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

01/10/2010

10 DATE OF REVISION OF THE TEXT

14/08/2014