Brunei Healthcare Manufacturing Ltd, William Nadin Way Swadlincote, Derbyshire, De11 0BB Tel: +44 (0)1283 228350 Fax: +44 (0)1283 228383

150mm

P12094

Patient Information Leaflet

Milk Thistle Tablets

Milk thistle standardised fruit extract 125 mg

Read all of this leaflet carefully before you take this product because it contains important information you need to know.

This product is available without prescription; however, you still need to use this product carefully to get the best results from it.

Keep this leaflet as you may need to read it again. Ask your doctor, pharmacist or qualified healthcare practitioner if you need more information or advice.

In this leaflet:

1.    What this product is and what it is used for

2.    Before you take this product

3.    How to take this product

4.    Possible side effects

5.    How to store this product

6.    Further information

1. What this product is and what it is used for?

This product contains:

• Milk thistle standardised fruit extract

This product is 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.

2.    Before you take this product

Do not take this product if you are:

•    allergic to Milk Thistle or to plants of the same plant family: (Asteraceae/Compositae) such as daisies, marigolds or artichokes

•    allergic to any of the ingredients of this product (see section 6)

•    are under 18 years old.

Tell your doctor before you take this product if you are currently suffering from active liver disease.

Taking other medicines

Tell your doctor or pharmacist before taking this product if you are taking any other medicines, including those obtained without a prescription.

Pregnancy and breast feeding Do not take this product if you are pregnant or breast feeding, because there is no evidence that it is safe to do so.

3.    How to take this product

Swallow the tablets whole with water.

Do not chew.

Adults and the elderly:

Take 1 - 2 tablets twice daily, before a meal.

Do not give to children or adolescents under 18 years old.

Do not exceed the stated dose.

If you take too many tablets by mistake, contact your doctor or pharmacist straight away and take this leaflet with you.

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Brunei Healthcare Manufacturing Ltd, William Nadin Way Swadlincote, Derbyshire, De11 0BB Tel: +44 (0)1283 228350 Fax: +44 (0)1283 228383

150mm

If your symptoms worsen or persist for more than one week, consult a doctor or qualified healthcare practitioner. If you have any questions or are not sure about anything, ask your doctor, pharmacist or qualified healthcare practitioner for advice.

4.    Possible side effects

Like all medicines, this product can cause side effects, although not everybody gets them.

The frequency of the side effects is not known. The following side effects have been reported:

•    nausea or feeling sick

•    diarrhoea

•    upset stomach

•    headache

Mild allergic skin reactions such as itching or skin rash, urticaria, hives, pruritis and anaphylaxis may occur.

Stop taking this product immediately if you experience any allergic skin reactions.

If you are concerned about any side effect, if a side effect becomes serious or if you notice a side effect not listed in this leaflet, please tell your doctor or qualified healthcare practitioner.

5.    How to store this product

Keep out of the reach and sight of children.

Do not use these tablets after the expiry date printed on the pack.

Do not store above 25^oC.

Store in the original packaging.

6. Further information

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.

Extraction solvent: Ethyl acetate 100% v/v Also contains:

Tablet core: calcium carbonate, maltodextrin, croscarmellose sodium microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

Film coating: hypromellose and purified talc.

This product is available in pack sizes of 30, 60 or 120 tablets.

Not all pack sizes are marketed.

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Alternatively you can get a paper Yellow Card form from your GP's surgery or pharmacy or call freephone 0808 100 3352 (available 10am - 2pm Monday - Friday)

To request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name: Milk Thistle Tablets Reference number: THR 20894/0072 THR holder and manufacturer is:

Brunel Healthcare Manufacturing Ltd, William Nadin Way, Swadlincote,

Derbyshire, DE11 0BB, U K.

Text revised: October 2011 THR 20894/0072

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