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Natures Garden Milk Thistle Capsules

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Document: leaflet NATURES GARDEN_THR 21710-0024 change

PATIENT INFORMATION LEAFLET


| NATURE’S GARDEN |

MILK THISTLE CAPSULES Milk Thistle Standardised Fruit Extract


Important notes

U Please read this leaflet carefully before you use this product because it contains important information

U Keep this leaflet; you may need to read it again

U Seek professional advice if you need more information

U Please tell a Doctor or a qualified Healthcare Practitioner if your symptoms worsen or do not improve after 1 week of taking this product

U Please tell a Doctor or a qualified Healthcare Practitioner if you suffer from side effects not listed in this leaflet and/or if any of the side effects become serious


3 - How to take this product

For oral use only.

For adults and elderly: Take 1 capsule 2 times daily; Swallow the whole capsule with water: Do not exceed the stated dose.

If you take too much of the product (overdose): Speak to a Doctor or a qualified Healthcare Practitioner immediately and take this leaflet and bottle with you.

If you forget to take this product: Do not take a double dose to make up for the missed dose(s). Continue to take your usual dose at the usual time. It does not matter if you have missed a dose.

Duration of use: If symptoms worsen or do not improve after one week, a Doctor or a qualified Healthcare Practitioner should be consulted.


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. It 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. This is based on traditional use only.


4 - Possible side effects

Like all medicines, this product can have side effects although the frequency is not known. Possible side effects are:

U Nausea (feeling sick)

U Diarrhoea U Upset stomach U Headache

U Mild allergic reactions such as itching and/or skin rash, urticaria, anaphylaxis, hives, pruritus

If any of the above side effects become serious or if you experience any other side effects not listed above consult your Doctor, Pharmacist or a qualified Healthcare Practitioner.

If you experience any allergic reactions, stop taking this product and consult your Doctor.


2 - Before you take this product

Do not take this product if you are:

U Under 18 years of age U Pregnant or breastfeeding U Allergic to Milk Thistle or plants of the Asteraceae/Compositae family such as daisies, marigolds or artichokes or to any of the ingredients in this product (see section 6 of this leaflet)

Consult a Doctor or a qualified Healthcare Practitioner if you are currently suffering from active liver disease.


5 - How to store this product

U Keep the capsules in the bottle until it is

time to take them

U Do not take the capsules after the expiry date (see outer label). The expiry date

refers to the last day of the month U Do not store above 25°C U Keep the bottle tightly closed U Keep in the original container U Keep the capsules out of sight and reach of children

More information on back panel


6 - Further information

Each hard capsule contains I33mg-324mg of 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.

This product also contains the following inactive (excipient) ingredients: Microcrystalline cellulose, Magnesium stearate, Silica colloidal hydrated.

Excipients in the extract: Maltodextrin.

Capsule shell: Hypromellose.

Each bottle contains 30, 50 or I00 clear; two piece capsules with beige/brown fill. Not all pack sizes may be marketed.


THR 21710/0024

Traditional Herbal Registration Holder

NBTY Europe Limited Samuel Ryder House Barling Way Nuneaton

Warwickshire, CV10 7RH United Kingdom

Manufacturer

NBTY Europe Limited Vitality House Sixth Avenue Centrum I00 Burton-on-Trent Staffordshire, DE14 2WP United Kingdom

If you would like further information about this product, please contact:

NBTY Europe Limited

Regulatory Services Department Samuel Ryder House Barling Way Nuneaton

Warwickshire, CVI0 7RH United Kingdom

Is this leaflet hard to see or read?

Contact us on:

Telephone: +44 (0) 2476 215 400

Fax: +44 (0) 2476 215 452

Email: customerservices@NBTYeurope.com

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

This leaflet was prepared on: 14/02/2014

THR”

CERTIFICATION MARK


BM802-000 01A I00000-000