LEAFLET SPEC

PATIENT INFORMATION LEAFLET

HOLLAND fr BARRETT

OVER INDULGENCE MILK THISTLE CAPSULES Milk Thistle standardised fruit extract

Important notes

U Please read this leaflet carefully before you start taking these capsules; It contains some important information about Holland & Barrett Over Indulgence Milk Thistle capsules.

U Keep this leaflet with the capsules; you may want to read it again or show it to your doctor; pharmacist or qualified healthcare practitioner.

What is 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

3 - How to take this product

Adults and the elderly

Take 1 capsule up to twice daily. Swallow the capsule whole with some water or other liquid. Do not chew the capsules.

Do not exceed the stated dose.

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

If you take too much of this product (overdose): If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you.

If you forget to take this product: Continue to take your usual dose at the usual time; it does not matter if you have missed a dose.

If you have any questions; or are unsure about anything; please ask your doctor; pharmacist or qualified healthcare practitioner.

5 - How to store this product

U Do not use your capsules after the expiry date U Return any out-of-date capsules to your pharmacist who will dispose of them for you. The expiry date is printed on the box and the blister pack U Store the capsules in a cool dry place U Do not store above 25°C U Keep the capsules out of the reach and sight of children

U Keep your capsules in the blister pack until it is time to take them

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

This product is a traditional herbal medicinal product containing Milk Thistle standardised fruit extract. It is a traditional herbal medicinal product used for the temporary relief of symptoms associated with occasional over indulgence of drink and food such as indigestion and upset stomach. This usage is based on traditional use only.

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 any of the ingredients or to plants of the Asteraceae/Compositae family such as daisies; marigolds or artichokes (see section 6)

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

4 - Possible side-effects

Like all medicines, this product can have side-effects. These are listed below.

U Nausea or feeling sick U Diarrhoea U Upset stomach U Headache

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

If these side-effects persist for more than a few days, or become troublesome, stop taking this product. These side-effects are often only temporary. Stop taking this product immediately if you experience any allergic skin reaction.

Other Side-Effects

Tell your doctor or pharmacist if you notice any other side-effect not mentioned in this leaflet.

Reporting of side effects

If you get any side-effects, talk to your doctor, pharmacist or nurse.This includes any possible side-effects not listed in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side-effects you can help provide more information on the safety of this medicine.

You must speak to a qualified healthcare practitioner if your symptoms worsen, if they do not improve after one week, or if side-effects not mentioned in this leaflet occur.

6 - Further information

Each hard capsule of this product contains 193 mg - 261 mg of standardised extract (as dry extract) from Milk Thistle fruits (Silybum mananum (L.J Gaertn.) (equivalent to 3.725g - I0.8l8g of Milk Thistle fruits). This amount of standardised extract corresponds to I08mg of silymarin, calculated as silibinin. Extraction solvent: Acetone 95% v/v.

This product also contains the following ingredients: Capsule contents: Mannitol, cellulose microcrystalline, croscarmellose sodium, silica colloidal anhydrous, magnesium stearate.

Capsule shell: Gelatin, purified water, titanium dioxide EI7I, sodium lauryl sulphate, iron (III)-oxide EI72 (red iron oxide), iron oxide hydrate EI72 (yellow iron oxide).

Each pack contains 30 hard capsules.

Registration holder for this product

Schwabe Pharma (UK) Ltd,

Alexander House, Mere Park, Dedmere Road, Marlow, Bucks, SL7 IFX

Manufactured for:

NBTY Europe Limited by:

Wiewelhove GmbH,

Gildestrasse 39, 49477 Ibbenburen, Germany

Traditional herbal registration number:

THR 23056/0010

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

This leaflet was prepared on: 18/06/2014

CERTIFICATION MARK

THR"

HB35293 OVER INDULGENCE LEAFLET

LEAFLET SIZE: 140mm x 180mm (flat)

45mm x 140mm (folded)

BLEED: N/A BULK: N/A ISSUE: 00A BARCODE: N/A

CHANGES FROM LAST PRINT: None

COLOURS:

K

P364

FONTS:

Gil Sans

Times New Roman FINISH:

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CAUTION: It is the vendors responsibility to print a scannable UPC code from either our artwork or your alternative UPC method

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