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VITABIOTICS MILK THISTLE TABLETS

Active substance(s): SILYMARIN

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Product: Max Strength Milk Thistle Tablets Leaflet
PL 20894/0071
Size: 140mm x 150mm (fold to 39x140mm with 2mm lip size)
Sides: 2 sided
Colour: Black
Code: PXXXXX
Pharmacode: TBC
Version: BRU006
Date: 21/10/2011
Page: 1 of 2

Brunel Healthcare Manufacturing Ltd, William Nadin Way
Swadlincote, Derbyshire, DE11 0BB
Tel: +44 (0)1283 228350 Fax: +44 (0)1283 228383

140mm

P00000

Patient Information Leaflet

Max Strength Milk Thistle Tablets
Milk thistle standardised fruit extract 500 mg

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.

150mm

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.

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 tablet 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.

APPROVED:
AMEND
REQUIRED:

COLOUR LIST:

1

Black

DATE:
Please check this proof on positioning, layout, text &
spelling, claims, design issue, colour & size. Please check
BBE/EXP positioning, Pcode, Barcode. Please make clear
necessary modification.
Brunel Healthcare Manufacturing Ltd cannot be held
responsible for errors that have been overlooked once
this proof has been Signed for Approval & returned.
ARTWORK CREATED BY: JULIA ROSS
ORIGINATION SOFTWARE: CORELDRAW X4

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

2. Before you take this product

PHARMACODE TBC

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

1st bar

last bar

Brunel Healthcare Manufacturing Ltd, William Nadin Way
Swadlincote, Derbyshire, DE11 0BB
Tel: +44 (0)1283 228350 Fax: +44 (0)1283 228383

Product: Max Strength Milk Thistle Tablets Leaflet
PL 20894/0071
Size: 140mm x 150mm (fold to 39x140mm with 2mm lip size)
Sides: 2 sided
Colour: Black
Code: PXXXXX
Pharmacode: TBC
Version: BRU006
Date: 21/10/2011
Page: 2 of 2

140mm

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

150mm

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 25oC.
Store in the original packaging.

6. Further information
Each film coated tablet contains 500 mg of
standardised extract (as dry extract) from
Milk Thistle fruits (Silybum marianum (L.)
Gaertner) (equivalent to 10.0 - 20.0 g of Milk
Thistle fruits) corresponding to 250 - 300 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:
Max Strength Milk Thistle Tablets
Reference number: THR 20894/0071
THR holder and manufacturer is:
Brunel Healthcare Manufacturing Ltd,
William Nadin Way, Swadlincote,
Derbyshire, DE11 0BB, U.K.
Text revised: October 2011
THR 20894/0071
Certification Mark

APPROVED:
AMEND
REQUIRED:

COLOUR LIST:

1

Black

DATE:
Please check this proof on positioning, layout, text &
spelling, claims, design issue, colour & size. Please check
BBE/EXP positioning, Pcode, Barcode. Please make clear
necessary modification.
Brunel Healthcare Manufacturing Ltd cannot be held
responsible for errors that have been overlooked once
this proof has been Signed for Approval & returned.
ARTWORK CREATED BY: JULIA ROSS
ORIGINATION SOFTWARE: CORELDRAW X4

Cutter guide

SUBSTRATE
PRODUCT COLOUR

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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