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A.VOGEL MILK THISTLE COMPLEX TABLETS

Active substance(s): CYNARA SCOLYMUS / PEUMUS BOLDUS / SILYBUM MARIANUM / TARAXACUM OFFICINALE

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Patient Information Leaflet

i

Important things you need to
know

Milk Thistle
Complex tablets

Do's & Don'ts

Information

This product is for relieving indigestion
and feelings of fullness and flatulence
associated with over-indulgence of food
or drink or both.
This product is suitable for adults over
18 years.
Don't take this product if you are
allergic to any of the ingredients: see
section 6.
Before you take this product: read
section 2.
Dosage instructions: see section 3.
Talk to your doctor if your symptoms
worsen or you do not feel any benefit
from this product within 2 weeks.
Side effects are minor: see section 4.
Now read the rest of this leaflet
carefully. Keep this leaflet. You may need
to read it again.

1. What this product is for
Milk Thistle Complex is a traditional
herbal medicinal product used for the
relief of:
Indigestion
Feelings of fullness and flatulence
associated with over-indulgence of food
or drink or both
This is based on traditional use only.

2. Before you use this
product
Do not take this product:
If you are under 18 years of age.
If you are allergic to:
Any of the ingredients in this
product (see section 6)
Plants of the daisy (Asteraceae/
Compositae) family. Artichoke,
Dandelion and Milk Thistle are
members of the daisy family.
If you suffer from:
Blockage of the bile duct
Blockage of the intestine
Inflammation of the bile duct
(cholangitis)
Gallstones
Biliary disorders
Peptic ulcer

S

Using

3. How to use this product
Adults and the elderly: Take one tablet
twice daily.
For oral use only. Don't take more than the
recommended dose.
Not for use in children or those under 18.

If you take too much
If you take too much and feel ill, talk to
your doctor. Taking too much is unlikely
to be harmful.

If you forget to take this product
Don't worry about the missed dose. Take
the next dose as usual.

If you feel this product isn't
working
See your doctor if your symptoms
worsen or do not improve within 2
weeks.

Liver disease including hepatitis
Kidney failure
Diabetes
Heart failure
If you are pregnant or breast-feeding.
40505IN1 09472900/100914

OKE
TICH
AR

616

Please turn over...

Milk Thistle Complex PIL UK Submission Sept 2014.indd 1

10/09/2014 09:07

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

Minor side effects
The following minor side effects can occur
when using this product.
Digestive symptoms
Feeling sick (nausea)
Diarrhoea accompanied by stomach
cramps
Abdominal pain
Increase in stomach acid
Heartburn

If you are concerned about any side effect
or if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

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.

Information

5. How to store this
product
Keep out of the reach and sight of
children.

What this product looks like and
the contents of the pack

Do not use this product after the expiry
date on the packaging. The expiry date
refers to the last day of that month.

The tablets are round and beige in colour.
Milk Thistle Complex is available in packs
containing 60 tablets.

Store below 30˚C.
Do not use this product if you notice a
change in colour. The tablets should be
beige in colour.

6. Further Information
What this product contains

Other

1 tablet contains the extracts (as dry
extract) of:

Headache
These are often short-lived and should
go away by themselves. However if they
are troubling you, talk to your doctor or
pharmacist.
Allergic reactions
Red, itchy spots (urticaria)

Fresh Artichoke leaves
4.6 mg
(Cynara scolymus L.) (1:30-31)
Extraction solvent: ethanol 65% V/V
Milk Thistle fruit
3.2 mg
(Silybum marianum L. Gaertn.) (1:2.0-2.1)
Extraction solvent: ethanol 58% V/V
Fresh Dandelion root & herb
1.2 mg
(Taraxacum officinalis WEB.) (1:17-18)
Extraction solvent: ethanol 51% V/V

Rash
Itching (pruritis)
Stop taking the product if these occur.
Difficulty breathing or dizziness
(anaphylaxis)
Stop taking the product immediately if this
occurs. Seek medical advice and take this
leaflet with you.

The other ingredients used for the
tablets are microcrystalline cellulose and
hydrogenated cottonseed oil.

Boldo leaves
0.7 mg
(Peumus boldus MOLINA) (1:10-11)
Extraction solvent: ethanol 70% V/V

Milk Thistle is a flowering plant which is
native to the Mediterranean. The extract
of the fruits are used to make Milk
Thistle Complex.
Boldo is an evergreen shrub which is
native to South America. The extract of
the leaves is used to make Milk Thistle
Complex.

You should also know

Traditional Herbal Registration
Holder and Manufacturer

Bioforce runs a helpline by phone and
email which can provide you with further
information.

Traditional Herbal Registration Holder
and Batch Release:
Bioforce (UK) Ltd,
2 Brewster Place,
Irvine, Ayrshire, UK
KA11 5DD

E-mail: enquiries@avogel.co.uk

Manufacturer:
Bioforce AG, CH-9325, Roggwil
Switzerland
THR No. 13668/0028

Certification Mark

Phone: 0845 608 5858

You can get a larger
print or audio version
of this leaflet.
Call this number:
0845 608 5858.

This leaflet was last revised in 09/2014.

About the ingredients of Milk
Thistle Complex
Artichoke and Dandelion are flowering
plants which have been used as food
throughout the world for many years.

40505IN1 09472900/100914

i

Side effects

616

Milk Thistle Complex PIL UK Submission Sept 2014.indd 2

10/09/2014 09:07

Patient Information Leaflet

i

Important things you need to
know

Digestisan
Milk Thistle
tablets

This product is for relieving indigestion
and feelings of fullness and flatulence
associated with over-indulgence of food
or drink or both.
This product is suitable for adults over
18 years.
Don't take this product if you are
allergic to any of the ingredients: see
section 6.
Before you take this product: read
section 2.
Dosage instructions: see section 3.
Talk to your doctor if your symptoms
worsen or you do not feel any benefit
from this product within 2 weeks.
Side effects are minor: see section 4.
Now read the rest of this leaflet
carefully. Keep this leaflet. You may need
to read it again.

A LI S

Do's & Don'ts

Information
1. What this product is for
Digestisan Milk Thistle tablets are a
traditional herbal medicinal product used
for the relief of:
Indigestion
Feelings of fullness and flatulence
associated with over-indulgence of food
or drink or both
This is based on traditional use only.

2. Before you use this
product
Do not take this product:
If you are under 18 years of age.
If you are allergic to:
Any of the ingredients in this
product (see section 6)
Plants of the daisy (Asteraceae/
Compositae) family. Artichoke,
Dandelion and Milk Thistle are
members of the daisy family.
If you suffer from:
Blockage of the bile duct
Blockage of the intestine
Inflammation of the bile duct
(cholangitis)
Gallstones
Biliary disorders
Peptic ulcer

S

Using

3. How to use this product
Adults and the elderly: Take one tablet
twice daily.
For oral use only. Don't take more than the
recommended dose.
Not for use in children or those under 18.

If you take too much
If you take too much and feel ill, talk to
your doctor. Taking too much is unlikely
to be harmful.

If you forget to take this product
Don't worry about the missed dose. Take
the next dose as usual.

If you feel this product isn't
working
See your doctor if your symptoms
worsen or do not improve within 2
weeks.

Liver disease including hepatitis
Kidney failure
Diabetes
Heart failure
If you are pregnant or breast-feeding.
XXXXXIN1 XXXXXXXX/170914

OKE
TICH
AR

XXX-

Digestisan Milk Thistle PIL UK Submission Sept 2014.indd 1

Please turn over...

17/09/2014 11:21

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

If you are concerned about any side effect
or if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

Reporting of side effects

Minor side effects
The following minor side effects can occur
when using this product.
Digestive symptoms
Feeling sick (nausea)
Diarrhoea accompanied by stomach
cramps
Abdominal pain
Increase in stomach acid
Heartburn

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.

Information

5. How to store this
product
Keep out of the reach and sight of
children.

What this product looks like and
the contents of the pack

Do not use this product after the expiry
date on the packaging. The expiry date
refers to the last day of that month.

The tablets are round and beige in colour.
Digestisan Milk Thistle tablets are available
in packs containing 60 tablets.

Store below 30˚C.
Do not use this product if you notice a
change in colour. The tablets should be
beige in colour.

6. Further Information
What this product contains

Other

1 tablet contains the extracts (as dry
extract) of:

Headache
These are often short-lived and should
go away by themselves. However if they
are troubling you, talk to your doctor or
pharmacist.
Allergic reactions
Red, itchy spots (urticaria)

Fresh Artichoke leaves
4.6 mg
(Cynara scolymus L.) (1:30-31)
Extraction solvent: ethanol 65% V/V
Milk Thistle fruit
3.2 mg
(Silybum marianum L. Gaertn.) (1:2.0-2.1)
Extraction solvent: ethanol 58% V/V
Fresh Dandelion root & herb
1.2 mg
(Taraxacum officinalis WEB.) (1:17-18)
Extraction solvent: ethanol 51% V/V

Rash
Itching (pruritis)
Stop taking the product if these occur.
Difficulty breathing or dizziness
(anaphylaxis)
Stop taking the product immediately if this
occurs. Seek medical advice and take this
leaflet with you.

The other ingredients used for the
tablets are microcrystalline cellulose and
hydrogenated cottonseed oil.

Boldo leaves
0.7 mg
(Peumus boldus MOLINA) (1:10-11)
Extraction solvent: ethanol 70% V/V

Milk Thistle is a flowering plant which is
native to the Mediterranean. The extract
of the fruits are used to make Digestisan
Milk Thistle tablets.
Boldo is an evergreen shrub which is
native to South America. The extract of
the leaves is used to make Digestisan
Milk Thistle tablets.

You should also know

Traditional Herbal Registration
Holder and Manufacturer

Bioforce runs a helpline by phone and
email which can provide you with further
information.

Traditional Herbal Registration Holder
and Batch Release:
Bioforce (UK) Ltd,
2 Brewster Place,
Irvine, Ayrshire, UK
KA11 5DD

E-mail: enquiries@avogel.co.uk

Manufacturer:
Bioforce AG, CH-9325, Roggwil
Switzerland
THR No. 13668/0028

Certification Mark

Phone: 0845 608 5858

You can get a larger
print or audio version
of this leaflet.
Call this number:
0845 608 5858.

This leaflet was last revised in 09/2014.

About the ingredients of
Digestisan Milk Thistle tablets
Artichoke and Dandelion are flowering
plants which have been used as food
throughout the world for many years.

XXXXXIN1 XXXXXXXX/170914

i

Side effects

XXX

Digestisan Milk Thistle PIL UK Submission Sept 2014.indd 2

17/09/2014 11:21

Expand view ⇕

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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