Holland & Barrett Milk Thistle Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Milk thistle extract (as dry root)

Available from:

Holland & Barrett International Limited

INN (International Name):

Milk thistle extract (as dry root)

Dosage:

.

Pharmaceutical form:

Capsule, hard

Prescription type:

Product not subject to medical prescription

Authorization status:

Authorised

Authorization date:

2014-09-26

Patient Information leaflet

PACKAGE LEAFLET: Information for the Patient
MILK THISTLE HARD CAPSULES
MILK THISTLE STANDARDISED FRUIT EXTRACT
IMPORTANT NOTES
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you
take this traditional herbal medicine because
it contains important information for you
◆
Always take this traditional herbal medicine
exactly as described in this leaflet or as your
doctor or pharmacist has told you
◆
Keep this leaflet. You may need to read it again
◆
Ask a healthcare professional eg a doctor or a
pharmacist if you need more information or advice
◆
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet
◆
You must talk to a doctor if you feel worse
or do not feel better after 1 week of taking
this traditional herbal medicine
1 - WHAT THIS TRADITIONAL HERBAL
MEDICINE IS AND WHAT IT IS USED FOR
2 - WHAT YOU NEED TO KNOW BEFORE YOU
TAKE THIS TRADITIONAL HERBAL MEDICINE
3 - HOW TO TAKE THIS TRADITIONAL HERBAL
MEDICINE
A traditional herbal medicinal product for the
symptomatic relief of digestive disorders such as
indigestion, feeling of fullness and flatulence,
exclusively based upon long-standing use.
Do not take this traditional herbal medicine if
you are:
◆
Under 18 years of age
◆
Allergic to Milk Thistle or plants of the
Asterceae/Compositae family such as daisies,
marigolds or artichokes
◆
Allergic to any ingredients in this traditional
herbal medicine (listed in section 6 of this
leaflet)
Warnings and Precautions
Talk to your doctor or pharmacist before
taking this traditional herbal medicine if you are
currently suffering from active liver disease.
Children and adolescents: Do not give this
traditional herbal medicine to children or adolescents
under 18 years as it is not known if it is safe to do so.
Other medicines and Holland & Barrett Milk
Thistle Hard Capsules including traditional
herbal medicines: Tell your doctor or
pharmacist if you are taking, have recently or
might take any other medicines, includi

Summary of Product characteristics

Health Products Regulatory Authority
29 May 2020
CRN008V4T
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Holland & Barrett Milk Thistle Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 133 mg – 324 mg of extract (as dry
extract) from _Silybum marianum _L. Gaertn, fructus (milk thistle
fruit) (equivalent to 3325 – 9720 mg of milk thistle fruit)
corresponding to 108 mg of silymarin, calculated as silibinin.
Extraction solvent: Acetone 99.9% v/v.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsules, hard
A two piece clear, hard capsule with a beige / brown fill.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product for the symptomatic relief of
digestive disorders such as indigestion, feelings of fullness
and flatulence exclusively based on long-standing use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral short-term use only.
This product is not indicated in patients less than 18 years of age
_ADULTS AND THE ELDERLY_
Take 1 capsule 2 times daily. Swallow the whole capsule with water.
Do not exceed the stated dose.
DURATION OF USE:
If symptoms worsen or do not improve after 1 weeks use of Holland &
Barrett Milk Thistle Hard Capsules, a qualified
healthcare professional e.g. a doctor or pharmacist should be
consulted.
The safety of Milk Thistle in children and adolescents under 18 years
of age has not been established as no data are available.
4.3 CONTRAINDICATIONS
- Do not use in cases of known hypersensitivity to Milk Thistle or to
plants of the Asteraceae (Compositae) family or to any of
the excipients in Holland & Barrett Milk Thistle Hard Capsules
- Patients under 18 years of age
- Pregnancy and lactation
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
- Do not exceed the stated dose
- Patients suffering from active liver disease should consult their
doctor before taking the product
Health Products Regulatory Authority
29 May 2020
CRN008V4T
Page 2 of 4
- Milk Thistle may alter the wa