Artichoke-Milk Thistle Complex Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Dry extract from fresh cynara scolymus l. leaves (1:30-31) extraction solvent:ethanol 65% v/v; Dry extract from silybum marianum l. gaertn fruits (1:2.0-2.1) extration solvent ethanol 58% v/v; Dry extract from fresh dandelion root&herb(taraxacum officinalis web) (1:17-18) extraction solvent:ethanol 51%; Dry extract from peumus boldus molina (1:10-11) extraction solvent:ethanol 70% v/v

Verfügbar ab:

A.Vogel Ireland Limited

INN (Internationale Bezeichnung):

Dry extract from fresh cynara scolymus l. leaves (1:30-31) extraction solvent:ethanol 65% v/v; Dry extract from silybum marianum l. gaertn fruits (1:2.0-2.1) extration solvent ethanol 58% v/v; Dry extract from fresh dandelion root&herb(taraxacum officinalis web) (1:17-18) extraction solvent:ethanol 51%; Dry extract from peumus boldus molina (1:10-11) extraction solvent:ethanol 70% v/v

Dosierung:

.

Darreichungsform:

Tablet

Verschreibungstyp:

Product not subject to medical prescription

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2014-07-25

Gebrauchsinformation

A.Vogel Ireland
Boldocynara tablets
IE - Dublin
CTD Module 1
November 2022
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2595.e06
Page 1 of 6
Boldocynara (10)
Art. no. 01325100
PATIENT INFORMATION LEAFLET
ARTICHOKE-MILK THISTLE
Complex tablets
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
PRODUCT BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this product exactly as described in this leaflet or as
your doctor,
pharmacist or nurse has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse
after 1 week.
WHAT IS IN THIS LEAFLET
1.
What Artichoke-Milk Thistle Complex is and what it is used for
2.
What you need to know before you take Artichoke-Milk Thistle Complex
3.
How to take Artichoke-Milk Thistle Complex
4.
Possible side effects
5.
How to store Artichoke-Milk Thistle Complex
6.
Contents of the pack and other information
1.
WHAT ARTICHOKE-MILK THISTLE COMPLEX IS AND WHAT IT IS USED FOR
Artichoke-Milk Thistle Complex is a traditional herbal medicinal
product
containing the extracts of fresh Artichoke leaves, Milk Thistle fruit,
fresh
Dandelion root & herb and Boldo leaves.
It is used to relieve digestive discomfort such as:
•
Indigestion
•
Feelings of fullness
•
Flatulence
This is exclusively based on long-standing use.
Artichoke-Milk Thistle Complex is for use in adults.
A.Vogel Ireland
Boldocynara tablets
IE - Dublin
CTD Module 1
November 2022
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2595.e06
Page 2 of 6
Boldocynara (10)
Art. no. 01325100
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARTICHOKE-MILK THISTLE COMPLEX
DO NOT TAKE ARTICHOKE-MILK THISTLE COMPLEX
�

Fachinformation

Health Products Regulatory Authority
14 December 2022
CRN00D9PP
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Artichoke-Milk Thistle Complex Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:

4.6 mg (as dry extract) _Cynara scolymus_ L., folium (Artichoke
leaves) (1:30-31), extraction solvent: ethanol 65% v/v.

3.2 mg (as dry extract) _Silybum marianum_ (L.) Gaertn. fructus (Milk
Thistle fruit) (1:2.0-2.1), extraction solvent:
ethanol 58% v/v.

1.2 mg (as dry extract) _Taraxacum officinalis_ Weber, radix cum herba
(Dandelion root and herb) (1:17-18),
extraction solvent: ethanol 51% v/v.

0.7 mg (as dry extract) _Peumus boldus_ Molina, folium (Boldo leaves)
(1:10-11), extraction solvent: ethanol 70% v/v.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
Beige-coloured, round biconvex tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
This product is indicated for use in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults (18 years and over): Take 1 tablet twice a day.
This product is not indicated in patients less than 18 years.
If the condition worsens or symptoms do not improve after 1 week a
qualified healthcare professional e.g. doctor or
pharmacist should be consulted.
METHOD OF ADMINISTRATION
For oral short-term use only.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to Artichoke, Dandelion,
Boldo or Milk Thistle preparations or to any of the
excipients listed in section 6.1.
Do not use in cases of known hypersensitivity to plants of the
Asteraceae (Compositae) family.
Do not use in cases of bile duct obstruction, cholangitis, liver
disease, gallstones and any other biliary disorders.
Pregnancy and lactation (See also sections 4.6 and 5.3).
Health Products Regulatory Authority
14 December