Digestisan oral drops

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Available from:

A.Vogel Ireland Limited

Dosage:

.

Pharmaceutical form:

Oral drops, solution

Authorization status:

Not marketed

Authorization date:

2014-02-07

Patient Information leaflet

A.Vogel Ireland
Boldocynara drops
IE - Dublin
CTD Module 1
January 2023
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2595.e04b
Page 1 of 6
Boldocynara (7)
Art. no. 01317700
PACKAGE LEAFLET:
INFORMATION FOR THE USER
DIGESTISAN
oral drops
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
a week.
WHAT IS IN THIS LEAFLET
1.
What Digestisan is and what it is used for
2.
What you need to know before you take Digestisan
3.
How to take Digestisan
4.
Possible side effects
5.
How to store Digestisan
6.
Contents of the pack and other information
1.
WHAT DIGESTISAN IS AND WHAT IT IS USED FOR
Digestisan is a traditional herbal medicinal product containing the
tinctures of
fresh Artichoke leaves, fresh Dandelion root and herb, Boldo leaves
and fresh
Peppermint herb.
Digestisan is used to relieve digestive discomfort. This is
exclusively based on
long-standing use.
Used to relieve:
•
Indigestion
•
Feelings of fullness
•
Flatulence
Digestisan is for use in adults.
A.Vogel Ireland
Boldocynara drops
IE - Dublin
CTD Module 1
January 2023
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2595.e04b
Page 2 of 6
Boldocynara (7)
Art. no. 01317700
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIGESTISAN
DO NOT TAKE DIGESTISAN
•
If you are ALLERGIC to:
o
Any of the ingredients of this product (listed in section 6)
o
Plants of the daisy (Asteraceae/Compositae) family. Artichoke
and Dandelion

Summary of Product characteristics

Health Products Regulatory Authority
09 February 2023
CRN00D8NJ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Digestisan oral drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (20 drops) of oral liquid contains:
- 218 mg of tincture from fresh _Cynara scolymus_ L., folium
(Artichoke leaves), (1:30-31). Extraction solvent: ethanol 65% v/v.
- 218 mg of tincture from fresh _Taraxacum officinalis_ Weber, radix
cum herba (Dandelion root and herb), (1:17-18). Extraction
solvent: ethanol 51% v/v.
- 34 mg of tincture from _Peumus boldus _Molina, folium (Boldo
leaves), (1:10-11). Extraction solvent: ethanol 70% v/v.
- 15 mg of tincture from fresh _Mentha x piperita_ L., herba
(Peppermint herb), (1:18-19). Extraction solvent: ethanol 65% v/v.
Ethanol content: 60% v/v
1 ml is equivalent to 38 drops.
EXCIPIENTS WITH KNOWN EFFECT:
One dose (20 drops) of oral liquid contains 255 mg of ethanol
(alcohol).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution (oral drops).
It is a brown clear liquid.
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): 15-20 drops 3 times daily
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. a doctor or
pharmacist should be consulted.
Method of administration
For oral short-term use only.
4.3 CONTRAINDICATIONS
Hypersensitivity to Artichoke, Dandelion, Boldo or Peppermint
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 or to menthol.
Health Products Regulatory Authority
09 February 2023
CRN00