Vistaprep Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Macrogol 3350; Sodium chloride; Potassium chloride; Sodium hydrogen carbonate

Available from:

Tillotts Pharma GmbH

ATC code:

A06AD; A06AD65

INN (International Name):

Macrogol 3350; Sodium chloride; Potassium chloride; Sodium hydrogen carbonate

Dosage:

110.44

Pharmaceutical form:

Powder for oral solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives; macrogol, combinations

Authorization status:

Marketed

Authorization date:

2016-01-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Vistaprep
®
Powder for oral solution.
Macrogol 3350, sodium chloride, sodium bicarbonate and potassium
chloride.
Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for you.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor or pharmacist.
–
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
–
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Vistaprep is and what it is used for
2. What
you
need
to
know
before
you
take
Vistaprep
3. How to take Vistaprep
4. Possible side effects
5. How to store Vistaprep
6. Contents of the pack and other information
1. What Vistaprep is and what it is used for
Vistaprep is a white powder for oral solution with
a laxative effect.
Vistaprep
is
used
for
bowel
cleansing
in
preparation for the examination of the colon
(colonoscopy) in adults over 18 years of age.
2. What you need to know before you take
Vistaprep
Do not take Vistaprep
—
— if you are allergic to macrogol 3350, sodium
chloride,
sodium
bicarbonate,
potassium
chloride saccharin sodium, orange flavour,
lemon-lime flavour, colloidal anhydrous silica
or
any
of
the
other
ingredients
of
this
medicine (listed in section6);
—
— if you have a bowel obstruction or suspected
bowel obstruction, strictures or perforations
in the gastrointestinal area, or if you are at
risk of perforations in the gastrointestinal
area;
—
— if you suffer from problems emptying your
stomach or have a severe, highly inflammatory
form of colitis (colon inflammation) and a
severe, abnormally enlarged colon due to
this colitis (toxic megacolon);
—
— if you have an impaired swallowing and gag
reflex, or suffer from general weakness.
Vistaprep should not be adminis

Summary of Product characteristics

Health Products Regulatory Authority
14 December 2020
CRN00C1CN
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vistaprep Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains the following active substances:
Macrogol 3350 105.000 g
Sodium chloride 2.800 g
Sodium bicarbonate 1.430 g
Potassium chloride 0.370 g
The electrolyte ion content of one sachet after preparation of 1,000
mL solution is equivalent to:
Sodium 65 mmol/L
Chloride 53 mmol/L
Bicarbonate 17 mmol/L
Potassium 5 mmol/L
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
Appearance: white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VistaPrep is used for bowel cleansing in preparation for colonoscopy.
VistaPrep is indicated in adults over 18 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For complete bowel cleansing, 3 up to a maximum of 4 litres of
VistaPrep solution must be taken. 1 sachet corresponds to 1 L
solution.
_Paediatric population_
VistaPrep should not be used in children because the safety has not
been established in this patient group.
Method of administration
The route of administration is for oral use.
The solution is drunk in portions of 200 - 300 mL every 10 minutes
until the rectal effluent is clear or 4 litres maximum have
been drunk.
Administration takes place over a period of about 4 hours, generally
on the examination day. The total amount required can
also be taken on the evening before, or a part taken on the evening
before and the remaining amount on the morning of the
examination day.
Patients should consume no solid food for 2 to 3 hours prior to
administration of VistaPrep until after the examination.
Precautions to be taken before handling or administering the medicinal
product
For instructions on reconstitution of the medicinal product before
administration, see section 6.6. For further directions for use
see section 6.2 Incompatibilities.
4.3 CONTRAINDICATIONS
Health Products Re