Moviprep Orange, powder for oral solution

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Macrogol 3350; Sodium sulfate anhydrous; Sodium chloride; Potassium chloride; Ascorbic acid; Sodium ascorbate

Dostupné z:

Norgine B.V.

ATC kód:

A06AD; A06AD65

INN (Medzinárodný Name):

Macrogol 3350; Sodium sulfate anhydrous; Sodium chloride; Potassium chloride; Ascorbic acid; Sodium ascorbate

Dávkovanie:

.

Forma lieku:

Powder for oral solution

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Osmotically acting laxatives; macrogol, combinations

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2011-02-18

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MOVIPREP ORANGE, POWDER FOR ORAL SOLUTION
Macrogol 3350, Sodium sulfate anhydrous, Sodium chloride, Potassium
chloride,
Ascorbic acid and Sodium ascorbate
_ _
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 Moviprep Orange is and what it is used for
2.
What you need to know before you take Moviprep Orange
3.
How to take Moviprep Orange
4.
Possible side effects
5.
How to store Moviprep Orange
6.
Contents of the pack and other information
1.
WHAT MOVIPREP ORANGE IS AND WHAT IT IS USED FOR
Moviprep Orange is an orange flavoured laxative contained in four
sachets. There are two large
sachets (‘sachet A’) and two small sachets (‘sachet B’). You
need all these for one treatment.
Moviprep Orange is intended for adults to clean the bowel so that they
are ready for
examination.
Moviprep Orange works by emptying the contents of your bowels, so you
should expect to have
watery bowel movements.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVIPREP ORANGE
DO NOT TAKE TAKE MOVIPREP ORANGE
•
if you are allergic (hypersensitive) to the active substances or any
of the other ingredients
of this medicine (listed in section 6)
•
if you have an obstruction in your intestine (gut)
•
if you have a perforated gut wall
•
if you have a disorder of stomach emptying
•
if you have paralysis of the gut (often occurs after an operation to
the abdomen)
2
•
if you suffer from phenylketonuria. This is a hereditary inability of
the body to use a
particular amino acid. M

Súhrn charakteristických

Health Products Regulatory Authority
18 January 2023
CRN00DD3M
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Moviprep Orange, powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The ingredients of Moviprep Orange are contained in two seperate
sachets.
SACHET A contains the following active substances:
Macrogol 3350 100 g
Sodium sulfate anhydrous 7.500 g
Sodium chloride 2.691 g
Potassium chloride 1.015 g
SACHET B contains the following active substances:
Ascorbic acid 4.700 g
Sodium ascorbate 5.900 g
The concentration of electrolyte ions when both sachets are made up to
one litre of solution is as follows:
Sodium 181.6 mmol/L (of which not more than 56.2 mmol is absorbable)
Sulfate 52.8 mmol/L
Chloride 59.8 mmol/L
Potassium 14.2 mmol/L
Ascorbate 56.5 mmol/L
Excipient(s) with known effect:
This product contains 0.175 g of aspartame and 0.120g of dextrose per
sachet A.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
Free flowing white to off-white powder in Sachet A.
Free flowing white to light brown powder in Sachet B.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Moviprep Orange is indicated in adults for bowel cleansing prior to
any clinical procedures requiring a clean bowel e.g. bowel
endoscopy or radiology .
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ADULTS AND OLDER PEOPLE _
A course of treat ment consists of two litres of Moviprep Orange. It
is strongly recommended that one litre of clear liquid,
which may include water, clear soup, fruit juice without pulp, soft
drinks, tea and/or coffee without milk, is also taken during
the course of treatment.
A litre of Moviprep Orange consists of one 'sachet A' and one 'sachet
B' dissolved together in water to make one litre of
solution. The reconstituted solution should be drunk over a period of
one to two hours. This process should be repeated with a
second litre of Moviprep Orange to complete the course.
This course of treatment can be taken either as div