Moviprep, powder for oral solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MACROGOL, SODIUM SULFATE, ANHYDROUS, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE

Available from:

Norgine BV Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands

ATC code:

A06AD

INN (International Name):

SODIUM ASCORBATE 5.900 g SODIUM CHLORIDE 2.691 g ASCORBIC ACID 4.700 g SODIUM SULFATE ANHYDROUS 7.500 g MACROGOL 3350 100 g POTASSIUM CHLORIDE 1.015 g

Pharmaceutical form:

POWDER FOR ORAL SOLUTION

Composition:

SODIUM ASCORBATE 5.900 g SODIUM CHLORIDE 2.691 g ASCORBIC ACID 4.700 g SODIUM SULFATE ANHYDROUS 7.500 g MACROGOL 3350 100 g POTASSIUM CHLORIDE 1.015 g

Prescription type:

OTC

Therapeutic area:

DRUGS FOR CONSTIPATION

Authorization status:

Authorised

Authorization date:

2011-02-21

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
MOVIPREP, 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 is and what it is used for
2.
What you need to know before you take Moviprep
3.
How to take Moviprep
4.
Possible side effects
5.
How to store Moviprep
6.
Contents of the pack and other information
1.
WHAT MOVIPREP IS AND WHAT IT IS USED FOR
Moviprep is a lemon 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 is intended for adults to clean the bowel so that
they are ready
for examination.
Moviprep 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
DO NOT TAKE TAKE MOVIPREP
•
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)
•
if you suffer from phenylketonuria. This is a hereditary inability of
the body to
Page 2 of 8
use a particular amino acid. Moviprep contains a source of
phenylalanine
•
if your body is

Summary of Product characteristics

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Moviprep,
powder for oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The ingredients of Moviprep are contained in two separate 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 0.233 g of aspartame per sachet A. For the
full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution.
Free flowing white to yellow powder in Sachet A.
Free flowing white to light brown powder in Sachet B.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Moviprep is indicated in adults for bowel cleansing prior to any
clinical procedures requiring a clean
bowel e.g. bowel endoscopy or radiology.
Page 2 of 9
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ADULTS AND OLDER PEOPLE _
A course of treatment consists of two litres of Moviprep. 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 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 to complete
this course.
This course of treatment can be taken either as divided or as single
doses and timing is dependent on
whether the clinical procedure is conducted with or without g