MOVIPREP, powder for oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

LTT Pharma Limited

ATC code:

A06AD; A06AD65

INN (International Name):

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

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:

Authorised

Authorization date:

2016-04-15

Patient Information leaflet

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
What Moviprep is and what it is used for
What you need to know before you take Moviprep
How to take Moviprep
Possible side effects
How to store Moviprep
Contents of the pack and other information
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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVIPREP
DO NOT TAKE MOVIPREP
*
if you are allergic (hypersensitive) to the active substances or any
of the
other ingredients 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 an hereditary inability of
the body
to use a particular amino acid. Moviprep contains a source of
phenylalanine.
*
if your body is unable to produce enough glucose-6-phosphate
dehydrogenase.
*
if you have toxic megacolon (a severe compli

Summary of Product characteristics

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
29.8 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.
Product imported from France
Free flowing white to yellow powder in Sachet A.
Free flowing white to light brown powder in Sachet B.
4 CLINICAL PARTICULARS
As per PA1336/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1336/001/001
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6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Aspartame (E951)
Acesulfame potassium (E950)
Lemon flavouring containing maltodextrin, citral, lemon oil, essential
oil of l