Moviprep, powder for oral solution

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

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

Mevcut itibaren:

Norgine B.V.

ATC kodu:

A06AD; A06AD65

INN (International Adı):

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

Doz:

.

Farmasötik formu:

Powder for oral solution

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Osmotically acting laxatives; macrogol, combinations

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2006-12-15

Bilgilendirme broşürü

2
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 use a
particular amino acid. Moviprep contains a source of phenylalanine
3
•
if your body is unable to produce en

Ürün özellikleri

Health Products Regulatory Authority
18 January 2023
CRN00DD3M
Page 1 of 7
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 .
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ADULTS AND OLDER PEOPLE_
A course of treat ment 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.
Health Products Regulatory Authority
18 January 2023
CRN00DD3M
Page 2 of 7
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