Moviprep oral powder sachets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Mevcut itibaren:

Forum Health Products Ltd

ATC kodu:

n/a

Farmasötik formu:

Not applicable

Sınıf:

No Controlled Drug Status

Reçete türü:

Never Valid To Prescribe As A VMP

Ürün özeti:

BNF: 01060500; GTIN: 5012748402010

Bilgilendirme broşürü

1
PACKAGE LEAFLET
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.
IF YOU NEED THE INFORMATION ON THIS LEAFLET IN AN ALTERNATIVE FORMAT,
SUCH AS LARGE TEXT, PLEASE RING
MEDICAL INFORMATION. FROM THE UK: 01895 826 606. FROM IRELAND: 00 44
1895 826 606
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)

Ürün özellikleri

OBJECT 1
MOVIPREP, POWDER FOR ORAL SOLUTION
Summary of Product Characteristics Updated 22-Aug-2017 | Norgine
Limited
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
Sodium sulfate anhydrous
Sodium chloride
Potassium chloride
100 g
7.500 g
2.691 g
1.015 g
SACHET B contains the following active substances:
Ascorbic acid
Sodium ascorbate
4.700 g
5.900 g
The concentration of electrolyte ions when both sachets are made up to
one litre of solution is as follows:
Sodium
Sulfate
Chloride
Potassium
Ascorbate
181.6 mmol/L (of which not more than 56.2 mmol is absorbable)
52.8 mmol/L
59.8 mmol/L
14.2 mmol/L
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.
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 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