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MOVIPREP ORANGE POWDER FOR ORAL SOLUTION

Active substance: SODIUM SULPHATE ANHYDROUS

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22217301
2
CC/14/015
MOVIPREP Orange
18/06/14
UK
PIL
N/A
TBC
310 x 210 mm
TBC
N/A
N/A

429930A04

Black

Barbara-Young

Digitally signed by Barbara Young
DN: cn=Barbara Young, o=Schawk
Newcastle, ou=QC,
email=barbara.young@schawk.com, c=GB
Date: 2014.06.18 14:07:58 +01'00'

Package Leaflet: Information for the User
powder for oral solution

Macrogol 3350, Sodium sulphate, 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. 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. 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 or Braille please ring from the UK: 0800 198 5000 and for
Medical Information, From the UK: 01895 826 606
From Ireland: 00 44 1895 826 606.
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 IS IT

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.
You are taking Moviprep Orange to make your bowels clean 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 Moviprep Orange if you suspect or your doctor
suspects:
§

Fonts used:
Eurostile LT Std-Bold Extended 2
ITC Eras Std-Bold
ITC Eras Std-Book
Smallest point sized used:
6.0 pt
Average Text Size (Body Text):
8.5 pt

you are allergic (hypersensitive) to the active substances or any of
the other ingredients of Moviprep Orange (listed in section 6).
§
you have an obstruction in your intestine (gut).
§
you have a perforated gut wall.
§
you have a disorder of stomach emptying.
§
you have paralysis of the gut (often occurs after an operation to
the abdomen).
§
you suffer from phenylketonuria. This is an hereditary inability
of the body to use a particular amino acid. Moviprep Orange
contains a source of phenylalanine.
§
your body is unable to produce enough glucose-6-phosphate
dehydrogenase.
§
you have toxic megacolon (a severe complication of acute colitis).
Take special care with MOVIPREP ORANGE
If you are in poor health or have a serious medical condition, you should
be particularly aware of the possible side effects listed in section 4.
Contact your doctor or pharmacist if you are concerned.
You should tell your doctor before taking Moviprep Orange if you have
any of the following:
-you need to thicken fluids in order to swallow them safely.
-a tendency to regurgitate swallowed drink, food or acid from the
stomach.
-kidney disease.
-heart failure or heart disease, including high blood pressue,
irregular heart beats or palpitations.
-thyroid disease
-dehydration.
-acute flare of inflammatory bowel disease (Crohn’s disease or
ulcerative colitis).
Moviprep Orange should not be given to patients with impaired
consciousness without medical supervision.
Taking other medicines
If you are taking other medicines take them at least one hour before
taking Moviprep Orange or at least one hour afterwards because they
may be flushed through your digestive system and not work so well.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Taking Moviprep Orange with food and drink
Do not take any solid food from when you start to take Moviprep
Orange until after the examination.
Pregnancy and breast-feeding
There are no data on the use of Moviprep Orange during pregnancy
or lactation and it should only be used if considered essential by the
physician. So if you are pregnant or breastfeeding, think you may be
pregnant or are planning a baby, ask your doctor for advice before
taking Moviprep Orange.

Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Moviprep Orange does not affect your ability to drive or use machines.
Important information about some of the ingredients of
Moviprep Orange
This medicinal product contains 56.2 mmol of absorbable sodium per
litre. To be taken into consideration by patients on a controlled sodium
diet.
This medicinal product contains 14.2 mmol of potassium per litre. To
be taken into consideration by patients with reduced kidney function or
patients on a controlled potassium diet.
Contains a source of phenylalanine. May be harmful for people with
phenylketonuria.

3.

HOW TO TAKE MOVIPREP ORANGE

Always take Moviprep Orange exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure. The
usual dose is 2 litres of solution, which is made up as follows:
This pack contains 2 clear bags each containing one pair of sachets:
sachet A and sachet B. Each pair of sachets (A and B) is to be dissolved
in water to make a one litre solution. This pack is therefore sufficient to
make up two litres of Moviprep Orange solution.
Before you take Moviprep Orange, please read carefully the following
instructions. You need to know:
§
When to take Moviprep Orange
§
How to prepare Moviprep Orange
§
How to drink Moviprep Orange
§
What you should expect to happen
When to take Moviprep Orange
Always take this medicine exactly as described in this leaflet or as your
doctor has told you. Check with your doctor if you are not sure. Your
treatment with Moviprep Orange must be completed before your clinical
procedure.
This course of treatment can be taken either as divided or single doses as
described below:
1.Divided doses: one litre of Moviprep Orange in the evening before
and one litre of Moviprep Orange in the early morning of the day of the
procedure.
2. Single dose: two litres in the evening before the clinical procedure or
two litres in the morning of the clinical procedure.
For the divided dose and single dose taken in the evening before
the procedure there should be at least one hour between the end of
intake of fluid (Moviprep Orange or clear liquid) and the start of the
colonoscopy.
For the single dose in the morning of the procedure, there should be
at least two hours between the end intake of Moviprep Orange and at
least one hour between the end of intake of any clear liquid and the
start of the colonoscopy.,
Important: Do not take any solid food from when you start
to take Moviprep Orange until after the examination.
How to prepare Moviprep Orange
§
Open one clear bag and remove the sachets A and B.
§
Add the contents of BOTH sachet A and sachet B to a 1 litre
container.
§
Add water to make up to the one litre mark of the container and
stir until all the powder has dissolved and the Moviprep Orange
solution is clear or slightly hazy. This may take up to 5 minutes.

How to drink Moviprep Orange
Drink the first litre of Moviprep Orange solution over one to two hours.
Try to drink a glassful every 10-15 minutes.
When you are ready, make up and drink the second litre of Moviprep
Orange solution made up with the contents of the sachets A and B from
the remaining bag.
During the course of this treatment, you are recommended to drink a
further one litre of clear liquid to prevent you feeling very thirsty and
becoming dehydrated. Water, clear soup, fruit juice (without pulp), soft
drinks, tea or coffee (without milk) are all suitable. These drinks can be
taken at any time you choose.
For the single dose in the morning of the procedure, there should be at
least two hours between the end intake of Moviprep orange and at least
one hour between the end of intake of any clear liquid and the start of
the colonoscopy.
What you should expect to happen
When you start drinking the Moviprep Orange solution, it is important
that you stay close to a toilet. At some point, you will start to experience
watery bowel movements. This is quite normal and indicates that the
Moviprep Orange solution is working. The bowel movements will stop
soon after you have finished drinking.

22217301
2
CC/14/015
MOVIPREP Orange
18/06/14
UK
PIL
N/A
TBC
310 x 210 mm
TBC
N/A
N/A

429930A04

Black

Fonts used:
Eurostile LT Std-Bold Extended 2
ITC Eras Std-Bold
ITC Eras Std-Book
Smallest point sized used:
6.0 pt
Average Text Size (Body Text):
8.5 pt

If you follow these instructions, your bowel will be clear, and this will
help you to have a successful examination. You should allow sufficient
time after your last drink to travel to the colonoscopy unit.
If you take more Moviprep Orange than you should
If you take more Moviprep Orange than you should you may develop
excessive diarrhoea, which can lead to dehydration. Take generous
amounts of fluid, especially fruit juices. If you are worried contact your
doctor or pharmacist.
If you forget to take Moviprep Orange
If you forget to take Moviprep Orange take the dose as soon as you
realise you have not taken it. If this is several hours after the time when
you should have taken it, contact your doctor or pharmacist for advice.
It is important that you complete your preparation at least an hour
before your procedure. When taking Moviprep Orange as a divided
dose and two hours before your procedure if taking all your Moviprep
Orange on the morning of the procedure.
If you have any further questions on the use of this product, ask your
doctor or pharmacist
Children
Moviprep Orange should not be taken by children aged
below 18 years.

Sachet A
Macrogol (also known as polyethylene glycol) 3350
Sodium sulphate anhydrous
Sodium chloride

Potassium chloride
Sachet B
Ascorbic acid
Sodium ascorbate

4.
POSSIBLE SIDE EFFECTS
Like all medicines, Moviprep Orange can have side effects although not
everybody gets them.
It is normal to get diarrhoea when you take Moviprep Orange.
Very common side effects (i.e. affects more than 1 user in 10 are:
Abdominal pain, abdominal distension, tiredness, feeling generally
unwell, soreness of the anus and nausea.
Common side effects (i.e. affects 1 to 10 users in 100) are: Hunger,
problems sleeping, dizziness, headache, vomiting, indigestion, thirst and
chills.
Uncommon side effects (i.e. affects 1 to 10 users in 1,000) are:
discomfort, difficulties swallowing, and changes to tests of liver function.
The following side effects have sometimes been seen but it is not known
how often they occur because the frequency cannot be estimated
from the available data: flatulence (wind), temporary increase in blood
pressure, irregular heart rhythm or palpitations, dehydration, retching
(straining to vomit), very low blood sodium levels that can cause
convulsions (fits) and changes to the levels of salts in the blood such as
decreased bicarbonate, increased or decreased calcium; increased or
decreased chloride; decreased phosphate. Blood potassium and sodium
levels could also decrease particularly in patients taking medicines
that affect the kidney such as ACE Inhibitors and diuretics used for the
treatment of heart disease.
These reactions usually only occur for the duration of the treatment.
Should they persist, consult your doctor.
Allergic reactions may occur.
If you experience any of the following, stop your intake of Moviprep
Orange and contact your doctor immediately. You should not take any
more Moviprep Orange until you have checked with your doctor.
-rash or itching
-swelling of your face, ankles or other part of your body
-palpitations
-extreme fatigue
-shortness of breath
If you do not have a bowel movement within 6 hours of taking
Moviprep Orange, stop the intake and contact your doctor immediately.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via Yellow Card Scheme
Website:www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.

Orange flavour (containing natural flavouring substances and
preparations maltodextrin, dextrose), aspartame (E951) and acesulfame
potassium (E950) as sweeteners.
What Moviprep Orange looks like and contents of the pack
This pack contains 2 clear bags each containing two pairs of sachets:
Sachet A and Sachet B. Each pair of sachets (A and B) is to be dissolved
in one litre of water.
Moviprep Orange powder for oral solution in sachets is available in pack
sizes of 1, 10, 40, 80, 160 and 320 packs of a single treatment. Hospital
packs of 40 single treatments. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder (UK):
Norgine Pharmaceuticals Limited, Widewater Place,
Moorhall Road, Harefield, UB9 6NS, UK
Marketing Authorisation Holder (Ireland):
Norgine BV, Hogehilweg 7, 1101 CA Amsterdam ZO, Netherlands
Manufacturer:
Norgine Limited, New Road, Hengoed, Mid Glamorgan, CF82 8SJ,
United Kingdom.
The medicinal product is authorised in the Member States of
the EEA under the following names:
Country
Tradename
Austria MOVIPREP Orange
Belgium MOVIPREP Sinaas/Orange
Denmark MOVIPREP Appelsin
Finland MOVIPREP Appelsini
Germany MOVIPREP Orange
Ireland MOVIPREP Orange
Italy MOVIPREP Arancio
Luxembourg
MOVIPREP Sinaas/Orange
Netherlands
MOVIPREP Orange 
Spain
MOVIPREP sabor Naranja
Sweden MOVPREP APELSIN
United Kingdom
MOVIPREP Orange
This leaflet was last approved in MM/YYYY
The following information is intended for healthcare professionals only.

5.
HOW TO STORE MOVIPREP ORANGE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated, after ‘EXP’,
on the carton. Please note that the expiry dates on the sachets may be
different from this. The expiry date refers to the last day of the month.
Keep Moviprep Orange sachets at room temperature (not above 25ºC).
After you have dissolved Moviprep Orange in the water, the solution
may be stored (keeping covered) at room temperature (not above 25ºC).
It may also be stored in the fridge (2ºC -8ºC). Do not keep it for more
than 24 hours.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment

100 g
7.500 g
2.691 g
1.015 g
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
181.6 mmol/L (of which not more than
56.2 mmol is absorbable)
Sulphate 52.8 mmol/L
Chloride 59.8 mmol/L
Potassium 14.2 mmol/L
Ascorbate 29.8 mmol/L
The other ingredients are:

Moviprep Orange should be administered with caution to fragile
patients in poor health or patients with serious clinical impairment
such as:
§

impaired gag reflex, or with a tendency to aspiration or
regurgitation
§
impaired consciousness
§
severe renal insufficiency (creatinine clearance <30 mL/min)
§
cardiac impairment (NYHA grade III or IV)
§
those at risk of arrhythmia, for example those on treatment for
cardiovascular disease or who have thyroid disease
§
dehydration
§
severe acute inflammatory disease
The presence of dehydration or electrolyte shifts should be corrected
before the use of Moviprep Orange.
Semi-conscious patients or patients prone to aspiration or
regurgitation should be closely observed during administration
especially if this is via a nasogastric route.
Moviprep Orange should not be given to unconscious patients.

6.
CONTENTS OF THE PACK AND OTHER
INFORMATION
What Moviprep Orange contains
The active substances are:

22217301

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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