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MOVIPREP ORANGE POWDER FOR ORAL SOLUTION

Active substance(s): ASCORBIC ACID / MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM ASCORBATE / SODIUM CHLORIDE / SODIUM SULPHATE ANHYDROUS

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Package leaflet: Information for the User
Moviprep® Orange, 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 on 01895 826 606.
What is 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 it is 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.
Moviprep Orange is intended for adults to clean the bowel 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.
What you need to know before you take
2.
Moviprep Orange

Do not take Moviprep Orange
••
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 Orange
contains a source of phenylalanine
••
if your body is unable to produce enough glucose-6-phosphate
dehydrogenase
••
if you have toxic megacolon (a severe complication of acute colitis).
Warnings and precautions
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.
Talk to your doctor or pharmacist 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 pressure,
irregular heartbeats 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.
Other medicines and Moviprep Orange
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any 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.
Moviprep Orange with food and drink
Do not take any solid food from when you start to take Moviprep
Orange until after the examination.
When taking Moviprep Orange you should continue to take plenty
of fluids. The fluid content of Moviprep Orange does not replace
your regular liquid intake.
Pregnancy, breast-feeding and fertility
There are no data on the use of Moviprep Orange during pregnancy
or breast-feeding and it should only be used if considered essential
by your doctor. If you are pregnant or breastfeeding, think you may
be pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

Driving and using machines
Moviprep Orange does not affect your ability to drive or use machines.
Moviprep Orange contains sodium, potassium and a
source of phenylalanine
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.
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal product.

3.

How to take Moviprep Orange

Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure. The recommended
dose is two litres of solution, which is made up as follows:
This pack contains two 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.
Use in children
Moviprep Orange should not be taken by children aged
below 18 years.
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 in the early morning of the day of the clinical
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 clinical 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 taken in the morning of the clinical 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
measuring jug that holds 1 litre.
••
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.
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.
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 clinical procedure when taking Moviprep Orange as
divided dose and two hours before your clinical procedure if taking all
your Moviprep Orange on the morning of the clinical procedure.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4.
Possible side effects
Like all medicines Moviprep Orange can cause side effects, although
not everybody gets them.
It is normal to get diarrhoea when you take Moviprep Orange.
Stop your intake and tell your doctor immediately if you have any of
the following side effects:
•• rash or itching
•• swelling of your face, ankles or other part of your body
•• palpitations
•• extreme fatigue
•• shortness of breath
These are symptoms of a severe allergic reaction.
If you do not have a bowel movement within 6 hours of taking
Moviprep Orange, stop the intake and contact your doctor
immediately.
Other side effects include:
Very common side effects (may affect more than 1 in 10 people):
Abdominal pain, abdominal distension, tiredness, feeling generally
unwell, soreness of the anus, nausea and fever.
Common side effects (may affect up to 1 in 10 people): Hunger, problems
sleeping, dizziness, headache, vomiting, indigestion, thirst and chills.
Uncommon side effects (may affect up to 1 in 100 people):
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 and decreased
phosphate. Blood potassium and sodium levels could also decrease.
These reactions usually only occur for the duration of the treatment.
Should they persist, consult your doctor.
Allergic reactions may cause a skin rash, itching, reddening of the
skin or a nettle rash, swollen hands, feet or ankles, headaches,
palpitations and shortness of breath.
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.
How to store Moviprep Orange
5.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton, after “EXP”. Please note that the expiry dates may be different
for the different sachets. The expiry date refers to the last day of the
month.
Keep Moviprep Orange sachets at room temperature (below 25ºC).
After you have dissolved Moviprep Orange in the water, the solution
may be stored (keeping covered) at room temperature (below 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.

6.
Contents of the pack and other information
What Moviprep Orange contains
Sachet A contains these active substances
100 g
Macrogol (also known as polyethylene glycol) 3350
Sodium sulfate anhydrous
7.500 g
Sodium chloride

2.691 g
Potassium chloride
1.015 g
Sachet B contains these 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:
181.6 mmol/L (of which not more than
Sodium
56.2 mmol is absorbable)
Chloride 59.8 mmol/L
Sulfate 52.8 mmol/L
Potassium 14.2 mmol/L
Ascorbate 29.8 mmol/L
The other ingredients are:
Orange flavour (containing natural flavouring substances and
preparations, maltodextrin, dextrose), aspartame (E951) and acesulfame
potassium (E950) as sweeteners. For further information refer to section 2.
What Moviprep Orange looks like and contents of the pack
This pack contains two 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 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:
Norgine Pharmaceuticals Ltd
Norgine House,
Widewater Place,
Moorhall Road,
Harefield
Uxbridge
Middlesex
UB9 6NS
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
MOVIPREP Orange 
Netherlands
Spain
MOVIPREP sabor Naranja
Sweden MOVPREP APELSIN
United Kingdom
MOVIPREP Orange
This leaflet was last revised in April 2016.
The following information is intended for healthcare professionals only:
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.
10037805

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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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