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MOVIPREP POWDER FOR ORAL SOLUTION

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

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40601205
3
CR/14/0140, CR/14/0157, CR/14/0259
MOVIPREP
22/11/15
UK
Pil
Hengoed
NOR-LFT9-V1
210 x 310mm
145
N/A
N/A

494924A03

Black

Package leaflet: Information for the User

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.

When taking Moviprep you should continue to take plenty of fluids.
The fluid content of Moviprep does not replace your regular liquid
intake.
Pregnancy, breast-feeding and fertility
There are no data on the use of Moviprep during pregnancy or
lactation and it should only be used if considered essential by the
physician. 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 Moviprep.
Driving and using machines
Moviprep does not affect your ability to drive or use machines.
Important information about some of the ingredients of
Moviprep
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 need the information on this leaflet in an
alternative format, such as large text, please ring Medical 3. How to take Moviprep
Information, From the UK: 01895 826 606. From Ireland: Always take Moviprep exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure. The
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.

Fonts used:
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Square 721 BT-Bold Extended
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Page 1 of 2

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 Moviprep (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 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 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 should not be given to patients with impaired
consciousness without medical supervision.
Other medicines and Moviprep
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 or at least one hour afterwards because they may
be flushed through your digestive system and not work so well.
Moviprep with food and drink
Do not take any solid food from when you start to take Moviprep until
after the examination.

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 solution.
Use in children
Moviprep should not be taken by children aged below
18 years.
Before you take Moviprep, please read carefully the following
instructions. You need to know:
•• When to take Moviprep
•• How to prepare Moviprep
•• How to drink Moviprep
•• What you should expect to happen
When to take Moviprep
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 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 in the evening before and
one litre 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 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 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 until after the examination.
How to prepare Moviprep
•• 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 solution is clear
or slightly hazy. This may take up to 5 minutes.

How to drink Moviprep
Drink the first litre of Moviprep 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
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

40601205
3
CR/14/0140, CR/14/0157, CR/14/0259
MOVIPREP
22/11/15
UK
Pil
Hengoed
NOR-LFT9-V1
210 x 310mm
145
N/A
N/A

494924A03

Black

Fonts used:
ITC Eras Std-Bold
ITC Eras Std-Regular
Square 721 BT-Bold Extended
Average Text Size (Body Text):
9.0 pt

Page 2 of 2

can be taken at any time you choose.
What you should expect to happen
When you start drinking the Moviprep 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 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 than you should
If you take more Moviprep 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
If you forget to take Moviprep 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 as divided dose and two hours before
your procedure if taking all your Moviprep on the morning of the
procedure.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

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.

4. Possible side effects
Like all medicines Moviprep can cause side effects, although not
everybody gets them.
It is normal to get diarrhoea when you take Moviprep.
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, stop the intake and contact your doctor immediately.
Other side effects include:
Very common side effects (may affect more than 1 user in 10):
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 which 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.

The other ingredients are:
Lemon flavouring (containing maltodextrin, citral, lemon oil, lime
oil, xanthan gum, vitamin E), aspartame (E951) and acesulfame
potassium (E950) as sweeteners. For further information refer to
section 2.
What Moviprep 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 powder for oral solution in sachets is available in pack sizes
of 1, 10, 40, 80, 160 and 320 packs of a single treatment. Not all
pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Norgine BV
Hogehilweg 7, 1101CA Amsterdam ZO,
The Netherlands
Manufacturer:
Norgine Limited, New Road, Hengoed,
Mid Glamorgan, CF82 8SJ, United Kingdom.
Or
Helsinn Birex Pharmaceuticals Ltd., Damastown Mulhuddart,
Dublin 15, Ireland.
The medicinal product is authorised in the Member States
of the EEA under the following names:
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain and United Kingdom: Moviprep.
Sweden: Movprep
This leaflet was last revised in {July 2015}.

5. How to store Moviprep
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 may be
different for the different sachets. The expiry date refers to the last day
of the month.
Keep Moviprep sachets at room temperature (below 25ºC).
After you have dissolved Moviprep in the water, the solution may be
stored (keeping covered) at room temperature (below 25°C). It may
also be stored in the fridge (2°C -8°C). Do not keep it for more than
24 hours.

6. Contents of the pack and other information
Sachet A contains these active substances:
Macrogol (also known as polyethylene glycol) 3350
100 g
Sodium sulfate anhydrous
7.500 g
Sodium chloride
2.691 g
Potassium chloride
1.015 g
Sachet B contains these 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
Chloride
Sulfate
Potassium
Ascorbate

181.6 mmol/L
(of which not more than 56.2 mmol is absorbable)
59.8 mmol/L
52.8 mmol/L
14.2 mmol/L
29.8 mmol/L

The following information is intended for healthcare professionals only:
Moviprep 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.
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 should not be given to unconscious patients.

40601205

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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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