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MOVIPREP POWDER FOR ORAL SOLUTION

Active substance: SODIUM SULPHATE ANHYDROUS

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Norgine Item No.:
Proof No.:
Change Control No.:
Product Name (including flavour):

22217201
1
CC/14/015
MOVIPREP

Date:
Market:
Component Type:
Manufacturing Site:
Technical Drawing No.:
Dimensions (mm):
Pharmacode:
Material Number:
On-line print requirements:

17/06/14
UK
PIL
N/A
N/A
310 x 210
TBC
N/A
N/A

Schawk Link No.:

429903A02

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 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.

Black

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
Technical Info

Profile

Artwork Approval Signatures
Artwork Studio:

Barbara-Young

Site:
Regulatory:
Commercial:
Global Commercial:
Trademark:
Global Artwork:

Fonts used:
Helvetica
ITCErasStd-Bold
ITCErasStd-Book
ITCErasStd-Demi
Square721BT-BoldExtended
Smallest point sized used:
6.0 pt
Average Text Size (Body Text):
8.0 pt

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 12:27:34 +01'00'

1. WHAT MOVIPREP IS AND WHAT IS IT 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.
You are taking Moviprep to make your bowels clean 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 Moviprep if you suspect or your doctor suspects:
• you are allergic (hypersensitive) to the active substances or any of the other
ingredients of Moviprep (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 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
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 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
heart beats 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.
Taking 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.
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 with food and drink
Do not take any solid food from when you start to take Moviprep until
after the examination.
Pregnancy and breast-feeding
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. 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.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
3. HOW TO TAKE MOVIPREP
Always take Moviprep 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 solution.
Before you take Moviprep, please read carefully the following instructions.
You need to know:
• When to take Moviprep
• How to prepare Moviprep solution
• 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
of Moviprep 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 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 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 a divided dose and two hours before your procedure if taking
all your Moviprep on the morning of the procedure.

Norgine Item No.:
Proof No.:
Change Control No.:
Product Name (including flavour):

22217201
1
CC/14/015
MOVIPREP

Date:
Market:
Component Type:
Manufacturing Site:
Technical Drawing No.:
Dimensions (mm):
Pharmacode:
Material Number:
On-line print requirements:

17/06/14
UK
PIL
N/A
N/A
310 x 210
TBC
N/A
N/A

Schawk Link No.:

429903A02

If you have any further questions on the use of this product, ask you
doctor or pharmacist.
Children
Moviprep should not be taken by children aged below
18 years.

Black

Technical Info

Artwork Approval Signatures
Artwork Studio:
Site:
Regulatory:
Commercial:
Global Commercial:
Trademark:
Global Artwork:

Fonts used:
Helvetica
ITCErasStd-Bold
ITCErasStd-Book
ITCErasStd-Demi
Square721BT-BoldExtended
Smallest point sized used:
6.0 pt
Average Text Size (Body Text):
8.0 pt

Profile

4. POSSIBLE SIDE EFFECTS
Like all medicines, Moviprep can have side effects although not
everybody gets them.
It is normal to get diarrhoea when you take Moviprep.
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 1000) 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 and 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 and
contact your doctor immediately. You should not take any more Moviprep
until you have checked with your doctor.
• rash or itching
• swelling of your face, ankles or other part if your body
• palpitations
• extreme fatigue
• shortness of breath
If you do not have a bowel movement within 6 hours of taking
Moviprep, 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.

What Moviprep looks like and contents of the pack
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
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.
The medicinal product is authorised in the Member States of the
EEA under the following names:
Country
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: Moviprep

This leaflet was last approved in MM/YYYY
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.

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 on the sachets may be
different from this. The expiry date refers to the last day of the month.
Keep Moviprep sachets at room temperature (not above 25ºC).
After you have dissolved Moviprep 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Sachet A contains these active substances:
Macrogol (also known as polyethylene glycol) 3350
100 g
Sodium sulphate 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:
Sodium
181.6 mmol/L
(of which not more than 56.2 mmol is absorbable)
Chloride

59.8 mmol/L

Sulphate
Potassium
Ascorbate

52.8 mmol/L
14.2 mmol/L
29.8 mmol/L

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.

22217201

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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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