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VISTAPREP 110G POWDER FOR ORAL SOLUTION

Active substance(s): MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

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1.3.1

PACKAGE LEAFLET
Package leaflet: Information for the user

VistaPrep 110g Powder for oral solution.
Macrogol 3350, sodium chloride, sodium bicarbonate and potassium chloride.

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
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.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What VistaPrep is and what it is used for
What you need to know before you take VistaPrep
How to take VistaPrep
Possible side effects
How to store VistaPrep
Contents of the pack and other information

1.

What VistaPrep is and what it is used for

VistaPrep is a white powder for oral solution with a laxative effect.
VistaPrep is used for bowel cleansing in preparation for the examination of the colon (colonoscopy) in adults over 18 years of age.

2.

What you need to know before you take VistaPrep

Do not take VistaPrep







if you are allergic to macrogol 3350, sodium chloride, sodium bicarbonate, potassium
chloride sulphur dioxide, glucose, saccharin sodium, orange flavour, lemon-lime flavour,
colloidal anhydrous silica or any of the ingredients of this medicine (listed in section 6);
if you have a bowel obstruction or suspected bowel obstruction, strictures or perforations
in the gastrointestinal area, or if you are at risk of perforations in the gastrointestinal area;
if you suffer from problems emptying your stomach or have a severe, highly inflammatory form of colitis (colon inflammation) and a severe, abnormally enlarged colon due to
this colitis (toxic megacolon);
if you have an impaired swallowing and gag reflex, or suffer from general weakness.

VistaPrep should not be administered to patients with impaired consciousness and patients prone
to choking or swallowing the wrong way (aspiration) with liquids.
Warnings and precautions
Contact your doctor:
 if you are an elderly patient
 if you have reflux disease (“heartburn”, reflux oesophagitis)
 if you have existing problems with your heart rhythm (SA block or sick sinus syndrome)
 if your heart does not pump efficiently (a condition called “heart failure”), and you have
discomfort when performing light to moderate exercise or while resting
 if your kidneys and/or liver are not working efficiently (renal and hepatic insufficiency)
 if you have kidney failure or liver disease
 if you have severe dehydration
 if you have severe colitis, diverticulitis or chronic inflammatory bowel disease
In these cases VistaPrep can only be used under the supervision of a doctor who will check your
electrolytes and fluid balance.
Children
There is no adequate experience for use in children. VistaPrep should therefore not be used in
children.
Other medicines and VistaPrep
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you take other medicines just before, during or up to 1 hour after taking VistaPrep, these may
possibly be flushed out during the bowel irrigation and/or may not be effective. However, if it is
essential that you must take these other medicines, ask your doctor in advance about an alternative option. This also applies to oral contraceptives (the “Pill”).
Macrogol 3350 may influence results of tests done using intestinal fluids.

VistaPrep with food and drink
You should not eat any solid food for 2 to 3 hours before drinking VistaPrep and until after the
examination.
Pregnancy, breast-feeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
There is no experience with use in pregnancy.
If you are pregnant, your doctor will perform a careful benefit-risk assessment before using
VistaPrep.

If necessary, you can also take VistaPrep during breast-feeding.
Driving and using machines
No special precautions are required.
VistaPrep contains glucose
The orange flavouring in VistaPrep contains glucose. Please do not take this medicine without
first consulting your doctor if you have been told that you have an intolerance to some sugars.
VistaPrep contains sulphur dioxide
The orange flavouring and lemon-lime flavouring contains sulphur dioxide (E220) which may
rarely cause hypersensitivity reactions and bronchospasm.
VistaPrep contains sodium and potassium
This medicine contains 20 mmol potassium and 260 mmol sodium per 4 litres of VistaPrep solution. This should be taken into consideration by patients on a controlled potassium or sodium diet.

3.

How to take VistaPrep

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage for adults (over 18 years of age)
For complete bowel cleansing, you must take 3 up to a maximum of 4 litres of VistaPrep solution.
1 sachet corresponds to 1 L solution.
Drink the solution in portions of 200-300 mL every 10 minutes, until you notice that the discharge from the anus is clear or 4 litres maximum have been drunk.
Take it over a period of about 4 hours, generally on the examination day. You can take the entire
required amount on the evening before, or some on the evening before and the remaining amount
on the morning of the examination day. Please agree the procedure with your doctor.
Duration of use:
VistaPrep is for single use before a scheduled bowel examination.
Preparing the solution:
Please prepare the almost colourless and slightly cloudy solution freshly before use. The contents
of one sachet are dissolved in one litre of lukewarm water. Make up 3-4 litres of solution in this
way. As 1 sachet of VistaPrep corresponds to 1 litre of solution, you will need 3 to 4 sachets to
produce 3-4 litres of solution. You can place the ready-to-use solution in the fridge to cool down
after preparation. The chilled solution is more pleasant to drink.
You must not add any other solutions or additives (especially sugar or flavourings not compatible
with VistaPrep solution) to the VistaPrep oral solution, as this, among other things, can result in a

change in the electrolyte composition in your blood. Furthermore, explosive gas mixtures may
develop in the intestines when the added substances are broken down by intestinal bacteria.
Please talk to your doctor if you have the impression that the effect of VistaPrep is too strong or
too weak.
If you take more VistaPrep than you should
Diarrhoea or watery stools is the goal of treatment with VistaPrep. However, if you have taken
much more VistaPrep than you should, severe symptoms of diarrhoea will occur.
In this case, you should drink plenty of liquid and always consult your doctor for advice.
If you forget to take VistaPrep
If you drink much less than the recommended amount, your bowel may not be thoroughly emptied. In this case, the examination cannot be carried out as planned. Therefore, please keep to the
dosage recommended by your doctor or as recommended in this leaflet.
If you stop taking VistaPrep
If you stop taking VistaPrep or discontinue it too soon, your bowel may not be thoroughly emptied. In this case, the examination cannot be carried out as planned.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Significant side effects or signs you should look out for and what to do if affected:
All medicines can cause allergic reactions. However, severe allergic reactions are very rare. If
you are affected by any of the following side effects, do not take any more VistaPrep and tell
your doctor as soon as possible:





Allergic skin rash
Circulatory disorders
Shortness of breath
Outbreaks of sweating with nausea

The following side effects have also been observed:
Very common side effects (may affect more than 1 in 10 people):

Nausea, feeling full and flatulence
Common side effects (may affect up to 1 in 10 people):

Vomiting, stomach cramps and anal irritation.
These phenomena are largely due to drinking a relatively large amount of liquid within a short
space of time. If symptoms occur in the gastrointestinal tract, administration of VistaPrep should
be temporarily slowed down or stopped until the symptoms subside.

Uncommon side effects (may affect up to 1 in 100 people):

General malaise and insomnia.
Very rare side effects (may affect up to 1 in 10,000 people):

Irregular or rapid heartbeat (heart rhythm disorders, tachycardia) and fluid accumulation
in the lungs (pulmonary oedema).

Drop in blood calcium, potassium and sodium levels with tangible signs of illness.

Neurological symptoms resulting from an electrolyte imbalance in the blood, which can
range from mild disorientation to general seizures.

Hives (urticaria), nasal discharge, runny nose (rhinorrhoea) or acute inflammation of the
skin (dermatitis) which are probably allergic in nature, anaphylactic shock.
Note:
There have been cases described where vomiting has occurred followed by bleeding due to tearing of the gullet (Mallory-Weiss syndrome) after swallowing solutions containing macrogol.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information
on the safety of this medicine.
5.

How to store VistaPrep

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 sachet and carton. The expiry
date refers to the last day of that month.
Storage conditions:
Powder: no special storage instructions.
Prepared solution: Store below 25°C for 3 hours at or store in a refrigerator (2°C-8°C) for 48
hours.
Discard any remaining oral solution if not consumed within 48 hours.

6.

Contents of the pack and other information

What VistaPrep contains
The active substances are (per sachet):
Macrogol 3350
105.000 g
Sodium chloride
2.800 g
Sodium bicarbonate
1.430 g
Potassium chloride
0.370 g

The electrolyte ion content of one sachet after preparation of 1,000 mL solution is equivalent to:
Sodium
65 mmol/L
Chloride
53 mmol/L
Bicarbonate
17 mmol/L
Potassium
5 mmol/L

-

The other ingredients are:
Saccharin sodium, colloidal anhydrous silica, orange flavouring (orange flavouring contains
natural flavourings, glucose, maltodextrin, gum Arabic (E414), alpha-tocopherol (E307),
sulphur dioxide (E220)) and lemon-lime flavouring (lemon-lime flavouring contains: natural flavourings and extracts, nature-identical flavourings, maltodextrin, gum Arabic (E414),
citric acid (E330), sulphur dioxide (E220)).
-

Trace amounts of butylated hydroxytoluene.

What VistaPrep looks like and contents of the pack
VistaPrep is a white powder for oral solution.
VistaPrep is available in packs of 4 sachets, as a bulk pack of 12 packs with 4 sachets or as a bulk
pack of 16 packs with 4 sachets of powder for oral solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Tillotts Pharma UK Ltd.
The Stables, Wellingore Hall,
Wellingore, Lincoln,
UK LN5 0HX
Tel: +44 1522 813500
E-mail: ukinfo@tillotts.com

Manufacturer
Klocke Pharma Service GmbH
Strassburger Str. 77
77767 Appenweier
Germany
This leaflet was last revised in October 2015.

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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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