Package Leaflet: Information for the User.

MOVIPREPqrange

Powder for oral solution

For a list of active substances please see section 6.

Read all of this leaflet carefully before you start taking this medicine.

-    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 be harmful even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What MOVIPREP Orange is and what it is used for

2.    Before you take MOVIPREP Orange

3.    How to take MOVIPREP Orange

4.    Possible side effects

5.    Howto store MOVIPREP Orange

6.    Further 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.    BEFORE YOU TAKE MOVIPREP Orange

Do not take MOVIPREP Orange if you suspect or your doctor suspects:

•    you are allergic (hypersensitive) to macrogol 3350 or any of the other ingredients of MOVIPREP Orange.

•    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.

•    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 breast feeding talk to your doctor 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. 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 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 one litre of water This pack is therefore sufficient to make up 2 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 solution

•    How to drink MOVIPREP Orange

•    What you should expect to happen

When to take MOVIPREP Orange

You should have been given instructions about when to take MOVIPREP Orange by your doctor or nurse. Your treatment with MOVIPREP Orange must be completed before your clinical examination and can be taken:

either divided as 1 litre of MOVIPREP Orange in the evening and 1 litre in the early morning of the day of the examination, or 2 litres in the evening before the examination.

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

•    Pour 1 litre of water into 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 the 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.

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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 realize 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.

If you have any further questions on the use of this product, ask you doctor or pharmacist.

Children

MOVIPREP Orange should not be taken by children aged below 18 years.

4. POSSIBLE SIDE EFFECTS

Other ingredients are:

Orange flavour (containing natural flavouring substances and preparations maltodextrin, dextrose, aspartame (E95I) and acesulfame potassium (E950) as sweeteners.

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 and chills.

Uncommon side effects (i.e. affects 1 to 10 users in 1,000) are: Discomfort, difficulties swallowing and change 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, 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.

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What MOVIPREP Orange 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 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 Limited, Widewater Place, Moorhall Road, Harefield, UB9 6NS, UK

Manufacturer:

Norgine Limited, New Road, Hengoed, Mid Glamorgan, CF82 8SJ, United Kingdom.

5.    HOW TO STORE MOVIPREP ORANGE

Keep out of the reach and sight of children.

Do not use MOVIPREP Orange after the expiry date which is stated on the carton and sachets.

The expiry date refers to the last day of the month.

Keep MOVIPREP Orange sachets at room temperature (not above 25°C). After you have dissolved MOVIPREP Orange in the water, the solution may be stored (keeping covered) at room temperature (not above 25°C). It may also be stored in the fridge (2°C - 8°C). Do not keep it for more than 24 hours.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6.    FURTHER INFORMATION

What MOVIPREP Orange contains

The active substances are:

Sachet A

Macrogol (also known as polyethylene glycol) 3350    100 g

NORGINE

The medicinal product is authorised in the Member States of the EEA under the following names:

Country    Tradename

Austria

Belgium

Denmark

Finland

Germany

Ireland

Italy

Luxembourg

Netherlands

Spain

Sweden

United Kingdom

MOVIPREP Orange MOVIPREP Sinaas/Orange MOVIPREP Appelsin MOVIPREP Appelsiini MOVIPREP Orange MOVIPREP Orange MOVIPREP Arancio MOVIPREP Sinaas/Orange MOVIPREP Orange MOVIPREP sabor Naranja MOVPREP APELSIN MOVIPREP Orange

This leaflet was last approved in 07/2012

The following information is intended for medical or healthcare professionals only.

Note for medical staff:

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)

•    dehydration

•    severe acute inflammatory disease

The presence of dehydration 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.