MOVIPREP Orange, powder for oral solution

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.

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

Do not take 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.

If you experience sudden abdominal pain or rectal bleeding when taking Moviprep Orange for bowel preparation, contact your doctor or seek medical advice immediately.

Children and adolescents

Moviprep Orange should not be taken by children and adolescents aged below 18 years.

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 medicine contains 8.4 g sodium (main component of cooking/table salt) per course of treatment. (A course of treatment consists of two litres of Moviprep Orange). This is equivalent to 420% of the recommended maximum daily dietary intake of sodium for an adult. To be taken into consideration by patients on a controlled sodium diet. Only a proportion (up to 2.6 g per course treatment) of sodium is absorbed.

This medicine contains 1.1 g potassium per course of treatment. (A course of treatment consists of two litres of Moviprep Orange). 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.

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 examination.

This course of treatment can be taken either as divided or single doses as described below:

For procedures conducted when you are put to sleep (using general anaesthesia):

1. Divided doses: one litre of Moviprep Orange in the evening before and one litre of Moviprep Orange in the early morning of the day of the examination. Ensure consumption of Moviprep Orange as well as any other clear fluids has finished at least two hours before the start of the examination.
2. Single dose: two litres of Moviprep Orange in the evening before the examination or two litres of Moviprep Orange in the morning of the examination. Ensure consumption of Moviprep Orange as well as any other clear fluids has finished at least two hours before the start of the examination.

For procedures conducted without the need for putting you to sleep (without using general anaesthesia):

1. Divided doses: one litre of Moviprep Orange in the evening before and one litre of Moviprep Orange in the early morning of the day of the examination. Ensure consumption of Moviprep Orange as well as any other clear fluids has finished at least one hour before the start of the examination.
2. Single dose: two litres of Moviprep Orange in the evening before the examination or two litres of Moviprep Orange in the morning of the examination. Ensure consumption of Moviprep Orange has finished at least two hours before the start of the examination. Ensure consumption of any clear fluids has finished at least one hour 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 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 until two hours before the examination under general anaesthesia at the latest and until one hour before the examination without general anaesthesia at the latest.

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 Moviprep Orange preparation at least an hour before your clinical procedure (without anaesthesia)or two hours before your clinical procedure (with anaesthesia).

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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

What Moviprep Orange contains

Sachet A contains these active substances

Macrogol (also known as polyethylene glycol) 3350 100 g

Sodium sulfate anhydrous 7.500 g

Sodium chloride 2.691g

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

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:

Manufacturer:

Or

Or