MOVIPREP ORANGE POWDER FOR ORAL SOLUTION - patient leaflet, side effects, dosage

e is and what it is used for

Moviprep Orange is an orange flavoured laxative contained in four sachets. There are two large sache ts (‚sachet A‘) and two small sachets (‚sachet B‘). You need all these fo r one treatment.

Moviprep Orange is intended for adults to clean the bowel so that they are ready for examination.

Moviprep Orange works by emptying the cont ents of your bowels, so you should expect to have watery bowel mo vements.

What you need to know before you take Moviprep Orange

Do not take Moviprep Orange

• if you are allergic (hypersensitive) to the active substances or

any of the other ingredients of this medicine (listed i n 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, y ou should be particularly aware of the possible side effects listed i n section 4. Contact your doctor or pharmacist if you are conc erned. 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 super vision.

If you experience sudden abdomin al pain or rectal bleeding when taking Moviprep Orange for bow el preparation, contact your doctor or seek medical advice immedia tely.

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 pha rmacist if you are taking, have recently taken or might take any oth er medicines.

If you are taking oth er medicines take them at least one hour before taking Moviprep O range or at least one hour afterwards because they may be flushed t hrough your digestive system and not work so well.

Moviprep O range with food and drink

Do not take any solid food from when you start to take Moviprep Orange un til after the examination.

When tak ing Moviprep Orange you should continue to take plenty of fluids. The fluid content of Moviprep Orange does not replace your r egular liquid intake.

Pre gnancy, breast-feeding and fertility

Th ere are no data on the use of Moviprep Orange during pregnancy o r 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 1.1g 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.

How to take Moviprep Or

ange

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The 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 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
• How to drink Moviprep Orange
• What you should expect to happen

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):

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.

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 proced ures conducted without the need for putting you to sleep (without using general anaesthesia):

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.

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 Ora nge 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 dear liquid to prevent you feeling very thirsty and b ecoming dehydrated. Water, clear soup, fruit Juice [without pulp}, soft drinks, tea or coffee [withoutmilk] are all suitable. These drinks can be taken until two hours before the examination under general anaest hesia at the latest and until one hour before the examination without general anaesthesia at the latest.

What you should expect to happen

When you s tart drinking the Moviprep Orange solution, it is important t hat you stay close to a toilet. At some point, you will start to exper ience watery bowel movements. This is quite normal and indicates t hat the Moviprep Orange solution is working. The bowel movemen ts will stop soon after you have finished drinking.

If you follow these instructions, your bowel will be clear, and this will help you to hav e a successful examination. You should allow sufficient time after yo ur last drink to travel to the colonoscopy unit.

If you take more Mo viprep Orange than you should

If you take more Movipre p Orange than you should you may develop excessive diarrhoe a, which can lead to dehydration. Take generous amounts of fluid, e specially fruit juices. If you are worried contact your doctor or pharm acist.

If you forget to take Moviprep Orange

If you forget to take Moviprep Ora nge take the dose as soon as you realise you have not taken it. If this i s several hours after the time when you should have taken it, cont act your doctor or pharmacist for advice. When taking Moviprep Ora nge as divided doses it is important that you complete your Movip rep Orange preparation at least; one hour before your examination (without use of general anaesthesia), or two hours before your exa mination (with use of general anaesthesia). When taking all your M oviprep Orange on the morning of the examination as a single dos e it is important that you complete your Moviprep Orange preparatio n at least two hours before your examination.

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

4. possible side effects

Like all medicines Moviprep Orange can cause side effects, although not everybody gets them.

It is normal to get diarrhoea when you take Moviprep Orange. 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 Orange, stop the intake and contact your doctor immediately.

Other side effects include;

Very common side effects (may affect more than 1 in 10 people); Abdominal pain, abdominal distension, tiredness, feelin g 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 th e frequency cannot be estimated from the available data; flatul ence (wind), temporary increase in blood pressure, irregular h eart rhythm or palpitations, dehydration, retching (straining to v omit), very low blood sodium levels that can cause convulsions (f its) and changes to the levels of salts in the blood such as decr eased bicarbonate, increased or decreased calcium; increased o r 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, consu lt your doctor.

Allergic reactions may ca use a skin rash, itching, reddening of the skin or a nettle rash, sw ollen hands, feet or ankles, headaches, palpitations and shor tness of breath.

Reporting of side effects

If you get any sid e effects, talk to your doctor, pharmacist or nurse. This includes an y possible side effects not listed in this leaflet. You can also report sid e effects directly via the Yellow Card Scheme Website; or search MHRA Yellow Card in the Google Pla y or Apple App store. By reporting side effects you can help prov ide more information on the safety of this medicine.

5. how to store moviprep orange

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 ca rton, after „EXP“. Please note that the expiry dates may be different f or the different sachets. The expiry date refers to the last day of the month.

Keep Moviprep Orange sachets at room temperature (below 25°C).

After you have dissolved Moviprep Orange 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.

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

What Moviprep Orange contains

Sachet A contains these active substances

Sachet B contains these active substances

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

• 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.

Marke ting Authorisation Holder and Manufacturer

Mark eting Authorisation Holder: Norgine Pharmaceuticals Limited

Norgine House Widewater Place Moorhall Road Harefield

Uxbridge UB9 6NS UK

Manutactur er: 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 Tradename

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 revised i n August 2020

MOVIPREP NORGINE and the sail logo are registered trademarks of the Norgine group of companies. NORGINE

Other sources of information

If you need the information on this leaflet in an alternative format, such as large print, or Braille please ring 0800 198 5000.

The following information is intended for healthcare professionals only; 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)
• those at risk of arrhythmia, for example those on treatment for cardiovascular disease or who have thyroid disease
• dehydration
• severe acute inflammatory bowel disease

The presence of dehydration or electrolyte shifts 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.

Package leaflet: Information for the User _ MOVIPREP ® Orange, powder for oral solution Macrogol 3350, Sodium sulfate anhydrous, Sodium chloride, ^3 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.

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

1. what moviprep orange is and what it is 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.

Moviprep Orange is intended for adults to clean the bowel 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. what you need to know before you take moviprep orange

Do not 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. ^5?

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 this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The 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 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
• How to drink Moviprep Orange
• What you should expect to happen

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. When taking Moviprep Orange as divided doses it is important that you complete your Moviprep Orange preparation at least; one hour before your examination (without use of general anaesthesia), or two hours before your examination (with use of general anaesthesia). When taking all your Moviprep Orange on the morning of the examination as a single dose it is important that you complete your Moviprep Orange preparation at least two hours before your examination.

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

4. possible side effects

Like all medicines Moviprep Orange can cause side effects, although not everybody gets them.

It is normal to get diarrhoea when you take Moviprep Orange. 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 Orange, stop the intake and contact your doctor immediately.

Other side effects include:

Very common side effects (may affect more than 1 in 10 people): 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 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 the Yellow Card Scheme Website: 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.

5. how to store moviprep orange

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 carton, after “EXP”. 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 Orange sachets at room temperature (below 25°C). After you have dissolved Moviprep Orange 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.

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 informationsachet a contains these active substances

Sachet B contains these active substances

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: Norgine Pharmaceuticals Limited

Norgine House Widewater Place Moorhall Road Harefield Uxbridge UB9 6NS UK

Manufacturer: Norgine B.V.

Antonio Vivaldistraat 150 1083 HP Amsterdam The Netherlands

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

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 revised in July 2021

MOVIPREP NORGINE and the sail logo are registered trademarks of the Norgine group of companies. NORGINE

Other sources of information

If you need the information on this leaflet in an alternative format, such as large print, or Braille please ring 0800 198 5000.

The following information is intended for healthcare professionals only: 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)
• those at risk of arrhythmia, for example those on treatment for cardiovascular disease or who have thyroid disease
• dehydration
• severe acute inflammatory bowel disease