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

1. what moviprep is and what it is 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.

Moviprep is intended for adults to clean the bowel 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 take Moviprep

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

Moviprep should not be given to patients with impaired consciousness without medical supervision.

Children and adolescents

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

Other medicines and Moviprep

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 or at least one hour afterwards because they may be flushed through your digestive system and not work so well.

Moviprep with food and drink

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

When taking Moviprep you should continue to take plenty of fluids. The fluid content of Moviprep does not replace your regular liquid intake.

Pregnancy, breast-feeding and fertility

There are no data on the use of Moviprep during pregnancy or breast feeding and it should only be used if considered essential by the 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.

Moviprep 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). 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). 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 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 solution.

Before you take Moviprep, please read carefully the following instructions. You need to know:

• When to take Moviprep
• How to prepare Moviprep
• 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 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 in the evening before and one litre of Moviprep in the early morning of the day of the examination. Ensure consumption of Moviprep 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 in the evening before the examination or two litres of Moviprep in the morning of the examination. Ensure consumption of Moviprep 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 in the evening before and one litre of Moviprep in the early morning of the day of the examination. Ensure consumption of Moviprep 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 in the evening before the examination or two litres of Moviprep in the morning of the examination. Ensure consumption of Moviprep 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 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 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 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.

Driving and using machines

Moviprep does not affect your ability to drive or use machines.