MOVIPREP, powder for oral solution

• 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.

1. What Moviprep is and what it is used for
2. What you need to know before you take Moviprep
3. How to take Moviprep
4. Possible side effects
5. How to store Moviprep
6. Contents of the pack and other information

• 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)

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:

• a tendency to regurgitate swallowed drink, food or acid from the stomach, or if you have problems with swallowing (see also Moviprep with food and drink).
• kidney disease.
• have heart failure, severe kidney problems or are taking blood pressure medicine
• 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).
• have epilepsy or a history of convulsions

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

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

If you experience (blood) vomiting followed by sudden chest, neck or abdominal pain, difficulty swallowing or difficulty breathing when taking Moviprep, stop taking medicine and promptly contact your doctor.

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking other medicines orally (e.g. oral contraceptive pill), you should not take them one hour before, during and one hour after taking Moviprep because they may be flushed through your digestive system and not work so well.

If taking oral contraceptives, you may need to use additional forms of contraception (e.g. condom) to prevent pregnancy.

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

If you need to thicken fluids in order to swallow them safely, Moviprep may counteract the effect of the thickener.

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

There are no data on the use of Moviprep 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.

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

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.

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

• 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.

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.

When you start drinking the Moviprep 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 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 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 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 as divided doses it is important that you complete your Moviprep 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 on the morning of the examination as a single dose it is important that you complete your Moviprep preparation at least two hours before your examination.

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 for 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.

Sachet A contains these active substances:

Macrogol (also known as polyethylene glycol) 3350 100 g

Sodium sulfate anhydrous 7.500 g

Sodium chloride 2.691 g

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 56.5 mmol/L

The other ingredients are

Lemon flavouring (containing maltodextrin, citral, lemon oil, lime oil, arabic gum, vitamin E), aspartame (E951) and acesulfame potassium (E950) as sweeteners. For further information refer to section 2.

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 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.

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