Moviprep

Patient Information Leaflet: User Information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Moviprep, powder for oral solution

Macrogol 3350 + anhydrous sodium sulfate + sodium chloride + potassium chloride + ascorbic acid +
sodium ascorbate

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Moviprep and what is it used for

Moviprep is a lemon-flavored laxative medicine consisting of four sachets.
The pack contains two large sachets ("sachet A") and two small sachets ("sachet B"). All four sachets are needed to complete one treatment cycle.
Moviprep is for use in adults and is used to cleanse the bowel, which allows it to be examined.
Moviprep causes bowel emptying, so you should expect to have watery stools after taking it.

2. Important information before taking Moviprep

When not to 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 a blockage in your intestines,
• if you have a perforated wall of the intestine,
• if you have problems with emptying your stomach,
• if you have paralysis of the intestine (often after abdominal surgery),
• if you have phenylketonuria. This is a hereditary inability of the body to process a certain amino acid. Moviprep contains a source of phenylalanine,
• if your body does not produce enough glucose-6-phosphate dehydrogenase,
• if you have toxic megacolon (a serious complication of acute colitis).

Warnings and precautions

If your overall health is poor or if you are seriously ill, you should be aware of the possible side effects, which are listed in section 4. If you are in doubt, you should consult your doctor or pharmacist.
Before taking Moviprep, you should discuss it with your doctor or pharmacist if:

• you have a tendency to bring up food, drinks, or stomach acid, or have problems with swallowing (see Moviprep with food and drink),
• you have kidney disease,
• you have heart failure, severe kidney problems, or are taking blood pressure medicines,
• you have heart failure or heart disease, including high blood pressure, irregular heartbeat, or palpitations,
• you have thyroid disease,
• you have become dehydrated,
• you have had an flare-up of inflammatory bowel disease (Crohn's disease or ulcerative colitis),
• you have epilepsy or have had seizures in the past. Moviprep should not be given to patients with impaired consciousness without medical supervision.

If you experience sudden stomach pain or rectal bleeding while taking Moviprep, you should contact your doctor or seek medical attention immediately.
If you experience vomiting (with blood), followed by sudden chest, neck, or stomach pain, difficulty swallowing, or difficulty breathing while taking Moviprep, you should stop taking the medicine and contact your doctor immediately.

Children and adolescents

Children and adolescents under 18 years of age should not take Moviprep.

Moviprep and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
If you are taking other oral medicines (e.g., oral contraceptive tablets), you should not take them for one hour before, during, and one hour after taking Moviprep, as they may be washed out of the gastrointestinal system and may not work effectively.
If you are taking oral contraceptive tablets, you may need to use additional contraceptive methods (e.g., condoms) to prevent pregnancy.

Moviprep with food and drink

You should not eat any solid food from the time you start taking Moviprep until the end of the examination.
If you need to thicken fluids to be able to swallow them safely, Moviprep may counteract the thickening effect.
While taking Moviprep, you should drink plenty of fluids. The fluid in the Moviprep solution does not replace your regular fluids.

Pregnancy, breastfeeding, and fertility

There is no data on the use of Moviprep during pregnancy and breastfeeding, so the medicine should only be used if your doctor thinks it is necessary. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice.

Driving and using machines

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

Moviprep contains sodium, potassium, and a source of phenylalanine

This medicine contains 8.4 g of sodium (the main component of common salt) in one treatment cycle (two liters of prepared Moviprep solution). This amount is 420% of the recommended maximum daily intake of sodium for an adult. You should take this into account if you are on a controlled sodium diet. Only part of the sodium is absorbed (up to 2.6 g in one treatment cycle).
This medicine contains 1.1 g of potassium in one treatment cycle (two liters of prepared Moviprep solution). You should take this into account if you have kidney problems or are on a controlled potassium diet.
This medicine contains a source of phenylalanine. It may be harmful to patients with phenylketonuria.

3. How to take Moviprep

You should always take this medicine exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
The recommended dose is two liters of solution, prepared as follows:
The pack contains two transparent bags, each containing one pair of sachets: sachet A and sachet B. Each pair of sachets (A and B) should be dissolved in water to make one liter of solution. This pack is therefore sufficient to make two liters of Moviprep solution.
Before taking Moviprep, you should read the following instructions carefully. You need to know:

• When to take Moviprep
• How to prepare Moviprep
• How to take Moviprep
• What to expect after taking Moviprep

When to take Moviprep

You should always take this medicine exactly as described in the leaflet or as your doctor has told you. If you are not sure, you should ask your doctor. The treatment with Moviprep must be completed before the examination starts.
The medicine can be taken in divided doses or as a single dose, as described below:

For procedures under general anesthesia:

• 1. Divided doses: one liter of Moviprep solution in the evening before the examination and one liter of Moviprep solution early in the morning of the examination day. You should ensure that you stop taking Moviprep, as well as other clear fluids, at least two hours before the start of the examination.
• 2. Single dose: two liters of Moviprep solution in the evening before the examination or two liters of Moviprep solution in the morning of the examination day. You should ensure that you stop taking Moviprep, as well as other clear fluids, at least two hours before the start of the examination.

For procedures without general anesthesia:

• 1. Divided doses: one liter of Moviprep solution in the evening before the examination and one liter of Moviprep solution early in the morning of the examination day. You should ensure that you stop taking Moviprep, as well as other clear fluids, at least one hour before the start of the examination.

• 2. Single dose: two liters of Moviprep solution in the evening before the examination or two liters of Moviprep solution in the morning of the examination day. You should ensure that you stop taking Moviprep at least two hours before the start of the examination. You should also ensure that you stop taking other clear fluids at least one hour before the start of the examination.

Important: You should not eat any solid food from the time you start taking Moviprep until the end of the examination.

How to prepare Moviprep

• Open one transparent bag and remove sachets A and B.
• Add the contents of BOTH sachets, A and B, to a measuring jug with a capacity of at least 1 liter.
• Add water to the 1-liter mark on the jug and stir until the powder is completely dissolved. The Moviprep solution should be clear or slightly cloudy. This may take up to 5 minutes.

How to take Moviprep

You should drink the first liter of Moviprep solution over a period of one to two hours. You should try to drink a full glass every 10-15 minutes.
When you are ready, you should prepare and drink the second liter of Moviprep solution made from the contents of sachets A and B from the remaining bag.
During the treatment with Moviprep, you are advised to drink an additional liter of clear fluid to prevent thirst and dehydration. Suitable fluids are: water, clear soups, fruit juices (without pulp), soft drinks, tea, or coffee (without milk). These fluids should be taken no later than two hours before the examination under general anesthesia and no later than one hour before the examination without general anesthesia.

What to expect after taking Moviprep

After you start taking the Moviprep solution, you should stay near a toilet. At some point, you will start to have watery stools. This is completely normal and means that the Moviprep solution is working. The bowel movements and the need to go to the toilet will stop soon after you finish drinking.
Following the instructions will allow your bowel to be cleansed, which will enable a successful examination to be performed. After the last intake of fluid, you should allow enough time to get to the colonoscopy unit.

What to do if you take more Moviprep than you should

Taking more Moviprep than recommended may lead to excessive diarrhea, which may cause dehydration. You should drink plenty of fluids, especially fruit juices. If you are in doubt, you should contact your doctor or pharmacist.

What to do if you miss a dose of Moviprep

If you miss a dose of Moviprep, you should take it as soon as you remember. If it is several hours after the scheduled time, you should consult your doctor or pharmacist.
If you are taking Moviprep in divided doses, it is very important that you finish taking the medicine at least one hour before the examination without general anesthesia or at least two hours before the examination under general anesthesia.
If you are taking Moviprep as a single dose in the morning of the examination day, it is very important that you finish taking the medicine at least two hours before the examination.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Moviprep can cause side effects, although not everybody gets them.
A typical symptom after taking Moviprep is diarrhea.
You should stop taking Moviprep and contact your doctor immediately if you notice any of the following:

• rash or itching,
• swelling of the face, ankles, or other parts of the body,
• palpitations,
• severe fatigue,
• shortness of breath.

These are symptoms of a severe allergic reaction.
You should stop taking Moviprep and contact your doctor immediately if you experience any of the following side effects:

• seizures. If you do not have a bowel movement within 6 hours of taking Moviprep, you should stop taking the medicine and contact your doctor immediately.

Other side effects:
Very common side effects (occurring in more than 1 in 10 people):
Abdominal pain, bloating, fatigue, general feeling of being unwell, anal pain, nausea, and fever.
Common side effects (occurring in fewer than 1 in 10 people):
Hunger, sleep disturbances, dizziness, headache, vomiting, indigestion, thirst, and chills.
Uncommon side effects (occurring in fewer than 1 in 100 people):
Discomfort, difficulty swallowing, and changes in liver function test results.
The following side effects have also been reported, but their frequency is not known: bloating (gas), transient increase in blood pressure, irregular heart rhythm or palpitations, dehydration, gagging, esophageal rupture due to vomiting, severe low sodium levels in the blood that can lead to seizures, and changes in electrolyte levels, such as decreased bicarbonate, increased or decreased calcium, increased or decreased chloride, and decreased phosphate. You may also experience decreased potassium and sodium levels in the blood.
These reactions usually occur only during the treatment period. If they persist, you should consult your doctor.
Allergic reactions can cause skin rash, itching, redness, or hives, swelling of hands, feet, or ankles, headache, palpitations, shortness of breath.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Pharmacovigilance Department of the State Medicines Control Agency, Žirmūnų str. 139A, 09120 Vilnius, Lithuania, tel.: +370 5 263 9188, fax: +370 5 263 9189, email: [[email protected]](mailto:[email protected]).
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Moviprep

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. Note that the expiry date may be different on different sachets.
The expiry date refers to the last day of the month.
The Moviprep sachets should be stored below 25°C.
After dissolving Moviprep in water, the solution should be stored below 25°C.
The solution can be stored in the refrigerator (2°C-8°C). The solution should be stored under cover. Do not store the solution for more than 24 hours.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Moviprep contains

Sachet Acontains the following active substances:
100 g
7,500 g
2,691 g
1,015 g
Sachet Bcontains the following active substances:
Macrogol (also known as polyethylene glycol) 3350
Anhydrous sodium sulfate
Sodium chloride
Potassium chloride
4,700 g
5,900 g
The concentration of electrolyte ions after dissolving both sachets in one liter of water is:
Sodium
Chloride
Sulfate
Potassium
Ascorbate
Ascorbic acid
Sodium ascorbate
181.6 mmol/l (of which no more than 56.2 mmol is absorbable)
59.8 mmol/l
52.8 mmol/l
14.2 mmol/l
56.5 mmol/l
The other ingredients are:
Lemon flavor (containing maltodextrin, citral, lemon oil, lime oil, xanthan gum, vitamin E) and aspartame (E 951) and acesulfame potassium (E 950) as sweeteners.
For further information, see section 2.

What Moviprep looks like and contents of the pack

The pack contains two transparent bags, each containing one pair of sachets: sachet A and sachet B. Each pair of sachets (A and B) should be dissolved in one liter of water.
Moviprep, powder for oral solution in sachets, is available in packs containing 1 treatment set.
For more detailed information, you should contact the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization Holder in Lithuania, the country of export:

Norgine BV
Antonio Vivaldistraat 150
1083HP Amsterdam
Netherlands

Manufacturer:

Norgine Limited
New Road, Hengoed
Mid Glamorgan CF82 8SJ
United Kingdom
Norgine BV
Antonio Vivaldistraat 150
1083HP Amsterdam
Netherlands
Recipharm Höganäs AB
Sporthallsvägen 6
Höganäs, 263 34
Sweden
SOPHARTEX
21 rue du Pressoir
28500 Vernouillet
France

Parallel Importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Lithuanian Marketing Authorization Number, in the country of export:LT/1/10/2314/001
Parallel Import License Number:281/21

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, United Kingdom (Northern Ireland): MOVIPREP
Sweden: MOVPREP

Date of approval of the leaflet: 21.05.2025

[Information about the trademark]
The following information is intended for healthcare professionals only:
Information intended for healthcare professionals only:
Moviprep should be used with caution in patients who are severely weakened, in poor general condition, and patients with clinical conditions such as:

• impaired gag reflex or tendency to choke or bring up food
• altered consciousness
• severe renal impairment (creatinine clearance <30 ml min)< li>
• heart failure (III or IV degree in the NYHA classification)
• patients at risk of arrhythmias, for example, patients with cardiovascular disease or thyroid disease
• dehydration
• severe acute inflammatory bowel disease

Dehydration or electrolyte disturbances should be corrected before administering Moviprep.
Patient who are partially conscious or at risk of choking or bringing up food must be closely monitored while taking the medicine, especially if it is administered nasogastrically.
Moviprep should not be given to unconscious patients.