Moviprep

Warning! Keep this 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
Please read the leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents

1. What Moviprep is and what it is 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 package and other information

1. What Moviprep is and what it is used for

Moviprep is a lemon-flavoured bowel cleansing medicine consisting of four sachets.
The package contains two large sachets (“sachet A”) and two small sachets (“sachet B”). All four sachets are required to complete a single treatment cycle.
Moviprep is intended for adults and is used to cleanse the intestines, thereby enabling their examination.
Moviprep causes emptying of the intestines; therefore, after taking it, expect watery bowel movements.

2. Important information before taking Moviprep

When not to take Moviprep:

• if the patient is allergic (hypersensitive) to the active substances or any of the other ingredients of this medicine (listed in section 6),
• if the patient has intestinal obstruction,
• if the patient has intestinal wall perforation,
• if the patient has impaired gastric emptying,
• if the patient has intestinal paralysis (often occurring after abdominal surgery),
• if the patient has phenylketonuria. This is an inherited inability of the body to process a specific amino acid. Moviprep contains a substance which is a source of phenylalanine,
• if the patient’s body does not produce sufficient glucose-6-phosphate dehydrogenase,
• if the patient has toxic megacolon (a serious complication of acute colitis).

Warnings and precautions
If the patient’s general health condition is poor or the patient suffers from a serious illness, they should be aware of possible adverse reactions listed in section 4. In case of doubt, contact a doctor or pharmacist.
Before starting to take Moviprep, discuss this with a doctor or pharmacist if:

• the patient has a tendency to regurgitate swallowed drinks, food, or stomach acid, or has swallowing difficulties (see Moviprep with food and drink),
• the patient has kidney disease,
• the patient has heart failure, severe kidney problems, or takes blood pressure-regulating medicines,
• the patient has been diagnosed with heart failure or heart diseases, including high blood pressure, irregular heartbeat, or palpitations,
• the patient has thyroid disorders,
• the patient is dehydrated,
• the patient has an acute flare-up of inflammatory bowel disease (Crohn’s disease or ulcerative colitis),
• the patient has epilepsy or has previously experienced seizures.

Moviprep must not be given to patients with impaired consciousness without medical supervision.
If, during the intake of Moviprep for bowel cleansing, the patient experiences sudden abdominal pain or rectal bleeding, they should contact a doctor or seek immediate medical help.
If vomiting (with blood) occurs during the intake of Moviprep, followed by sudden chest, neck, or abdominal pain, difficulty swallowing, or difficulty breathing, the patient should stop taking the medicine and contact a doctor immediately.

Children and adolescents
Moviprep must not be used in children and adolescents under 18 years of age.

Moviprep and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
If the patient is taking other oral medicines (e.g. oral contraceptive tablets), they must not be taken one hour before, during, or one hour after taking Moviprep, as otherwise the medicines may be flushed out of the gastrointestinal tract and may not work effectively.
If the patient is taking oral contraceptive tablets, additional contraceptive methods (e.g. condoms) may be necessary to prevent pregnancy.

Moviprep with food and drink
Do not consume any solid foods from the moment the intake of Moviprep begins until the end of the examination.
If the patient requires thickened fluids to swallow them safely, Moviprep may counteract the thickening effect.
During the intake of Moviprep, the patient should drink large amounts of fluids. The fluid contained in the Moviprep solution does not replace regularly consumed fluids.

Pregnancy, breastfeeding, and fertility
There are no data on the use of Moviprep during pregnancy or breastfeeding. Therefore, the medicine should only be used if the doctor considers it necessary. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Moviprep has no influence on the ability to drive or operate machinery.

Moviprep contains sodium, potassium, and a source of phenylalanine
This medicine contains 8.4 g of sodium (main component of table salt) in one treatment cycle (a treatment cycle consists of two litres of prepared Moviprep solution). This amount represents 420% of the recommended maximum daily sodium intake for an adult. This should be taken into account for patients on a sodium-controlled 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 (a treatment cycle consists of two litres of prepared Moviprep solution). This should be taken into account for patients with impaired kidney function or those on a potassium-controlled diet.
This medicine contains a source of phenylalanine. It may be harmful for patients with phenylketonuria.

3. How to take Moviprep

Always take this medicine exactly as described in this leaflet or as your doctor has instructed. In case of doubt, consult your doctor or pharmacist.

The recommended dose is two litres of solution prepared as follows:
The package contains two transparent sachets, each containing a pair of sachets: sachet A and sachet B. Each pair of sachets (A and B) should be dissolved in water to obtain one litre of solution. Therefore, this package is sufficient to prepare two litres of Moviprep solution.

Before taking Moviprep, carefully read the instructions below. The patient must know:

• When to take Moviprep;
• How to prepare Moviprep;
• How to take Moviprep;
• What to expect after taking the medicine.

When to take Moviprep
This medicine must always be taken as described in the leaflet or as instructed by the doctor. In case of doubt, consult your doctor. Treatment with Moviprep must be completed before the examination begins.

The medicine can be taken either in divided doses or as a single dose, as described below:

For procedures performed under sedation (general anaesthesia):

1. Divided doses: one litre of Moviprep solution in the evening the day before the examination and one litre of Moviprep solution early in the morning on the day of the examination. Ensure that the intake of Moviprep, as well as other clear fluids, is completed at least two hours before the start of the examination.
2. Single dose: two litres of Moviprep solution in the evening the day before the examination or two litres of Moviprep solution in the morning on the day of the examination. Ensure that the intake of Moviprep, as well as other clear fluids, is completed at least two hours before the start of the examination.

For procedures performed without sedation (without general anaesthesia):

1. Divided doses: one litre of Moviprep solution in the evening the day before the examination and one litre of Moviprep solution early in the morning on the day of the examination. Ensure that the intake of Moviprep, as well as other clear fluids, is completed at least one hour before the start of the examination.
2. Single dose: two litres of Moviprep solution in the evening the day before the examination or two litres of Moviprep solution in the morning on the day of the examination. Ensure that the intake of Moviprep is completed at least two hours before the start of the examination. Ensure that the intake of other clear fluids is completed at least one hour before the start of the examination.

Important: Do not consume any solid foods from the moment the intake of Moviprep begins until the end of the examination.

How to prepare Moviprep

• Open one transparent sachet and remove sachets A and B.
• Add the contents of BOTH sachets A and B into a measuring jug with a capacity of at least 1 litre.
• Add water up to the 1-litre mark indicated on the jug and mix 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
The first litre of Moviprep solution should be drunk within one to two hours. The patient should aim to drink a full glass every 10–15 minutes.
When ready, the patient should prepare and drink the second litre of Moviprep solution prepared from the contents of sachets A and B from the remaining sachet.
During the use of Moviprep, it is recommended to additionally drink one more litre of clear fluid to prevent thirst and dehydration. Suitable fluids include: water, light clear soups, fruit juices (without pulp), soft drinks, tea, or coffee (without milk). These drinks should be consumed no later than two hours before the examination under general anaesthesia and no later than one hour before the examination without general anaesthesia.

What to expect after taking the medicine
After starting to take the Moviprep solution, the patient should stay close to a toilet. At some point, the patient will begin to pass watery stools. This is completely normal and indicates that the Moviprep solution is working. Bowel movements and the need to defecate will cease shortly after stopping drinking.
Following these instructions will help cleanse the bowel, enabling successful completion of the examination. After the last fluid intake, allow sufficient time for travel to the endoscopy unit.

Taking more than the recommended dose of Moviprep
Taking more than the recommended dose of Moviprep may lead to excessive diarrhoea, which may cause dehydration. The patient should drink large amounts of fluids, especially fruit juices. In case of doubt, contact a doctor or pharmacist.

Missing a dose of Moviprep
If a dose of Moviprep is missed, the patient should take it as soon as they realize they have missed it. If several hours have passed since the scheduled dose, consult a doctor or pharmacist.
If the patient is taking Moviprep in divided doses, it is very important to complete the intake at least one hour before the examination without general anaesthesia or at least two hours before the examination under general anaesthesia.
If the patient is taking Moviprep as a single dose in the morning on the day of the procedure, it is very important to complete the intake at least two hours before the examination.
In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Moviprep can cause adverse reactions, although not everyone will experience them.
A typical symptom after taking Moviprep is diarrhoea.
The patient should stop taking Moviprep and contact their doctor immediately if they notice any of the following symptoms:

• rash or itching,
• facial swelling, ankle swelling, or swelling of other body parts,
• palpitations,
• significant fatigue,
• shortness of breath.

These are symptoms of a severe allergic reaction.
The patient should stop taking Moviprep and contact their doctor immediately if any of the following adverse reactions occur:

• seizures.

If no bowel movement occurs within 6 hours after taking Moviprep, the patient should stop taking the medicine and contact their doctor immediately.

Other adverse reactions:
Very common adverse reactions (occur in more than 1 in 10 people):
Abdominal pain, bloating, fatigue, general malaise, anal pain, nausea, and fever.
Common adverse reactions (occur in up to 1 in 10 people):
Hunger, sleep disturbances, dizziness, headache, vomiting, dyspepsia, thirst, and chills.
Uncommon adverse reactions (occur in up to 1 in 100 people):
Discomfort, difficulty swallowing, and changes in liver function test results.

The following adverse reactions have also been observed, although frequency data are unavailable: flatulence, transient increase in blood pressure, irregular heartbeat or palpitations, dehydration, vomiting reflex, oesophageal rupture due to vomiting, very low blood sodium levels that may lead to seizures, and changes in blood electrolyte levels, such as decreased bicarbonate levels, increased or decreased calcium levels, increased or decreased chloride levels, and decreased phosphate levels. There may also be decreased blood potassium and sodium levels.
These reactions usually occur only during treatment. If they persist, medical advice should be sought.
Allergic reactions may cause skin rash, itching, skin redness, or urticaria, swelling of hands, feet or ankles, headache, palpitations, and shortness of breath.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Moviprep

Keep this medicine 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 vary between different sachets.
The expiry date refers to the last day of the stated month.
Medicinal product in sachets: Store below 25°C.
After reconstitution: Store below 25°C. The solution may be stored in a refrigerator (2°C–8°C).
Keep the solution covered. Do not store the solution for longer than 24 hours.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

6. Contents of the package and other information

What Moviprep contains
Pouch A contains the following active substances:
Macrogol (also known as polyethylene glycol) 3350 100 g
Anhydrous sodium sulfate 7.500 g
Sodium chloride 2.691 g
Potassium chloride 1.015 g
Pouch B contains the following active substances:
Ascorbic acid 4.700 g
Sodium ascorbate 5.900 g

The concentration of electrolyte ions after dissolving both pouches in one litre of water is:
Sodium
Chloride
Sulfate
Potassium
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 flavour (containing maltodextrin, citral, lemon oil, lemongrass oil, xanthan gum, α-tocopherol) and aspartame (E 951) and potassium acesulfame (E 950) as sweetening agents.
For additional information, see section 2.

What Moviprep looks like and contents of the pack
The pack contains two transparent bags, each containing one pair of pouches: pouch A and pouch B. Each pair of pouches (A and B) must be dissolved in one litre of water.
Moviprep, powder for oral solution in pouches, is available in packs containing 1 therapeutic set.
For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in the Czech Republic, country of export:
Norgine BV
Antonio Vivaldistraat 150
1083HP Amsterdam
The Netherlands

Manufacturer:
Norgine BV
Antonio Vivaldistraat 150
1083HP Amsterdam
The Netherlands
Recipharm Höganäs AB
Sporthallsvägen 6
263 34 Höganäs
Sweden
SOPHARTEX
21 rue du Pressoir
28500 Vernouillet
France

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 61/966/10-C
Parallel Import Authorisation Number: 294/25

This medicinal product is authorised for marketing in 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, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, United Kingdom (Northern Ireland): MOVIPREP
Sweden: MOVPREP

The following information is intended exclusively for medical personnel and healthcare professionals:
Information intended exclusively for healthcare professionals:
Moviprep should be used with caution in very weak patients with poor general condition and in patients with clinical disorders such as:

• impaired gag reflex or tendency to choking or regurgitation
• disturbances in consciousness
• severe renal impairment (creatinine clearance < 30 ml/min)
• cardiac failure (NYHA class III or IV)
• in individuals at risk of arrhythmias, for example those being treated for cardiovascular diseases or thyroid disorders
• dehydration
• acute flare-up of severe inflammatory bowel disease.

Dehydration or electrolyte imbalances must be corrected prior to administration of Moviprep.
Partially conscious patients or those at risk of choking or regurgitation must remain under close supervision during administration of the medicinal product, particularly when administered via nasogastric route.
Moviprep must not be administered to unconscious patients.