Moviprep

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Moviprep, powder for oral solution
Macrogol 3350 + sodium sulfate anhydrous + sodium chloride + potassium chloride + ascorbic acid +
sodium ascorbate
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, 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 of the leaflet

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 pack and other information

1. What Moviprep is and what it is used for

Moviprep is a lemon-flavoured bowel cleansing preparation consisting of four sachets.
The pack 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 use in adults and is used to cleanse the bowel, thereby enabling its examination.
Moviprep causes emptying of the intestines; therefore, after taking it, expect to pass watery stools.

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 (commonly 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 severe 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 difficulty swallowing (see Moviprep with food and drink),
• the patient has kidney disease,
• the patient has heart failure, severe kidney problems, or is taking blood pressure medications,
• 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 phase of inflammatory bowel disease (Crohn’s disease or ulcerative colitis),
• the patient has epilepsy or has previously experienced seizures.

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

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

Moviprep with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
If the patient is taking other oral medications (e.g. oral contraceptives), they should 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 contraceptives, additional contraceptive methods (e.g. condoms) may be necessary to prevent pregnancy.

Moviprep with food and drink
Do not consume any solid food from the time you start taking Moviprep until the end of the examination.
If the patient requires thickened fluids to safely swallow them, Moviprep may counteract the thickening effect.
While taking Moviprep, 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 and breastfeeding. Therefore, the medicine should only be used if a doctor considers it necessary. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, 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 in patients on a sodium-controlled diet. Only part of the sodium is absorbed (up to 2.6 g per 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 in 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 instructed by your doctor. 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 Moviprep

When to take Moviprep
This medicine should 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.
The medicine can be taken as split doses or as a single dose, according to the following descriptions:
For procedures performed under anaesthesia (general anaesthesia):

1. Split doses: one litre of Moviprep solution in the evening on the day before the examination and one litre of Moviprep solution early in the morning on the day of the examination. Ensure that 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 on the day before the examination or two litres of Moviprep solution in the morning on the day of the examination. Ensure that 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 anaesthesia (without general anaesthesia):

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

Important: Do not consume any solid food from the time you start taking Moviprep 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 consumed within one to two hours. The patient should aim to drink a full glass every 10–15 minutes.
When ready, prepare and drink the second litre of Moviprep solution made from the contents of sachets A and B from the remaining sachet.
While taking 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), carbonated drinks, tea or coffee (without milk). These drinks should be consumed no later than two hours before examination under general anaesthesia and no later than one hour before examination without general anaesthesia.

What to expect after taking Moviprep
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 intake.
Following these instructions will help to cleanse the intestines, enabling successful completion of the examination. After the last fluid intake, allow sufficient time for travel to the endoscopy unit.

Taking more Moviprep than recommended
Taking more Moviprep than recommended may lead to excessive diarrhoea, which may result in dehydration. 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 the dose was missed. If several hours have passed since the scheduled dose, consult a doctor or pharmacist.
If the patient is taking Moviprep in split doses, it is very important to complete 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 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 all medicines, Moviprep can cause adverse reactions, although not everybody will experience them.
A typical symptom after taking Moviprep is diarrhoea.
The patient should stop taking Moviprep and contact a doctor immediately if any of the following symptoms occur:

• rash or itching,
• swelling of the face, ankles or 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 a 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 a 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 no more than 1 in 10 people):
Hunger, sleep disturbances, dizziness, headache, vomiting, indigestion, thirst, and chills.
Uncommon adverse reactions (occur in no more than 1 in 100 people):
Discomfort, difficulty swallowing, and changes in liver function test results.
The following adverse reactions have also been observed, although data on their frequency are lacking: flatulence (gas), transient increase in blood pressure, irregular heartbeat or palpitations, dehydration, vomiting reflex, oesophageal rupture due to vomiting, very low blood sodium levels which 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 a decrease in blood potassium and sodium levels.
These reactions usually occur only during treatment. If they persist, consult a doctor.
Allergic reactions may cause skin rash, itching, skin redness or hives, swelling of hands, feet or ankles, headache, palpitations, or shortness of breath.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +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. Please note that the expiry date may differ between individual sachets.
The expiry date refers to the last day of the stated month.
Store Moviprep sachets at a temperature below 25°C.
After dissolving Moviprep in water, store the solution at a temperature below 25°C.
The solution may be stored in a refrigerator (2°C–8°C). The solution should be kept covered. Do not store the solution for longer than 24 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack 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

Electrolyte ion concentration 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, vitamin E) and sweeteners: aspartame (E 951) and acesulfame potassium (E 950).
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 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 sachets, is available in packs containing 1 therapeutic set.
For more detailed information, please contact the responsible party or the parallel importer.

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

Manufacturer:
Norgine Limited
New Road, Hengoed
Mid Glamorgan CF82 8SJ
United Kingdom
Norgine BV
Antonio Vivaldistraat 150
1083HP Amsterdam
The 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

Marketing Authorisation Number in Lithuania, country of export: LT/1/10/2314/001
Parallel Import Authorisation Number: 281/21

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following trade 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 in poor general condition and in patients with clinical disorders such as:

• Impaired gag reflex or tendency to choke or regurgitate food
• Disorders of 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 before 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, especially when administered via nasogastric route.

Moviprep must not be given to unconscious patients.