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

Before taking the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 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 intended for adults and is used for bowel cleansing, which enables examination of the bowel. Moviprep causes bowel emptying, so after taking it, you should expect to have watery stools.

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 intestinal obstruction,
• if you have perforation of the intestinal wall,
• if you have gastric emptying disorders,
• if you have intestinal paralysis (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 possible side effects, which are listed in section 4. In case of doubts, consult a doctor or pharmacist. Before taking Moviprep, discuss it with your doctor or pharmacist if:

• you have a tendency to regurgitate swallowed drinks, food, or stomach acid, or have problems with swallowing (see Moviprep with food and drink),
• you have kidney disease,
• you have heart failure or heart disease, including high blood pressure, irregular heartbeat, or palpitations,
• you have thyroid disease,
• you have dehydration,
• you have an exacerbation of inflammatory bowel disease (Crohn's disease or ulcerative colitis).

Moviprep should not be given to patients with impaired consciousness without medical supervision. If you experience sudden abdominal pain or rectal bleeding while taking Moviprep for bowel cleansing, consult a doctor or seek medical help immediately.

Children and adolescents

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

Moviprep and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. If you are taking other oral medicines (e.g., oral contraceptives), do not take them within one hour before, during, or one hour after taking Moviprep, as they may be flushed out of the digestive system and may not work effectively.

Moviprep with food and drink

Do not eat any solid food from the start of taking Moviprep until the end of the examination. If you need to thicken fluids to swallow them safely, Moviprep may counteract the thickening effect. While taking Moviprep, 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 taken if your doctor considers it necessary. 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.

Driving and using machines

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

Moviprep contains sodium, potassium, and aspartame (a source of phenylalanine)

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

3. How to take Moviprep

Always take this medicine exactly as your doctor has told you. If you are not sure, 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 enough to make two liters of Moviprep solution. Before taking Moviprep, read the instructions below 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

Always take this medicine exactly as described in the leaflet or as your doctor has told you. If you are not sure, ask your doctor. The treatment with Moviprep must be completed before the examination starts. You can take the medicine in divided doses or in one 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. 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. 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. 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. Ensure that you stop taking Moviprep, as well as other clear fluids, at least two hours before the start of the examination.

Ensure that you stop taking other clear fluids at least one hour before the start of the examination.

Important: Do not eat any solid food from the start of 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 up 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

Drink the first liter of Moviprep solution within one to two hours. Try to drink a full glass every 10-15 minutes. When you are ready, 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, it is recommended to drink an additional liter of clear fluid to prevent thirst and dehydration. Suitable fluids include: water, clear soups, fruit juices (without pulp), soft drinks, tea, or coffee (without milk). These drinks 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 starting to take the Moviprep solution, 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, making it possible to successfully perform the examination. After the last fluid intake, allow enough time to get to the colonoscopy unit.

Taking more Moviprep than recommended

Taking more Moviprep than recommended may lead to excessive diarrhea, which may cause dehydration. Drink plenty of fluids, especially fruit juices. In case of doubts, consult a doctor or pharmacist.

Missing a dose of Moviprep

If you miss a dose of Moviprep, take it as soon as you remember. If it is several hours after the scheduled dose, consult a doctor or pharmacist. If you are taking Moviprep in divided doses, it is very important to 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 in a single dose in the morning of the examination day, it is very important to finish taking the medicine at least two hours before the examination. In case of any further doubts about taking this medicine, consult a 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. If you notice any of the following symptoms, stop taking Moviprep and contact your doctor immediately:

• 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. If you do not have a bowel movement within 6 hours of taking Moviprep, 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 no more than 1 in 10 people): Hunger, sleep disorders, dizziness, headache, vomiting, indigestion, thirst, and chills. Uncommon side effects (occurring in no more 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 unknown: bloating (gas), transient increase in blood pressure, irregular heart rhythm or palpitations, dehydration, gagging, very low sodium levels in the blood that may lead to seizures, and changes in electrolyte levels, such as decreased bicarbonate, increased or decreased calcium, increased or decreased chloride, and decreased phosphate. Potassium and sodium levels in the blood may also decrease. These reactions usually occur only during the treatment period. If they persist, consult a doctor. Allergic reactions may 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 those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Moviprep

Keep the 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 be different on different sachets. The expiry date refers to the last day of the month. Medicinal product in sachets: Store in a temperature below 25°C. After reconstitution: Store in a temperature below 25°C. The solution can be stored in the refrigerator (2°C–8°C). Store the solution under cover. Do not store the solution for more than 24 hours. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 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
29.8 mmol/l
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 therapeutic set. For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

Norgine B.V.
Antonio Vivaldistraat 150
1083HP Amsterdam
Netherlands

Manufacturer:

Recipharm Höganäs AB
Sporthallsvägen 6
Höganäs, 263 34
Sweden
Norgine Ltd.
New Road
Tir-y-Berth, Hengoed
Mid Glamorgan, CF82 8SJ
United Kingdom
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
Austrian marketing authorization number:1-26774

Parallel import authorization number: 218/24

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 revision of the leaflet: 29.05.2024

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

• impaired gag reflex or tendency to choke or regurgitate 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, e.g., those being treated for cardiovascular diseases or thyroid diseases
• dehydration
• acute severe exacerbation of inflammatory bowel disease

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