Moviprep powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Moviprep powder for oral solution

Macrogol 3350, Anhydrous sodium sulfate, Sodium chloride, Potassium chloride, Ascorbic acid and Sodium ascorbate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Moviprep is and what it is used for
2. What you need to know 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 laxative supplied in four sachets. There are two large sachets (“sachet A”) and two small sachets (“sachet B”). You need all of them for one course of treatment.

Moviprep is indicated in adults for bowel cleansing in preparation for an examination. Moviprep works by emptying the contents of your bowel, so you should expect to experience bowel movements.

2. What you need to know before taking Moviprep

Do not take Moviprep:

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6);
• if you have an intestinal obstruction;
• if you have a perforation in the wall of your gastrointestinal tract;
• if you have impaired gastric emptying;
• if you have gastrointestinal paralysis (sometimes occurring after abdominal surgery);
• if you suffer from phenylketonuria. This is an inherited condition in which the body cannot properly process a particular amino acid. Moviprep contains a source of phenylalanine;
• if your body is unable to produce sufficient glucose-6-phosphate dehydrogenase;
• if you have toxic megacolon (a severe complication of acute colitis).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Moviprep. If you have fragile health or a serious medical condition, you should be aware of the possible adverse effects listed in section 4. If this applies to you, contact your doctor or pharmacist.

Consult your doctor or pharmacist before starting to take Moviprep if you have any of the following conditions:

• a tendency to regurgitate ingested drinks, food, or acid from the stomach, or if you have difficulty swallowing (see also Taking Moviprep with food and drink),
• kidney disease,
• severe kidney problems or are taking medications for blood pressure,
• heart failure or heart diseases including high blood pressure, irregular heartbeat, or palpitations,
• thyroid disease,
• dehydration,
• acute episodes or inflammatory bowel disease (Crohn's disease or ulcerative colitis),
• epilepsy or a history of seizures.

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

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

If you develop sudden abdominal pain or rectal bleeding while taking Moviprep for bowel preparation, contact your doctor or seek medical attention immediately.

Children and adolescents

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

Taking Moviprep with other medicines

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

If you are taking other oral medications (e.g., oral contraceptives), you must not take them within one hour before, during, or up to one hour after taking Moviprep, as they may be flushed out of the digestive tract and may not work properly.

If you are taking oral contraceptives, you may need to use additional contraceptive methods (e.g., condom) to prevent pregnancy.

Taking Moviprep with food and drink

Do not eat any solid food from the time you start taking Moviprep until after your medical examination.

If you require thickened liquids to swallow safely, Moviprep may neutralize the thickening agent's effect.

While taking Moviprep, you should continue to drink plenty of fluids. The liquid content of Moviprep does not replace your normal daily fluid intake.

Pregnancy, breastfeeding, and fertility

There are no data or the data are limited regarding the use of Moviprep during pregnancy or breastfeeding, 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and use of machines

Moviprep does not affect the ability to drive or operate machinery.

Moviprep contains sodium, potassium, and aspartame

This medicine contains 8.4 g of sodium (the main component of table/cooking salt) per treatment (one treatment consists of two liters of Moviprep). This corresponds to 420% of the maximum recommended daily sodium intake for an adult. This should be taken into account when treating patients on low-salt (low-sodium) diets. Only a portion (up to 2.6 g per treatment) of this sodium is absorbed.

This medicine contains 1.1 g of potassium per treatment (one treatment consists of two liters of Moviprep). This should be taken into account when treating patients with kidney failure or on low-potassium diets.

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to take Moviprep

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is two liters of solution, which is prepared as follows:

This package contains two transparent bags, each with a pair of sachets: sachet A and sachet B. Each pair of sachets (A and B) must be dissolved in water to prepare one liter of solution. Therefore, this package contains enough quantity to prepare two liters of Moviprep solution.

Before taking Moviprep, please read the following instructions carefully. You need to know:

• When to take Moviprep.
• How to prepare Moviprep.
• How to drink Moviprep.
• What to expect.

When to take Moviprep

Follow exactly the instructions for use of the medicine contained in this leaflet or as indicated by your doctor. If in doubt, ask your doctor. Your treatment with Moviprep must be completed before the examination takes place.

This treatment can be taken either as split doses or as a single dose, as described below:

For procedures performed under sedation (using general anesthesia):

1. Split dose: one liter of Moviprep the night before, and one liter of Moviprep early on the morning of the examination day. Make sure that the intake of Moviprep, as well as any other clear liquids, is completed at least two hours before the start of the examination.

2. Single dose: two liters the night before the clinical procedure or two liters on the morning of the examination. Make sure that the intake of Moviprep, as well as any other clear liquids, is completed at least two hours before the start of the examination.

For procedures performed without sedation (without general anesthesia):

1. Split dose: one liter of Moviprep the night before and one liter of Moviprep early on the morning of the examination day. Make sure that the intake of Moviprep, as well as any other clear liquids, is completed at least one hour before the start of the examination.

2. Single dose: two liters of Moviprep the night before the examination or two liters of Moviprep on the morning of the examination. Make sure that the intake of Moviprep is completed at least two hours before the start of the examination. Ensure that the intake of any clear liquids is completed at least one hour before the examination.

Important: Do not consume any solid food from the start of Moviprep intake until after the examination.

How to prepare Moviprep

• Open one of the transparent bags and remove sachets A and B.
• Add the contents of BOTH sachet A and sachet B into a one-liter measuring jug.
• Add water to the container up to one liter and stir until all the powder has dissolved and the Moviprep solution is clear or slightly cloudy. This may take up to five minutes.

How to drink Moviprep

Drink the first liter of Moviprep solution over one or two hours. Try to drink a full glass every 10–15 minutes.

When ready, prepare and drink the second liter of solution, prepared with the contents of sachets A and B from the remaining bag.

During this treatment, it is recommended that you drink an additional liter of clear liquid to help prevent thirst and dehydration. Water, broth, fruit juices (without pulp), soft drinks, tea, or coffee (without milk) are suitable. These drinks may be taken up to two hours before the examination under general anesthesia and up to one hour before the examination without general anesthesia.

What to expect

When you start drinking the Moviprep solution, it is important that you stay close to a toilet. At some point, you will begin to feel intestinal movements. This is completely normal and indicates that Moviprep is working. Your bowel movements will stop shortly after you finish drinking the solution.

If you follow these instructions, your bowel will be cleaned, which will help ensure a proper examination. Make sure you allow enough time to reach the colonoscopy unit from the time of your last drink.

If you take more Moviprep than you should

If you take more Moviprep than you should, you may experience excessive diarrhea, which can lead to dehydration. Drink plenty of fluids, especially fruit juices.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

It is recommended to bring the medicine package and leaflet to healthcare personnel.

If you forget to take Moviprep

If you forget to take Moviprep, take the missed dose as soon as you realize you have not taken it. If several hours have passed since you were supposed to take it, seek advice from your doctor or pharmacist.

When taking Moviprep as a split dose, it is important that you complete the administration of Moviprep at least one hour before the examination (without general anesthesia), or two hours before your examination (with general anesthesia). When taking all of Moviprep on the morning of the examination as a single dose, it is important that you complete the administration of Moviprep at least two hours before the examination.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Moviprep may cause adverse effects, although not everyone experiences them.

It is normal to experience diarrhoea when you take Movipren.

Stop taking it and tell your doctor immediately if you experience any of the following adverse effects:

• rash or itching
• swelling of the face, ankles or other parts of the body
• palpitations
• extreme tiredness
• difficulty breathing

These are symptoms of a severe allergic reaction.

Stop taking Moviprep and contact your doctor immediately if you experience any of the following adverse effects:

• seizures

If you do not have a bowel movement within 6 hours after taking Moviprep, stop taking it and contact your doctor immediately.

Other adverse effects include:

• Very common adverse effects (may affect more than 1 in 10 patients): abdominal pain, bloating, fatigue, malaise, irritation around the anus, nausea, and fever.
• Common adverse effects (may affect up to 1 in 10 patients): hunger, sleep disturbances, dizziness, headache, vomiting, indigestion, thirst, and chills.
• Uncommon adverse effects (may affect up to 1 in 100 patients): discomfort, difficulty swallowing, and changes in liver function tests.

The following adverse effects have occurred rarely, although their frequency is unknown because it cannot be estimated from the available data: flatulence (gas), temporary increase in blood pressure, irregular heartbeat or palpitations, dehydration, retching (feeling of nausea), 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, increased or decreased calcium, increased or decreased chloride, and decreased phosphate. Potassium and sodium levels may also decrease, particularly in patients taking medications that affect the kidneys, such as ACE inhibitors and diuretics used to treat heart conditions.

These reactions usually only occur during treatment. If they persist, consult your doctor.

Allergic reactions that may cause skin rash, itching, skin redness or hives, swelling of hands, feet or ankles, headache, palpitations, and difficulty breathing.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Moviprep

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. Please note that expiry dates may differ for the individual sachets. The expiry date refers to the last day of the month indicated.

Store Moviprep sachets at room temperature (below 25 °C).

After preparing the Moviprep solution in water, the solution may be stored (while kept covered) at room temperature (below 25 °C). It may also be stored in the refrigerator (between 2 and 8 °C). Do not store the solution for longer than 24 hours.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Moviprep

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 concentration when both pouches are dissolved in one litre of solution is as follows:

Sodium 181.6 mmol/l (of which no more than 56.2 mmol are absorbable)

Sulfate 52.8 mmol/l

Chloride 59.8 mmol/l

Potassium 14.2 mmol/l

Ascorbate 56.5 mmol/l

The other components are:

Lemon flavour (containing maltodextrin, citral, lemon oil, lime oil, arabic gum, vitamin E), aspartame (E-951) and potassium acesulfame (E-950) as sweeteners. For further information, see section 2.

Nature of the product and contents of the pack

This package contains two transparent bags, each with a 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 is available in cartons containing 1, 10, 40, 80, 160 and 320 treatments. Hospital pack of 40 single treatments. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Norgine BV, Antonio Vivaldistraat 150, 1083 HP Amsterdam, The Netherlands.

Manufacturer:

Norgine BV, Antonio Vivaldistraat 150, 1083 HP Amsterdam, The Netherlands.

or

SOPHARTEX, 21 rue du Pressoir, 28500 Vernouillet, France.

or

Meribel Pharma Höganäs AB, Sporthallsvägen 6, Höganäs, 263 35, Sweden.

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2nd floor

28046, Madrid

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany, Austria, Belgium, Bulgaria, Denmark, Slovakia, Slovenia, Spain, Estonia, Finland, France, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, The Netherlands, Poland, Portugal, the Czech Republic and Romania: Moviprep.

Sweden: Movprep.

Date of the most recent review of this leaflet: 03/2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

This information is intended for healthcare professionals only: