MOVIPREP POWDER FOR ORAL SOLUTION

Introduction

Patient Information: Summary of Product Characteristics

Moviprep Powder for Oral Solution

Macrogol 3350, Anhydrous Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, and Sodium Ascorbate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Moviprep and what is it used for
2. What you need to know before you take Moviprep
3. How to take Moviprep
4. Possible side effects
5. Storage of 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 contained in four sachets. There are two large sachets ("sachet A") and two small sachets ("sachet B"). You will need all of them for a treatment.

Moviprep is indicated in adults for bowel cleansing prior to clinical procedures. Moviprep works by emptying the contents of your bowels, and you should expect to have bowel movements.

2. What you need to know before you take Moviprep

Do not take Moviprep:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you have a bowel obstruction;
• if you have a perforation of the gastrointestinal wall;
• if you have gastroparesis;
• if you have paralytic ileus (sometimes occurs after abdominal surgery);
• if you have phenylketonuria. This is a rare, inherited disorder that affects the body's ability to break down an amino acid called phenylalanine. Moviprep contains a source of phenylalanine;
• if your body is unable to produce enough glucose-6-phosphate dehydrogenase;
• if you have toxic megacolon (a serious complication of acute colitis).

Warnings and precautions

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

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

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

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

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

If you experience sudden abdominal pain or rectal bleeding while taking Moviprep for bowel preparation, contact your doctor or go to a doctor immediately.

Children and adolescents

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

Taking Moviprep with other medicines

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

If you are taking other oral medicines (e.g., oral contraceptives), do not take them from one hour before, during, and until one hour after taking Moviprep, as they may be eliminated from the gastrointestinal tract and not work properly.

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

Taking Moviprep with food and drinks

Do not take any solid food from the start of taking Moviprep until after the medical examination.

If you need to thicken liquids to swallow them safely, Moviprep may neutralize the effect of the thickener.

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

Pregnancy, breastfeeding, and fertility

There are limited data on the use of Moviprep during pregnancy or breastfeeding, and it should only be used if your doctor considers it essential. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Moviprep contains sodium, potassium, and aspartame

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

This medicine contains 1.1 g of potassium per treatment (a treatment consists of two liters of Moviprep). This should be taken into account in the treatment of patients with kidney problems 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 the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

This pack contains two transparent bags, each containing a pair of sachets: sachet A and sachet B. Each pair of sachets (A and B) should be dissolved in water to prepare one liter of solution. This pack contains enough 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 to happen.

When to take Moviprep

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor. If you are unsure, ask your doctor. Your treatment with Moviprep should be completed before the examination is carried out.

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

For procedures performed under general anesthesia:

1. Divided doses: one liter of Moviprep on the evening before and one liter of Moviprep early on the morning of the examination day. Make sure that the consumption of Moviprep, as well as any other clear liquid, has ended at least two hours before the start of the examination.

1. Single dose: two liters on the evening before the procedure or two liters on the morning of the examination. Make sure that the consumption of Moviprep, as well as any other clear liquid, has ended at least two hours before the start of the examination.

For procedures performed without the need for general anesthesia:

1. Divided doses: one liter of Moviprep on the evening before and one liter of Moviprep early on the morning of the examination day. Make sure that the consumption of Moviprep, as well as any other clear liquid, has ended at least one hour before the start of the examination.

1. Single dose: two liters of Moviprep on the evening before the examination or two liters of Moviprep on the morning of the examination. Make sure that the consumption of Moviprep has ended at least two hours before the start of the examination. Make sure that the consumption of any clear liquid has ended at least one hour before the examination.

Important: Do not take any solid food from the start of taking Moviprep until after the medical examination.

How to prepare Moviprep

• Open one of the transparent bags and remove the sachets A and B.
• Add the contents of BOTH sachets A and B to a measuring jug with a capacity of one liter.
• 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 the Moviprep solution over 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 the Moviprep solution, prepared with the contents of the sachets A and B from the remaining bag.

During the course of this treatment, it is recommended that you drink an additional liter of clear liquid to prevent the sensation of thirst and prevent dehydration. Water, broth, fruit juices (without pulp), soft drinks, tea, or coffee (without milk) are suitable. These drinks can 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 to happen

When you start drinking the Moviprep solution, it is essential that you are near a toilet. At some point, you will start to feel bowel movements. This is completely normal and indicates that Moviprep is working. The bowel movements will stop soon after you finish drinking it.

If you follow these instructions, your bowels will be clean, and this will help you have a successful examination. You should allow enough time to get to the colonoscopy unit from the last time you 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 liquids, especially fruit juices.

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

It is recommended to take the packaging and the leaflet of the medicine to the healthcare personnel.

If you forget to take Moviprep

If you forget to take Moviprep, take the dose as soon as you remember. If several hours have passed since you should have taken it, ask your doctor or pharmacist for advice.

When taking Moviprep as divided doses, it is essential 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 you take all the Moviprep in the morning of the examination as a single dose, it is essential that you complete the administration of Moviprep at least two hours before the examination.

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

4. Possible side effects

Like all medicines, Moviprep can cause side effects, although not everybody gets them.

It is normal to experience diarrhea when you take Moviprep.

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

• rash or itching
• swelling of the face, ankles, or other parts of the body
• palpitations
• extreme fatigue
• 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 side effects:

• Seizures

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

Other side effects include:

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

The following side effects have occurred, but their frequency is not known, as it cannot be estimated from the available data: flatulence (gas), temporary increase in blood pressure, irregular heartbeats or palpitations, dehydration, nausea (feeling of vomiting), esophageal rupture caused by vomiting, low sodium levels in the blood that can cause seizures, and changes in blood salt 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 disease.

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

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

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side 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 which is stated on the carton after EXP. Note that the expiry dates may be different for the different sachets. The expiry date is the last day of the month stated.

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

After preparing the Moviprep solution in water, the solution can be stored (kept covered) at room temperature (below 25°C). It can also be stored in the refrigerator (between 2 and 8°C). Do not store it 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. These measures will help protect the environment.

6. Container Content and Additional Information

Moviprep Composition

Pouch Acontains 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 Bcontains the following active substances:

Ascorbic acid 4,700 g

Sodium ascorbate 5,900 g

The electrolyte concentration when both pouches are dissolved in one liter 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 flavor (containing maltodextrin, citral, lemon oil, lime oil, gum arabic, vitamin E), aspartame (E-951) and acesulfame potassium (E-950) as sweeteners. For more information, see section 2.

Product Appearance and Container Content

This container contains two transparent bags with a pair of pouches each: pouch A and pouch B. Each pair of pouches (A and B) must be dissolved in one liter of water.

Moviprep oral solution powder is available in boxes of 1, 10, 40, 80, 160, and 320 treatments. Hospital packaging of 40 single treatments. Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

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

Manufacturer:

Norgine Limited, New Road, Hengoed, Mid Glamorgan, CF82 8SJ, United Kingdom.

or

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

or

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

or

Recipharm Höganäs AB, Sporthallsvägen 6, Höganäs, 263 35, Sweden.

Further information about this medicinal product can be obtained from 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 Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

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

Sweden: Movprep.

Date of the last revision of this leaflet:03/2025

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

This information is intended only for healthcare professionals: