Label: Information for the Patient

Moviprep Oral Solution Powder

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

Read this label carefully before taking this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Moviprep is a lemon-flavored laxative found in four packets. There are two large packets (“Packet A”) and two small packets (“Packet B”). You need the entire contents for treatment.

Moviprep is indicated for adults to clean the intestines so they are ready for an examination. Moviprep acts by emptying the contents of your intestines, so you should expect to feel bowel movements.

Do not take Moviprep:

• if you are allergic to the active ingredients or any of the other components of this medication (listed in section 6);
• if you have an obstruction in the intestine;
• if you have a perforation in the wall of your gastrointestinal tract;
• if you have alterations in gastric emptying;
• if you have paralysis of the gastrointestinal tract (sometimes occurs after abdominal surgery);
• if you suffer from phenylketonuria. This is a congenital inability of the body to use a particular amino acid. Moviprep contains a source of phenylalanine;
• if your body is unable to produce sufficient glucose-6-phosphatase;
• 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 a delicate health or a serious medical condition, be aware of the possible adverse effects listed in section 4. If this is your case, contact your doctor or pharmacist.

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

• 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,
• heart failure, severe kidney problems, or taking medications for high blood pressure,
• heart failure or cardiovascular diseases including high blood pressure, irregular heartbeats, or palpitations,
• thyroid disease,
• dehydration,
• acute episodes or inflammatory intestinal disease (Crohn's disease or ulcerative colitis),
• 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 medication and contact your doctor immediately.

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

Children and adolescents

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

Taking Moviprep with other medications

Inform your doctor or pharmacist if you aretaking,havetakenrecently or may need to takeany other medication.

If you are taking other oral medications (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 digestive tract and not act correctly.

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 drinks

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

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

When taking Moviprep, you should continue to ingest liquids in abundance. The liquid content of Moviprep does not replace your usual intake of liquids.

Pregnancy, breastfeeding, and fertility

There are no data or these are limited regarding the use ofMoviprep during pregnancy or breastfeeding and it should only be used if the doctor considers it essential.If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

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

Moviprep contains sodium, potassium, and aspartame

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

This medication contains 1.1 g of potassium per treatment (one treatment consists of two liters of Moviprep). This should be taken into account in the treatment of patients with renal insufficiency or low-potassium diets.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of 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 with a pair of sachets each: sachet A and sachet B. Each pair of sachets (A and B) must be dissolved in water to prepare one liter of solution. This package therefore 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 you should expect to happen.

When to take Moviprep

Follow exactly the administration instructions of the medication contained in this leaflet or as indicated by your doctor. In case of doubt, ask your doctor.Your Moviprep treatment should be completed before the examination takes place.

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

For procedures performed when you are asleep (using general anesthesia):

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

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

For procedures performed without the need to sleep (without general anesthesia):

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

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

Important: Do not take 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 the sachets A and B
• Add the contents of BOTH, sachet A and sachet B, to a one-liter measuring jug.
• Add water to the container until one liter and stir until all the powder has dissolved and the Moviprep solution is clear or slightly turbid. This may take up to five minutes.

How to drink Moviprep

Drink the first liter of the Moviprep solution over a period of one or 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 you should 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 intestinal movements. This is completely normal and indicates that Moviprep is working. Your intestinal movements will cease immediately after you have finished drinking it.

By following these instructions, your intestine will be clean, and this will help you have a correct examination. You should reserve enough time to get to the colonoscopy unit from the last time you drink.

What to do if you take more Moviprep than you should

If you take more Moviprep than you should, you may experience excessive diarrhea that 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 medication and the amount ingested.

It is recommended to bring the package and the medication leaflet to the healthcare staff.

What to do if you forget to take Moviprep

If you forget to take Moviprep, take the dose as soon as you realize you have not taken it. If several hours have passed since you should have taken it, ask your doctor or pharmacist for advice.

When taking Moviprep as divided dosesit is essential that you complete the administration of Moviprep at least one hour before theexamination (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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Moviprep may cause side effects, although not everyone will experience them.

It is normal to experience diarrhea when taking Moviprep.

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

• hives 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 immediately contact your doctor if you experience any of the following side effects:

•seizures

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

Other side effects include:

• Very common side effects (may affect more than 1 in 10 patients) are: abdominal pain, bloating, fatigue, general discomfort, 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, although their frequency is unknown since it cannot be estimated with the available data: flatulence (gas), temporary increase in blood pressure, irregular heartbeats or palpitations, dehydration, nausea, esophageal rupture caused by vomiting, very low sodium levels in the blood that may cause 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 disease.

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

Allergic reactions that may cause skin rash, itching, skin redness, or urticaria, hand, foot, or ankle inflammation, headaches, palpitations, and difficulty breathing.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Do not usethis medicationafter the expiration date that appears onthe packagingafter EXP. Note that expiration dates may be different for the various packets. The expiration date is the last day of the month indicated.

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

After preparing the Moviprep solution in water, the solution can be stored (keeping it 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 through drains or in the trash. Dispose of the containers and unused medications at the SIGRE collection pointat the pharmacy.In case of doubtask your pharmacist how to dispose of the containers and unused medications.This will help protect the environment.

Composition of Moviprep

Packet Acontains the following active substances:

Macrogol (also known as polyethylene glycol) 3350100 g

Anhydrous sodium sulfate7,500 g

Sodium chloride2,691 g

Potassium chloride1,015 g

Packet Bcontains the following active substances:

Vitamin C4,700 g

Sodium ascorbate5,900 g

The concentration of electrolytes when both packets have been dissolved in one liter of solution is as follows:

Sodium181.6 mmol/l (of which no more than 56.2 mmol are absorbable)

Sulfate52.8 mmol/l

Chloride59.8 mmol/l

Potassium14.2 mmol/l

Ascorbate56.5 mmol/l

The other components are:

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

Appearance of the product and contents of the packaging

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

Moviprep powder for oral solution isavailable in packs of1, 10, 40, 80, 160 and 320treatments.Hospital pack of 40 unique treatments.Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Norgine BV,Antonio Vivaldi Street 150, 1083 HP Amsterdam, Netherlands.

Manufacturer responsible:

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

or

Norgine BV, Antonio Vivaldi Street 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 by contacting 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 themember 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.

Last review date of this leaflet:03/2025

Further detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

This information is intended solely for healthcare professionals: