Label: Information for the Patient

Moviprep Orange Flavor Powder for Oral Solution

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

Read this label carefully before starting to take 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 only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this label.See section 4.

6. Contents of the pack and additional information

Moviprep Orange Flavor is an orange-flavored laxative found in four sachets. There are two large sachets (“sachet A”) and two small sachets (“sachet B”). You need the entire contents for treatment.

Moviprep Orange Flavor is indicated for adults to clean the intestineso that it is ready for an examination. Moviprep Orange Flavor acts by emptying the contents of your intestine, so you should expect to feel bowel movements.

Do not take Moviprep Orange Flavor:

• 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 your intestine (gastrointestinal tract);
• 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 hereditary inability of the body to use a particular amino acid. Moviprep Orange Flavor 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 Orange Flavor.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.

You should consult your doctor before taking Moviprep Orange Flavor if you have any of the following situations:

• tendency to regurgitate drinks, food, or acid from the stomach, or if you have difficulty swallowing(also see Taking Moviprep Orange Flavor 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 or chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis),
• epilepsy or a history of seizures.

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

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

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

Children and adolescents

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

Taking Moviprep Orange Flavor with other medications

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

If you are taking oral medications (e.g., oral contraceptives), do not take them from one hour before, during, and until one hour after taking Moviprep Orange Flavor, 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., condoms) to avoid pregnancy.

Taking Moviprep Orange Flavor with food and drinks

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

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

When taking Moviprep Orange Flavor, 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 ofMoviprepOrange Flavorduring pregnancy or breastfeeding and it should only be used if the doctor considers it essential.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

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

Moviprep Orange Flavor contains sodium, potassium, aspartame, and glucose

This medication contains 8.4 g of sodium (main component ofsalt/table salt) in each treatment (one treatment consists of two liters of Moviprep Orange Flavor).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 the sodium is absorbed.

This medication contains 1.1 g of potassium per treatment (one treatment consists of two liters of Moviprep Orange Flavor). 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.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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 contains sufficient quantity to prepare two liters of Moviprep Orange Flavor solution.

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

• When to take Moviprep Orange Flavor.
• How to prepare Moviprep Orange Flavor.
• How to drink Moviprep Orange Flavor.
• What you should expect to happen.

When to take Moviprep Orange Flavor

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 treatment with Moviprep Orange Flavor should have been completed before the examination is performed.

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

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

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

1. Single dose: two liters of Moviprep Orange Flavor the night before the examination or two liters of Moviprep Orange Flavor on the morning of the examination. Make sure that the consumption of Moviprep Orange Flavor, 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 Orange Flavor the night before and one liter of Moviprep Orange Flavor early in the morning on the day of the examination. Make sure that the consumption of Moviprep Orange Flavor, 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 Orange Flavor the night before the examination or two liters of Moviprep Orange Flavor on the morning of the examination. Make sure that the consumption of Moviprep Orange Flavor 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 Orange Flavor intake until after the examination.

How to prepare Moviprep Orange Flavor

• 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 up to the line that marks one liter and agitate until all the powder has dissolved and the Moviprep Orange Flavor solution is clear or slightly turbid. This may take up to five minutes.

How to drink Moviprep Orange Flavor

Drink the first liter of the Moviprep Orange Flavor 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 Orange Flavor 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 a 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 Orange Flavor 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 Orange Flavor 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 sufficient time to arrive at the colonoscopy unit from the last time you drink.

If you take more Moviprep Orange Flavor than you should

If you take more Moviprep Orange Flavor than you should, you may experience excessive diarrhea that can lead to dehydration. Drink plenty of fluids, especially fruit juices. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Moviprep Orange Flavor

If you forget to take Moviprep Orange Flavor, 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 Orange Flavor in divided dosesit is essential that you complete the administration of Moviprep Orange Flavor at least one hour before the examination(without general anesthesia) or two hours before the examination (with general anesthesia). When taking all of Moviprep Orange Flavor in the morning of the examination as a single dose, it is essential that you complete the administration of Moviprep Orange Flavor at least two hours before the examination.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

It is normal to experience diarrhea when taking Moviprep Orange Flavor.

Stop taking and immediately tell 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 Orange Flavor 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 after taking Moviprep, stop consumption 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.

Rare 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. Blood potassium and sodium levels may also decrease.

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 on 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.Be aware that expiration dates may be different for the various packets.The expiration date is the last day of the month indicated.

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

After preparing the Moviprep Orange Flavor 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 medicines you no longer need at the SIGRE collection pointof the pharmacy.In case of doubtask your pharmacist how to dispose of the containers and medicines you no longer need.By doing so, you will help protect the environment.

Composition of MoviprepOrange Flavor

The active principles are:

Over Acontains the following active principles:

Macrogol (also known as polyethylene glycol) 3350100 g

Anhydrous sodium sulfate7,500 g

Sodium chloride2,691 g

Potassium chloride1,015 g

Over Bcontains the following active principles:

Ascorbic acid4,700 g

Sodium ascorbate5,900 g

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

Sodium181.6 mmol/l (of which not 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 (excipients) are:

Orange flavor (natural flavorings, maltodextrin, dextrose), aspartame (E-951) and acesulfame potassium (E-950) as sweeteners. For more information, see section 2.

Appearance of the product and contents of the package

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 one liter of water.

Moviprep Orange Flavor powder for oral solution isavailable in packs of1, 10, 40, 80, 160 and 320treatments. Hospital pack of 40 treatments. Some pack sizes may not be marketed.

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

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

or

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

For more information about this medicine, 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 medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

CountryName

GermanyMOVIPREP Orange

AustriaMOVIPREP Orange

BelgiumMOVIPREP Sinaas/ Orange

DenmarkMOVIPREP Appelsin

SpainMOVIPREP Orange Flavor

FinlandMOVIPREP Appelsiini

FranceMOVIPREP Orange

NetherlandsMOVIPREP Orange

IrelandMOVIPREP Orange

ItalyMOVIPREP Arancio

LuxembourgMOVIPREP Sinaas/ Orange

United Kingdom MOVIPREPOrange

(Northern Ireland)

SwedenMOVIPREP APELSIN

Last review date of this leaflet:12/2024

For more detailed information about this medicine, please visit 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: