MOVIPREP ORANGE FLAVOR ORAL SOLUTION POWDER

Introduction

Package Leaflet: 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 entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 symptoms are the same as yours.
• If you experience 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 Package Leaflet

1. What is Moviprep Orange Flavor and what is it used for
2. What you need to know before you take Moviprep Orange Flavor
3. How to take Moviprep Orange Flavor
4. Possible side effects
5. Storage of Moviprep Orange Flavor

1. Contents of the pack and further information

1. What is Moviprep Orange Flavor and what is it used for

Moviprep Orange Flavor is an orange-flavored laxative contained in four sachets. There are two large sachets ("sachet A") and two small sachets ("sachet B"). You need all of them for a treatment.

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

2. What you need to know before you take Moviprep Orange Flavor

Do not take Moviprep Orange Flavor:

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have a blockage in the intestine (gastrointestinal tract);
• if you have a hole in the wall of your gastrointestinal tract;
• if you have changes in gastric emptying;
• if you have paralysis of the gastrointestinal tract (sometimes occurs after abdominal surgery);
• if you have 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 enough glucose-6-phosphate dehydrogenase;
• if you have toxic megacolon (a severe complication of acute colitis).

Warnings and precautions

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

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

• tendency to regurgitate drinks, food, or acid from the stomach, or if you have difficulty swallowing (see also Taking Moviprep Orange Flavor with food and drinks),
• kidney disease,
• you have heart failure, severe kidney problems, or are taking medications for blood pressure,
• heart failure or heart diseases 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 Orange Flavor should not be given to patients with altered consciousness without medical supervision.

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

If you experience vomiting (with blood) followed by sudden chest, neck, or abdominal pain, difficulty swallowing, or difficulty breathing when taking Moviprep Orange Flavor, stop taking the medicine 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 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 Orange Flavor, as they may be eliminated from the digestive 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 Orange Flavor with food and drinks

Do not take any solid food from the start of 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 drink plenty of liquids. The liquid content of Moviprep does not replace your normal fluid intake.

Pregnancy, breastfeeding, and fertility

There are limited or no data on the use of Moviprep Orange Flavor 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 Orange Flavor does not affect your ability to drive or use machines.

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

This medicine contains 8.4 g of sodium (the main component of table salt/cooking salt) per treatment (one treatment consists of two liters of Moviprep Orange Flavor). 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 the sodium is absorbed.

This medicine 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 kidney problems or those on low-potassium diets.

This medicine 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 some sugars, consult them before taking this medicine.

3. How to take Moviprep Orange Flavor

Follow the instructions for taking 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 with 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 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 to expect to happen.

When to take Moviprep Orange Flavor

Follow the instructions for taking the medicine contained in this leaflet or as indicated by your doctor. If you are unsure, ask your doctor. Your treatment with Moviprep Orange Flavor 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 Orange Flavor the night before and one liter of Moviprep Orange Flavor early on the morning of the examination day. Make sure that the consumption of Moviprep Orange Flavor, as well as any other clear liquid, has ended 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 ended at least two hours before the start of the examination.

For procedures performed without the need for anesthesia:

1. Divided doses: one liter of Moviprep Orange Flavor the night before and one liter of Moviprep Orange Flavor early on the morning of the examination day. Make sure that the consumption of Moviprep Orange Flavor, 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 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 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 Orange Flavor until after the medical examination.

How to prepare Moviprep Orange Flavor

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

How to drink Moviprep Orange Flavor

Drink the first liter of the Moviprep Orange Flavor 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 Orange Flavor solution, prepared with the contents of 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 feeling 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 until two hours before the examination under general anesthesia and until one hour before the examination without general anesthesia.

What to 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 bowel movements. This is completely normal and indicates that Moviprep Orange Flavor is working. The bowel movements will stop soon after you finish drinking it.

If you follow these instructions, your intestine will be clean, and this will help you have a proper examination. You should allow enough time to get to 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, 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 taken.

If you forget to take Moviprep Orange Flavor

If you forget to take Moviprep Orange Flavor, 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 Orange Flavor in divided doses, it is essential that you complete the administration of Moviprep Orange Flavor at least one hour before the examination (without using general anesthesia) or two hours before the examination (using 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

It is normal for diarrhea to appear when you take Moviprep Orange Flavor.

Stop taking and tell your doctor immediately if you have any of the following side 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 Orange Flavor 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, although 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. Blood potassium and sodium levels may also decrease.

These reactions usually only appear 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, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Moviprep Orange Flavor

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. Note that the expiry dates may be different for the different sachets. The expiry 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 (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. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Moviprep CompositionOrange Flavor

The active ingredients are:

Sachet Acontains the following active ingredients:

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

Sachet Bcontains the following active ingredients:

Ascorbic acid 4,700 g

Sodium ascorbate 5,900 g

The electrolyte concentration when both sachets 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 (excipients) are:

Orange flavor (natural flavoring substances and preparations, maltodextrin, dextrose), aspartame (E-951) and potassium acesulfame (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 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 oral solution powder is available in boxes of 1, 10, 40, 80, 160, and 320 treatments. Hospital packaging of 40 treatments. Only some packaging 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

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

or

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

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:

CountryName

Germany MOVIPREP Orange

Austria MOVIPREP Orange

Belgium MOVIPREP Sinaas/Orange

Denmark MOVIPREP Appelsin

Spain MOVIPREP Orange Flavor

Finland MOVIPREP Appelsiini

France MOVIPREP Orange

Netherlands MOVIPREP Orange

Ireland MOVIPREP Orange

Italy MOVIPREP Arancio

Luxembourg MOVIPREP Sinaas/Orange

United Kingdom MOVIPREP Orange

(Northern Ireland)

Sweden MOVIPREP APELSIN

Date of the last revision of this leaflet:12/2024

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: