Moviprep Orange Flavour Powder for Oral Solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Moviprep Orange Flavour 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, because it contains important information for you.

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

Leaflet contents

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

2. What you need to know before taking Moviprep Orange Flavour

3. How to take Moviprep Orange Flavour

4. Possible side effects

5. How to store Moviprep Orange Flavour

6. Contents of the container and other information

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

Moviprep Orange Flavour is an orange-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 Orange Flavour is indicated in adults for bowel cleansing in preparation for an examination. Moviprep Orange Flavour 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 Orange Flavour

Do not take Moviprenp Orange Flavour:

• 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 an intestinal obstruction (gastrointestinal tract blockage);
• 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 have phenylketonuria. This is an inherited condition in which the body cannot properly process a particular amino acid. Moviprep Orange Flavour 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

Talk to your doctor or pharmacist before taking Moviprep Orange Flavour. 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.

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

• tendency to regurgitate ingested liquids, food, or acid from the stomach, or if you have difficulty swallowing (see also Taking Moviprep Orange Flavour with food and drink),
• kidney disease,
• severe kidney problems or heart failure, or if you are taking medications for blood pressure,
• heart failure or heart disease, 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 Orange Flavour 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 Flavour for bowel preparation, contact your doctor or seek immediate medical attention.

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

Children and adolescents

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

Taking Moviprep Orange Flavour 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 one hour after taking Moviprep Orange Flavour, 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 Orange Flavour with food and drink

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

If you require thickened liquids to swallow safely, Moviprep Orange Flavour may neutralize the thickening effect.

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

Pregnancy, breast-feeding and fertility

There are no or limited data on the use of Moviprep Orange Flavour during pregnancy or breast-feeding, and it should only be used if your doctor considers it essential.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Moviprep Orange Flavour contains sodium, potassium, aspartame and glucose

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

This medicine contains 1.1 g of potassium per treatment (a treatment consists of two litres of Moviprep Orange Flavour). This should be taken into account when treating patients with renal insufficiency or potassium-restricted 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 certain sugars, consult him before taking this medicine.

3. How to take Moviprep Orange Flavour

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 litres of solution, which is prepared as follows:

This package contains two transparent pouches, 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 litre of solution. Therefore, this package contains enough quantity to prepare two litres of Moviprep Orange Flavour solution.

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

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

When to take Moviprep Orange Flavour

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your doctor. If in doubt, ask your doctor. Your treatment with Moviprep Orange Flavour must be completed before the examination is carried out.

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

For procedures performed under sedation (using general anaesthesia):

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

2. Single dose: two litres of Moviprep Orange Flavour the evening before the examination, or two litres of Moviprep Orange Flavour on the morning of the examination. Make sure that consumption of Moviprep Orange Flavour, 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 anaesthesia):

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

2. Single dose: two litres of Moviprep Orange Flavour the evening before the examination, or two litres of Moviprep Orange Flavour on the morning of the examination. Make sure that consumption of Moviprep Orange Flavour is completed at least two hours before the start of the examination. Ensure that consumption of any clear liquids is completed at least one hour before the examination.

Important: Do not eat any solid food from the start of taking Moviprep Orange Flavour until after the examination.

How to prepare Moviprep Orange Flavour

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

How to drink Moviprep Orange Flavour

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

When ready, prepare and drink the second litre of Moviprep Orange Flavour solution, prepared with the contents of sachets A and B from the remaining pouch.

During the course of this treatment, it is recommended that you drink an additional litre 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 anaesthesia and up to one hour before the examination without general anaesthesia.

What to expect

When you start drinking the Moviprep Orange Flavour 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 Orange Flavour 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. Allow sufficient time to reach the colonoscopy unit from the time of your last drink.

If you take more Moviprep Orange Flavour than you should

If you take more Moviprep Orange Flavour than you should, you may experience excessive diarrhoea, which 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 Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Moviprep Orange Flavour

If you forget to take Moviprep Orange Flavour, take the dose as soon as you remember. If several hours have passed since the dose should have been taken, seek advice from your doctor or pharmacist. When taking Moviprep Orange Flavour as split doses, it is important that you complete administration of Moviprep Orange Flavour at least one hour before the examination (without general anaesthesia) or two hours before the examination (with general anaesthesia). When taking all of Moviprep Orange Flavour on the morning of the examination as a single dose, it is important that you complete administration of Moviprep Orange Flavour 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 Orange Flavour may cause adverse effects, although not everyone gets them.

It is normal to experience diarrhoea when taking Moviprep Orange Flavour.

Stop taking the medicine 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 serious allergic reaction.

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

• Seizures

If you have not had 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 people): abdominal pain, abdominal distension, fatigue, malaise, anal irritation, nausea, and fever.
• Common adverse effects (may affect up to 1 in 10 people): hunger, sleep disturbances, dizziness, headache, vomiting, indigestion, thirst, and chills.
• Uncommon adverse effects (may affect up to 1 in 100 people): discomfort, difficulty swallowing, and changes in liver function tests.

The following adverse effects have occurred occasionally, 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 (urge to vomit), oesophageal rupture due to vomiting, very low blood sodium levels which 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 levels of potassium and sodium may also decrease.

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

Allergic reactions that may cause skin rash, itching, redness of the skin 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 type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Moviprep Orange Flavour

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 Orange Flavour at room temperature (below 25 °C).

After preparing the Moviprep Orange Flavour 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Moviprep Orange Flavour

The active substances are:

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

The electrolyte concentration when both powders are dissolved in one litre of solution is as follows:

Sodium 181.6 mmol/l (of which no more than 56.2 mm/ol 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 flavour (natural flavouring substances and preparations, maltodextrin, dextrose), aspartame (E-951) and potassium acesulfame (E-950) as sweeteners. For further information, see section 2.

Appearance of the medicine and contents of the pack

This pack contains two transparent bags, each containing a pair of sachets: pouch A and pouch B. Each pair of pouches (A and B) must be dissolved in one litre of water.

Moviprep Orange Flavour powder for oral solution is available in kits containing 1, 10, 40, 80, 160 and 320 treatments. Hospital pack of 40 treatments. Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Norgine BV
Antonio Vivaldistraat 150
1083 HP Amsterdam
The Netherlands

Manufacturer:

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

or

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

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:

Norgine de España, S.L.U.
Paseo de la Castellana, 91, 2nd floor
28046 Madrid
Spain

This medicine is authorised in the European Economic Area member states under the following names:

Country Name
Germany MOVIPREP Orange
Austria MOVIPREP Orange
Belgium MOVIPREP Sinaas/Orange
Denmark MOVIPREP Appelsin
Spain MOVIPREP Orange Flavour
Finland MOVIPREP Appelsiini
France MOVIPREP Orange
The Netherlands MOVIPREP Orange
Ireland MOVIPREP Orange
Italy MOVIPREP Arancio
Luxembourg MOVIPREP Sinaas/Orange
Sweden MOVIPREP APELSIN

Date of latest revision of this leaflet: 12/2024

Detailed information on this medicine 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: