MOVICOL PEDIATRIC NEUTRAL FLAVOR 6.9 g ORAL SOLUTION POWDER IN SACHETS

Introduction

Package Leaflet: Information for the Patient

Movicol Pediatric Neutral Flavor6.9 gpowder for oral solution in sachet

Macrogol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for the child.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to the child only, and should not be given to others, even if they have the same symptoms as the child, as it may harm them.
• If the child experiences side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Movicol Pediatric Neutral Flavor and what is it used for
2. What you need to know before starting to give Movicol Pediatric Neutral Flavor
3. How to take Movicol Pediatric Neutral Flavor
4. Possible side effects
5. Storage of Movicol Pediatric Neutral Flavor
6. Package Contents and Additional Information

1. What is Movicol Pediatric Neutral Flavor and what is it used for

The name of this medication is Movicol Pediatric Neutral Flavor 6.9 g powder for oral solution in sachet.

This medication belongs to the group of medications known as osmotic laxatives and is indicated for the treatment of constipation in children from 1 to 11 years old, and for fecal impaction (severe constipation without response to treatment) in children from 5 to 11 years old.

Movicol Pediatric Neutral Flavor helps the child have a comfortable bowel movement, even if they have been constipated for a long time.

2. What you need to know before starting to give Movicol Pediatric Neutral Flavor

Do not give Movicol Pediatric Neutral Flavor if the child has:

• intestinal blockage (intestinal obstruction, ileus),
• perforation of the intestinal wall,
• a severe inflammatory bowel disease, such as ulcerative colitis, Crohn's disease, or toxic megacolon,
• intestinal paralysis,
• allergy to the active ingredients or to any of the other components of this medication (listed in section 6).

If the child has a heart or kidney problem, a swallowing reflex disorder, or esophagitis due to reflux (heartburn caused by the backflow of stomach contents into the esophagus), they should consult their doctor before starting to take Movicol Pediatric Neutral Flavor.

Warnings and Precautions

When taking Movicol Pediatric Neutral Flavor, the child should continue to drink plenty of fluids. The liquid content of Movicol does not replace their usual fluid intake.

Other Medications and Movicol Pediatric Neutral Flavor

Tell your doctor if the child is taking, has recently taken, or may need to take any other medication.

Some medications, such as antiepileptics, may not be as effective when taken with Movicol Pediatric Neutral Flavor.

When large volumes of Movicol Pediatric Neutral Flavor are taken (e.g., for fecal impaction), other medications may be eliminated through the digestive system.

The child should not take other oral medications from 1 hour before to 1 hour after taking Movicol Pediatric Neutral Flavor.

If you need to thicken liquids to swallow them safely, Movicol Pediatric Neutral Flavor may neutralize the effect of the thickener.

Pregnancy and Breastfeeding

Movicol Pediatric Neutral Flavor can be taken during pregnancy and breastfeeding.

If the child's mother is pregnant or breastfeeding, thinks she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before administering this medication.

Movicol Pediatric Neutral Flavor contains Sodium

Movicol Pediatric Neutral Flavor contains 93.4 mg of sodium (main component of table salt/cooking salt) per sachet. This is equivalent to 4.6% of the maximum recommended daily sodium intake for an adult.

3. How to take Movicol Pediatric Neutral Flavor

This medication can be taken at any time without the need for food.

Dissolve the contents of each sachet in 62.5 ml (1/4 cup) of water and take it.

Chronic Constipation

The dose of Movicol Pediatric Neutral Flavor depends on the child's age and response to treatment.

• As an initial dose, children from 1 to 6 years old should take 1 sachet of 6.9 grams (= 1 dose) per day.
• Children from 7 to 11 years old should take 2 sachets of 6.9 grams per day.

Your doctor may indicate an increase in the number of sachets until the child has an adequate bowel movement. If the dose is increased, it should be done every 2 days. Children under 2 years old should not take more than 2 sachets per day. In children from 2 to 11 years old, it is usually not necessary to take more than 4 sachets per day.

It is not necessary to take the entire drink at once. If the child prefers, they can take half of the drink in the morning and half in the afternoon.

Fecal Impaction

Before the child takes Movicol Pediatric Neutral Flavor for fecal impaction, it should be medically confirmed that the child has this condition.

Daily dosing schedule:

The daily number of sachets should be taken in divided doses, all consumed within 12 hours (e.g., from 8 am to 8 pm). Each sachet should be dissolved in 62.5 ml (1/4 cup) of water. Treatment can be stopped when the medication has taken effect, as evidenced by the passage of large volumes of stool or watery diarrhea.

How to Prepare:

Open the sachet and pour the contents into a glass. Add 1/4 cup (about 62.5 ml) of water. Stir well until the powder is completely dissolved, resulting in a clear or slightly cloudy solution, and then give it to the child to drink.

If desired, orange juice can be added to the drink to give it flavor. If the child is taking Movicol Pediatric Neutral Flavor for fecal impaction, it will be easier to dissolve 12 sachets in 750 ml of water.

Duration of Treatment:

Chronic Constipation:

Treatment should be continued for at least 6-12 months.

Fecal Impaction:

Treatment with Movicol Pediatric Neutral Flavor may last up to 7 days.

If the child takes more Movicol Pediatric Neutral Flavor than they should:

If the child experiences excessive diarrhea, dehydration may occur. If this happens, stop treatment with Movicol Pediatric Neutral Flavor and give the child plenty of fluids. If you are concerned, consult your doctor or pharmacist.

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.

If you forget to give Movicol Pediatric Neutral Flavor:

Give the dose as soon as you remember.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Tell your doctor immediately and stop giving Movicol Pediatric Neutral Flavor if the child:

• experiences a severe allergic reaction that causes difficulty breathing or swelling of the face, lips, tongue, or throat.

Very Common Side Effects (affect more than 1 in 10 people)

• stomach pain
• stomach noises

Common Side Effects (affect more than 1 in 100 but less than 1 in 10 people)

• diarrhea
• vomiting
• nausea
• anal discomfort (uncomfortable feeling around the anus)

If the child is being treated for chronic constipation, diarrhea usually improves if the dose is reduced.

Uncommon Side Effects (affect more than 1 in 1,000 but less than 1 in 100 people)

• bloating
• gas

Rare Side Effects (affect less than 1 in 1,000 people)

• Allergic reactions, which may include difficulty breathing.

Other reported side effects include:

skin rash (hives), itching, redness of the skin, or urticaria, swelling of hands, feet, or ankles, headache, indigestion, and high or low potassium levels in the blood.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Movicol Pediatric Neutral Flavor

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

Do not use this medication after the expiration date stated on the sachet and carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Once Movicol Pediatric Neutral Flavor has been dissolved in water, if the child does not take it immediately, store the solution covered and in the refrigerator (between 2°C and 8°C).

Discard any solution that has not been used within 24 hours.

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Movicol Pediatric Neutral Flavor

Each 6.9 g sachet contains:

Macrogol 3350 6.563 g

Sodium Chloride 175.4 mg

Sodium Bicarbonate 89.3 mg

Potassium Chloride 25.1 mg

Movicol Pediatric Neutral Flavor does not contain colorants, flavorings, or sweeteners.

When one sachet is dissolved in 62.5 ml (1/4 cup) of water, it contains:

Appearance of the Product and Package Contents

Movicol Pediatric Neutral Flavor is available in rectangular sachets and tubular sachets (sticks).

Movicol Pediatric Neutral Flavor is a white powder.

Movicol Pediatric Neutral Flavor is presented in cartons with 6, 8, 10, 20, 30, 40, 50, 60, or 100 sachets.

Not all pack sizes and sachet sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Norgine Healthcare B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

Manufacturer:

Norgine BV

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

or

Recipharm Höganäs AB

Sporthallsvägen 6

Höganäs, 263 35

Sweden

You can request more information about this medication from the local representative of the Marketing Authorization Holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2ª Planta

28046 Madrid

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany Macrogol Norgine Junior Neutral Pulver zur Herstellung einer Lösung zum Einnehmen

Austria MOVICOL Junior aromafrei

Belgium MOVICOL Junior Neutral

Spain Movicol Pediátrico Sabor Neutro

Finland MOVICOL Junior Plain

Ireland MOVICOL Paediatric Plain

Italy MOVICOL Bambini 6,9 g polvere per soluzione orale Senza Aroma

Luxembourg MOVICOL Junior Neutral

Malta MOVICOL Paediatric Plain

Portugal Movicol Pediátrico Sabor Neutro

Sweden Movicol Junior Neutral

Date of the last revision of this package leaflet:03/2023

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