MOVICOL PEDIATRIC CHOCOLATE FLAVOR 6.9 g ORAL SOLUTION POWDER IN SACHET

Introduction

Package Leaflet: Information for the Patient

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

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

The name of this medication is Movicol Pediatric Chocolate 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 over 2 years old, and fecal impaction (severe constipation without response to treatment) in children over 5 years old.

Movicol Pediatric Chocolate 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 Chocolate Flavor

Do not give Movicol Pediatric Chocolate 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), consult your doctor before starting to give Movicol Pediatric Chocolate Flavor.

Warnings and Precautions

When taking Movicol Pediatric Chocolate 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 Chocolate 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 given with Movicol Pediatric Chocolate Flavor.

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

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

If you need to thicken liquids for the child to swallow safely, Movicol Pediatric Chocolate Flavor may neutralize the effect of the thickener.

Pregnancy and Breastfeeding

Movicol Pediatric Chocolate 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, consult your doctor or pharmacist before administering this medication.

Movicol Pediatric Chocolate Flavor contains benzyl alcohol and sodium

Movicol Pediatric Chocolate Flavor contains 7.0 mg of benzyl alcohol per sachet.

Benzyl alcohol may cause allergic reactions.

This medication should not be used for more than one week in children under 3 years of age unless advised by your doctor or pharmacist.

Consult your doctor or pharmacist if the child has liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause side effects (metabolic acidosis).

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

3. How to take Movicol Pediatric Chocolate 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 Chocolate Flavor depends on the child's age and response to treatment.

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

Your doctor may instruct you to increase the number of sachets until the child has a satisfactory bowel movement. If the dose is increased, it should be done every two days. 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 Chocolate Flavor for fecal impaction, it must 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, you can add orange juice to the drink to give it flavor. If the child is taking Movicol Pediatric Chocolate 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 Chocolate Flavor may last up to 7 days.

If the Child Takes More Movicol Pediatric Chocolate Flavor than They Should

If the child experiences excessive diarrhea, dehydration may occur. If this happens, stop treatment with Movicol Pediatric Chocolate 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 Chocolate 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 Chocolate 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)

• Abdominal pain
• Bowel sounds

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)

• Bloated stomach
• 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 Medication Surveillance System for Human Use: 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 Chocolate Flavor

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown 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 you have dissolved Movicol Pediatric Chocolate Flavor 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. Deposit the packaging and medications you no longer need in the SIGRE Collection Point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Movicol Pediatric Chocolate Flavor

Each 6.9 g sachet contains:

Macrogol 3350 6.563 g

Sodium Chloride 175.4 mg

Sodium Bicarbonate 89.3 mg

Potassium Chloride 15.9 mg

The other ingredients (excipients) are: potassium acesulfame (E-950) and chocolate flavor (which contains benzyl alcohol (E-1519), see section 2 "Movicol Pediatric Chocolate Flavor contains benzyl alcohol and sodium").

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 Chocolate Flavor is available in rectangular and tubular sachets (sticks).

Movicol Pediatric Chocolate Flavor is a white to light brown powder.

Movicol Pediatric Chocolate 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 by contacting 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 Schokoladengeschmack

Belgium MOVICOL Junior Aroma / MOVICOL Junior Arôme

Spain Movicol Pediátrico Sabor Chocolate

Finland Movicol Junior Chocolate

Ireland Movicol Paediatric Chocolate flavour

Italy MOVICOL Bambini 6,9 g polvere per soluzione orale gusto Cioccolato

Portugal Movicol Pediátrico Chocolate

Sweden Movicol Junior Choklad

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 Health Products (AEMPS) http://www.aemps.gob.es