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 this leaflet carefully before starting to give this medicine to the child, as it contains important information for the child.

- Keep this leaflet, as you may need to read it again.

- If you have any doubts, consult your doctor, pharmacist or nurse.

- This medicine has been prescribed only for the child, and should not be given to other people even if they have the same symptoms as the child, as it may harm them.

- If the child experiences any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What isMovicol Pediatric Neutral Flavorand what it is used for

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

3. How to takeMovicol Pediatric Neutral Flavor

4. Possible side effects

5. Storage ofMovicol Pediatric Neutral Flavor

6. Contents of the pack and additional information

The name of this medication is Movicol Pediatric Neutral Flavor6,9 gpowder for oral solution in a 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, and fecal impaction (very severe constipation without response to treatment) in children from 5 to 11 years.

Movicol Pediatric Neutral Flavor helps the child to have a comfortable intestinal evacuation evenif they have been constipated for a long time.

Do not give Movicol Pediátrico Sabor Neutro if the child has:

• a bowel obstruction (intestinal blockage, ileus),
• perforation of the intestinal wall,
• a severe inflammatory intestinal disease, such as ulcerative colitis, Crohn's disease, or toxic megacolon,
• intestinal paralysis,
• an 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 alteration, or gastroesophageal reflux esophagitis (stomach burning caused by the return flow of stomach contents into the esophagus), consult with their doctor before starting to give Movicol Pediátrico Sabor Neutro.

Warnings and precautions

When taking Movicol Pediátrico Sabor Neutro, they should continue to drink plenty of liquids. The liquid content of Movicol does not replace their usual intake of liquids.

Other medications and Movicol Pediátrico Sabor Neutro

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

Some medications, such as antiepileptics, may not be as effective when taken with Movicol Pediátrico Sabor Neutro.

When large volumes of Movicol Pediátrico Sabor Neutro are taken (for example, for fecal impaction), other medications may be eliminated through the digestive system.

The child should not take other oral medications from one hour before to one hour after taking Movicol Pediátrico Sabor Neutro.

If you need to thicken liquids to safely swallow them, Movicol Pediátrico Sabor Neutro may neutralize the thickening effect.

Pregnancy and breastfeeding

Movicol Pediátrico Sabor Neutro can be taken during pregnancy and breastfeeding.

If the woman is pregnant or breastfeeding, believes she may be pregnant, or intends to become pregnant, consult their doctor or pharmacist before administering this medication.

Movicol Pediátrico Sabor Neutro contains sodium

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

This medication can be taken at any time without the need to accompany it with food.

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

Chronic Constipation

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

• As an initial dose, children aged 1 to 6 years should take 1 sachet of6.9 grams(=1 dose) per day.
• Children aged 7 to 11 years, 2 sachets of6.9 gramsper day.

Your doctor may instruct you to increase the number of sachets until the child has an adequate bowel movement. If the dosage is increased, it should be done every two days.Children under 2 years old should not take more than 2 sachets per day.In children aged 2 to 11 years, 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 must be medically confirmed that the child is in this condition.

Daily dosage schedule:

The daily number of sachets should be taken in divided doses, all consumed within 12 hours (for example, from 8 in the morning to 8 in the evening). Each sachet should be dissolved in 62.5ml (1/4 of a glass) of water. Treatment can be interrupted when the medication has taken effect. This is evident by the deposition of large volumes of feces or watery diarrhea.

How to prepare:

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

If desired, you can add orange juice 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 750ml of water.

Treatment duration:

Chronic Constipation:

Treatment should be prolonged 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, interrupt the treatment with Movicol Pediatric Neutral Flavor and give the child plenty of fluids. If you are concerned, consult with your doctor or pharmacist.

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 forgot to give MovicolPediatric Neutral Flavor:

Give the dose as soon as you remember that you have to take it.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Inform your doctor immediately and stop administering Movicol Pediatric Unflavored if the child:

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

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

• stomach pain
• gastrointestinal noises

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

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

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

Rare Adverse Effects (affect more than 1 in 1,000 but less than 1 in 100 people)

• swollen stomach
• gas

Uncommon Adverse Effects (affect less than 1 in 1,000 people)

• Allergic reactions, which may include shortness of breath or difficulty breathing.

Other reported adverse effects include:

skin rash (urticaria), itching, skin redness or urticaria, hand, foot, or ankle inflammation, headaches, indigestion, and high or low potassium levels in the blood.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and the box 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 Neutral 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).

Dispose of any solution that has not been used within 24 hours.

Medications should not be thrown down the drain or in the trash. Deposit the containers and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Movicol Pediatric Neutral Flavor Composition

Each sachet of6.9 gcontains:

Macrogol 33506.563 g

Sodium Chloride175.4 mg

Sodium Bicarbonate89.3 mg

Potassium Chloride25.1 mg

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

When one sachet is dissolved in 62.5 ml (a quarter of a glass) of water, it contains:

Product Appearance and Packaging Contents

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

Movicol Pediatric Neutral Flavor is a white powder.

Movicol Pediatric Neutral Flavor is packaged in boxes containing 6, 8, 10, 20, 30, 40, 50, 60, or 100 sachets.

Only some packaging sizes and sachet sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Norgine Healthcare B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

Responsible Manufacturer::

Norgine BV

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

Or

Recipharm Höganäs AB

Sporthallsvägen 6

Höganäs, 263 35

Sweden

For further information about this medicinal product, 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 medicinal product is authorized in the Member States of the European Economic Area with the following names:

GermanyMacrogol Norgine Junior Neutral Powder for the Preparation of a Solution for Oral Administration

AustriaMOVICOL Junior Aroma-Free

BelgiumMOVICOL Junior Neutral

SpainMovicol Pediatric Neutral Flavor

FinlandMOVICOL Junior Plain

IrelandMOVICOL Paediatric Plain

ItalyMOVICOL Bambini 6.9 g Powder for Oral Solution Without Flavor

LuxembourgMOVICOL Junior Neutral

MaltaMOVICOL Paediatric Plain

PortugalMovicol Pediatric Neutral Flavor

SwedenMovicol Junior Neutral

Last review date of this leaflet:03/2023

For detailed information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es