Leaflet: information for the patient

Movicol Paediatric Chocolate Flavour6.9 goral solution powder 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.

- 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 side effects, consult your doctor, pharmacist or nurse, even if they do not appear in this leaflet.See section 4.

1. What is Movicol Paediatric Chocolate Flavour and what it is used for

2. What you need to know before starting to give Movicol Paediatric Chocolate Flavour

3. How to take Movicol Paediatric Chocolate Flavour

4. Possible side effects

5. Storage of Movicol Paediatric Chocolate Flavour

6. Contents of the pack and additional information

The name of this medicine is Movicol Pediátrico Sabor Chocolate6,9 gpowder for oral solution in sachet. This medicine, belongs to the group of medicines known as osmotic laxatives and is indicated in the treatment of constipation in children over 2 years, and fecal impaction (very strong constipation without response to treatment) in children over 5 years.

MovicolPediátrico Sabor Chocolate helps the child to have a comfortable intestinal evacuation even if they have been constipated for a long time.

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

• an intestinal blockage (intestinal obstruction, ileus),
• intestinal wall perforation,
• 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 alteration, or gastroesophageal reflux (stomach burning caused by the return flow of stomach contents into the esophagus), consult with the doctor before starting Movicol Pediátrico Sabor Chocolate.

Warnings and precautions

When taking Movicol Pediátrico Sabor Chocolate, the child should continue to drink plenty of liquids. The liquid content of Movicol does not replace the child's usual liquid intake.

Other medications and Movicol Pediátrico Sabor Chocolate

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

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

When large volumes of Movicol Pediátrico Sabor Chocolate 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 Chocolate.

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

Pregnancy and breastfeeding

Movicol Pediátrico Sabor Chocolate 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 with the doctor or pharmacist before administering this medication.

Movicol Pediátrico Sabor Chocolate contains alcohol bencílico and sodium

Movicol Pediátrico Sabor Chocolate contains 7.0 mg of alcohol bencílico per sachet.

Alcohol bencílico may cause allergic reactions.

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

Consult with the doctor or pharmacist if the child has liver or kidney diseases. This is because large amounts of alcohol bencílico may accumulate in the body and cause adverse effects (metabolic acidosis).

Movicol Pediátrico Sabor Chocolate 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 dose of Movicol Pediatric Chocolate Flavor depends on the child's age and their response to treatment.

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

Your doctor may instruct you to increase the number of sachets until the child has an adequate bowel evacuation. 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 is in this condition.

Daily dosing 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. The treatmentcan 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 serve it 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 750ml of water.

Treatment duration:

Chronic Constipation:

The treatment should be prolonged for at least 6-12 months.

Fecal Impaction:

The treatment with Movicol Pediatric Chocolate Flavor can 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, interrupt the treatment with Movicol PediatricChocolate Flavorand 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to give MovicolPediatric Chocolate 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 Chocolate 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)

• Abdominal pain
• Gut sounds

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 for chronic constipation, diarrhea usually improves if the dose is reduced.

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

• Swollen stomach
• Gas

Rare 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 Medicinal Products 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 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).

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. In this way, you will help protect the environment.

Composition of Movicol Paediatric Chocolate Flavour

Each sachet of6.9 gcontains:

Macrogol 33506.563 g

Sodium chloride175.4 mg

Sodium bicarbonate89.3 mg

Potassium chloride15.9 mg

The other components (excipients) are: potassium acesulfame (E-950) and chocolate aroma (which contains benzyl alcohol (E-1519), see section 2 “Movicol Paediatric Chocolate Flavour contains benzyl alcohol and sodium”).

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

Appearance of the product and contents of the pack

Movicol Paediatric Chocolate Flavour is available in rectangular sachets and in tubular sachets (sticks).

Movicol Paediatric Chocolate Flavour is a white to light brown powder.

Movicol Paediatric Chocolate Flavour is presented in boxes containing 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.

Only some pack sizes and sachet sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Marketing authorisation holder:

Norgine Healthcare B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

Manufacturer responsible::

Norgine BV

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

Or

Recipharm Höganäs AB

Sporthallsvägen 6

Höganäs, 263 35

Sweden

Further information on this medicinal product can be obtained by contacting 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 medicinal product is authorised in the Member States of the European Economic Area with the following names:

GermanyMacrogol Norgine Junior Schokoladengeschmack

BelgiumMOVICOL Junior Aroma/MOVICOL Junior Arôme

SpainMovicol Paediatric Chocolate Flavour

FinlandMovicol Junior Chocolate

IrelandMovicol Paediatric Chocolate flavour

ItalyMOVICOL Bambini 6.9 g powder for oral solution chocolate flavour

PortugalMovicol Paediatric Chocolate

SwedenMovicol Junior Choklad

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

Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es