Movicol Pediatric Chocolate 6.9 g powder for oral solution in sachet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Movicol Pediatric Chocolate Flavor 6.9 g powder for oral solution in sachet

Macrogol 3350, Sodium chloride, Sodium bicarbonate, Potassium chloride

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

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

Leaflet contents

1. What Movicol Pediatric Chocolate Flavor is and what it is 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 adverse effects
5. How to store Movicol Pediatric Chocolate Flavor
6. Contents of the pack and other information

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

The name of this medicine is Movicol Pediatric Chocolate Flavour 6.9 g powder for oral solution in sachet. This medicine belongs to a group of medicines known as osmotic laxatives and is indicated for the treatment of constipation in children over 2 years of age, and for fecal impaction (severe constipation unresponsive to treatment) in children over 5 years of age.

Movicol Pediatric Chocolate Flavour 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 substances or to any of the other components of this medicine (listed in section 6).

If the child has a heart or kidney condition, a swallowing reflex disorder, or reflux esophagitis (heartburn caused by stomach contents flowing back into the esophagus), you should consult with 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 the child's normal fluid intake.

Other medicines and Movicol Pediatric Chocolate Flavor

Inform your doctor if the child is taking, has recently taken, or might need to take any other medicines.

Some medicines, such as antiepileptics, may be less effective when administered together with Movicol Pediatric Chocolate Flavor.

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

The child should not take any other oral medicines from one hour before up to one hour after taking Movicol Pediatric Chocolate Flavor.

If you need to thicken liquids to swallow them safely, Movicol Pediatric Chocolate Flavor may neutralize the thickening agent's effect.

Pregnancy and breastfeeding

Movicol Pediatric Chocolate Flavor may be taken during pregnancy and breastfeeding.

If the girl is pregnant or breastfeeding, thinks she may be pregnant, or plans to become pregnant, consult your doctor or pharmacist before administering this medicine.

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 medicine should not be used for longer than one week in children under 3 years of age unless directed 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 may accumulate in the body and cause adverse effects (metabolic acidosis).

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

3. How to take Movicol Pediatric Chocolate Flavor

This medicine can be taken at any time of day, with or without food.

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

Chronic constipation

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

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

Your doctor may instruct you to increase the number of sachets until the child achieves adequate bowel movements. If the dose is increased, it should be done every two days. More than 4 sachets per day is rarely needed.

It is not necessary to drink the entire solution at once. If preferred, the child may take half of the solution in the morning and half in the evening.

Fecal impaction

Before administering Movicol Pediatric Chocolate Flavor for fecal impaction, a medical diagnosis confirming this condition in the child must be established.

Daily dosing regimen:

The daily number of sachets should be taken in divided doses, all consumed within 12 hours (for example, from 8 a.m. to 8 p.m.). Each sachet must be dissolved in 62.5 ml (1/4 glass) of water. Treatment may be interrupted once the medicine has taken effect. This is evident by the passage of large volumes of stools or watery diarrhea.

How to prepare:

• Open the sachet and pour the contents into a glass. Add 1/4 glass (approximately 62.5 ml) of water. Stir well until the powder has completely dissolved, resulting in a clear or slightly cloudy solution, and then give it to the child to drink.
• If desired, orange juice may be added to the drink to improve the taste. If the child is taking Movicol Pediatric Chocolate Flavor for fecal impaction, it may be easier to dissolve 12 sachets in 750 ml of water.

Duration of treatment:

Chronic constipation:

Treatment should continue 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 develops 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 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 adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Immediately tell your doctor and stop administering Movicol Pediatric Chocolate Flavor if the child:

• Experiences a severe allergic reaction causing difficulty breathing or swelling of the face, lips, tongue, or throat.

Very common adverse effects (affect more than 1 in 10 people)

• Abdominal pain
• Intestinal 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 for chronic constipation, diarrhea usually improves when the dose is reduced.

Uncommon adverse effects (affect more than 1 in 1,000 but less than 1 in 100 people)

• Bloating
• Gas

Rare adverse effects (affect less than 1 in 1,000 people)

• Allergic reactions, possibly including dyspnea or difficulty breathing.

Other reported adverse effects include:

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Movicol Pediatric Chocolate Flavor

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

Do not use this medicine after the expiry date stated on the sachet and carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Once Movicol Pediatric Chocolate 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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and containers. 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 components (excipients) are: potassium acesulfame (E-950) and chocolate flavor (containing 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 (a quarter of a glass) of water, it contains:

Appearance of the product and contents of the pack

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

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

Movicol Pediatric Chocolate Flavor is supplied in carton packs containing 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.

Only certain pack sizes and sachet types may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Norgine Healthcare B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
The Netherlands

Manufacturer:

Norgine BV
Antonio Vivaldistraat 150
1083 HP Amsterdam
The Netherlands

Or

Meribel Pharma Höganäs AB
Sporthallsvägen 6
263 35 Höganäs
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 under the following names:

Germany Macrogol Norgine Junior Chocolate Flavor
Belgium MOVICOL Junior Flavor /MOVICOL Junior Arôme
Spain Movicol Pediatric Chocolate Flavor
Finland Movicol Junior Chocolate
Ireland Movicol Paediatric Chocolate flavour
Italy MOVICOL Bambini 6,9 g powder for oral solution, chocolate flavor
Portugal Movicol Pediatric Chocolate
Sweden Movicol Junior Choklad

Date of most recent revision of this leaflet: 03/2023

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