Movicol Pediatrico sabor neutro 6.9 g powder for oral solution in sachet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Movicol Pediatric Neutral Flavour 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 the child; do not give it to other people, 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 these are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Movicol Pediatric Neutral Flavour is and what it is used for
2. What you need to know before starting to give Movicol Pediatric Neutral Flavour
3. How to take Movicol Pediatric Neutral Flavour
4. Possible adverse effects
5. How to store Movicol Pediatric Neutral Flavour
6. Contents of the pack and other information

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

The name of this medicine is Movicol Pediatric Neutral 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 aged 1 to 11 years, and for faecal impaction (severe constipation unresponsive to treatment) in children aged 5 to 11 years.

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

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

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

• 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 substances or to any of the other components of this medicine (listed in section 6).

If the child has a heart or kidney condition, impaired swallowing reflex, or reflux esophagitis (heartburn caused by stomach contents flowing back into the esophagus), you should consult with the doctor before starting Movicol Pediatric Neutral Flavor.

Warnings and precautions

While taking Movicol Pediatric Neutral 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 Neutral Flavor

Tell 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 taken together with Movicol Pediatric Neutral Flavor.

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

The child should not take any other oral medicines from one hour before until one hour after taking Movicol Pediatric Neutral Flavor.

If you need to thicken liquids for safe swallowing, Movicol Pediatric Neutral Flavor may neutralize the effect of the thickening agent.

Pregnancy and breastfeeding

Movicol Pediatric Neutral 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 her doctor or pharmacist before using this medicine.

Movicol Pediatric Neutral Flavor contains sodium

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

3. How to take Movicol Pediatric Neutral 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 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 aged 1 to 6 years should take 1 sachet of 6.9 grams (=1 dose) per day.
• Children aged 7 to 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 increasing the dose, this should be done every two days. Children under 2 years of age should not take more than 2 sachets per day. In children aged 2 to 11 years, more than 4 sachets per day is usually not necessary.

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 afternoon.

Fecal impaction

Before a child takes Movicol Pediatric Neutral Flavor for fecal impaction, a medical professional must confirm that the child actually has this condition.

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 should be dissolved in 62.5 ml (1/4 glass) of water. Treatment may be interrupted once the medicine has taken effect. This is indicated 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 glass (approximately 62.5 ml) of water. Stir well until the powder is completely dissolved, resulting in a clear or slightly cloudy solution, and then have the child drink it.

If desired, orange juice may be added to the drink to improve the taste. If the child is taking Movicol Pediatric Neutral 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 Neutral Flavor may last up to 7 days.

If the child takes more Movicol Pediatric Neutral Flavor than prescribed:

Excessive diarrhea may lead to dehydration. If this occurs, 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Immediately tell your doctor and stop administering Movicol Pediatric Neutral 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)

• stomach pain
• stomach rumbling

Common adverse effects (affect more than 1 in 100 but fewer than 1 in 10 people)

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

If the child is being treated for chronic constipation, diarrhoea usually improves when the dose is reduced.

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

• bloated stomach
• flatulence

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

• Allergic reactions, which may include dyspnoea 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 notice any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Neutral 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 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.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other 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 (a quarter of a glass) of water, it contains:

Appearance of the medicinal product and contents of the pack

Movicol Pediátrico Sabor Neutro is available in rectangular sachets and tubular sachets (sticks).

Movicol Pediátrico Sabor Neutro is a white powder.

Movicol Pediátrico Sabor Neutro is supplied in cartons 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 on 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 European Economic Area member states under the following names:

Germany Macrogol Norgine Junior Neutral Powder for oral solution

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 most recent review 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