Movicol Junior Chocolate | Macrogol 3350, sodium chloride, sodium bicarbonate and potassium chloride | uses, dose and side effects

The name of this medicine is Movicol Junior Chocolate. It is a laxative for the treatment of chronic constipation in children from 2 to 11 years and for the treatment of very severe constipation (so-called fecaloma) in children from 5 to 11 years.

Movicol Junior Chocolate helps children to have a pleasant bowel function even if they have been constipated for a long time.

Macrogol 3350, sodium chloride, sodium bicarbonate, and potassium chloride contained in Movicol Junior Chocolate may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before giving Movicol Junior Chocolate

Do not give Movicol Junior Chocolate if your doctor has told you that your child has

narrowing of the intestine (intestinal obstruction, ileus )
ulcers in the intestinal wall
severe inflammatory bowel disease such as ulcerative colitis, Crohn’s disease or toxic megacolon
allergy to active substances or any of the other ingredients of this medicine (listed in section 6).

If your child has heart or kidney problems, vomiting reflex, or reflux esophagitis (heartburn caused by a reflux of stomach contents to the esophagus), you should talk to your doctor before giving Movicol Junior Chocolate.

Warnings and cautions

When your child takes Movicol Junior Chocolate, the child should continue to drink a lot. The liquid in Movicol Junior Chocolate should not replace your child’s normal fluid intake.

Other medicines and Movicol Junior Chocolate

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.

Some medications, e.g. against epilepsy, may be less effective when using Movicol Junior Chocolate.

When your child takes large amounts of Movicol Junior Chocolate (eg with fecaloma), your child should not take any other medicines within one hour before or after taking Movicol Junior Chocolate.

If you need to thicken liquids to be able to swallow them safely, Movicol Junior Chocolate can counteract the effect of the thickener.

Pregnancy and breastfeeding

Movicol Junior Chocolate can be used during pregnancy and breastfeeding. Ask your pharmacist or doctor for advice before taking Movicol Junior Chocolate.

Movicol Junior Chocolate contains benzyl alcohol and sodium

Movicol Chocolate contains 7.0 mg benzyl alcohol per sachet. Benzyl alcohol can cause allergic reactions.

Do not use Movicol Junior Chocolate for more than a week for children under 3 years of age, unless your doctor or pharmacist recommends it.

Consult your doctor or pharmacist if your child has impaired liver or kidney function. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).

Movicol Junior Chocolate contains 93.4 mg of sodium (the main ingredient in table salt/table salt) per sachet. This corresponds to 4.6% of the recommended maximum daily intake of sodium for an adult.

How to give Movicol Junior Chocolate

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

This medicine can be given at any time with or without food.

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

Chronic constipation:

The dose of a Movicol Junior Chocolate depends on the age of the child and how it responds to the treatment.

As a starting dose, 1 sachet (= 1 dose ) should be given daily to children from 2 to 6 years of age.
2 sachets daily should be given to children from 7 to 11 years.
Your doctor may ask you to increase the number of sachets until your child has a soft stool. Normally no more than 4 sachets per day are needed.

It is not necessary to take the whole drink at the same time, if your child prefers, half the drink can be taken in the morning and a half in the evening.

Fecal:

Before your child takes Movicol Junior Chocolate for feces, it should be medically confirmed that your child has this condition.

A treatment regimen with Movicol Junior Chocolate is as follows:

Age	Day 1	Day 2	Day 3	Day 4	Day 5	Day 6	Day 7
5-11	4	6	8	10	12	12	12

The daily number of sachets must be divided into several occasions. All doses should be taken within 12 hours (eg 08: 00-20: 00). Each sachet is dissolved in 62.5 ml (1/4 glass) of water. Treatment can be stopped when the medicine has worked. This is shown by the fact that your child has large amounts of feces and/or watery diarrhea.

Instructions for use

Open the sachet and dissolve the contents of a quartz (¼) glass of water (approx. 62.5 ml). Stir well until all the powder has dissolved and the Movicol Junior Chocolate solution is clear or slightly cloudy, then let your child drink.
If you want, you can add some seasoning to the drink, e.g. orange juice. If your child takes Movicol Junior Chocolate for the treatment of fecal matter, it may be easier to dissolve 12 bags in 750 ml of water.

Length of treatment

Chronic constipation:

The treatment must last for a longer period, at least 6-12 months.

Fecal:
Treatment with Movicol Junior Chocolate can be up to 7 days.

If your child has been given too much Movicol Junior Chocolate

Your child may have diarrhea. Stop giving Movicol Junior Chocolate until diarrhea subsides and then continue with a lower dose.

If you forget to give your child Movicol Junior Chocolate

Give dose one as soon as you remember.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately and stop giving Movicol Junior Chocolate to your child:

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

Very common side effects (affects more than 1 person in 10)

abdominal pain
stomach noise

Common side effects (affects more than 1 in 100 people but less than 1 in 10 people)

diarrhea
vomiting
nausea
anal discomfort (uncomfortable feeling in the ass)
tenderness in the tail

If your child is being treated for chronic constipation, diarrhea usually improves when a dose is reduced.

Uncommon side effects (affects more than 1 in 1,000 people but less than 1 in 100 people)

swollen stomach
gases

Rare side effects (affects less than 1 in 1,000 people)

allergic reactions that may include shortness of breath or difficulty breathing.

Other reported side effects:

Skin rash ( hives ), itching, reddening or hives, swollen hands, feet or ankles, headache, stomach upset, high or low potassium levels in the blood.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Movicol Junior Chocolate

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

Do not use this medicine after the expiry date which is stated on the sachet and carton after EXP.
The expiration date is the last day of the specified month.
No special storage instructions.
Once you have mixed Movicol Junior Chocolate with water and your child cannot drink it immediately, it can be covered and stored in the refrigerator (2 ° C – 8 ° C). Solution not used within 24 hours should be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

Each 6.9-gram sachet of Movicol Junior Chocolate Powder for oral solution contains the following active substances: Show larger

Macrogol 3350Sodium chloride sodium bicarbonatePotassium chloride

6.563 g0.1754 g0.0893 g0.0159 g

Movicol Junior Chocolate contains chocolate flavor (which includes benzyl alcohol E1519 see section 2 Movicol Junior Chocolate contains benzyl alcohol and sodium ) and acesulfame potassium (E950) as sweeteners.

When a sachet is mixed with a glass of water (62.5 ml), the solution contains:

SodiumChlorideHydrocarbonatePotassium

65 mmol / liter51 mmol / liter17mmol / liter5.4 mmol / liter

What the medicine looks like and contents of the pack

Movicol Junior Chocolate is a white to light brown powder

Movicol Junior Chocolate is available in packs of 6, 8, 10, 20, 30, 40, 50, 60, or 100 sachets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Norgine BV

Antonio Vivaldi Street 150

1083 HP Amsterdam

Netherlands

Manufacturer

Norgine Ltd.

New Road

Hengoed, Mid Glamorgan CF82 8SJ