MOVICOL Paediatric Chocolate flavour

Read all of this leaflet carefully before you start to give this medicine to your child because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s.
• If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Movicol Paediatric Chocolate flavour is and what it is used for
2. What you need to know before you give Movicol Paediatric Chocolate flavour
3. How to give Movicol Paediatric Chocolate flavour
4. Possible side effects
5. How to store Movicol Paediatric Chocolate flavour
6. Contents of the pack and other information

Warnings and precautions

When taking Movicol Paediatric Chocolate flavour you should continue to take plenty of fluids. The fluid content of Movicol should not replace your regular liquid intake.

Other medicines and Movicol Paediatric Chocolate flavour

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

Some medicines, e.g. anti-epileptics, may not work as effectively during use with Movicol Paediatric Chocolate flavour.

When taking large volumes of Movicol Paediatric Chocolate flavour (e.g. for faecal impaction), your child should not take other medicines within one hour of taking Movicol Paediatric Chocolate flavour.

Pregnancy and breast feeding

Movicol Paediatric Chocolate flavour can be given during pregnancy and whilst breastfeeding. Ask your pharmacist or doctor for advice before giving Movicol Paediatric Chocolate flavour.

Movicol Paediatric Chocolate contains benzyl alcohol

Movicol Paediatric Chocolate contains 7.0 mg of benzyl alcohol per sachet. Benzyl alcohol may cause allergic reactions.

Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist.

Ask your doctor or pharmacist for advice if your child has a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in the body and may cause side effects (called “metabolic acidosis”).

Movicol Paediatric Chocolate contains 93.4 mg sodium (main component of cooking/table salt) per sachet This is equivalent to 4.6% of the recommended maximum daily dietary intake of sodium for an adult.

Chronic Constipation:

The dose of Movicol Paediatric Chocolate flavour depends on the age of the child and their response to treatment.

• As a starting dose, children aged 2 to 6 years should be given 1 sachet (=1 dose) each day.
• Children aged 7 to 11 should be given 2 sachets each day.

Your doctor may tell you to increase the number of sachets taken until your child has a soft bowel movement. If the dose does need increasing, this should be done every other day. Normally, no more than 4 sachets are required to be taken in one day.

It is not necessary to take all of the drink at one time, if the child prefers it, half the drink can be taken in the morning and half in the evening.

Faecal impaction:

Before your child takes Movicol Paediatric Chocolate flavour for faecal impaction, it should be confirmed medically that your child has this condition.

A course of treatment with Movicol Paediatric Chocolate flavour is as follows:

Number of Movicol Paediatric Chocolate flavour sachets

For Children age 5 to 11

Day 1 = 4 sachets

Day 2 = 6 sachets

Day 3 = 8 sachets

Day 4 = 10 sachets

Day 5 = 12 sachets

Day 6 = 12 sachets

Day 7 = 12 sachets

The daily number of sachets should be taken in divided doses, all taken within 12 hours (e.g. 8am – 8pm). Each sachet dissolved in 62.5 ml (1/4 of a glass) of water. Treatment can be stopped when the medicine has worked. This is shown by your child passing large volumes of stool and/or watery diarrhoea.

How to mix

• Open the sachet and pour the contents into a glass. Add ¼ glass (about 62.5ml) of water to the glass. Stir well until all the powder has dissolved and the Movicol Paediatric Chocolate flavour solution is clear or slightly hazy, then give it to your child to drink.
• If you like you can add a flavour such as orange squash to the drink. If your child is taking Movicol Paediatric Chocolate flavour for faecal impaction it may be easier to dissolve 12 sachets in 750ml of water.

Duration of treatment:

Chronic constipation:

Treatment needs to be for a prolonged period of time, at least 6 – 12 months.

Faecal impaction:

Treatment with Movicol Paediatric Chocolate flavour can be for up to 7 days.

If your child takes more Movicol Paediatric Chocolate flavour than they should:

Your child may develop excessive diarrhoea, which can lead to dehydration. If this occurs, stop taking Movicol Paediatric Chocolate flavour and drink plenty of fluids. If you are worried contact your doctor or pharmacist.

If you forget to give Movicol Paediatric Chocolate flavour:

Give the dose as soon as you remember.

Tell your doctor immediately and stop giving Movicol Paediatric Chocolate flavour if your child:

• gets a serious allergic reaction which causes difficulty in breathing or swelling of the face, lips, tongue or throat.

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

• stomach pains
• stomach rumbles

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

• diarrhoea
• vomiting (being sick)
• nausea (feeling sick)
• anal discomfort (uncomfortable sensation around the bottom).

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

Uncommon side effects (more than 1 in 1000 but less than 1 in 100 people):

• swollen stomach
• wind

Rare side effects (less than 1 person in 1000)

• allergic reactions, which may include breathlessness or difficulty in breathing

Other side effects reported include:

Skin rash (hives), itching, reddening of the skin or a nettle rash, swollen hands, feet or ankles, headaches, indigestion, high or low levels of potassium in the blood.

Reporting of side effects

If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

What Movicol Paediatric Chocolate flavour contains

Each 6.9g sachet of Movicol Paediatric Chocolate flavour powder for oral solution contains the following:

Macrogol 3350 6.563 g

Sodium Chloride 0.1754 g

Sodium Hydrogen Carbonate 0.0893 g

Potassium Chloride 0.0159 g

Movicol Paediatric Chocolate flavour contains chocolate flavour (which includes benzyl alcohol E1519, see section 2 “MOVICOL Paediatric Chocolate contains benzyl alcohol and sodium”) and acesulfame potassium E950 as a sweetener.

When it is made into a drink with ¼ glass (62.5ml) of water, each sachet gives the equivalent of:

Sodium 65 millimoles/litre

Chloride 51 millimoles/litre

Potassium 5.4 millimoles/litre

Bicarbonate 17 millimoles/litre

What Movicol Paediatric Chocolate flavour looks like and contents of the pack

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

Movicol Paediatric Chocolate flavour is available in boxes of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.

Not all pack sizes may be marketed.

Marketing authorisation holder:

Manufacturer:

Or

Or