MOVICOL Paediatric Chocolate flavour 6.8g powder for oral solution

• 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.

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

• a blockage in their intestine (gut obstruction, ileus)
• a perforated gut wall
• severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic megacolon
• an allergy to the active substances or any of the other ingredients of Movicol Paediatric Chocolate flavour (listed in section 6).

If your child has a heart or kidney problem, an impaired gag reflex or reflux oesophagitis (heart-burn caused by back-flow of stomach contents into the oesophagus), you should talk to your doctor before giving Movicol Paediatric Chocolate flavour.

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.

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), other medicines may be flushed through your digestive system.

Your child should not take any other medicines by mouth together with Movicol Paediatric Chocolate flavour and for one hour before and for one hour after taking Movicol Paediatric Chocolate flavour.

If you need to thicken fluids in order to swallow them safely, Movicol Paediatric Chocolate flavour may counteract the effect of the thickener.

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 flavour 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 flavour 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.

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.

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:

Patients aged 5-11 years, should take on Day 1, 4 sachet of Movicol Paediatric Chocolate flavour sachets; on Day 2, 6 sachet of Movicol Paediatric Chocolate flavour sachets; on Day 3, 8 sachet of Movicol Paediatric Chocolate flavour sachets; on Day 4, 10 sachet of Movicol Paediatric Chocolate flavour sachets; on Day 5, 12 sachet of Movicol Paediatric Chocolate flavour sachets; on Day 6, 12 sachet of Movicol Paediatric Chocolate flavour sachets; and one Day 7, 12 sachet of Movicol Paediatric Chocolate flavour 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.

• 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.

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.

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.

Give the dose as soon as you remember.

• 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.

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.

Each 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

Movicol Paediatric Chocolate flavour is available in rectangular sachets and tubular (stickpack) sachets.

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 sachets and pack sizes may be marketed.

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