Patient Information Leaflet
MOVICOL® Paediatric Plain 6.9g sachet, powder for oral solution
Please read all of this leaflet carefully before taking your medicine.
- Keep this leaflet. You may need to read it again.
- If you have any questions or are unsure about anything, ask your doctor or pharmacist.
If you need the information on this leaflet to be supplied in an alternative format , such as large print, please ring Medical Information. From the UK 01895 826 606. From Ireland 00 44 1895 826 606.
In this leaflet:
- 1.What is MOVICOL Paediatric Plain and what is it used for?
- 2.Before you take MOVICOL Paediatric Plain
- 3.How to take MOVICOL Paediatric Plain
- 4.Possible side effects
- 5.Storing MOVICOL Paediatric Plain
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1. What is MOVICOL Paediatric Plain and what is it used for?
The name of this medicine is MOVICOL Paediatric Plain 6.9g sachet, powder for oral solution. It is a laxative for the treatment of chronic constipation in children aged 2 to 11 years and for the treatment of very bad constipation called faecal impaction in children aged 5 to 11 years. For children over 12 years of age it is recommended to use MOVICOL 13.8g sachet, powder for oral solution.
MOVICOL Paediatric Plain helps you to have a comfortable bowel movement even if you have been constipated for a long time.
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2. Before you take MOVICOL Paediatric Plain
Do not take MOVICOL Paediatric Plain if your doctor has told you that you have:
- a blockage in your intestine (gut)
- a perforated gut wall
- severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic megacolon
- paralysis of the bowel
- impaired heart or kidney function
- an allergy to any of the ingredients
Taking MOVICOL Paediatric Plain with food and drink
This medicine can be taken at any time with or without food or drink.
Pregnancy and breast feeding
If your child is pregnant or breast feeding talk to your doctor before giving MOVICOL Paediatric Plain.
Driving and using machines
MOVICOL Paediatric Plain does not affect your ability to drive or use machines.
Tell your doctor about any other medicines you are taking.
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3. How to take MOVICOL Paediatric Plain
Chronic Constipation:
The dose of MOVICOL Paediatric Plain depends on the age of the child and their response to treatment. As a starting dose children aged 2 to 6 should be given 1 sachet each day, and 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. This does not normally need more than 4 sachets taken in one day.
The dose should be adjusted up or down as required to product soft, regular stools. If the child gets very loose stools or diarrhoea the dose of MOVICOL Paediatric Plain should be reduced by 1 sachet (if they are taking 2 or more sachets a day) or a day’s treatment is missed out if they are taking 1 sachet a 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:
A course of treatment with MOVICOL Paediatric Plain is as follows:
Daily dosage regimen:
- Age 5 - 11 (years)
- Day 1: 4 MOVICOL Paediatric Plain sachets
- Day 2: 6 MOVICOL Paediatric Plain sachets
- Day 3: 8 MOVICOL Paediatric Plain sachets
- Day 4: 10 MOVICOL Paediatric Plain sachets
- Day 5: 12 MOVICOL Paediatric Plain sachets
- Day 6: 12 MOVICOL Paediatric Plain sachets
- Day 7: 12 MOVICOL Paediatric Plain sachets
The daily number of sachets should be taken in divided doses, all consumed within 12 hours (e.g. 8 am – 8pm). Treatment can be stopped when the medicine has worked. This is shown by the patient passing large volumes of stool and/or watery diarrhoea.
Open the sachet and pour the contents into a glass. Add a quarter of a glass (62.5ml) of water. Stir well until all the powder has dissolved and the MOVICOL Paediatric Plain solution is clear or slightly hazy, then drink it. If you like you can add a flavour such as orange squash to the drink. If your child is taking MOVICOL Paediatric Plain for faecal impaction it may be easier to dissolve 8 sachets in 500ml (about 1 pint) of water.
Duration of treatment
Chronic Constipation:
Treatment of children with chronic constipation needs to be for a prolonged period (at least 6 – 12 months).
Faecal impaction:
Treatment with MOVICOL Paediatric Plain can be for up to 7 days.
If you take more MOVICOL Paediatric Plain than you should
You may develop diarrhoea. Stop taking MOVICOL Paediatric Plain until it clears, and then start again at a lower dose. If you are worried contact your doctor or pharmacist.
If you forget to take MOVICOL Paediatric Plain
Take the dose as soon as you remember to take it.
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4. Possible side effects
Like all medicines, MOVICOL Paediatric Plain can have side effects.
Sometimes children have stomach ache or rumbles or feel bloated, sick or have diarrhoea, this is most likely to occur when MOVICOL Paediatric Plain is given in high doses to treat faecal impaction. If your child is feeling sick or vomits do not stop giving the medicine but give it more slowly throughout the day. Allergic reactions can occur but are very rare. If any of the above are troublesome or last more than a few days tell your doctor or pharmacist.
If your child feels weak, breathless, very thirsty with a headache or get puffy ankles stop taking MOVICOL Paediatric Plain and tell your doctor immediately.
If you notice any side effects not mentioned in this leaflet please inform your doctor or pharmacist.
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5. Further Information
Keep all medicines out of the reach and sight of children
Do not use MOVICOL Paediatric Plain after the expiry date on the sachet and carton.
Do not store your MOVICOL Paediatric Plain sachets above 25°C.
Once you have made up MOVICOL Paediatric Plain in water, if your child cannot drink it straight away keep it covered and in the fridge (2°C – 8°C). Throw away any solution not used in a 24 hour period.
Each 6.9g sachet of MOVICOL Paediatric Plain contains the following active ingredients:
- Macrogol 3350: 6.563 g
- Sodium chloride: 0.1754 g
- Sodium bicarbonate: 0.0893 g
- Potassium chloride: 0.0251 g
MOVICOL Paediatric Plain contains no colours, flavours, or sweeteners.
When it is made into a drink with a quarter of a glass (62.5ml) of water each sachet gives the equivalent of:
- Sodium: 65 mmol/l
- Chloride: 53 mmol/l
- Bicarbonate: 17 mmol/l
- Potassium: 5.4 mmol/l
MOVICOL Paediatric Plain 6.9g sachet, powder for oral solution is available in boxes of 20 or 30 sachets.
UK Marketing authorisation holder:
Norgine Pharmaceuticals Ltd
Moorhall Rd
Harefield
Middx
UB9 6NS
U.K.
IE Marketing authorisation holder:
Norgine Ltd
Moorhall Rd
Harefield
Middx
UB9 6NS
U.K.
Manufacturer:
Norgine Ltd
New Road
Hengoed
Mid Glamorgan
CF82 8SJ
U.K.
This medicine is available in the countries listed under the following trade names:
- Austria and Germany: MOVICOL Junior aromafrei
- Belgium and Sweden: MOVICOL Junior Neutral
- Finland: MOVICOL Junior Plain
- Italy: MOVICOL Pediátrico senza aroma
- Spain: MOVICOL Pediátrico Sabor Neutro
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Date approved: March 2008