Movicol Paediatric Chocolate Flavour 6.9g Sachet Powder For Oral Solution
PACKAGE LEAFLET
Package leaflet: Information for the patient
MOVICOL® Paediatric Chocolate flavour 6.9g sachet, powder for oral solution
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
1. What Movicol Paediatric Chocolate flavour is and what it is used for
The name of this medicine is Movicol Paediatric Chocolate flavour 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.
Movicol Paediatric Chocolate flavour helps your child to have a comfortable bowel movement even if they have been constipated for a long time.
2. What you need to know before you give Movicol Paediatric Chocolate flavour
Do not give Movicol Paediatric Chocolate flavour if your doctor has told you that your child has:
- 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.
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.
3. How to give Movicol Paediatric Chocolate flavour
This medicine can be given at any time with or without food.
Dissolve the content of each sachet in 62.5 ml (1/4 of a glass) of water and drink.
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.
|
Number of Movicol Paediatric Chocolate flavour sachets | |||||||
|
Age (years) |
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 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 'A 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Movicol Paediatric Chocolate flavour
Keep this medicine out of the sight and reach of children.
■ Do not use Movicol Paediatric Chocolate flavour after the expiry date which is stated on the sachet and carton.
■ The expiry date refers to the last day of that month.
■ Do not store your Movicol Paediatric Chocolate flavour above 25°C.
■ Once you have made up Movicol Paediatric Chocolate flavour in water, if your child cannot drink it straight away keep it covered and in the fridge (2 - 8°C). Throw away any solution not used within a 24 hour period.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Movicol Paediatric Chocolate flavour contains
Macrogol 3350 6.563 g
Sodium Chloride 0.1754 g
Sodium Hydrogen 0.0893 g
Carbonate
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 acesulfame potassium E950 as a sweetener.
When it is made into a drink with H glass (62.5ml) of water, each sachet gives the equivalent of:
Sodium
Chloride
Potassium
Bicarbonate
65 millimoles/litre 51 millimoles/litre 5.4 millimoles/litre 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:
[To be completed nationally]
Manufacturer:
Norgine Limited, New Road, Hengoed, Mid Glamorgan, CF82 8SJ, U.K.
This medicinal product is authorised in the Member States of the EEA under the following names
Austria
Belgium
Germany
Finland
Ireland
Italy
Movicol Junior Schoko
MOVICOL Junior Aroma /MOVICOL Junior Arome Macrogol Norgine Junior Schokoladengeschmack Movicol Junior Chocolate Movicol Paediatric Chocolate flavour
MOVICOL Bambini 6,9 g polvere per soluzione orale gusto Cioccolato
|
Luxembourg |
MOVICOL Junior Arome |
|
Netherlands |
Movicolon Junior Chocolate |
|
Portugal |
Movicol Pediatrico Chocolate |
|
Spain |
MOVICOL Pediatrico Sabor Chocolate |
|
Sweden |
Movicol Junior Choklad |
|
United Kingdom |
Movicol Paediatric Chocolate flavour |
This leaflet was last revised in rYY/MMMMI