Skip to Content

COMPOUND MACROGOL 6.9G POWDER FOR ORAL SOLUTION

Active substance(s): MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
< INVENTED NAME >
Powder for Oral Solution
Read all of this leaflet carefully before you give this medicine to your child.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child. Do not pass it on to others. It may
harm them, even if their symptoms are the same as your child’s.
• 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 your pharmacist.
In this leaflet:
1. What < Invented Name > is and what it is used for
2. Before you give < Invented Name >
3. How to give < Invented Name >
4. Possible side effects
5. How to store < Invented Name >
6. Further Information
1.

What < Invented Name > is and what it is used for

The name of this medicine is < Invented Name, 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.
It helps your child to have a comfortable bowel movement even if they have been constipated
for a long time.
2.

Before you use < Invented Name >

Do not give < Invented Name > if your doctor has told you that your child has:
! an allergy to any of the ingredients listed in section 6.
! a perforated gut wall.
! a blockage in their intestine (gut obstruction, ileus)
! severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic
megacolon.
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 < Invented Name >.
Taking other medicines
Some medicines e.g. anti-epileptics, may not work effectively during use with < Invented
Name >. Tell your doctor about any other medicines your child is taking. When taking large
volumes of < Invented Name > (e.g. for faecal impaction), your child should not take other
medicines within one hour of taking < Invented Name >.
Taking < Invented Name > with food and drink
This medicine can be given at any time with or without food.
Page 1 of 4

5(*

Version 

$SSURYHG

3DJHRI

Pregnancy and breast-feeding
If your child is pregnant or breast feeding talk to your doctor before giving < Invented Name >.
Driving and using machines
< Invented Name > has no effect on the ability to drive or use machines.
3.

How to use < Invented Name >

Always give < Invented Name > exactly as your doctor or pharmacist has told you. You should
check with your doctor or pharmacist if you are not sure.
Chronic Constipation:
The dose of < Invented Name > 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 each day.
! Children aged 7 to 11 years should be give 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.
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 < Invented Name > for faecal impaction, it should be confirmed
medically that your child has this condition.
A course of treatment for faecal impaction in children aged 5 to 11 years is as follows:
Day 1 - 4 sachets
Day 5 - 12 sachets
Day 2 - 6 sachets
Day 6 - 12 sachets
Day 3 - 8 sachets
Day 7 - 12 sachets
Day 4 - 10 sachets
The daily number of sachets should be taken in divided doses, all consumed within 12 hours
(e.g. 8am to 8pm). Treatment can be stopped when the medicine has worked. This is shown by
the child passing large volumes of stool and/or watery diarrhoea.
Method of Administration
! 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.
! For the treated 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 can be up to 7 days.
If your child takes more < Invented Name > than they should
Your child may develop diarrhoea. Stop giving < Invented Name > until it clears and then start
again at a lower does. If you are worried contact your doctor or pharmacist.
Page 2 of 4

5(*

Version 

$SSURYHG

3DJHRI

If you forget to give < Invented Name >
Give the dose as soon as you remember.
4.

Possible side effects

Like all medicines, < Invented Name > can cause side effects, although not everybody gets
them.
Tell your doctor immediately and stop giving < Invented Name > if your child:
! feels weak, is breathless or has difficulty in breathing, is very thirsty with a headache or
gets puffy ankles.
Very common side effects (more than 1 person in 10):
If your child is being treated for chronic constipation your child may:
• get stomach pain or rumbles, or have diarrhoea but this will usually improve when the
dose is reduced
If your child is being treated for faecal impaction your child may:
• be sick, have a swollen stomach or stomach pain or have soreness around the bottom.
Common side effects (more than 1 in 100 but less than 1 in 10 people):
If your child is being treated for chronic constipation your child may:
• feel sick or actually get sick, have a swollen stomach or suffer from wind or soreness
around the bottom.
If your child is being treated for faecal impaction your child may:
• feel sick, have mild diarrhoea or have stomach rumbles.
Rare side effects (less than 1 person in 10000):
• allergic reactions, which may include an itchy skin rash (hives), breathlessness or
difficult in breathing.
If any of the side effects gets serious or last more than a few days, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
5.

How to store < Invented Name >

Keep out of the reach and sight of children.
Do not use < Invented Name > after the expiry date which is stated on the carton and sachet.
The expiry date refers to the last day of that month.
Once you have made up < Invented Name > 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.
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.
6.

Further Information

What < Invented Name > contains
Page 3 of 4

5(*

Version 

$SSURYHG

3DJHRI

The active substances are macrogol 3350 (6.563g), sodium chloride (175.4mg), sodium
hydrogen carbonate (89.3mg) and potassium chloride (23.3mg).
The other ingredients are lemon flavour and acesulfame potassium (E950) as a sweetener. The
lemon flavour contains the following ingredients: acacia gum (E414) and flavouring.
What < Invented Name > looks like and contents of the pack
< Invented Name > is a white powder packed in sachets. It is available in boxes of 2, 6, 8, 10,
20, 30, 40, 50, 60 or 100 sachets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is .
The manufacturer is .
This medicinal product is authorised in the Member States of the EEA under the
following names:
United Kingdom
Compound Macrogol 6.9g powder for oral solution
Belgium
Macrogol + Electrolytes Junior Teva, poeder voor drank
Germany
Macrogol-ratiopharm Junior 6.9g, Pulver zur Herstellung einer
Lösung zum Einnehmen
Yaprel pediatrico 6.9g polvo para solucion oral
Spain

Deleted: Curapeg Junior

This leaflet was last approved in MM/YYYY
< To be completed nationally>

Approved by:

Page 4 of 4

5(*

Version 

$SSURYHG

3DJHRI

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

7HYD3KDUPDFHXWLFDOV(XURSH%9
SLOHXWUDFNHG

APPROVALS
Signed by
.DWDULLQD*UDQ

5(*

Meaning of Signature
5HJXODWRU\$IIDLUV$SSURYDO

Version 

$SSURYHG

Server Date
)HE$0

3DJHRI

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide