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MACROGOL ORAL POWDER COMPOUND

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

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Macrogol Oral Powder,
Compound
powder for oral solution in sachet
Read all of this leaflet carefully before you can
start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist has told
you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more
information or advice.
• If you get any of the side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet,
see section 4.
• You must talk to your doctor if you do not feel
better or feel worse.
In this leaflet:
1. What Macrogol Oral Powder is and what it is
used for
2. What you need to know before you take
Macrogol Oral Powder
3. How to take Macrogol Oral Powder
4. Possible side effects
5. How to store Macrogol Oral Powder
6. Contents of the pack and other information

1. What Macrogol Oral Powder is and
what it is used for
The name of this medicine is Macrogol Oral
Powder, Compound.
I t is a laxative for the treatment of constipation
in adults, adolescents and elderly. It is not
recommended for children below 12 years of age.
Macrogol Oral Powder, Compound helps you to
have a comfortable bowel movement even if you
have been constipated for a long time. It also works
in very bad constipation called faecal impaction.

2. What you need to know before you
take Macrogol Oral Powder
Do not take Macrogol Oral Powder if your
doctor has told you that you have:
• a blockage in your 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 substance or any of the
other ingredients of Macrogol Oral Powder
(listed in section 6).
Warnings and precautions
When taking Macrogol Oral Powder you should
continue to take plenty of fluids. The fluid content
of Macrogol Oral Powder should not replace your
regular liquid intake.

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This medicinal product contains 8.125 mmol
sodium per 125 mL. To be taken into consideration
by patients on a controlled sodium diet.
Talk to your doctor or pharmacist before taking
Macrogol Oral Powder
Heart conditions
Follow the special instructions in section 3 if
you are taking Macrogol Oral Powder for faecal
impaction
Children and adolescents
Not recommended for children (below 12 years of
age).
Other medicines and Macrogol Oral Powder
Tell your doctor or pharmacist if you are taking,
or have recently taken or might take any other
medicines.
Some medicines, e.g. anti-epileptics, may not
work as effectively during use with Macrogol Oral
Powder.
Pregnancy and breast-feeding
Macrogol Oral Powder can be taken during
pregnancy and whilst breast-feeding. If you
are pregnant, trying to become pregnant or
breastfeeding ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Macrogol Oral Powder does not affect your ability
to drive or use machines.

3. How to take Macrogol Oral
Powder
Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you
are not sure.
This medicine can be taken at any time with or
without food.
Dissolve the content of each sachet in 125 ml
(1/4 pint) of water and drink
Constipation
A dose of Macrogol Oral Powder is 1 sachet
dissolved in 125 ml (1/4 pint) of water.
Take this 1-3 times a day according to the severity
of your constipation.
Faecal Impaction
Before you take Macrogol Oral Powder for faecal
impaction, it should be confirmed that you have
this condition.
A dose of 8 sachets a day of Macrogol Oral Powder
is needed for the treatment of faecal impaction.
Each sachet dissolved in 125ml (1/4 pint) of water.
The 8 sachets should be taken within 6 hours for up
to 3 days if required. If you have a heart condition,
do not take more than 2 sachets in any one hour.
How to mix:
Open the sachet and pour the contents into a glass.
Add about 125ml or ¼ pint of water to the glass.
Stir well and drink it. If you are taking Macrogol
Oral Powder for faecal impaction it may be easier
to dissolve all 8 sachets in 1 litre of water.
Duration of treatment:
Constipation:
Treatment with Macrogol Oral Powder usually lasts
for about 2 weeks. If you need to take Macrogol
Oral Powder for longer, please see your doctor.

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If your constipation is caused by an illness such as
Parkinson’s disease or multiple sclerosis (MS),
or if you take medicines that cause constipation
your doctor may recommend that you take
Macrogol Oral Powder for longer than 2 weeks.
If you need to take Macrogol Oral Powder for
longer, please see your doctor.
Usually for long term treatment that dose can be
lowered to either 1 or 2 sachets a day.
Faecal Impaction
Treatment with Macrogol Oral Powder can be for
up to 3 days.
If you take more Macrogol Oral Powder than
you should
You may develop excessive diarrhoea, which can
lead to dehydration. Stop taking Macrogol Oral
Powder until it clears and drink plenty of fluids,
then start again at a lower dose. If you are worried
contact your doctor or pharmacist.
If you forget to take Macrogol Oral Powder
Take the dose as soon as you remember to take it.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor immediately and stop taking
Macrogol Oral Powder if you:
• Get a serious allergic reaction which causes
difficulty in breathing or swelling of the face,
lips, tongue or throat.
Other side effects include:
Allergic reactions which may cause a skin rash,
itching, reddening of the skin or a nettle rash,
swollen hands, feet or ankles, headaches and high
and low levels of potassium in the blood.

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 to protect the
environment.

6. Contents of the pack and other
information
What Macrogol Oral Powder sachets contain
Each 13.7 g sachet of Macrogol Oral Powder
contains the following:
Macrogol 3350
13.125 g
Sodium chloride
0.3507 g
Sodium hydrogen carbonate
0.1785 g
0.0466 g
Potassium chloride
Macrogol Oral Powder also contains lemon flavour
and acesulfame potassium (E950) as a sweetener.
The lemon flavour contains the following
ingredients: acacia gum (E414) and flavouring.
When it is made into a drink with 125 millilitres
of water, each sachet gives the equivalent of:
65 mmol/l
Sodium
53 mmol/l
Chloride
Hydrogen carbonate
17 mmol/l
Potassium
5.4 mmol/l
What Macrogol Oral Powder looks like and
contents of the pack
Macrogol Oral Powder is a white powder.
Macrogol Oral Powder is available in boxes of
8, 10, 20, 30, 50 or 100 sachets.
Not all pack sizes may be marketed.
The marketing authorisation holder
Chanelle Medical,
Loughrea, Co. Galway, Ireland.

Sometimes you may have indigestion, stomach
ache or rumbles. You may also feel bloated, suffer
from wind, feel sick or vomit, may also experience
soreness of the anus (bottom) and may have mild
diarrhoea when starting to take Macrogol Oral
Powder. These side effects generally get better if
you reduce the amount Macrogol Oral Powder you
take.

Manufacturer
Chanelle Medical,
Loughrea, Co. Galway, Ireland

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via United Kingdom; Yellow Card
Scheme; Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

This leaflet was last revised in 07/2016

Distributor
Co-Pharma Limited
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire, WD18 9SS, UK

5. How to store Macrogol Oral
Powder
Keep this medicine out of the sight and reach of
children.
Do not use Macrogol Oral Powder after the expiry
date which is stated on the carton and sachet.
The expiry date refers to the last day of that month.
Unopened sachet: No special storage conditions.
Once you have made up Macrogol Oral Powder
in water, if you cannot drink it straight away keep
it covered and store in a refrigerator (2°C – 8°C).
Throw away any solution not used within a
24 hour period.

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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.

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