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COMPOUND MACROGOL 13.7G POWDER FOR ORAL SOLUTION

Active substance: SODIUM HYDROGEN CARBONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Compound Macrogol 13.7g powder for oral solution
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Compound Macrogol
13.7g powder for oral solution carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 14 days for
chronic constipation, or after 3 days for faecal impaction.
• 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 Compound Macrogol 13.7g powder for oral solution is and what it is used for
2.
Before you take Compound Macrogol 13.7g powder for oral solution
3.
How to take Compound Macrogol 13.7g powder for oral solution
4.
Possible side effects
5.
How to store Compound Macrogol 13.7g powder for oral solution
6.
Further Information
1. What Compound Macrogol 13.7g powder for oral solution and what it is used for
The name of this medicine is Compound Macrogol 13.7g powder for oral solution.
It is a laxative for the treatment of chronic constipation in adults, children (aged 12 years and
above) and the elderly.
It 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 (complete severe
constipation).
2. Before you take Compound Macrogol 13.7g powder for oral solution
Do not take Compound Macrogol 13.7g powder for oral solution
if you are allergic (hypersensitive) to macrogol 3350, sodium chloride, sodium hydrogen
carbonate, potassium chloride or any of the other ingredients listed in section 6.
if you have a perforated gut wall.
if you have a blockage in your intestine (gut obstruction, ileus) for example by paralysis of the
intestine.
if you have severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic
megacolon.
If any of these apply to you, please talk to your doctor or pharmacist for further advice.
Take special care with Compound Macrogol 13.7g powder for oral solution
If you develop side effects such as swelling, shortness of breath, feeling tired, dehydration (symptoms
include increasing thirst, dry mouth and weakness) or heart problems you should stop taking
Compound Macrogol 13.7g powder for oral solution and contact your doctor immediately.
Do not take Compound Macrogol 13.7g powder for oral solution for longer periods of time unless you
have been instructed to do so by your doctor; for example if you take drugs that can cause constipation
or if you have a disease which cause constipation for example Parkinson’s disease or multiple sclerosis
(MS).

Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines,
including medicines obtained without a prescription.
Pregnancy and breast-feeding
There is no documented experience from the use of macrogol in pregnant women or during breastfeeding. However no effects during pregnancy or on the breastfed newborn/infant are anticipated, since
systemic exposure to macrogol is negligible. Compound Macrogol 13.7g powder for oral solution can
be used during pregnancy or while breast-feeding if necessary.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Compound Macrogol 13.7g powder for oral solution has no effect on the ability to drive or use
machines.
Always take Compound Macrogol 13.7g powder for oral solution exactly as your doctor or pharmacist
has told you. You should check with your doctor or pharmacist if you are not sure.
3. How to take Compound Macrogol 13.7g powder for oral solution
This medicine can be taken at any time with or without food or drink.
Chronic Constipation (constipation for a long time)
Dosage – adults and children above 12 years
1 sachet one to three times daily. The normal dose for most patients is 1-2 sachets per day. Depending
on the individual response 3 sachets per day might be needed. The dose depends on the severity of your
constipation. The dose can be adjusted down to the lowest effective dose after a couple of days. The
time of the treatment is normally 2 weeks. If the symptoms persist after 2 weeks of treatment contact
your doctor.
Children (below 12 years of age)
Not recommended.
Patients with renal insufficiency
No dosage change is necessary for treatment of chronic constipation.
Patients with a heart condition
Do not take more than 2 sachets in one hour.
Faecal Impaction (complete severe constipation)
Before you take this medicine for faecal impaction, it should be confirmed that you have this condition.
Dosage – adults and children above 12 years
The usual dose for faecal impaction (complete severe constipation) is 8 sachets daily. The 8 sachets
should be taken within a 6 hour period each day for up to 3 days if required.
Children (below 12 years of age)
Not recommended.
Patients with renal insufficiency
No dosage change is necessary for treatment of faecal impaction
Patients with a heart condition
Do not take more than 2 sachets in one hour.

Method of Administration
Dissolve the contents of 1 sachet in a glass of water (125ml or ¼ pint), stir well and drink. If you are
being treated for faecal impaction it may be easier to dissolve all 8 sachets in 1 litre of water.
If you take more Compound Macrogol 13.7g powder for oral solution than you should
You may develop diarrhoea. Stop taking Compound Macrogol 13.7g powder for oral solution until it
clears, then start again at a lower dose. If you are worried contact your doctor or pharmacist.
If you forget to take Compound Macrogol 13.7g powder for oral solution
Take the dose as soon as you remember and then continue on as before. Do not take a double dose to
make up for a forgotten dose.
4. Possible side effects
Like all medicines, Compound Macrogol 13.7g powder for oral solution can cause side effects,
although not everybody gets them.
If you experience any of the following side effects, stop taking Compound Macrogol 13.7g powder for
oral solution and see your doctor immediately:
a serious allergic reaction which causes difficulty in breathing or dizziness, or swelling of the
face, lips, tongue or throat.
signs of an allergy, such as a rash, itching, or shortness of breath.
The following side effects have also been reported:
Common (occur in more than 1 in 100 users): stomach rumbling, swollen stomach or stomach
pain, suffering from wind, vomiting, feeling sick, indigestion or a sore anus (bottom). If you
experience mild diarrhoea when you start to take Compound Macrogol 13.7g powder for oral
solution your condition will generally get better if you reduce the amount of Compound
Macrogol 13.7g powder for oral solution you take.
Very rare (occur in less than 1 in 10,000 users): hives, reddening of the skin or a nettle rash,
swelling of the hands, feet or ankles.
Other side effects include: headaches, high and low levels of potassium in the blood.
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 pharmacist.
5. How to store Compound Macrogol 13.7g powder for oral solution
Keep out of the reach and sight of children.
Do not use Compound Macrogol 13.7g powder for oral solution 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 Compound Macrogol 13.7g powder for oral solution 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.
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 Compound Macrogol 13.7g powder for oral solution contains
The active substances are macrogol 3350 (13.125g), sodium chloride (350.7mg), sodium hydrogen
carbonate (178.5mg) and potassium chloride (46.6mg).

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 Compound Macrogol 13.7g powder for oral solution looks like and contents of the pack
Compound Macrogol 13.7g powder for oral solution is a white powder packed in sachets. It is available
in boxes of 8, 10, 20, 30, 50 or 100 sachets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Eastbourne BN22 9AG
This leaflet was last revised in April 2013
PL 00289/1409

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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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