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COMPOUND MACROGOL 13.7G POWDER FOR ORAL SOLUTION

Active substance(s): MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM CHLORIDE / 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 before you 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. This medicine is available without prescription. However, you still need to take this
medicine 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.

• If you get any 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 a doctor if you do not feel better ir if you feel worse after 14 days for chronic
constipation, or after 3 days for faecal impaction.
• This medicine has been prescribed for you only. Do not pass it on to others. It may

harm them, even if their signs of illness are the same as yours.
What is in this leaflet:
1.
What Compound Macrogol 13.7g powder for oral solution is and what it is used for
2.
What you need to know 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.
Contents of the pack and other 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. What you need to know 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 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.
Warnings and precautions
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).
Other medicines and Compound Macrogol 13.7g powder for oral solution
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,
including medicines obtained without a prescription.
Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
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.
Driving and using machines
Compound Macrogol 13.7g powder for oral solution has no effect on the ability to drive or use
machines.
3. How to take Compound Macrogol 13.7g powder for oral solution
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.
This medicine can be taken at any time with or without food or drink.
Chronic Constipation (constipation for a long time)
Dosage – adults, adolescents and older people
The recommended dose is 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.
Use in children

This medicine is not recommended for children below 12 years of age.
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, adolescents and older people
The recommended 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.
Use in children

This medicine is not recommended for children below 12 years of age.

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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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 (may affect up to 1 in 10 people): 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 (may affect up to 1 in 10,000 people): hives, reddening of the skin or a nettle rash,
swelling of the hands, feet or ankles.
Not known (frequency cannot be estimated from the available data : 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.

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 the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Compound Macrogol 13.7g powder for oral solution
Keep this medicine out of the sight and reach of children.

Do not use this medicine 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away of medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other 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 September 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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