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COMPOUND MACROGOL ORAL POWDER SUGAR FREE

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

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Package leaflet: Information for the user

Compound
Macrogol Oral
Powder Sugar Free
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,
pharmacist or nurse have 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 side effects, talk to your doctor, pharmacist or nurse. 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 or if you feel worse after
14 days for chronic constipation, or after 3 days for faecal impaction.
What is in this leaflet:
1. What Compound Macrogol Oral Powder Sugar Free is and what it is used for
2. What you need to know before you take Compound Macrogol Oral Powder
Sugar Free
3. How to take Compound Macrogol Oral Powder Sugar Free
4. Possible side effects
5. How to store Compound Macrogol Oral Powder Sugar Free
6. Contents of the pack and other information
1. What Compound Macrogol Oral Powder Sugar Free is and what it is
used for
Macrogol 3350 is a laxative used for the treatment of constipation, especially if
you have been constipated for a long time. It is also used to treat a build up of
hard faeces in your bowel which may be a result of long-term constipation (this
is known as faecal impaction). Macrogol 3350 makes your faeces softer and
easier to pass, giving you relief from constipation. The electrolytes help to
maintain your body’s normal levels of sodium, potassium and water while you
are being treated for constipation.
2. What you need to know before you take Compound Macrogol Oral
Powder Sugar Free
Do not take Compound Macrogol Oral Powder Sugar Free:
- if you are allergic (hypersensitive) to macrogol 3350, sodium chloride,
sodium hydrogen carbonate, potassium chloride or acesulfame potassium
- if you have a perforation in the wall of your intestine
- if you have a blockage in your intestine
- if you have paralysis of the intestine (for example, your intestines may
stop working due to intestinal surgery or severe infection)
- if you have ulcerative colitis, Crohn’s disease or toxic megacolon
If any of these applies to you, please talk to your doctor, pharmacist or nurse for
further advice.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Compound Macrogol Oral
Powder Sugar Free to treat faecal impaction, as prior to taking this medicine it
should be confirmed that you have this condition.

Other medicines and Compound Macrogol Oral Powder Sugar Free
Some medicines, e.g. anti-epileptics, may not work as effectively if they are
taken at the same time as Compound Macrogol Oral Powder Sugar Free. Please
tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. You should not take any other medicines by mouth
for one hour before and for one hour after taking Compound Macrogol Oral
Powder Sugar Free.
Compound Macrogol Oral Powder Sugar Free with food and drink
Food and drink have no influence on the effect of Compound Macrogol Oral
Powder Sugar Free.
Pregnancy and breast-feeding
Compound Macrogol Oral Powder Sugar Free can be taken during pregnancy
and whilst 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.
Driving and using machines
Compound Macrogol Oral Powder Sugar Free has no effect on the ability to
drive or use machines.
Compound Macrogol Oral Powder Sugar Free contains potassium and
sodium
Compound Macrogol Oral Powder Sugar Free contains 0.68mmol (26mg) of
potassium per sachet. This should be taken into consideration if you take more
than one sachet daily and you have reduced kidney function, or if you are on a
controlled potassium diet.
Compound Macrogol Oral Powder Sugar Free contains 8.13mmol (187mg) of
sodium per sachet. This should be taken into consideration if you are on a
controlled sodium diet.
3. How to take Compound Macrogol Oral Powder Sugar Free
Always take this medicine exactly as described in this leaflet or as your doctor,
pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse
if you are not sure. Compound Macrogol Oral Powder Sugar Free should be
taken orally.
Compound Macrogol Oral Powder Sugar Free is a laxative for the treatment of
constipation and faecal impaction in adults, children (aged 12 years and above)
and the elderly.
Constipation
The usual dose for constipation is one sachet taken one to three times daily.
Faecal impaction
The usual dose for faecal impaction is eight sachets daily. All eight sachets
must be taken within a six hour period. If you have a heart condition, do not
take more than two sachets (in 250ml of water) in any one hour.
How to mix
Compound Macrogol Oral Powder Sugar Free should be made up by dissolving
the contents of one sachet in a glass of water (125ml or a quarter pint). Stir
well until all the powder has dissolved. If you are being treated for faecal
impaction, you can dissolve the contents of all eight sachets together in a large
container (in one litre of water).
Duration of treatment
Constipation
The course of treatment for constipation does not normally last longer than 2
weeks. Your treatment may last for longer than two weeks if you have ongoing
constipation, or a disease that causes constipation (such as Parkinson’s disease
or multiple sclerosis), or if you are taking other regular medicines that can
cause constipation. In these cases, your doctor may reduce your dose to one
sachet taken one or two times daily.
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Faecal impaction
The course of treatment for faecal impaction does not normally last longer than
3 days.
If you take more Compound Macrogol Oral Powder Sugar Free than
you should
You may experience severe pains and swelling in your abdomen, or vomiting or
diarrhoea, which can lead to dehydration. If this occurs, stop taking Compound
Macrogol Oral Powder Sugar Free and drink plenty of fluids. If you are worried
contact your doctor or pharmacist.
If you forget to take Compound Macrogol Oral Powder Sugar Free
If you forget to take a dose, take it 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 stop taking Compound Macrogol Oral Powder Sugar Free
To get the most benefit from Compound Macrogol Oral Powder Sugar Free,
always finish the course of treatment recommended by your doctor or
pharmacist. This will make sure that your constipation is cleared, otherwise the
symptoms you are suffering from may persist.

Do not use this medicine if you notice that any of the sachets is damaged.
Reconstituted Compound Macrogol Oral Powder Sugar Free solution can be
covered and stored in the refrigerator (2˚C to 8˚C), and should be used within
six hours. After six hours, any unused solution should be discarded.
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 Compound Macrogol Oral Powder Sugar Free contains
The active substances are macrogol 3350 (13.125g), sodium chloride
(350.7mg), sodium hydrogen carbonate (178.5mg) and potassium chloride
(46.6mg). Compound Macrogol Oral Powder Sugar Free also contains
acesulfame potassium (E950).

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.

What Compound Macrogol Oral Powder Sugar Free looks like and contents
of the pack
Compound Macrogol Oral Powder Sugar Free is a white powder that is packed
in sachets.

If you have any further questions on the use of this medicine, ask your doctor,
pharmacist or nurse.

Each sachet contains 13.7g of powder and is packed in cartons containing 2, 8,
10, 20, 30, 50 and 100 sachets. Not all of these pack sizes are marketed.

4. Possible side effects

Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK

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 Oral Powder Sugar Free and see your doctor immediately:
- signs of a serious allergic reaction, such as difficulty in breathing, or swelling
of the face, lips, tongue or throat
- signs of an allergy, such as a rash, reddening of the skin, nettle rash, itching
or shortness of breath
- signs of a change in your body’s fluid or electrolyte levels, such as swelling
(mainly in the ankles), feeling fatigued, dehydration or increased thirst with
headache. These symptoms may be a sign that the potassium levels in your
blood are higher or lower than normal.
The following side effects are also possible:
-

abdominal pain
feeling bloated
suffering from wind
indigestion
soreness of the anus (bottom)
mild diarrhoea
nausea
vomiting
swelling of your abdomen
stomach rumbling

Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK
This medicinal product is authorised in the Member States of the EEA
under the following names:
Belgium – Laxido Natuur/Nature
Germany – Laxido Natural
Luxembourg – Laxido Nature
Finland, Ireland and Sweden – Laxido
UK – Compound Macrogol Oral Powder Sugar Free
This leaflet was last revised in 10/2015.

By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Compound Macrogol Oral Powder Sugar Free
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.
You should store unopened sachets below 25˚C.

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Reporting of side effects
If you get 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

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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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