COMPOUND MACROGOL ORAL POWDER SUGAR FREE

Active substance: 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 because it contains important
information for you.
This medicine is available without prescription. However, you still need to take
Compound Macrogol Oral Powder Sugar Free 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 effect not
listed in this leaflet, please tell your doctor or pharmacist. See section 4.
In this leaflet:
1. What Compound Macrogol Oral Powder Sugar Free is and what it is used for
2. 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. Further 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. 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 or pharmacist for
further advice.
Take special care with Compound Macrogol Oral Powder Sugar Free
Before taking Compound Macrogol Oral Powder Sugar Free to treat faecal
impaction, you should have this condition confirmed by your doctor.

Taking other medicines
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, or have recently taken, any
other medicines, including medicines obtained without a prescription. 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.
Taking 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, trying to become pregnant or
breast-feeding, ask your pharmacist or doctor for advice before taking
Compound Macrogol Oral Powder Sugar Free.
Driving and using machines
Compound Macrogol Oral Powder Sugar Free has no effect on the ability to
drive or use machinery.
Important information about some of the ingredients of Compound
Macrogol Oral Powder Sugar Free
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 Compound Macrogol Oral Powder Sugar Free exactly as your doctor
or pharmacist has told you. You should check with your doctor or pharmacist if
you are not sure. Compound Macrogol Oral Powder Sugar Free should be taken
orally.
Adults, children (aged 12 years and above) and the elderly:
The usual dose for constipation is one sachet taken one to three times daily.
This course of treatment for constipation does not normally last longer than 2 weeks.
The usual dose for faecal impaction is eight sachets daily. All eight sachets
must be taken within a six hour period. This course of treatment for faecal
impaction does not normally last longer than 3 days. If you have a heart condition,
do not take more than two sachets (in 250ml of water) in any one hour.
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).
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.
PX2032/4

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. If this happens, 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.
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 you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Compound Macrogol Oral Powder Sugar Free 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

Reporting of side effects
If you get any side effects, talk to your doctor or 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

5. HOW TO STORE COMPOUND MACROGOL ORAL POWDER SUGAR FREE
Keep out of the reach and sight of children.
Do not use Compound Macrogol Oral Powder Sugar Free 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.
Do not use Compound Macrogol Oral Powder Sugar Free 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.
Unused sachets of Compound Macrogol Oral Powder Sugar Free should not be
disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of unused sachets, which you no longer require. These measures will
help to protect the environment.
6. FURTHER 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).
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.
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.
Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK
Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK
This leaflet was last revised in February 2014.

PX2032/4

By reporting side effects you can help provide more information on the safety of
this medicine.

Compound Macrogol Strides PIL xxxx:Layout 1 10/03/2014 11:33 Page 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Compound
Macrogol Oral
Powder Sugar Free
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 Oral Powder Sugar Free 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 effect not
listed in this leaflet, please tell your doctor or pharmacist. See section 4.
In this leaflet:
1. What Compound Macrogol Oral Powder Sugar Free is and what it is used for
2. 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. Further 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. 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 or pharmacist for
further advice.
Take special care with Compound Macrogol Oral Powder Sugar Free
Before taking Compound Macrogol Oral Powder Sugar Free to treat faecal
impaction, you should have this condition confirmed by your doctor.

Taking other medicines
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, or have recently taken, any other medicines,
including medicines obtained without a prescription. 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.
Taking 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, trying to become pregnant or
breast-feeding, ask your pharmacist or doctor for advice before taking Compound
Macrogol Oral Powder Sugar Free.
Driving and using machines
Compound Macrogol Oral Powder Sugar Free has no effect on the ability to drive
or use machinery.
Important information about some of the ingredients of Compound
Macrogol Oral Powder Sugar Free
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 Compound Macrogol Oral Powder Sugar Free exactly as your doctor
or pharmacist has told you. You should check with your doctor or pharmacist if
you are not sure. Compound Macrogol Oral Powder Sugar Free should be taken
orally.
Adults, children (aged 12 years and above) and the elderly:
The usual dose for constipation is one sachet taken one to three times daily.
This course of treatment for constipation does not normally last longer than 2 weeks.
The usual dose for faecal impaction is eight sachets daily. All eight sachets must
be taken within a six hour period. This course of treatment for faecal impaction
does not normally last longer than 3 days. If you have a heart condition, do not take
more than two sachets (in 250ml of water) in any one hour.
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).
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.
xxxxxx

Compound Macrogol Strides PIL xxxx:Layout 1 10/03/2014 11:33 Page 2

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. If this happens, 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.
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.

5. HOW TO STORE COMPOUND MACROGOL ORAL POWDER SUGAR FREE
Keep out of the reach and sight of children.
Do not use Compound Macrogol Oral Powder Sugar Free 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.
Do not use Compound Macrogol Oral Powder Sugar Free 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.

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

Unused sachets of Compound Macrogol Oral Powder Sugar Free should not be
disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of unused sachets, which you no longer require. These measures will help
to protect the environment.

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

Like all medicines, Compound Macrogol Oral Powder Sugar Free can cause side
effects, although not everybody gets them.

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).

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

Reporting of side effects
If you get any side effects, talk to your doctor or 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

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.
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.
Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK
Manufacturer
Co-Pharma Limited
Unit 4
Metro Centre
Tolpits Lane
Watford
Hertfordshire
WD18 9SS
United Kingdom

xxxxxx

This leaflet was last revised in February 2014.
By reporting side effects you can help provide more information on the safety of
this medicine.

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.

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