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 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.
In this leaflet:
1. What Compound Macrogol Oral Powder is and what it is used for
2. Before you take Compound Macrogol Oral Powder
3. How to take Compound Macrogol Oral Powder
4. Possible side effects
5. How to store Compound Macrogol Oral Powder
6. Further information
1. WHAT COMPOUND MACROGOL ORAL POWDER 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.

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. 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.
Taking Compound Macrogol Oral Powder with food and drink
Food and drink have no influence on the effect of Compound Macrogol Oral
Powder.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, talk to your doctor before taking
Compound Macrogol Oral Powder.
Driving and using machines
Compound Macrogol Oral Powder has no effect on the ability to drive or use
machinery.
Important information about some of the ingredients of Compound
Macrogol Oral Powder
Compound Macrogol Oral Powder 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 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
Always take Compound Macrogol Oral Powder 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 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.

2. BEFORE YOU TAKE COMPOUND MACROGOL ORAL POWDER
Do not take Compound Macrogol Oral Powder
- 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

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.

If any of these applies to you, please talk to your doctor or pharmacist for
further advice.

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.

Take special care with Compound Macrogol Oral Powder
Before taking Compound Macrogol Oral Powder to treat faecal impaction, you
should have this condition confirmed by your doctor.

Compound Macrogol Oral Powder should be made up by dissolving the contents
of one sachet in a glass of water (125ml or a quarter pint). 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).

PX2032/3

If you take more Compound Macrogol Oral Powder 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
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
To get the most benefit from Compound Macrogol Oral Powder, 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 can cause side effects,
although not everybody gets them.
If you experience any of the following side effects, stop taking Compound
Macrogol Oral Powder 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

You should store unopened sachets below 25˚C.
Do not use Compound Macrogol Oral Powder if you notice that any of the
sachets is damaged.
Reconstituted Compound Macrogol Oral Powder 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 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 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 also contains acesulfame
potassium (E950).
What Compound Macrogol Oral Powder looks like and contents of the pack
Compound Macrogol Oral Powder 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 approved in August 2012.

If any of the side effects becomes 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 ORAL POWDER
Keep out of the reach and sight of children.

PX2032/3

Do not use Compound 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.

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 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.
In this leaflet:
1. What Compound Macrogol Oral Powder is and what it is used for
2. Before you take Compound Macrogol Oral Powder
3. How to take Compound Macrogol Oral Powder
4. Possible side effects
5. How to store Compound Macrogol Oral Powder
6. Further information
1. WHAT COMPOUND MACROGOL ORAL POWDER 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.

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. 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.
Taking Compound Macrogol Oral Powder with food and drink
Food and drink have no influence on the effect of Compound Macrogol Oral
Powder.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, talk to your doctor before taking
Compound Macrogol Oral Powder.
Driving and using machines
Compound Macrogol Oral Powder has no effect on the ability to drive or use
machinery.
Important information about some of the ingredients of Compound
Macrogol Oral Powder
Compound Macrogol Oral Powder 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 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
Always take Compound Macrogol Oral Powder 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 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.

2. BEFORE YOU TAKE COMPOUND MACROGOL ORAL POWDER
Do not take Compound Macrogol Oral Powder
- 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

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.

If any of these applies to you, please talk to your doctor or pharmacist for
further advice.

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.

Take special care with Compound Macrogol Oral Powder
Before taking Compound Macrogol Oral Powder to treat faecal impaction,
you should have this condition confirmed by your doctor.

Compound Macrogol Oral Powder should be made up by dissolving the
contents of one sachet in a glass of water (125ml or a quarter pint). 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).

If you take more Compound Macrogol Oral Powder 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.

Do not use Compound 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.

If you forget to take Compound Macrogol Oral Powder
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.

You should store unopened sachets below 25˚C.

If you stop taking Compound Macrogol Oral Powder
To get the most benefit from Compound Macrogol Oral Powder, 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.

Reconstituted Compound Macrogol Oral Powder 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.

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 can cause side effects,
although not everybody gets them.
If you experience any of the following side effects, stop taking Compound
Macrogol Oral Powder 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

Do not use Compound Macrogol Oral Powder if you notice that any of the
sachets is damaged.

Unused sachets of Compound Macrogol Oral Powder 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 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 also contains acesulfame
potassium (E950).
What Compound Macrogol Oral Powder looks like and contents of the
pack
Compound Macrogol Oral Powder is a white powder that is packed in sachets.

- signs of an allergy, such as a rash, reddening of the skin, nettle rash,
itching or shortness of breath

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.

- 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:

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

If any of the side effects becomes 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 ORAL POWDER
Keep out of the reach and sight of children.

This leaflet was last approved in August 2012.

1018257

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

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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