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LAXAGOL POWDER FOR ORAL SOLUTION

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

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PACKAGE LEAFLET

Patient Information Leaflet

LAXAGOL 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 LAXAGOL
carefully to get the best results from it.






Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need information or advice.
You must contact a doctor if your symptoms worsen or do not improve after:
2 weeks for the treatment of constipation.
3 days for the treatment of faecal impaction.
If any of the side effects become serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What is LAXAGOL and what is it used for?
2. Before you take LAXAGOL
3. How to take LAXAGOL
4. Possible side effects
5. Storing LAXAGOL
6. Further information

1. What is LAXAGOL and what is it used for?
The name of this medicine is LAXAGOL powder for oral solution. It is a laxative for the
treatment of constipation in adults, adolescents and elderly. It is not recommended for
children below 12 years of age.
LAXAGOL helps you to have a normal bowel movement even if you have been
constipated for a long time. LAXAGOL also works when there is a build up of hard
faeces in your bowel which may be a result of long-term constipation (called faecal
impaction).
LAXAGOL contains macrogol 3350 which 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 LAXAGOL
Do not take LAXAGOL if your doctor has told you that you have:
• a blockage in your intestine (gut obstruction, ileus)
• a perforated gut wall
• severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or
toxic megacolon
• an allergy (hypersensitivity) to macrogol 3350, sodium chloride, sodium
hydrogen carbonate, potassium chloride or any of the other ingredients of
LAXAGOL
Take special care with LAXAGOL
Before taking LAXAGOL to treat faecal impaction, you should have this condition
confirmed by your doctor.
Heart conditions
Follow the special instructions in section 3 if you are taking LAXAGOL for faecal
impaction.
Pregnancy and breast feeding
If you are pregnant or breast feeding talk to your doctor before taking LAXAGOL.
Driving and using machines
LAXAGOL does not affect your ability to drive or use machines.
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. You should not
take any other medicines by mouth for one hour before and for one hour after taking
LAXAGOL.

Important information about some of the ingredients of LAXAGOL
LAXAGOL 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. If this is the case please
contact your doctor or pharmacist.
LAXAGOL contains 8.13mmol (187mg) of sodium per sachet. This should be taken into
consideration if you are on a controlled sodium diet. If this is the case please contact
your doctor or pharmacist.
The lemon flavouring used in LAXAGOL may rarely cause allergic reactions (itch or
rash) and difficulty in breathing. If this happens to you then stop taking LAXAGOL and
immediately see your doctor.

3. How to take LAXAGOL
Always take LAXAGOL exactly as your doctor or pharmacist has told you. You should
check with your doctor or pharmacist if you are not sure. LAXAGOL should be taken
orally. This medicine can be taken at any time with or without food or drink.
Constipation:
A dose of LAXAGOL is 1 sachet.
Take this 1 –3 times a day according to the severity of your constipation.
Faecal impaction:
A dose is 8 sachets a day of LAXAGOL for the treatment of faecal impaction. The 8
sachets should be taken within 6 hours for up to 3 days if required. If you have a heart
condition do not take more than 2 sachets (in 250ml of water) in any one hour.
How to mix:
Open the sachet and pour the contents into a glass. Add about 125ml or a quarter pint of
water to the glass. Stir well until all the powder has dissolved and the LAXAGOL
solution is clear or slightly hazy, then drink it. If you are taking LAXAGOL for faecal
impaction it may be easier to dissolve 8 sachets in 1 litre of water.
Duration of treatment:
Constipation:
Treatment with LAXAGOL usually lasts for about 2 weeks. If you need to take
LAXAGOL for longer, please see your doctor. If your constipation is caused by an
illness such as Parkinson’s disease or multiple sclerosis (MS), or if you take medicines
that cause constipation your doctor may recommend that you take LAXAGOL for longer
than 2 weeks.
Usually for long term treatment that dose can be lowered to either 1 or 2 sachets a day.
Faecal impaction:
Treatment with LAXAGOL can be for up to 3 days.
If you take more LAXAGOL than you should:
You may develop diarrhoea, experience severe pains in the abdomen and or vomiting.
If this happens, contact your doctor or pharmacist. Stop taking LAXAGOL until it clears.
If you forget to take LAXAGOL:
Take the dose as soon as you remember to take it 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 product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, LAXAGOL can have side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking LAXAGOL and see your
doctor immediately:
- Get a serious allergic reaction which causes difficulty in breathing, or swelling of
the face, lips, tongue or throat.
The following side effects are also possible:
- Allergic reactions which may cause a skin rash, itching, reddening of the skin or a
nettle rash, swollen hands, feet or ankles, headaches and high and low levels of
potassium in the blood.

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- Sometimes you may have indigestion, stomach ache or rumbles. You may also
feel bloated, suffer from wind, feel sick or vomit, may also experience soreness
of the anus (bottom) and may have mild diarrhoea when starting to take
LAXAGOL. These side effects generally get better if you reduce the amount
LAXAGOL you take.
If any of the above side effects are troublesome or last more than a few days or if you
notice any side effects not mentioned in this leaflet, please inform your doctor or
pharmacist.

5. Storing LAXAGOL
Keep all medicines out of the reach and sight of children
Do not use LAXAGOL after the expiry date on the carton and sachet. The expiry date
refers to the last day of that month.
Do not store above 25°C.
Once you have made up LAXAGOL in water, if you cannot drink it straight away keep it
covered and in the fridge (2 – 8°C). Throw away any solution not used within a 6 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 LAXAGOL contains:
Each 13.8g sachet of LAXAGOL contains the following:

Macrogol 3350: 13.125 g

Sodium Chloride: 0.3507 g

Sodium Bicarbonate (sodium hydrogen carbonate): 0.1785 g

Potassium Chloride: 0.0466 g
LAXAGOL also contains lemon flavour, and acesulfame potassium as a sweetener.
Lemon flavour contains the following ingredients: nature-identical flavouring substances,
flavouring preparations, natural flavouring substances, maltodextrin and starch
modified.
When it is made into a drink with 125 millilitres of water, each sachet gives the
equivalent of:

Sodium: 65 millimoles/litre

Chloride: 53 millimoles/litre

Potassium: 5.4 millimoles/litre

Bicarbonate (hydrogen carbonate): 17 millimoles/litre
What LAXAGOL looks like and contents of the pack
LAXAGOL is a white powder that is packed in sachets. It has a lemon taste and smell.
LAXAGOL is available in boxes of 2, 8, 20, 30, 50 or 100 sachets. Not all pack sizes
may be marketed.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd.
Mckenzie House,
Bury Street, Ruislip,
Middlesex,
HA4 7TL
UK
Manufacturer:
M&A Pharmachem Ltd.
Bolton,
England,
BL5 2AL
UK
This leaflet was last approved in January 2013.

For information in large print, on tape, on CD or in
Braille, phone 020 8900 2122.
Laxagol, Powder for solution
PL 17507/0091
PA 1352/5/1
P0091-01/4

Auden Mckenzie

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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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