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ISOPEG 13.8G SACHET 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 patient

 
ISOPEG
13.8g sachet, powder for oral solution
 

 

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
 

 

 Keep this leaflet. You may need to read it again.
 If you have any questions or are unsure about anything, ask your doctor, pharmacist or
nurse. 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.
 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.

 

 
What is in this leaflet:
1. What Isopeg is and what it is used for
2. What you need to know before you take Isopeg
3. How to take Isopeg
4. Possible side effects
5. How to store Isopeg
6. Contents of the pack and other information

 
1. What Isopeg is and what it is used for

 
The name of this medicine is Isopeg 13.8g sachet, 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.

 
Isopeg helps you to have a comfortable bowel movement even if you have been constipated
for a long time. Isopeg also works in very bad constipation called faecal impaction.

 
2. What you need to know before you take Isopeg

 
Do not take Isopeg 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 to the active substance or any of the other ingredients of Isopeg (listed in
section 6).
Warnings and precautions
When taking Isopeg you should continue to take plenty of fluids. The fluid content of Isopeg
should not replace your regular liquid intake.

 
Heart conditions
Follow the special instructions in section 3 if you are taking Isopeg for faecal impaction

 
Other medicines and Isopeg

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

 
Some medicines, e.g. anti-epileptics, may not work as effectively during use with Isopeg.

 
Pregnancy and breast feeding
Isopeg 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
Isopeg.
 

 
 

Driving and using machines
Isopeg does not affect your ability to drive or use machines.
 

 
 

3. How to take Isopeg

 
This medicine can be taken at any time with or without food.

 
Dissolve the content of each sachet in 125ml (1/4 pint) of water and drink.

 
Constipation:

 
A dose of Isopeg is one sachet dissolved in 125ml (1/4 pint) of water. Take this 1 –3 times a
day, according to the severity of your constipation.

 
Faecal impaction:

 
Before you take Isopeg for faecal impaction, it should be confirmed that you have this
condition.

 
A dose of 8 sachets a day of Isopeg is needed for the treatment of faecal impaction. Each
sachet dissolved in 125ml (1/4 pint) of water. 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 two sachets in
any one hour.

 
How to mix:
Open the sachet and pour the contents into a glass. Add 125 ml or ¼ pint of water to the glass
until all the powder has dissolved and the Isopeg solution is clear or slightly hazy, then drink
it. If you like, you can add a flavour such as orange squash to the drink. If you are taking
Isopeg for faecal impaction, it may be easier to dissolve 8 sachets in 1 litre of water.

 
Duration of treatment:
Constipation:
Treatment with Isopeg usually lasts for about 2 weeks. 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 Isopeg for longer than 2 weeks.
If you need to take Isopeg for longer, please see your doctor.

 
Usually for long term treatment the dose can be lowered to either 1 or 2 sachets a day.

 
Faecal impaction:
Treatment with Isopeg can be for up to 3 days.

If you take more Isopeg than you should:
You may develop excessive diarrhoea, which can lead to dehydration. If this occurs, stop
taking Isopeg and drink plenty of fluids. If you are worried contact your doctor or pharmacist.

 
If you forget to take Isopeg:
Take the dose as soon as you remember to take it.

 
4. Possible side effects

 
Like all medicines, this medicine can cause side effects, although not everybody gets them.

 
Tell your doctor immediately and stop taking Isopeg if you:

 
• Get a serious allergic reaction which causes difficulty in breathing, or swelling of the face,
lips, tongue or throat.

 
Other side effects include:
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.

 
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 Isopeg. These side effects generally get
beeterif you reduce the amount of Isopeg you take.

 
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 Yellow Card
Scheme Website: 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 Isopeg

 
Keep this medicine out of the sight and reach of children
Do not use Isopeg after the expiry date which is stated on the sachet and carton.
Do not store above 25ºC.
Once you have made up Isopeg in water, if you cannot drink it straight away, keep it covered
and in the fridge (2 - 8ºC). Throw away any solution not used within a six hour period.

 
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 Isopeg contains
Each 13.8g sachet of Isopeg contains the following:

 
Macrogol 3350
Sodium Chloride

13.125 g
0.3507 g

Sodium Bicarbonate
Potassium Chloride

0.1785 g
0.0466 g

 
Isopeg also contains lime and lemon flavour, and acesulfame potassium as a sweetener.
When it is made into a drink with 125 millilitres of water, each sachet gives the equivalent of:
Sodium
Chloride
Potassium
Bicarbonate

65 millimoles/litre
53 millimoles/litre
5.4 millimoles/litre
17 millimoles/litre

 
Isopeg is available in boxes of 20, 30 or 50 sachets.

 
Marketing authorisation holder:
Norgine BV Hogehilweg 7, 1101CA Amsterdam ZO, The Netherlands

 
Manufacturer:
Norgine Limited, New Road, Hengoed, Mid Glamorgan, CF82 8SJ, U.K.

 
This leaflet was last revised in 03/2015

If you need the information on this leaflet to be supplied in an alternative format, such as
large print or braille please ring from the UK: 0800 198 5000 and for Medical Information:
01895 826 606

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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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