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Isopeg 13.8g Sachet Powder For Oral Solution

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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 'A 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 25°C.

Once you have made up Isopeg 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 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:

13.125 g 0.3507 g


Macrogol 3350 Sodium Chloride

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