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1. Macrolyte 13.8g Sachet Powder For Oral Solution
2. Macrolyte 13.8g Sachet Powder For Oral Solution

MACROLYTE

13.8g sachet, powder for oral solution

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

In this leaflet:

1.    What is MACROLYTE and what is it used for?

2.    Before you take MACROLYTE

3.    How to take MACROLYTE

4.    Possible side effects

5.    Storing MACROLYTE

1.    What is MACROLYTE and what is it used for?

The name of this medicine is MACROLYTE 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.

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

2.    Before you take MACROLYTE

Do not take MACROLYTE 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 any of the ingredients.

Heart conditions

Follow the special instructions in section 3 if you are taking MACROLYTE for faecal impaction

Pregnancy and breast feeding

MACROLYTE 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 MACROLYTE.

Driving and using machines

MACROLYTE does not affect your ability to drive or use machines.

Taking other medicines

Some medicines, e.g. anti-epileptics, may not work as effectively during use with MACROLYTE. Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

3.    How to take MACROLYTE

This medicine can be taken at any time with or without food or drink Constipation:

A dose of MACROLYTE is one sachet. Take this 1 -3 times a day, according to the severity of your constipation.

Faecal impaction:

A dose of 8 sachets a day of MACROLYTE is needed 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 two sachets in any one hour.

Open the sachet and pour the contents into a glass. Add 125 ml or % pint of water to the glass until all the powder has dissolved and the MACROLYTE 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 MACROLYTE for faecal impaction, it may be easier to dissolve 8 sachets in 1 litre of water.

Duration of treatment:

Constipation:

Treatment with MACROLYTE 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 MACROLYTE 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 MACROLYTE can be for up to 3 days.

If you take more MACROLYTE than you should:

You may develop diarrhoea. Stop taking MACROLYTE until it clears, and then start again at a lower dose. If you are worried contact your doctor or pharmacist.

If you forget to take MACROLYTE:

Take the dose as soon as you remember to take it.

4.    Possible side effects?

Like all medicines, MACROLYTE can have side effects.

Tell your doctor immediately and stop taking MACROLYTE 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 MACROLYTE. These side effects generally get better if you reduce the amount of MACROLYTE you take. If any of the above 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 MACROLYTE

Keep all medicines out of the reach and sight of children

Do not use MACROLYTE after the expiry date on the sachet.

Store your MACROLYTE at room temperature (do not store above 25°C). Once you have made up MACROLYTE 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.

Each 13.8g sachet of MACROLYTE contains the following:

Macrogol 3350 Sodium Chloride Sodium Bicarbonate Potassium Chloride

MACROLYTE 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:

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

MACROLYTE is available in boxes of 20, 30 or 50 sachets. Marketing authorisation holder:

Norgine BV Hogehilweg 7, 1101CA Amsterdam ZO, The Netherlands Manufacturer:

Norgine Ltd, New Road, Hengoed, Mid Glamorgan, CF82 8SJ, U.K.

This leaflet was last revised in 07/2013

PL 20142/0001