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Movicol 13.8g Sachet Powder For Oral Solution

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Macrogol 3350    13.125    g

Sodium Chloride    0.3507    g

Sodium Bicarbonate    0.1785    g

Potassium Chloride    0.0466    g


Patient Information Leaflet

MOVICOL®

13.8g sachet, powder for oral solution

Please read all of this leaflet carefully before taking your medicine.

-    Keep this leaflet. You may need to read it again.

-    if you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed foryou. Do not pass it on to others. it may harm them, even if their symptoms are the same as yours.

-    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.

f 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.

In this leaflet:

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

2.    Before you take MOVICOL

3.    How to take MOVICOL

4.    Possible side effects

5.    Storing MOVICOL

6.    Further information

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

The name of this medicine is MOVICOL 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.

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

2.    Before you take MOVICOL

Do not take MOVICOL 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 substances or any of the other ingredients of MOVICOL

Heart conditions

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

Pregnancy and breast feeding

MOVICOL 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 MOVICOL.

Driving and using machines

MOVICOL 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 MOVICOL. 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 MOVICOL

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

Constipation:

A dose of MOVICOL is 1 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 MOVICOL 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 2 sachets in any one hour. How to mix

Open the sachet and pour the contents into a glass. Add about l25ml or 1/4 pint of water to the glass. Stir well until all the powder has dissolved and the MOVICOL solution is clear or slightly hazy, then drink it. If you are taking MOVICOL for faecal impaction it may be easier to dissolve 8 sachets in 1 litre of water.

Duration of treatment

Constipation:

Treatment with MOVICOL usually lasts for about 2 weeks.

If you need to take MOVICOL 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 MOVICOL for longer than 2 weeks.

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

Faecal impaction:

Treatment with MOVICOL can be for up to 3 days.

If you take more MOVICOL than you should

You may develop excessive diarrhoea, which can lead to dehydration. If this occurs, stop taking MOVICOL and drink plenty of fluids.

If you are worried contact your doctor or pharmacist.

If you forget to take MOVICOL

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

4.    Possible side effects

Like all medicines, MOVICOL can have side effects.

Tell your doctor immediately and stop taking MOVICOL 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 MOVICOL. These side effects generally get better if you reduce the amount MOVICOL 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 MOVICOL

Keep all medicines out of the reach and sight of children

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

Do not store above 25°C.

Once you have made up MOVICOL 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

Each 13.8g sachet of MOVICOL contains the following:

MOVICOL also contains lime and lemon flavour, and acesulfame potassium as a sweetener. Lemon and lime flavour contains the following ingredients: acacia solids, maltodextrin, lime oil, lemon oil, citral, citric acid and water.

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    17    millimoles/litre

What MOVICOL looks like and contents of the pack MOVICOL is available in boxes of 2, 6, 8, 10, 20, 30, 50, 60 or 100 sachets. Not all pack sizes may be marketed.

Marketing authorisation holder:

Norgine Ltd, Moorhall Rd, Harefield,

Middx UB9 6NS, U.K.

Manufacturer:

Norgine Ltd, New Road, Hengoed, Mid Glamorgan CF82 8SJ

MOVICOL is available throughout Europe. In Germany it is called MOVICOL V® and in the Netherlands it is called MOVICOLON®.

This leaflet was last revised in 05/2013.    ^

PL 00322/0070