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|2. Before you take MOVICOL|


Patient Information Leaflet

MOVICOL® 13.8g sachet, powder for oral solution

This medicine is called MOVICOL 13.8g sachet, powder for oral solution but it will be referred to as MOVICOL through the remainder of this leaflet.

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 for you. 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.

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|

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.

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

If you are pregnant or breast feeding talk to your

doctor 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 125ml 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.

|5. Storing MOVICOL|


Each 13.8g sachet of MOVICOL contains the


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.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

•    Keep all medicines out of the sight and reach of children

   Do not use MOVICOL shown after the expiry date (Exp:) on the sachet and carton. The date refers to the last day of that month.

•    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.

•    If your medicine becomes discoloured or shows any other signs of deterioration, consult your doctor or pharmacist who will tell you what to do.

•    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

following:

Macrogol 3350     13.1250    g

Sodium chloride ............................ 0.3507    g

Sodium bicarbonate ...................... 0.1785    g

Potassium chloride............................ 0.0466    g

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 Bicarbonate 17 millimoles/litre Potassium 5.4 millimoles/litre

What MOVICOL looks like and contents of the pack

MOVICOL is a white free-flowing, almost odourless powder, which dissolves in water to give a colourless solution with an odour of lemons.

MOVICOL is available in boxes of 20 sachets.

Manufacturer and Product Licence Holder:

Manufactured by SOPHARTEX 21, rue du Pressoir 28500 VERNOUILLET France

Procured from within the EU and repackaged by Mediwin Limited, PL Holder Mediport Limited,

13 Martello Enterprise Centre, Courtwick Lane, Littlehampton, West Sussex, BN17 7PA, UK.

@    PL: 18980/0841

MOVICOL is a registered trademark of the Norgine group of companies

Date of Leaflet preparation 13/11/2013

REF: ####

PIL-8330189800841-S0003