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Patient Information Leaflet

MOVICOL®

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. 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 breastfeeding. If you are pregnant, trying to become pregnant or breastfeeding, 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. Howto 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.

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.

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.

5.    Storing MOVICOL

Keep all medicines out of the sight and reach of children

MOVICOL should not be stored above 25°C. After reconstitution, store covered in a refrigerator (2°C-8°C). Discard any solution not used within 6 hours.

If your doctor tells you to stop taking the powder, please take it back to the pharmacist for safe disposal. Only keep the powder if your doctor tells you to.

If the powder becomes discoloured or shows signs of deterioration, you should seek the advice of your pharmacist.

Do not use MOVICOL after the expiry date on the sachet. 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 sachet contains 13.125g of macrogol 3350, 0.3507g of sodium chloride, 0.1785g of sodium bicarbonate and 0.0466g of potassium chloride as the active ingredients. When made into a drink with 125ml of water, each sachet gives the equivalent of 65mmoles/litre of sodium, 53mmoles/litres of chloride, 17mmoles/litre of bicarbonate and 5.4mmoles/litre of potassium.

MOVICOL also contains the following: lemon flavour and acesulfame potassium as a sweetener.

What MOVICOL looks like and contents of the pack

MOVICOL is presented in a carton containing sachets with free flowing white powder.

Each carton contains 20 sachets.

Manufactured by: Norgine Ltd, Hengoed, Midglamorgan, OF 82 8SJ, Wales, UK,

Or

Laboratories Macors, Zl La Plaine des Isles, 89000 Auxerre,

Or

Laboratories Sophartex, 21 rue du Pressoir, 28500, Vernouille.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU.

Movicol® PL No: 18799/0697    —?—

Leaflet date: 25.11.2013

MOVICOL is a registered trademark of Norgine Ltd.