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Movicol

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Document: leaflet MAH BRAND_PLPI 18799-2591 change

Package leaflet: Information for the patient

MOVICOL® Plain 13.7g Sachet, powder for oral solution

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

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

•    Ask your pharmacist if you need more information or advice.

•    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.

•    You must talk to a doctor if you do not feel better or if you feel worse.

The name of your medicine is MOVICOL Plain 13.7g Sachet, powder for oral solution but will be referred to as Movicol Plain throughout this leaflet.

What is in this leaflet:

1.    What Movicol Plain is and what it is used for

2.    What you need to know before you take Movicol Plain

3.    How to take Movicol Plain

4.    Possible side effects

5.    How to store Movicol Plain

6.    Contents of the pack and other information

1.    What Movicol Plain is and what it is used for

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

2.    What you need to know before you take Movicol Plain

Do not take Movicol Plain if your doctor has told you that you have:

-    a blockage of your intestine (gut obstruction, paralysis of the intestine (ileus))

-    a perforated gut wall

-    severe inflammatory bowel disease like ulcerative colitis, Crohn's disease, or toxic megacolon

-    an allergy to the active substances of Movicol Plain (listed in section 6).

Warnings and precautions

When taking Movicol Plain you should continue to take plenty of fluids. The fluid content of Movicol Plain should not replace your regular liquid intake.

Heart conditions

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

Other medicines and Movicol Plain

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 Movicol Plain.

Pregnancy and breast-feeding

Movicol Plain 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 Plain.

Driving and using machines

Movicol Plain does not affect your ability to drive or use machines.

3. How to take Movicol Plain

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

Dissolve the content of each sachet in 125ml (14 pint) of water and drink.

Constipation:

A dose of Movicol Plain is 1 sachet dissolved in 125ml (14 pint) of water.

Take this 1-3 times a day according to the severity of your constipation.

Faecal impaction:

Before you take Movicol Plain for faecal impaction, it should be confirmed that you have this condition.

A dose of 8 sachets a day of Movicol Plain 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 2 sachets in any one hour.

How to mix

Open the sachet and pour the contents into a glass. Add about 125ml or 14 pint of water to the glass. Stir well until all the powder has dissolved and the Movicol Plain solution is clear or slightly hazy, then drink it. If you are taking Movicol Plain for faecal impaction it may be easier to dissolve 8 sachets in 1 litre of water.

Duration of treatment

Constipation:

Treatment with Movicol Plain usually lasts for about 2 weeks. If you need to take Movicol Plain 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 Plain for longer than 2 weeks. If you need to take Movicol Plain 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 Movicol Plain can be for up to 3 days.

If you take more Movicol Plain than you should

You may develop excessive diarrhoea, which can lead to dehydration. If this occurs, stop taking Movicol Plain and drink plenty of fluids. If you are worried contact your doctor or pharmacist.

If you forget to take Movicol Plain

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 Movicol Plain if you:

•    Get a serious allergic reaction which causes difficulty in breathing or dizziness, 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 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 Plain. These side effects generally get better if you reduce the amount of Movicol Plain 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.

5.    How to store Movicol Plain

•    Keep out of the sight and reach of children.

•    Do not store above 25°C.

•    Once you have made up Movicol Plain in water, if you cannot drink it straight away keep it.

•    Store the reconstituted solution at (2-8°C) (in a refrigerator and keep covered). Throw away any solution not used within a 6 hour period.

•    Do not take the medicine after the expiry date which is stated on the carton and sachet label after ‘Exp'. The expiry date refers to the last day of that month.

•    If the powder becomes discolored or shows any signs of deterioration, seek the advice of your pharmacist.

•    Remember if your doctor tells you to stop taking the powder, return any unused sachets to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

•    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.    Contents of the pack and other information

What Movicol Plain contains

Each 13.7g sachet of Movicol Plain contains the following:

Macrogol 3350    13.125g

Sodium chloride    0.3508g

Sodium Bicarbonate    0.1786g

Potassium chloride    0.0502g

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

Hydrogen Bicarbonate    17    millimoles/litre

Potassium    5.4 millimoles/litre

What Movicol Plain looks like and contents of the pack

Movicol Plain is a white free-flowing, almost odourless powder for oral solution.

Movicol Plain is available as pack of 30 or 50 sachets.

Manufactured by: Norgine Ltd, New Road, Tir-y-Berth, Hengoed, Mid Glamorgan, CF82 8SJ, UK.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare,

Unit 4, Bradfield Road, Ruislip, Middlesex,

HA4 0NU, UK.

MOVICOL® Plain 13.7g Sachet, powder for oral solution; PL 18799/2591    ryi

Leaflet date: 30.06.2016

Movicol is a registered trademark of VELINOR AG