Read all of this lea'let carefully before you start to give this medicine to your child because It contains important information for you.

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

*    If you have any further questions, ask your doctor, pharmacist or nurse.

•    This medicine has been prescribed for your child. Do not pass it on to others.

it may harm them, even if their signs of illness are the same as your child's.

*    If your child gets any side effects, talk to your doctor, pharmacistor nurse. This includes any possible side effects not listed in this leaflet. See section 4.

If you need the information on this leaflet in an alternative format, such as large print, please ring from the UK: OflOO 198 5000. From Ireland: 00 44 1895826 606

What Is In this leaflet:

1.    What Movitol Paediatric Plain is and what it is used for

2.    What you need to know before you give Movitol Paediiatric Plain

3.    How to give Movicol Paediatric Plain

4.    Possible side effects

5.    How to store Movicol Paediatric Plain

6.    Contents of the pack a nd other information

1. What Movlcol Paediatric Plain Is and what It Is used for

The name of this medicine is Movitol Paediatric Plain 6.9g sachet, powder for oral solution. It is a laxative for the treatment of chronic constipation in children aged 2 to 11 years and for the treatment of very bad constipation (called faecal impaction) in children aged 5 to 11 years.

Movicol Paediatric Plain helps your child to have a comfortable bowel movement even if they have been constipated for a long time.

Other medicines and Movicol Paediatric Plant

Tell your doctor if your child is taking or has recently taken or might take any other medicines. Some medicines, e.g. anti-epilleptics, may not work as effectively during use with Movicol Paediatric Plain.

When taking large volumes of Movicol Paediatric Plain (e.g. for faecal impaction), your child should not take within one hour of taking Movicol Paediatric Plain.

Pregnancy and breast feeding

Movicol Paediatric Plain can be given during pregnancy and whilst breast feeding. Ask your pharmacist or doctor for advice before giving Movicol Paediatric Plain.

3. How to give Movicol Paediatric Plain

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

Dissolve the content of each sachet in 62.5 ml (V4 of a glass) of water and drink.

Chronic Constipation: The dose of Movicol Paediatric Plain depends on the age of the child and their response to treatment.

*    As a starting dose, children aged 2 to 6 should be given 1 sachet (=1 dose) each day.

*    Children aged 7 to 11 should be given 2 sachets each day.

*    You r doctor may tell you to i ncrease the number of sachets taken until your child has a soft bowel movement. If the dose does need increasing, this should be done every other day. Normally, no more than 4 sachets are required to be taken in one day.

It is not necessary to take all of the drink at one timq, if the child prefen ft, half the drink can be taken in the morning and half in the evening.

Faecal Impaction:

ReforeyourchildtakesMovicolPaediatric Plain for faecal impaction, it should be confirmedmedicallythatyourchildhasthis condition.

A course of treatment with Movicol Paediatric Plain is as follows:

2. What you need to know before you give Movicol Paediatric Plain

Do rot give Movicol Paediatric Plain if your doctor has told you that your child has:

*    a blockage in thei r 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 of Movicol Paediatric Plain (listed in section 6).

If your child has a heart or kidney problem, an impaired gag reflex or reflux oesophagitis (heart-burn caused by back-flow of stomach contents into the oesophagus), you should talk to your doctor before giving Movitol Paediatric Plain.

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

The daily number of sachets should be taken in divided doses, all taken within 12 hours (e.g. 3 am - 3cm). Each sachet dissolved in 62.5 ml CV4 of a glass) of water. Treatment can be stopped when the medicine has worked. This is shown by your child passing large volumes of stool and/or watery diarrhoea.

How to mix

*    Open the sachet and pour the contents into a glass. Add about 62.5ml or V4 glass of water to the glass. Stir well untfl all the powder has dissolved and the Movicol Paediatric Plain solution is dear or slightly hazy, then give it to your child to drink.

*    If you like you can add a flavour such as orange squash to the drink. If your child is faking Movicol Paediatric Plain for faecal impaction it may be easier to dissolve

12 sachets in 750ml of water.

Duration of treatment Chronic Constipation:

Treatment needs to be for a prolonged period of time, at least 6 to 12 months.

Faecal impaction:

Treatment with Movicol Paediatric Plain can be for up to 7 days.

If your child takes more Movicol Paediatric Plain than they should:

Your child may develop excessive diarrhoea. If this occurs stop taking Movicol Paediatric Plain and drink plenty of fluids. If you are worried contact your doctoror pharmacist

If you forget to give Movicol Paediatric Plain

Give the dose as soon as you remember.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop giving Movicol Paediatric Plain if your child:

*    gets a serious allergic reaction which causes

d ifficuhty in brearthi ng or swelling of the face, lips, tongue or throat.

Very common side effects (more than 1 person in 101

*    stomach pains

*    stomach rumbles

Common side effects (more than 1 in 100 but less than 1 in 10 people):

*    diarrhoea

*    vomiting (being sick)

*    nausea (feeling sick)

*    anal discomfort (uncomfortablesensation around tbe bottom).

If your child is being treated for chronic constipation, diarrhoea will usually improve when the dose is reduced.

Uncommon side effects (more than 1 in 1000 but less than 1 in 10O people)

*    swollen stomach

*    wind

Rare side effects (less than 1 person in 1000)

*    allergic reactions, which may include, breathlessness or difficulty in breathing.

Other side effects reported include:

Skin rash (hives), itching, reddening of the skin or a nettle rash, swollen hands, feet or ankles, headaches, indigestion, high or low levels of potassium in the blood.

Reporting of side effects UK: If your child gets 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

IE: If your child gets any siide 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 viaHPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. Ey reporting side effects you can help provide more information on the safely of this medicine.

5. How to store Movicol Paediatric Plain

Keep this medicine out of the sight and reach of children.

*    Do not use Movicol Paediatric Plain after the expiry date which is stated on the sachet and carton.

*    The expiry date refers to the last day of that month

■ Do not store your Movicol Paediatric Plain above 2.5'C

* Once you have made up Movicol Paediatric Plain in water, if your child cannot drink it straight away keep it covered and in the ftidge(2-3^I'Q. Throwawayanysolutionnot used within a 24 hour period.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other Information

What Movicol Paediatric Plain contains

Each 6.9g sachet of Movicol Paediatric Plain contains the following:

MatrogoI 3350    5.563 g

Sodiumchloride    0.1754g

Sodium hydrogen carbonate    O.G693g

Potassium chloride    0.0251 g

Movicol Paediatric Plain contains no colours, flavours or sweeteners.

When it is made into a drink with Ifl glass (62.5ml) of water, each sachet gives the equivalent of:

Sodium    65 m i I lim oles/litre

Chloride    53 m i I lim oles/litre

Potassium    5.4 mi I lim oles/litre

Bicarbonate    17 m i I lim oles'litre

What Movicol Paediatric Plain looks like and contents of the pack

Movicol Paediatric Plain is a white powder. Movicol Paediatric Plain is available in boxes of 6, 8, 10. 20, 30, 40. 50, 60 or 100 sachets. Not all pack sizes may be marketed.

UK Marketing authorisation holder:

Norigine Pharmaceuticals Limited, Moorhall Rd,

Harefield, Middx UE9 6N5, U.K. NO R G|N E IE Ma rketing a uthorisation holder:

Norgine Ltd, Moorhall Rd, Harefield, Uxbridge, Middx UB9 SN^U.K.

Manufacturer

Norgine Limited, New Road,

Hengoed, Mid Glamorgan,

CF32 8SJ, U.K.

This medicinal product is authorised in the Member States of the EEA under the following

Austria    MOVICOL¹* Junior aroma frei

Germany    MOVICOL® Junior aromafrei

Belgium    MOVICOL® Junior Neutral

Sweden    MOVICOL® Junior Neutral

Finland    MOVICOL®    Junior Plain

UK    MOVICOL®    Paediatric Plain

Ireland    MOVICOL®    Paediatric Plain

Italy    MOVICOL®    Bambini 6,9 g polvere

per soluzione orale Senza Aroma Spain    MOVICOL® PediAtrico Sabor

Neutro

Netherlands MOVICOLON® Junior Nature! Luxembourg MOVICOL® Junior Neutral Denmark    MOVICOL® Junior Neutral

Norway    MOVICOL® Junior

Switzerland MOVICOL® Paediatric Plain The leaflet was last revised in 10/2015 MOVKOL, NORGINE and the sail logo are registered trademarks of the Norgine group of companies.