Package leaflet: Information for the patient

Molative Paediatric 6.9 g Powder for Oral Solution

(macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride)

Read all of this leaflet carefully before you start giving your child this medicine 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 or pharmacist.

•    This medicine has been prescribed for your child only. 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 or pharmacist. This includes any possible side effects not listed in this ieaflet.

What is in this leaflet

1.    What Molative Paediatric is and what it is used for

2.    What you need to know before you give Molative Paediatric

3.    How to give Molative Paediatric

4.    Possible side effects

5.    How to store Molative Paediatric

6.    Contents of the pack and other information

1.    What Molative Paediatric is and what it is used for

The name of this medicine is Molative Paediatric 6.9 g, powder for oral solution. It is a laxative (a medicine used to help your child pass stools) for the treatment of long-term (chronic) constipation in children aged 2 to 11 years.

Also, this medicine is used for the treatment of faecal impaction, in children aged 5 to 11 years (a condition where large amounts of stool builds up in the rectum and/or colon which cannot be passed easily by your child).

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

2.    What you need to know before you give Molative Paediatric

Do not give Molative Paediatric if your doctor has told you that your child:

•    is allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride or any of the other ingredients of this medicine (listed in section 6).

•    has a blockage in their intestine (gut obstruction, ileus)

•    has a perforated gut wall

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

Warnings and precautions

Talk to your doctor or pharmacist before you give Molative Paediatric if your child has a heart or kidney problem, problems with their gag reflex, reflux oesophagitis (heart-burn caused by back-flow of stomach contents into the oesophagus) or decreased level of consciousness.

Other medicines and Molative Paediatric

Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.

Some medicines, e.g. medicines to treat epilepsy, may not work as effectively during use with Molative Paediatric.

When taking large volumes of Molative Paediatric (e.g. for faecal impaction), your child should not take other medicines within one hour of taking this medicine.

Pregnancy and breast-feeding

This subsection is not relevant for Molative Paediatric since it is intended for children aged 2 to 11 years, however the following information is relevant to the active ingredient, macrogol 3350.

Molative Paediatric can be given during pregnancy and whilst breast-feeding.

If your child is pregnant or breast-feeding, you think she might be pregnant or is planning to have a baby, ask your doctor or pharmacist for advice before giving this medicine.

Molative Paediatric contains potassium, sodium and sorbitol

This medicine contains 0.31 mmol (12.2 mg) of potassium per sachet. This should be taken into consideration if your child is taking more than one sachet daily and has reduced kidney function, or if your child is on a controlled potassium diet.

This medicine contains 4.06 mmol (93.4 mg) of sodium per sachet. This should be taken into consideration if your child is on a controlled sodium diet.

The lemon lime flavour in this medicine contains sorbitol. If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this medicine.

3. How to give Molative Paediatric

Always give this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

For Chronic Constipation:

The dose of Molative Paediatric depends on the age of the child and their response to treatment.

The recommended dose is

•    As a starting dose, children aged 2 to 6 years should be given 1 sachet each day.

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

•    Your doctor may tell you to increase 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 should be taken in one day.

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

For Faecal impaction:

Before your child takes this medicine for faecal impaction, it should be confirmed medically that your child has this condition.

The daily number of sachets should be taken in divided doses, all taken within 12 hours (e.g. 8am - 8pm). Treatment can be stopped when the medicine has worked. You would notice 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 A glass (about 62.5ml) of water. Stir well until all the powder has dissolved and the solution is clear 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 taking Molative Paediatric for faecal impaction, it may be easier to dissolve several sachets in a larger quantity of water, for example 12 sachets in 750ml, see table above. If your child cannot drink it straight away, you may keep it in the refrigerator (see section 5 "How to store Molative Paediatric").

Duration of treatment

Chronic constipation:

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

Faecal impaction:

Treatment with Molative Paediatric can be for up to 7 days.

If your child takes more Molative Paediatric than they should

Your child may become sick and develop excessive diarrhoea. Your child may experience an intense swollen or painful stomach. If this occurs, stop taking Molative Paediatric and drink plenty of fluids. If you are worried contact your doctor or pharmacist.

If you forget to give your child Molative Paediatric

Give the dose as soon as you remember.

Do not take a double dose to make up for a forgotten dose, but continue the treatment as described in this leaflet.

If you stop giving your child Molative Paediatric

To get the most benefit from Molative Paediatric, always finish the course of treatment according to the directions in this package leaflet or as your doctor or pharmacist have told you. This will make sure that your child's constipation is cleared, otherwise your child's condition may persist.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following side effects, stop giving your child this medicine immediately and contact your doctor or take your child to the nearest hospital casualty department straight away:

Rare (may affect up to 1 in 1,000 people)

•    serious allergic reaction which causes sudden signs of allergy such as rash, itching or hives on the skin, shortness of breath, difficulty in breathing or swelling of the face, lips, tongue, throat or other parts of the body (anaphylaxis, angioedema).

Other possible side effects

Very common (may affect more than 1 in 10 people)

•    stomach pains

•    stomach rumbles

Common (may affect up to 1 in 10 people)

•    diarrhoea

•    vomiting (being sick)

•    nausea (feeling sick)

•    anal discomfort (uncomfortable sensation around the bottom).

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

Uncommon (may affect up to 1 in 100 people)

•    swollen stomach

•    wind

Not known (frequency cannot be estimated from the available data)

•    skin rash (hives)

•    itching

•    reddening of the skin or a nettle rash

•    pain, swelling,redness and heat around the bottom (peri-anal inflammation)

•    shortness of breath

•    swollen hands, feet or ankles

•    headaches

•    indigestion

•    high or low levels of potassium in the blood.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Molative Paediatric

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

Do not use this medicine after the expiry date which is stated on the carton and sachet after 'EXP'. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any of the sachets have been damaged.

Do not store above 25°C.

Once you have dissolved Molative Paediatric in water, if your child cannot drink it straight away, you may keep it in the refrigerator (2°C - 8°C) for up to 24 hours.

Any unused solution should be thrown away after 24 hours.

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 Molative Paediatric contains

One sachet of Molative Paediatric contains the following active ingredients:

Macrogol 3350    6.563 g

Sodium Chloride    175.4 mg

Sodium Hydrogen Carbonate 89.3 mg Potassium Chloride    23.3 mg

When it is made into a drink with 62.5 ml (1/4 glass) of water, each sachet gives the equivalent of:

Sodium    65    mmol/l

Chloride    53    mmol/l

Potassium    5.0    mmol/l

Bicarbonate    17    mmol/l

The other ingredients are colloidal anhydrous silica, saccharin sodium, orange flavour (orange flavour contains: flavouring substances and flavouring preparations, maltodextrin, acacia gum, alpha-tocopherol) and lemon lime flavour (lemon lime flavour contains: flavouring preparations, maltodextrin, mannitol, gluconolactone, sorbitol (see section 2, "Molative Paediatric contains potassium, sodium and sorbitol"), acacia gum, colloidal anhydrous silica).

What Molative Paediatric looks like and contents of the pack

Molative Paediatric is a white powder.

Each sachet contains 6.9 g of powder and is packed in cartons containing 20, 30, 50 and 60 sachets.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Manufacturer

Klocke Pharma-Service GmbH,

Strassburger Strasse 77, 77767 Appenweier, Germany

This leaflet was last revised in 01/2016

763366

v1/May 2015