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MOLATIVE PAEDIATRIC 6.9 G POWDER FOR ORAL SOLUTION

Active substance(s): MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

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Molative Paediatric 6.9 g
Powder for Oral Solution
(macrogol 3350, sodium chloride, sodium
hydrogen carbonate, potassium chloride)

TBC

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 leaflet.

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

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

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

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

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.

For Chronic Constipation:

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.

Macrogol 3350 Potassium Chloride Sodium

Description Bicarbonate Sodium Chloride 3350 6.9 g all
Component Type Leaflet
Affiliate Item Code 763366
Superceded Affiliate Item Code NA
TrackWise PR No. 763366
MA No. NA
Packing Site/Printer NA
Supplier Code TBC

Pharma Code TBC
SAP No. NA
Vendor Job No. 269533
Trackwise Proof No. 2
Glams Proof No. NA
Client Market United Kingdom
Keyline/Drawing No. NA
Barcode Info NA

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.
A course of treatment with Molative Paediatric
is as follows:
Number of Molative Paediatric sachets
Age Day Day Day Day Day Day Day
(years) 1
2
3
4
5
6
7
5 - 11 4
6
8 10 12 12 12
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.

TBC

Package leaflet: Information for the patient

How to mix

• Open the sachet and pour the contents into
a glass. Add ¼ 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”).

Date: 23 Dec 2015
No. of colours

1

Time: 14:37
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Dimensions 148 x 297 mm

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v1/May 2015

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.

TBC

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.

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

TBC

Duration of treatment

Manufacturer

Klocke Pharma-Service GmbH,
Strassburger Strasse 77, 77767 Appenweier,
Germany
This leaflet was last revised in 01/2016

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.

Macrogol 3350 Potassium Chloride Sodium

Description Bicarbonate Sodium Chloride 3350 6.9 g all
Component Type Leaflet
Affiliate Item Code 763366
Superceded Affiliate Item Code NA
TrackWise PR No. 763366
MA No. NA
Packing Site/Printer NA
Supplier Code TBC

Pharma Code TBC
SAP No. NA
Vendor Job No. 269533
Trackwise Proof No. 2
Glams Proof No. NA
Client Market United Kingdom
Keyline/Drawing No. NA
Barcode Info NA

763366

Date: 23 Dec 2015
No. of colours

1

Time: 14:37
Page Count

Colours

Black

Non-Print
Colours

Codes

2/2

Equate CMYK
with
Main Font Myriad Pro
Dimensions 148 x 297 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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