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LAXIDO PAEDIATRIC PLAIN 6.9 G POWDER FOR ORAL SOLUTION

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

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Laxido Paediatric Plain
6.9 g, powder for oral solution
Read all of this leaflet carefully before you 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 the 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 their doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Laxido Paediatric Plain is and what it is used for
2. What you need to know before you give Laxido Paediatric Plain
3. How to give Laxido Paediatric Plain
4. Possible side effects
5. How to store Laxido Paediatric Plain
6. Contents of the pack and other information

3. HOW TO GIVE LAXIDO PAEDIATRIC PLAIN
Always give Laxido Paediatric Plain exactly as the doctor or pharmacist
has told you. Check with the doctor or pharmacist if you are not sure.
Laxido Paediatric Plain should be taken orally.
Chronic constipation
The usual dose for chronic constipation depends on the age of the
child and their response to treatment.
- As a starting dose, children aged 2 to 6 years should be given 1
sachet each day and children aged 7 to 11 years should be given 2
sachets each day.
- The 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 are required to be taken in
one day.
This course of treatment for chronic constipation needs to be for a
prolonged period of time, at least 6 to 12 months.
It is not necessary to take all of the drink at one time, if the child
prefers it, half the drink can be taken in the morning and half in the
evening.
Faecal impaction
A course of treatment with Laxido Paediatric Plain is as follows:
Number of Laxido Paediatric Plain sachets
Age
Day 1 Day 2 Day 3 Day 4 Day 5 Day 6
(years)

Day 7

Laxido Paediatric Plain contains macrogol 3350 and the electrolytes
sodium chloride, sodium hydrogen carbonate and potassium chloride.

5 to 11 4

12

Laxido Paediatric Plain is a laxative used for the treatment of chronic
constipation in children aged 2 to 11 years. It is also used to treat a
build up of hard faeces in the bowel in children aged 5 to 11 years,
which may be a result of long-term constipation (this is known as
faecal impaction). Macrogol 3350 makes your child’s faeces softer and
easier to pass, giving them relief from constipation. The electrolytes
help to maintain the body’s normal levels of sodium, potassium and
water while your child is being treated for constipation.

The daily number of sachets should be taken in divided doses, all taken
within 12 hours (e.g. 8am to 8pm). Treatment can be stopped when
the medicine has worked. This is shown by your child passing large
volumes of stool and/or watery diarrhoea. This course of treatment for
faecal impaction can be for up to 7 days.

1. WHAT LAXIDO PAEDIATRIC PLAIN IS AND WHAT IT IS USED FOR

2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE LAXIDO
PAEDIATRIC PLAIN
Do not give Laxido Paediatric Plain if your doctor has told you
that your child:
- is allergic (hypersensitive) to macrogol 3350, sodium chloride,
sodium hydrogen carbonate or potassium chloride
- has a perforation in the wall of their intestine
- has a blockage in their intestine
- has paralysis of the intestine (for example, your child’s intestines
may stop working due to intestinal surgery or severe infection)
- has ulcerative colitis, Crohn’s disease or toxic megacolon.
If any of these applies to your child, please talk to their doctor or
pharmacist for further advice.
Warnings and precautions
Before giving Laxido Paediatric Plain to your child for faecal impaction,
it should be confirmed by their doctor that your child has this
condition.
If your child has a heart or kidney problem, an impaired gag reflex,
reflux oesophagitis (heartburn caused by back-flow of stomach
contents in the oesophagus) or reduced consciousness, you should talk
to their doctor before giving Laxido Paediatric Plain.
Other medicines and Laxido Paediatric Plain
Some medicines, e.g. anti-epileptics, may not work as effectively if
they are taken at the same time as Laxido Paediatric Plain. Please tell
their doctor, pharmacist or nurse if your child is taking, has recently
taken, or might take any other medicines, including medicines
obtained without a prescription. When taking large volumes of Laxido
Paediatric Plain (e.g. for faecal impaction), your child should not take
other medicines within one hour of taking Laxido Paediatric Plain.

6

8

10

12

12

How to mix
Laxido Paediatric Plain should be made up by dissolving the contents
of one sachet in a quarter glass of water (62.5 ml). Stir well until all
the powder has dissolved and the Laxido Paediatric Plain 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 Laxido Paediatric Plain for faecal impaction it may be easier to
dissolve 12 sachets in 750 ml of water. In this case, the reconstituted
solution must be stored in accordance with the relevant instructions
provided in section 5.
If your child takes more Laxido Paediatric Plain than they
should
Your child may experience severe pains and swelling in their abdomen,
or vomiting or diarrhoea. If this happens, contact their doctor or
pharmacist.
If you forget to give Laxido Paediatric Plain
If you forget to give your child a dose, give it as soon as you remember
and then continue on as before. Do not give a double dose to make up
for a forgotten dose.
If you stop giving Laxido Paediatric Plain
To get the most benefit from Laxido Paediatric Plain, always make sure
that your child finishes the course of treatment recommended by their
doctor, pharmacist or nurse. This will make sure that your child’s
constipation is cleared, otherwise the symptoms they are suffering
from may persist.
If you have any further questions on the use of this medicine, ask the
doctor, pharmacist or nurse.

Laxido Paediatric Plain with food, drink and alcohol
Food and drink have no influence on the effect of Laxido Paediatric
Plain.
Pregnancy, breast-feeding and fertility
Laxido Paediatric Plain can be given during pregnancy and whilst
breast-feeding.
Driving and using machines
Laxido Paediatric Plain has no effect on the ability to drive or use
machinery.
Laxido Paediatric Plain contains sodium
This medicinal product contains 4.06 mmol (or 93 mg) of sodium per
sachet. This should be taken into consideration if your child is on a
controlled sodium diet.

PX2304/2

4. POSSIBLE SIDE EFFECTS
Like all medicines, Laxido Paediatric Plain can cause side effects,
although not everybody gets them.
If your child experiences any of the following side effects, stop giving
Laxido Paediatric Plain and see their doctor immediately:
- signs of a serious allergic reaction, such as difficulty in breathing, or
swelling of the face, lips, tongue or throat
- signs of an allergy, such as a rash, reddening of the skin, nettle rash,
itching or shortness of breath
- signs of a change in the fluid or electrolyte levels in your child’s
body, such as swelling (mainly in the ankles), feeling fatigued,
dehydration or increased thirst with headache. These symptoms
may be a sign that the potassium levels in your child’s blood are
higher or lower than normal.
The following side effects are most common:
- abdominal pain
- stomach rumbling
- diarrhoea
- vomiting
- nausea
- soreness of the anus (bottom)
If your child is being treated for chronic constipation, diarrhoea will
usually improve when the dose is reduced.
The following side effects are less common:
- swelling of your child’s abdomen
- suffering from wind
- indigestion
Reporting of side effects
If your child gets any side effects, talk to their 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 LAXIDO PAEDIATRIC PLAIN
Keep this medicine out of the sight and reach of children.
Do not use Laxido Paediatric Plain after the expiry date which is stated
on the carton and sachet. The expiry date refers to the last day of that
month.
You should store unopened sachets below 25 °C.
Reconstituted Laxido Paediatric Plain solution can be covered and
stored in the refrigerator (2 °C to 8 °C), and should be used within 24
hours. After 24 hours, any unused solution should be discarded.
Do not use Laxido Paediatric Plain if you notice that any of the sachets
are damaged.
Do not throw away any medicines via wastewater or household waste.
Ask the 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 Laxido Paediatric Plain contains
The active substances in each sachet are macrogol 3350 (6.563 g),
sodium chloride (175.4 mg), sodium hydrogen carbonate (89.3 mg)
and potassium chloride (25.1 mg).
Laxido Paediatric Plain does not contain any other ingredients. It does
not contain any colours, flavours or sweeteners.
What Laxido Paediatric Plain looks like and contents of the
pack
Laxido Paediatric Plain is a white powder for oral solution that is
packed in sachets.
Each sachet contains 6.9 g of powder and is packed in cartons
containing 2, 6, 8, 10, 20, 30, 50 and 100 sachets. Not all of these pack
sizes are marketed.
Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK

This medicinal product is authorised in the Member States of
the EEA under the following names:
Germany, Ireland and UK – Laxido Paediatric Plain
Portugal – Laxido Mini
Belgium and Luxembourg – Laxido Junior Neutral
Sweden – Laxido Junior
This leaflet was last revised in April 2016

PX2304/2

Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK

PIL:

Laxido Paediatric RX

Ink Colour:

Black

Fold Configuration:
155mm

1

2

155mm

Dimensions: 155 x 330mm

Finished dimensions

77.5mm

77.5mm
110mm

Folded

3

110mm

Supplied:

110mm

PX2304/2

Pharmacode: 23042

220mm

PX No:

Folded Size: 77.5mm x 110mm
APPROVED BY:

Date:

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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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