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MACILAX PAEDIATRIC 6.9 G POWDER FOR ORAL SOLUTION

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

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Package leaflet:
Information for the user

Macilax Paediatric
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 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. See
section 4.

What is in this leaflet
1. What Macilax Paediatric is and what it is used for
2. What you need to know before you use use Macilax Paediatric
3. How to use Macilax Paediatric
4. Possible side effects
5. How to store Macilax Paediatric
6. Contents of the pack and other information

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Ask your doctor or pharmacist for advice before giving this medicine.
Driving and using machines
Macilax Paediatric does not affect the ability to drive or use machine.
The name of this medicine is Macilax Paediatric 6.9 g Powder For Oral
Macilax Paediatric contains potassium, sodium and sorbitol
Solution. It is a laxative for the treatment of chronic constipation in children
Macilax Paediatric contains 0.3 mmol (12 mg) potassium per sachet. This
aged 2 to 11 years and for the treatment of very bad constipation (called faecal should be taken into consideration if your child takes more than three sachets
impaction) in children aged 5 to 11 years.
daily and has reduced kidney function, or if your child is on a controlled
It helps your child to have a comfortable bowel movement even if your child
potassium diet.
has been constipated for a long time.
Macilax Paediatric contains 4.1 mmol (94 mg) sodium per sachet. This should
be taken into consideration if your child is on a controlled sodium diet.
What you need to know before you use
The lemon lime flavour in Macilax Paediatric contains sorbitol. If you have
Macilax Paediatric
been told by your doctor that your child has an intolerance to some sugars,
Do not give Macilax Paediatric to your child,
contact your doctor before giving this medicinal product.
• if your child is allergic to macrogol 3350, sodium chloride, sodium hydrogen
carbonate, potassium chloride, or any of the other ingredients of this
How to use Macilax Paediatric
medicine (listed in section 6)
• if your child has a perforated gut (bowel) wall
Always give this medicine exactly as your doctor has told you. Check with your
• if your child has a blockage in the intestine (gut obstruction, ileus)
doctor or pharmacist if you are not sure.
• if your child has severe inflammatory bowel disease such as ulcerative
This medicine can be taken at any time with or without food.
colitis, Crohn’s disease or toxic megacolon.
Chronic constipation (constipation for long time):
Warnings and precautions
The dose of Macilax Paediatric depends on the age of the child and their
Talk to your doctor or pharmacist before giving Macilax Paediatric to your child,
response to treatment.
if your child has a heart or kidney problem, an impaired gag reflex or reflux
• As a starting dose, children aged 2 to 6 years should be given 1 sachet each
oesophagitis (heart-burn caused by back-flow of stomach contents into the
day.
oesophagus).
• Children aged 7 to 11 years should be given 2 sachets each day.
When taking Macilax Paediatric the child should continue to take plenty of
• Your doctor may tell you to increase the number of sachets taken until your
fluids. The fluid content of Macilax Paediatric should not replace the regular
child has a soft bowel movement. The dose will not usually exceed 4
liquid intake.
sachets per day.
Other medicines and Macilax Paediatric
It is not necessary to take all of the drink at one time: if the child prefers it, half
Tell your doctor or pharmacist if your child is taking, has recently taken or
the drink can be taken in the morning and half in the evening.
might take any other medicines.
Faecal impaction (complete severe constipation):
Some medicines, e.g. anti-epileptics(medicines for epilepsy), may not work as
Before your child takes Macilax Paediatric for faecal impaction, it should be
effectively during use with Macilax Paediatric.
confirmed medically that your child has this condition.
When taking large volumes of Macilax Paediatric (e.g. for faecal impaction),
A course of treatment is as follows:
your child should not take other medicines within one hour of taking Macilax
Number of sachets
Paediatric.
Age (years) Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7
Pregnancy and breast-feeding
Macilax Paediatric can be taken during pregnancy and whilst breast-feeding.
5 - 11
4
6
8
10
12
12
12

1.

What Macilax Paediatric is and what it is used for

2.

3.

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The daily number of sachets should be taken one at a time, all consumed
within 12 hours (e.g. 8 am to 8 pm). Treatment can be stopped when the
medicine has worked. This is shown by the child passing large volumes of stool
and/or watery diarrhoea.
Method of administration
• Open the sachet and pour the contents into a glass. Add ¼ glass (about
62.5 ml) of water to the glass. 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 your child is taking Macilax Paediatric for faecal impaction it may be easier
to dissolve 12 sachets in 750 ml of water and to administer the solution
evenly spread over a 12 hour period. Reconstituted Macilax Paediatric
solution should be covered and stored in the refrigerator (2°C to 8°C).
Duration of treatment
• Chronic constipation: Treatment needs to be for a prolonged period of time,
at least 6 to 12 months.
• Faecal impaction: Treatment can be for up to 7 days.
If your child takes more Macilax Paediatric than they should
You child may develop excessive diarrhoea, which can lead to dehydration. If
this occurs, your child should stop taking Macilax Paediatric and drink plenty of
fluids. If you are worried contact your doctor or pharmacist.
If you forget to give Macilax Paediatric
If you forget to give 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 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 your child experiences any of the following side effects, tell your
doctor immediately and stop giving Macilax Paediatric to your child:
• signs of an allergic reaction, such as shortness of breath or difficulty in
breathing, swelling of the face, lips, tongue or throat, nettle rash, itching,
skin rash or reddening of the skin
• signs of a change in your child’s fluid or electrolyte levels, such as swelling
(mainly in the ankles), feeling weak, increasingly tired or increased thirst
with headache.

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Very common side effects (may affect more than 1 in 10 people):
• stomach pains
• stomach rumbles.
Common side effects (may affect up to 1 in 10 people):
• diarrhoea. If your child is being treated for chronic constipation, diarrhoea
will usually improve when the dose is reduced
• vomiting (being sick)
• nausea (feeling sick)
• anal discomfort (uncomfortable sensation around the bottom).
Uncommon side effects (may affect up to 1 in 100 people):
• swollen stomach
• wind.
Rare side effects (may affect up to 1 in 1,000 people):
• allergic reactions, which may include breathlessness or difficulty in
breathing.
Fequency not known (frequency cannot be estimated from the
available data):
• swelling of the face, lips or throat
• 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
If your child gets 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.

Version:

How to store Macilax 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. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that any of the sachets is damaged.
Do not store above 25°C.

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If reconstituted Macilax Paediatric solution cannot be taken straight away, it
should 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 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 Macilax Paediatric contains
The active substances are:
macrogol 3350
6.563 g
sodium chloride
175.4 mg
sodium hydrogen carbonate
89.3 mg
potassium chloride
23.3 mg
The other ingredients are silica colloidal anhydrous, saccharin sodium, orange
flavour (Orange flavour contains: flavouring preparations and substances,
natural flavouring substances, maltodextrin, acacia, α-tocopherol) and lemon
lime flavour (Lemon lime flavour contains: natural lemon oil, natural powder
flavour lemon, powder flavour lime, maltodextrin, mannitol, gluconolactone,
sorbitol, acacia, silica colloidal anhydrous).
What Macilax Paediatric looks like and contents of the pack
Macilax Paediatric is a white powder.
Each sachet contains 6.9 g of powder and is packed in cartons containing 30
and 50 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany
This leaflet was last revised in 04/2017.
PL 00289/1816

EBNUK15555b

248638.02-GB

Expand Transcript

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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