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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

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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.

Macilax Paediatric contains potassium, sodium and sorbitol
Macilax Paediatric contains 0.3 mmol (12 mg) potassium per sachet. This
should be taken into consideration if your child has reduced kidney function, or
The name of this medicine is Macilax Paediatric 6.9 g Powder For Oral
if your child is on a controlled potassium diet.
Solution. It is a laxative for the treatment of chronic constipation in children
Macilax Paediatric contains 4.1 mmol (94 mg) sodium per sachet. This should
aged 2 to 11 years and for the treatment of very bad constipation (called faecal be taken into consideration if your child is on a controlled sodium diet.
impaction) in children aged 5 to 11 years.
The lemon lime flavour in Macilax Paediatric contains sorbitol. If you have
It helps your child to have a comfortable bowel movement even if your child
been told by your doctor that your child has an intolerance to some sugars,
has been constipated for a long time.
contact your doctor before giving this medicinal product.

1.

What Macilax Paediatric is and what it is used for

2.

What you need to know before you use
Macilax Paediatric

Do not give Macilax Paediatric to your child
• if 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)
• if your child has a perforated gut (bowel) wall
• if your child has a blockage in the intestine (gut obstruction, ileus)
• if your child has severe inflammatory bowel disease such as ulcerative
colitis, Crohn’s disease or toxic megacolon.
Warnings and precautions
Talk to your doctor or pharmacist before giving Macilax Paediatric to your child,
What is in this leaflet:
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
1. What Macilax Paediatric is and what it is used for
oesophagus).
2. What you need to know before you use Macilax Paediatric Other medicines and Macilax Paediatric
Tell your doctor or pharmacist if your child is taking, has recently taken or
might take any other medicines.
3. How to use Macilax Paediatric
Some medicines, such as anti-epileptics, may not work as effectively during
use with Macilax Paediatric.
4. Possible side effects
When taking large volumes of Macilax Paediatric (e.g. for faecal impaction),
your child should not take other medicines within one hour of taking Macilax
5. How to store Macilax Paediatric
Paediatric.
Macilax Paediatric with food and drink
6. Contents of the pack and other information
Macilax Paediatric can be given at any time with or without food or drink.
Driving and using machines
Macilax Paediatric has no effect on the ability to drive or use machinery.

3.

How to use Macilax Paediatric

Always give this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
Chronic constipation (constipation for long time):
The dose of Macilax Paediatric 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.
• Children aged 7 to 11 years 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. The dose will not usually exceed 4
sachets per day.
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 (complete severe constipation):
Before your child takes Macilax Paediatric for faecal impaction, it should be
confirmed medically that your child has this condition.
A course of treatment is as follows:
Number of sachets
Age (years) Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7
5 - 11
4
6
8
10
12
12
12
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
This can cause severe pain and swelling in the abdomen (stomach), vomiting
(sickness) or diarrhoea. If this happens, 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 allergy, such as skin rash, itching, reddening of the skin, nettle
rash, shortness of breath or difficulty in breathing, or swelling of the face,
lips, tongue or throat
• 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.
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.
Frequency 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 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 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.
This medicinal product does not require any special storage conditions.

Reconstituted Macilax Paediatric 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 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
Klocke Pharma-Service GmbH:
Straßburger Straße 77
77767 Appenweier
Germany
70043-A
This leaflet was last revised in 01/2014
297 x 148
PL 00289/1816
248638.01-GB

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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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