Laxido Paediatric Plain, 6.9 g sachet, powder for oral solution

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Macrogol 3350; Sodium chloride; Sodium hydrogen carbonate; Potassium chloride

Verfügbar ab:

Galen Pharma Ireland Limited

ATC-Code:

A06AD; A06AD65

INN (Internationale Bezeichnung):

Macrogol 3350; Sodium chloride; Sodium hydrogen carbonate; Potassium chloride

Dosierung:

6.9 gram(s)

Darreichungsform:

Powder for oral solution in sachet

Therapiebereich:

Osmotically acting laxatives; macrogol, combinations

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2015-05-22

Gebrauchsinformation

1.3.1 Package Leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAXIDO PAEDIATRIC PLAIN, 6.9 G SACHET, 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
1.
WHAT LAXIDO PAEDIATRIC PLAIN IS AND WHAT IT IS USED FOR
Laxido Paediatric Plain contains macrogol 3350 and the electrolytes
sodium chloride, sodium
hydrogen carbonate and potassium chloride.
Laxido Paediatric Plain is a laxative used for the treatment of
chronic constipation in children
aged 1 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.
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 to macrogol 3350, sodium chloride, sodium hydrogen
carbonate or potassium chloride
-
has a perforation in the wall of their intestine

Fachinformation

Health Products Regulatory Authority
07 December 2021
CRN00CQ02
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Laxido Paediatric Plain, 6.9 g sachet, powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains the following quantitative composition of active
ingredients:
Macrogol 3350 6.563 g
Sodium Chloride 175.4 mg
Sodium Hydrogen Carbonate 89.3 mg
Potassium Chloride 25.1 mg
The content of electrolyte ions per sachet following reconstitution in
62.5 ml of water is equivalent to:
Sodium 65 mmol/l
Chloride 53 mmol/l
Hydrogen Carbonate (Bicarbonate) 17 mmol/l
Potassium 5.4 mmol/l
3 PHARMACEUTICAL FORM
Powder for oral solution.
Single-dose sachet containing a white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Laxido Paediatric Plain is indicated for the treatment of chronic
constipation in children aged 1 to 11 years.
Laxido Paediatric Plain is indicated for the treatment of faecal
impaction in children from the age of 5 years, defined as
refractory constipation with faecal loading of the rectum and/or
colon.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Laxido Paediatric Plain is for oral use.
_Posology_
_Chronic constipation:_
The usual starting dose is 1 sachet daily for children aged 1 to 6
years, and 2 sachets daily for children aged 7 to 11 years. The
dose should be adjusted up or down as required to produce regular soft
stools. If the dose needs increasing this is best done
every second day. For children below 2 years of age, the maximum
recommended dose should not exceed 2 sachets a day.
For children aged 2 to 11 years, the maximum recommended dose needed
does not normally exceed 4 sachets a day.
Treatment of children with chronic constipation needs to be for a
prolonged period (at least 6 to 12 months). However, safety
and efficacy have only been proven for a period of up to 3 months.
Treatment should be stopped gradually and resumed if
constipation recurs.
_Faecal impaction:_
A course of treatment for faecal impaction with Laxido Paedi