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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

Galen Limited

ATC code:

A06AD; A06AD65

INN (International Name):

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

Dosage:

6.9 gram(s)

Pharmaceutical form:

Powder for oral solution in sachet

Administration route:

Oral use

Units in package:

Sachet contains 6.9 g of powder and is packed in cartons containing 2, 6, 8, 10, 20, 30, 50 and 100 sachets.

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Almac Pharma Services Limited

Therapeutic group:

Osmotically acting laxatives

Therapeutic area:

Osmotically acting laxatives; macrogol, combinations

Therapeutic indications:

For the treatment of chronic constipation in children aged 2 to 11 years and of of faecal impaction in children from the age of 5 years, defined as refractory constipation with faecal loading of the rectum and/or colon.

Authorization status:

Marketed

Authorization date:

2015-05-22

Patient Information leaflet

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 recommended 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.
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
Day 7
(years)
5 to 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 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.
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.
DURATION OF TREATMENT
CHRONIC CONSTIPATION
The course of treatment for chr

Summary of Product characteristics

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 2 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 2 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.
The maximum 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 Paediatric
Plain is for up to 7 days as follows:
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__