Laxido Paediatric Plain 6.9 g, powder for oral solution

Land: Storbritannien

Sprog: engelsk

Kilde: myHealthbox

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Indlægsseddel Indlægsseddel (PIL)
29-04-2024
Produktets egenskaber Produktets egenskaber (SPC)
29-04-2024

Aktiv bestanddel:

Macrogol 3350, Sodium Chloride, Sodium Hydrogen Carbonate, Potassium Chloride

Tilgængelig fra:

Galen Limited

ATC-kode:

A06A D65

INN (International Name):

Macrogol 3350, Sodium Chloride, Sodium Hydrogen Carbonate, Potassium Chloride

Dosering:

6.563 g, 175.4 mg, 89.3 mg, 25.1 mg

Lægemiddelform:

Powder for oral solution.

Indgivelsesvej:

Oral use

Enheder i pakken:

Sachets are packed in cartons of 2, 6, 8, 10, 20, 30, 50 or 100 sachets

Recept type:

POM - Prescription Only Medicine

Fremstillet af:

Almac Pharma Services Limited

Terapeutisk gruppe:

Osmotically acting laxatives

Terapeutiske indikationer:

It is used for the treatment of chronic constipation in children aged 2 to 11 years and 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.

Autorisation status:

Authorised

Autorisation dato:

2015-06-02

Indlægsseddel

                                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
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.  This course of
treatment for
faecal impaction can be for up to 7 days.
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 faec
                                
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Produktets egenskaber

                                Laxido Paediatric Plain 6.9 g, powder for oral solution
Summary of Product Characteristics Updated 08­Jun­2015 | Galen Limited
1. Name of the medicinal product
Laxido Paediatric Plain 6.9 g, 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.
Single­dose sachet containing a white powder.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of chronic constipation in children aged 2 to 11 years.
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.
_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 fa
                                
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