LAXATEV PAEDIATRIC 6.9 Grams Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MACROGOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE

Available from:

Teva Pharma B.V.

ATC code:

A06AD65

INN (International Name):

MACROGOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE

Dosage:

6.9 Grams

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives

Authorization status:

Authorised

Authorization date:

2014-02-28

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAXATEV 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 _Laxatev Paediatric_ is and what it is used for
2.
What you need to know before you use _Laxatev Paediatric_
3.
How to use _Laxatev Paediatric_
4.
Possible side effects
5.
How to store _Laxatev Paediatric_
6.
Contents of the pack and other information
1. WHAT LAXATEV PAEDIATRIC IS AND WHAT IT IS USED FOR
The name of this medicine is _Laxatev Paediatric 6.9 g Powder for Oral
Solution_. It is a laxative for
the treatment of chronic constipation in children aged 2 to 11 years
and for the treatment of very bad
constipation (called faecal impaction) in children aged 5 to 11 years.
It helps your child to have a comfortable bowel movement even if your
child has been constipated for
a long time.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE _LAXATEV PAEDIATRIC_
DO NOT GIVE _LAXATEV 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 _Laxatev Paediatric_
to your child, if you

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Laxatev Paediatric 6.9g Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains the following active ingredients:
Macrogol 3350
6.563 g
Sodium chloride
175.4 mg
Sodium hydrogen carbonate
89.3 mg
Potassium chloride
23.3 mg
The content of electrolyte ions per sachet when made up to 62.5 ml of
solution is as follows:
Sodium
65 mmol/l
Chloride
53 mmol/l
Hydrogen carbonate
17 mmol/l
Potassium
5 mmol/l
Excipient with known effect: sorbitol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution
Single-dose sachet containing a free flowing white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of chronic constipation in children 2 to 11 years of
age.
For the treatment of faecal impaction in children 5 to 11 years of
age, defined as refractory constipation with faecal
loading of the rectum and/or colon.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_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 to be
increased 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 proved for a period of up to three
months. Treatment should be stopped gradually
and resumed if constipation recurs.
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