Molative Paediatric oral powder 6.9g sachets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Macrogol '3350'; Sodium; Chloride; Bicarbonate; Potassium

Verfügbar ab:

Viatris UK Healthcare Ltd

ATC-Code:

A06AD65

INN (Internationale Bezeichnung):

Macrogol '3350'; Sodium; Chloride; Bicarbonate; Potassium

Dosierung:

105gram/1litre ; 65mmol/1litre ; 53mmol/1litre ; 17mmol/1litre ; 5.4mmol/1litre

Darreichungsform:

Powder

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 01060400; GTIN: 5016695007175

Gebrauchsinformation

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOLATIVE PAEDIATRIC 6.9 G POWDER FOR ORAL SOLUTION
macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium
chloride
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING YOUR CHILD
THIS MEDICINE 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.
WHAT IS IN THIS LEAFLET
1.
What Molative Paediatric is and what it is used for
2.
What you need to know before you give Molative Paediatric
3.
How to give Molative Paediatric
4.
Possible side effects
5.
How to store Molative Paediatric
6.
Contents of the pack and other information
1.
WHAT MOLATIVE PAEDIATRIC IS AND WHAT IT IS USED FOR
The name of this medicine is Molative Paediatric 6.9 g, powder for
oral solution. It is a laxative (a
medicine used to help your child pass stools) for the treatment of
long-term (chronic) constipation in
children aged 2 to 11 years.
Also, this medicine is used for the treatment of faecal impaction, in
children aged 5 to 11 years (a
condition where large amounts of stool builds up in the rectum and/or
colon which cannot be passed
easily by your child).
Molative Paediatric helps your child to have a comfortable bowel
movement even if they have been
constipated for a long time.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE MOLATIVE PAEDIATRIC
DO NOT GIVE MOLATIVE PAEDIATRIC IF YOUR DOCTOR HAS TOLD YOU THAT 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).

has a blockage in their intestine (gut obstruction, ileus)


Fachinformation

OBJECT 1
MOLATIVE PAEDIATRIC 6.9 G POWDER FOR ORAL
SOLUTION
Summary of Product Characteristics Updated 19-Dec-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Molative Paediatric 6.9 g Powder for Oral Solution
2. Qualitative and quantitative composition
Each sachet of Molative Paediatric 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
Potassium
5 mmol/l
Bicarbonate
17 mmol/l
Excipient with known effect:
Each sachet contains 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 crystalline 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 from the age of five
years, 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 – 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 or a
prolonged period (at least 6 – 12
months). However, safety and efficacy of Molative Paediatric has only
been proved for a period of up to
three months. Treatment should be stopped gradually and resumed if
constipation recurs.
FAECAL IMPACTION
A course of treatment for faecal impaction with Molative Paediatric is
for up to 7 days as follows:
_DAILY DOSAGE REGIMEN:_
NUMBER OF MOLATIVE PAEDIATRIC SACHETS
Age (years)
Day 1
Da