Movicol Junior Lemon-Lime Flavour

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Macrogol 3350 6.536 g;  ; Potassium chloride 23.3mg; Sodium bicarbonate 89.3mg; Sodium chloride 175.4mg

Available from:

CARSL Consulting

INN (International Name):

Macrogol 3350 6.536 g

Pharmaceutical form:

Powder for oral solution

Composition:

Active: Macrogol 3350 6.536 g   Potassium chloride 23.3mg Sodium bicarbonate 89.3mg Sodium chloride 175.4mg Excipient: Acesulfame potassium Lemon & Lime. Trusil 463842

Units in package:

Sachet, laminate, Paper/LDPE/AL/LDPE 6.9g, 30 dose units

Class:

General sale

Prescription type:

General sale

Manufactured by:

Clariant GmbH

Therapeutic indications:

For effective relief from constipation, treatment of chronic constipation. Movicol is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by physical examination of abdomen and rectum.

Product summary:

Package - Contents - Shelf Life: Sachet, laminate, Paper/LDPE/AL/LDPE 6.9g - 30 dose units - 36 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2004-01-12

Summary of Product characteristics

MOVICOL Junior Lemon-Lime Flavour Datasheet – June 2020
Page 1 of 7
NEW ZEALAND DATASHEET
1 PRODUCT NAME
MOVICOL
®
Junior Lemon
‐
Lime Flavour
(macrogol 3350 6.563 g plus electrolytes) Oral Powder for Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of MOVICOL Junior contains:
Macrogol 3350 6.563 g
Sodium chloride 175.4 mg
Sodium bicarbonate 89.3 mg
Potassium chloride 23.3 mg
Contains sodium. For full list of excipients, see 6.1 List of
excipients.
3 PHARMACEUTICAL FORM
Sachets containing free-flowing white powder for oral solution.
The content of electrolyte ions per sachet when made up with 62.5 mL
of water is:
Sodium 65 mmol/L
Potassium 5.4 mmol/L
Chloride 53 mmol/L
Bicarbonate 17 mmol/L
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For effective relief of constipation in adults.
For treatment of chronic constipation in adults and children aged 2
years and older.
For resolving faecal impaction, defined as refractory constipation
with faecal loading of the
rectum, or the rectum and colon, confirmed by physical examination of
abdomen and rectum,
in adults and children aged 2 years and older.
For prevention of recurrence of faecal impaction in children aged 2
years and older.
Use in children aged 2 years and older should be limited to 12 weeks
except under medical
supervision.
4.2 Dose and method of administration
ADULTS AND CHILDREN OVER 12 YEARS
_CONSTIPATION:_ The dose is 2 sachets daily and may be increased up to
6 sachets daily if
required. For chronic constipation the dose may be reduced to 1 sachet
daily according to
individual response.
For patients of 12 years and older using 2 sachets daily or more, it
is recommended to use
MOVICOL.
MOVICOL Junior Lemon-Lime Flavour Datasheet – June 2020
Page 2 of 7
_FAECAL IMPACTION:_ 16 sachets daily, all of which should be consumed
within 6 hours. A
course of treatment for faecal impaction does not normally exceed 3
days. For patients of
12 years and older it is recommended to use MOVICOL.
CHILDREN 2 YEARS AND OLDER
_CHRONIC CONSTIPATION AN