Movicol Lemon-Lime Flavour

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Macrogol 3350 13.125 g;  ; Potassium chloride 46.6mg; Sodium bicarbonate 178.5mg; Sodium chloride 350.7mg

Available from:

CARSL Consulting

INN (International Name):

Macrogol 3350 13.125 g

Dosage:

13.8 g

Pharmaceutical form:

Powder for oral solution

Composition:

Active: Macrogol 3350 13.125 g   Potassium chloride 46.6mg Sodium bicarbonate 178.5mg Sodium chloride 350.7mg Excipient: Acesulfame Lemon & Lime. Trusil 463842

Units in package:

Sachet, laminate, Paper/LDPE/Al/LDPE 13.8g, 1 dose unit

Class:

General sale

Prescription type:

General sale

Manufactured by:

Union Carbide Corporation

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 13.8g - 1 dose units - 36 months from date of manufacture stored at or below 25°C - Sachet, laminate, 13.8g sachet packs - 8 dose units - 36 months from date of manufacture stored at or below 25°C - Sachet, laminate, 13.8g sachet packs - 20 dose units - 36 months from date of manufacture stored at or below 25°C - Sachet, laminate, 13.8g sachet packs - 30 dose units - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1998-06-29

Patient Information leaflet

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INFORMATION FOR
CONSUMERS
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Consumer Medicine
Information
Movicol
®
Macrogol 3350
What is in this leaflet
Please read this leaflet carefully before taking your medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist.
What is this medicine?
The name of this medicine is Movicol. Each sachet contains:
Macrogol 3350 13.125 g
Sodium chloride 350.7 mg
Sodium bicarbonate 178.5 mg
Potassium chloride 46.6 mg
When it is made into a drink with 125 mL of water, each sachet gives the equivalent of:
Sodium 65 mmol/L
Chloride 53 mmol/L
Bicarbonate 17 mmol/L
Potassium 5.4 mmol/L
Movicol also contains lime and lemon flavour, and potassium acesulfame as a sweetener.
There are 8, 20 or 30 sachets in a box. Each sachet contains 13.8 grams of Movicol powder. You add
the powder to water to make a drink.
What is Movicol used for?
Movicol helps you to have a comfortable bowel movement even if you have been constipated for a long
time. Movicol also works in faecal impaction (as determined by your doctor).
Before you take Movicol
Do not take Movicol if your doctor has told you that you have:
an obstruction in your intestine (gut)
a perforated gut wall
severe inflammatory bowel disease, like ulcerative colitis, Crohn's disease, or toxic megacolon
an allergy to macrogol.
If you are pregnant or breast feeding, talk to your doctor before you take Movicol.
Laxative products such as Movicol have the potential to interact with other medications, by altering their
absorption. Close monitoring of the effects of your medications may be necessary when you commence
or cease to take Movicol regularly. It is important that you should discuss 

Summary of Product characteristics

MOVICOL Lemon-Lime Flavour Datasheet – June 2020
Page 1 of 5
NEW ZEALAND DATASHEET
1 PRODUCT NAME
MOVICOL Lemon-Lime Flavour (macrogol 3350 13.125 g and electrolytes)
powder for oral
solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of MOVICOL Lemon-Lime Flavour contains:
Macrogol 3350
13.125 g
Sodium chloride
350.7 mg
Sodium bicarbonate
178.5 mg
Potassium chloride
46.6 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 to 125 mL 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 from constipation, treatment of chronic
constipation. MOVICOL Lemon-
Lime Flavour 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.
4.2 Dose and method of administration
CONSTIPATION: The dose is 1 sachet daily. This may be increased to 2-3
sachets daily, if
required.
FAECAL IMPACTION: 8 sachets daily, consumed within 6 hours. A course
of treatment for faecal
impaction does not normally exceed 3 days.
PATIENTS WITH IMPAIRED CARDIOVASCULAR FUNCTION: For the treatment of
faecal impaction the
dose should be divided so that no more than two sachets are taken in
any one hour.
PATIENTS WITH RENAL INSUFFICIENCY: No dosage change is necessary for
treatment of either
constipation or faecal impaction.
ADMINISTRATION
For oral
administration. Each sachet should be dissolved in 125 mL water. For
faecal
impaction 8 sachets may be dissolved in 1 litre of water. Store the
solution refrigerated and
discard any solution not used within 6 hours.
MOVICOL Lemon-Lime Flavour Datasheet – June 2020
Page 2 of 5
Also see Section 4.4 Special Warnings and Precautions for use.
4.3 Contraindications
Intestinal perforation or obstruction due to str