Duphalac Fruity

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Lactulose 667 mg/mL

Available from:

BGP Products

INN (International Name):

Lactulose 667 mg/mL

Dosage:

667 mg/mL

Pharmaceutical form:

Oral solution

Composition:

Active: Lactulose 667 mg/mL Excipient: Plum aroma

Units in package:

Bottle, plastic, 200 mL

Class:

General sale

Prescription type:

General sale

Manufactured by:

Abbott Healthcare Products B.V

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, - 200 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 300 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 500 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 800 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 1000 mL - 24 months from date of manufacture stored at or below 30°C - Sachet, laminate, 15 mL, carton of 20 sachets - 20 dose units - 24 months from date of manufacture stored at or below 30°C

Authorization date:

2010-09-13

Patient Information leaflet

Duphalac Fruity Oral Liquid 

Page 1 of 5   

_DUPHALAC_
 
_FRUITY_
_ _

Lactulose 10.0 g/15 mL Oral Liquid with plum flavour 

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 

This leaflet answers some common questions about Duphalac Fruity. 

It does not contain all the available information. 

It does not take the place of talking to your doctor or pharmacist. 

IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST. 

KEEP THIS LEAFLET WITH THE MEDICINE. 
You may need to read it again. 

WHAT DUPHALAC FRUITY IS USED FOR 

Duphalac Fruity belongs to a group of medicines known as laxatives.

Duphalac Fruity is used to treat chronic constipation.  It can be
taken by pregnant women.  
It works by increasing the amount of water and stool bulk in the
bowel, promoting normal bowel activity. 

Duphalac Fruity can also be used to treat portal-systemic
encephalopathy (PSE), also known as hepatic 
encephalopathy (a disease of the brain that occurs when the liver is
not working properly. Symptoms are caused 
by too much ammonia in the blood). It works by lowering the level of
ammonia in the blood. 

Duphalac Fruity can be used where a soft stool is considered of
medical benefit (haemorrhoids, anal surgery). 

ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT
WHY DUPHALAC FRUITY HAS BEEN PRESCRIBED 
OR RECOMMENDED FOR YOU. 
Your doctor or pharmacist may have prescribed or recommended Duphalac
Fruity for another reason.   

There is no evidence that Duphalac Fruity is addictive. 

BEFORE YOU TAKE DUPHALAC FRUITY 
_ _
_WHEN YOU MUST NOT TAKE IT _

DO NOT TAKE DUPHALAC FRUITY IF YOU: 
  ARE ALLERGIC TO LACTULOSE, GALACTOSE, LACTOSE OR ANY OTHER
SUGAR. 
  HAVE GALACTOSAEMIA 
  HAVE A DISACCHARIDASE DEFICIENCY 
  ARE ON A LOW-GALACTOSE OR GALACTOSE-FREE DIET 
  ARE ON A LACTOSE-FREE DIET 
  HAVE A BOWEL OBSTRUCTION (BLOCKAGE OTHER

Summary of Product characteristics

1

DATA SHEET 

NAME OF MEDICINE 

DUPHALAC FRUITY  
lactulose 10.0g/15 mL Oral Liquid 

PRESENTATION 

Duphalac Fruity is a sweet, clear, colourless
to brownish yellow liquid with a specific 
gravity of 1.33. Each 15 mL of Duphalac Fruity contains
10 g lactulose as the active 
ingredient, furthermore 0.225 g plum aroma, 1.5 g or less of
galactose, 0.9 g or less of 
lactose, 0.7 g or less of epilactose, 0.3 g or less of
tagatose, and 0.1 g or less of 
fructose. Duphalac Fruity oral solution may also contain very small
amounts of hydrogen 
peroxide and sodium hydroxide from the route of synthesis. 

USES 

ACTIONS 

Therapeutic Class:  Laxative 

Lactulose strengthens the growth of the health-promoting bacteria of
the genus 
Bifidobacterium and may suppress potentially pathogenic bacteria like
Clostridium and 
Escherichia coli. Consequently, it is often described as a prebiotic
substance. Its effects 
on the balance of the intestinal flora may contribute to its action in
hepatic 
encephalopathy (see Portal-Systemic Encephalopathy, below).  
METABOLISM IN INFANTS: Administration of lactulose to infants fed
with cow’s milk 
produces a predominance of lactobacilli in the stools, thus
simulating the intestinal flora 
following maternal milk feeding. Lactulose also appears to
increase the production of 
lysosome in infants receiving cow’s milk. 

PORTAL-SYSTEMIC ENCEPHALOPATHY (Hepatic Encephalopathy; “hepatic
coma”): 
Portal-Systemic Encephalopathy (PSE) is a
neuropsychiatric syndrome from a disorder 
of cerebral function, which can complicate all forms of liver
disease. The major sites of 
cerebral involvement are the cortex extrapyramidal system and
cerebellum. Clinical 
features include intellectual deterioration, disturbances of
consciousness and 
neurological abnormalities. 

It is generally accepted that PSE involves exposure
of the brain to nitrogenous 
substances arising from the gut from bacte