Duphalac

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

lactulose 667 g/l

Available from:

Abbott Healthcare Products Limited

ATC code:

A06AD11

INN (International Name):

lactulose

Pharmaceutical form:

oral liquid

Authorization status:

Authorised

Authorization date:

2006-01-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 
DUPHALAC 
3.335 g / 5 ml Oral Solution lactulose 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
MEDICINES. 

This medicine is available without prescription. However, you
still need to take Duphalac 
carefully to get the best results from it. 

• 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 you. Do not pass it on to
others. It 
may harm them, even if their symptoms are the same as yours. 

If any of the side effects gets  serious, or if you
notice any side effects not listed in  this 
leaflet, please tell your doctor or pharmacist. 

IN THIS LEAFLET: 
1. What Duphalac is and what it is used for 
2. Before you take Duphalac 
3. How to take Duphalac 
4. Possible side effects 
5. How to store Duphalac 
6. Further information 

1. WHAT DUPHALAC IS, 
Duphalac contains a laxative  called lactulose. It makes the
stool softener and easier to 
pass, by drawing water into the bowel. It is not absorbed
into your body.   

WHAT DUPHALAC IS USED FOR 
Duphalac is used to treat constipation (infrequent bowel movement, hard
and dry stools) 
to produce a soft stool.  

Duphalac is used to treat hepatic encephalopathy, also
called portal systemic  
encephalopathy (a liver disease causing difficulty thinking, tremor,
decreased level of 
consciousness including coma).  

2. BEFORE YOU TAKE DUPHALAC  

DO NOT TAKE DUPHALAC : 
if you are allergic (hypersensitive) to lactulose or any of
the other ingredients of 
Duphalac (listed in Section 6). 

If you suffer from 
–  galactosaemia (a severe genetic disorder where you cannot
digest galactose) 
–  blockage in your bowel (apart from normal constipation) . 

 If you a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Duphalac 3.335 g / 5 ml Oral Solution 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Lactulose solution containing 3.335 g of lactulose per 5 ml. 
For a full list of excipients, see section 6.1 
3. PHARMACEUTICAL FORM 

Oral solution. 
Clear, colourless to pale brownish – yellow viscous liquid. 

4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

(1) In the treatment of constipation. 
(2) In the treatment of hepatic encephalopathy. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 

The lactulose solution may be administered diluted or undiluted. 

A single dose of lactulose should be swallowed in one and should
not be kept in the mouth for an 
extended period of time. 

The posology should be adjusted according to the individual needs
of the patient. In case of a single daily 
dose, this should be taken at the same time, e.g. during 
breakfast. During the therapy with laxatives it is 
recommended to drink sufficient amounts of fluids(1.5-2litres equal to
6-8 glasses) during the day. 

DOSING IN CONSTIPATION   

 Lactulose may be given as a single daily dose or in two
divided doses, for Duphalac in bottles the measuring cup 
should be used. 

Several days (2-3days) of treatment may be needed
before treatment effect occurs. 

Adults: 
15 ml twice daily 
Children 5-10 years: 
10 ml twice daily 
Children 2-5 years: 
5 ml twice daily 
Infants 1-2 years: 
2.5 ml -5 ml twice daily 
Infants 1 month-1 year: 
2.5 ml twice daily 

DOSING IN HEPATIC ENCEPHALOPATHY    

Initially 30 to 50 ml three times daily; dosage should be
subsequently adjusted to produce 2 to 3 
soft stools daily. 

4.3 CONTRAINDICATIONS 

Hypersensitivity to the active substance or
to any of the ingredients. 
Use in patients who require a