DUPHALAC 3.335 g/5ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LACTULOSE

Available from:

BGP Products Ltd

ATC code:

A06AD11

INN (International Name):

LACTULOSE

Dosage:

3.335 g/5ml

Pharmaceutical form:

Oral Solution

Administration route:

Oral use

Units in package:

300 or 1000 ml

Prescription type:

Product not subject to medical prescription

Manufactured by:

Abbott Biologicals B.V.

Therapeutic group:

Osmotically acting laxatives

Therapeutic area:

Osmotically acting laxatives

Therapeutic indications:

Constipation Hepatic encephalopathy (HE): treatment and prevention of hepatic coma or precoma

Authorization status:

Authorised

Authorization date:

2015-03-27

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 THIS
MEDICINE BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or
as your doctor,
pharmacist or nurse have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects talk to your
doctor, pharmacist or nurse.  This includes any 
possible side effects not listed in this leaflet.  See section 4.
- You must talk to a doctor if you do not feel better or if you feel
worse after several 
days.
WHAT IS IN THIS LEAFLET:
1. What Duphalac is and what it is used for
2. What you need to know before you take Duphalac
3. How to take Duphalac
4. Possible side effects
5. How to store Duphalac
6. Contents of the pack and other information
1. WHAT DUPHALAC IS AND WHAT IT IS USED FOR
WHAT DUPHALAC IS 
Duphalac contains a laxative called lactulose. 
It makes the stool softer 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 movements,
hard and dry stools).
Duphalac is used to treat or prevent hepatic encephalopathy (a
liver disease causing 
confusion, tremor, decreased level of consciousness including
coma). This is also known 
as a ‘hepatic coma’.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DUPHALAC
DO NOT TAKE DUPHALAC:
 if you are allergic (hypersensitive) to
v
This information is confidential
Lactulose
SOLID 2000023391
1.0
– lactulose 
– any of the other ingredients of Duphalac (listed in Section 6).
 If you suffer from
– galactosaemia (a sever genetic disorder where you cannot
digest 
galactose)
– blockage in your gastrointestinal tract (apart from normal
constipation)
– gastrointestinal tract perforation or risk of ga

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duphalac 3.335g/5ml 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
Constipation
Hepatic encephalopathy (HE): treatment and prevention of hepatic coma or precoma.
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 – 2 litres, equal to 6-8 glasses) during the day.
For Duphalac in bottles the measuring cup may be used.
DOSING IN CONSTIPATION
Lactulose may be given as a single daily dose or in two divided doses; for Duphalac in bottles the measuring cup may
be used.
After a few days the starting dosage may be adjusted to the maintenance dose based upon treatment response. Several
days (2-3 days) of treatment may be needed before treatment effect occurs.
Starting dose daily
Maintenance dose daily
Adults and adolescents
15 – 45 ml
15 – 30 ml
Children (7-14 years)
15 ml
10 – 15 ml
Children (1-6 years)
5 – 10 ml
5 – 10 ml
Infants under 1 year
Up to 5 ml
Up to 5 ml
HEALTH PRODUCTS REGULATORY AUTHORITY
_________________________________________________________________________________________________________