DUPHALAC 3.335 MG/5ml Oral Solution

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

LACTULOSE

Saadav alates:

Abbott Healthcare Products Ltd

INN (Rahvusvaheline Nimetus):

LACTULOSE

Annus:

3.335 MG/5ml

Ravimvorm:

Oral Solution

Retsepti tüüp:

Product not subject to medical prescription

Volitamisolek:

Authorised

Loa andmise kuupäev:

0000-00-00

Infovoldik

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.
• Keep this leaflet. You may need to read it again.
• If you have further question, 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 get 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 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) 
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 sever genetic disorder where you cannot digest
galactose)
-
blockage in your bowel (apart from normal constipation)
v
This information is confidential
Lactulose
SOLID 1000555108
1.0
If you are not sure, talk to your doctor or pharmacist before taking
Duphalac.
TAKE SPECIAL CARE WITH DUPHALAC
Please consult your doctor before taking Duphalac if you suffer
from any medical 
conditions or illnesses, in particular:
– if you are unable to digest milk sugar (lactose) You should
not take Duphalac if you 
suff

Toote omadused

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
(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 – 2 litres, 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 (2-3 days) of treatment may be needed before treatment effect occurs.
DOSING IN HEPATIC ENCEPHALOPATHY
Initially 30 – 50 ml three times daily; dosage should be adjusted to produce 2 to 3 soft stools daily.
Adults
15ml twice daily
Children 5-10 years
10ml twice daily
Children 2-5 years
5ml twice daily
Infants 1- 2 years
2.5 - 5ml twice daily
Infants 1month – 1 year
2.5ml twice daily
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 15/07/2014_
_CRN 2149609_
_page number: 1_
4.3 CONTRAIN