Duphalac 3.35g/5ml oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lactulose

Available from:

Viatris UK Healthcare Ltd

ATC code:

A06AD11

INN (International Name):

Lactulose

Dosage:

680mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01060400; GTIN: 5099151015280 5099151015297 5012781025108

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DUPHALAC
LACTULOSE 3.335 G/5 ML ORAL SOLUTION
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 or pharmacist 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.

You must talk to your 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 hepatic encephalopathy (a liver disease
causing confusion, tremor,
decreased level of consciousness). Hepatic encephalopathy can lead to
a hepatic coma.
2.
WHAT YOU NEED TO KNOW 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).

You have a rare problem called 'galactosaemia'.

You have a blockage caused by anything else but normal constipation,
digestive perforation or
risk of digestive perforation.
Do not take Duphalac if any of the above apply to you. If you are not
sure, talk to your doctor or
pharmacist before taking Duphalac.
WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacist before taking Duphalac

Summary of Product characteristics

OBJECT 1
DUPHALAC
Summary of Product Characteristics Updated 01-Nov-2016 | Mylan
Products Limited
1. Name of the medicinal product
Duphalac
®
2. Qualitative and quantitative composition
Lactulose 3.335 g/5 ml.
For excipients, see 6.1
3. Pharmaceutical form
Oral solution.
A clear, viscous liquid, colourless to brownish yellow.
4. Clinical particulars
4.1 Therapeutic indications
1. For the treatment of constipation.
2. For the treatment of hepatic encephalopathy (HE); hepatic coma.
4.2 Posology and method of administration
The lactulose solution may be administered diluted or undiluted. Each
dose may if necessary be taken
with water or fruit juices, etc.
Each 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 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 lactulose in bottles the measuring cup may be used.
For lactulose in 15 ml single dose sachets the corner of the sachet
should be torn off and contents taken
immediately.
Dosing in constipation:
Lactulose may be given as a single daily dose or in two divided doses,
for lactulose 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.
_Lactulose oral solution in bottles or 15 ml single dose sachets:_
Starting dose daily
Maintenance dose daily
Adults and adolescents
15-45 ml, corresponding to 1-3
sachets
15-30 ml, corresponding to 1-2
sachets
Children
(7-14 years)
15 ml, corresponding to 1 sachet
10-15 ml, corresponding to 1
sachet*
Children
(1-6 years)
5-10 ml
5-10 ml
Infants under 1 year
up to 5 ml
up to 5 ml
* If the maintenance dose is below 15 ml, lactulo