Duphalac 3.335 g/5 ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lactulose

Available from:

Mylan IRE Healthcare Limited

ATC code:

A06AD; A06AD11

INN (International Name):

Lactulose

Dosage:

3.335 g/5ml

Pharmaceutical form:

Oral solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Osmotically acting laxatives; lactulose

Authorization status:

Not marketed

Authorization date:

1983-04-01

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
–
lactulose or
–
any of the other ingredients of Duphalac (see sections 2 and 6).

if you suffer from
–
galactosaemia (a severe genetic disorder where you cannot digest
galactose)
–
blockage in your gastrointestinal tract (apart from normal
constipation)
–
gastrointestinal perforation or risk of gastrointestinal perforation
(damage/puncture to the gastric and/or intestinal wall)
If you are not sure, talk to your doctor or pharmacist before tak

Summary of Product characteristics

Health Products Regulatory Authority
13 May 2022
CRN00CXQL
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duphalac 3.335 g/5 ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lactulose 3.335 g per 5 ml oral solution (as Lactulose, liquid 667
g/l)
For a full list of excipients, see section 6.1
Duphalac contains residues from the route of production with known
effect, see section 4.4.
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.
DOSING IN CONSTIPATION
Lactulose may be given as a single daily dose or in two divided doses.
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
Method of Administration
Oral use.
For Duphalac in bottles the measuring cup may be used to administer
the appropriate dose.
DOSING IN HEPATIC ENCEPHALOPATHY (HE)
Adults:
For oral administration
Health Products Regulatory Authority
13 May 2022
CRN00CXQL
Page 2 of 5
Starting Dose
Maintenance Dose
3 to 4 times daily 30-45