Lactulose Crescent 3.35 g/5 ml Solution

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

LACTULOSE

Dostępny od:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

Kod ATC:

A06AD11

INN (International Nazwa):

LACTULOSE 3.35 g/5ml

Forma farmaceutyczna:

ORAL SOLUTION

Skład:

LACTULOSE 3.35 g/5ml

Typ recepty:

OTC

Dziedzina terapeutyczna:

DRUGS FOR CONSTIPATION

Podsumowanie produktu:

Licence number in the source country: NOT APPLICAPABLE

Status autoryzacji:

Authorised

Data autoryzacji:

2020-12-01

Ulotka dla pacjenta

Page
1
of
6
PACKAGE LEAFLET: INFORMATION FOR THE USER
LACTULOSE CRESCENT 3.35G/ 5ML 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, pharmacist
or nurse has 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 Lactulose Solution is and what it is used for
2. What you need to know before you take Lactulose Solution
3. How to take Lactulose Solution
4. Possible side effects
5. How to store Lactulose Solution
6. Contents of the pack and other information
1.
WHAT LACTULOSE SOLUTION IS AND WHAT IT IS USED FOR
Lactulose is a laxative. It makes the stool softer and easier to pass,
by drawing water into the
bowel. It is not absorbed into your body.
It is used to treat:
•
constipation (infrequent bowel movements, hard and dry stools)
•
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 LACTULOSE SOLUTION
DO NOT TAKE LACTULOSE SOLUTION IF:
•
you are allergic (hypersensitive) to lactulose or any of the other
ingredients (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 Lactulose Solution if any of the above apply to you. If
you are not sure, talk to
your doctor or pharmacist
BEFORE
taking Lactulose Solution.
Page
2
of
6
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Lactulo

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Lactulose
Crescent 3.35 g/5 ml
Solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Lactulose 3.35 g/5 ml.
For excipients, see 6.1
3. PHARMACEUTICAL FORM
Oral Solution.
A clear or not more than slightly opalescent, viscous liquid,
colourless to brownish yellow.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of constipation.
For the treatment of hepatic encephalopathy (HE); hepatic coma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Posology. _
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.
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.
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
Dosing in HE (for adults only):
_Starting dose_
: 3 to 4 times daily 30-45 ml (6-9 x 5 ml spoonfuls). This dose may be
adjusted to the
maintenance dose to achieve two or three soft stools each day.
Paediatric population:
The safety and efficacy in children (newborn to 18 years of age) with
hepatic encephalopathy (HE)
have not been established. No data are available.
Elderly patients and pati