Lactulose Fresenius 670mg/ml oral solution

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Lactulose

Disponible des:

Fresenius Kabi Austria GmbH

Codi ATC:

A06AD; A06AD11

Designació comuna internacional (DCI):

Lactulose

Dosis:

670 milligram(s)/millilitre

formulario farmacéutico:

Oral solution

tipo de receta:

Product not subject to medical prescription

Área terapéutica:

Osmotically acting laxatives; lactulose

Estat d'Autorització:

Marketed

Data d'autorització:

2010-11-26

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
LACTULOSE FRESENIUS 670 MG/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 or pharmacist 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 or pharmacist. 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 3 days.
_ _
_ _
WHAT IS IN THIS LEAFLET
1. What Lactulose Fresenius is and what it is used for
2. What you need to know before you take Lactulose Fresenius
3. How to take Lactulose Fresenius
4. Possible side effects
5. How to store Lactulose Fresenius _ _
6. Contents of the pack and other information_ _
1.
WHAT LACTULOSE FRESENIUS IS AND WHAT IT IS USED FOR
Lactulose Fresenius 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.
Lactulose Fresenius is used to:
-
treat the symptoms of constipation
-
treat a special liver disease (portal systemic encephalopathy)
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LACTULOSE FRESENIUS
DO NOT TAKE LACTULOSE FRESENIUS
-
if you are allergic to lactulose or any of the other ingredients of
this medicine (listed in
section 6).
-
if you suffer from
-
galactosaemia (a severe genetic disorder where you cannot digest
galactose)
-
acute inflammatory bowel disease (like Crohn's disease or ulcerative
colitis)
blockage in your bowel (apart from normal constipation), digestive
perforation or
risk of digestive perforation, abdominal pain of undetermined cause
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Lactulose Fresenius.

Fitxa tècnica

Health Products Regulatory Authority
15 June 2022
CRN00CY48
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lactulose Fresenius 670mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 670 mg Lactulose (as lactulose liquid).
3 PHARMACEUTICAL FORM
Oral solution
Clear colourless to pale brownish yellow, viscous solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
• Symptomatic treatment of Constipation
• Treatment of portal systemic encephalopathy
Lactulose Fresenius is indicated in adults and for constipation only
in children and adolescents aged 1 month to 18 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The posology should be adjusted according to the individual needs of
the patient. The starting dose can be adjusted after
adequate treatment effect individually (maintenance dose). Several
days (2-3 days) of treatment may be needed in some
patients before adequate treatment effect occurs. In case of single
daily dose, this should be taken at the same time of the day,
e.g. during breakfast. During the therapy with laxatives it is
recommended to drink sufficient amounts of fluids (1.5-2 l/day,
equal to 6-8 glasses).
CONSTIPATION
Starting dose
Maintenance dose
Adults
15 - 45 ml
corresponding to 10 - 30 g
lactulose
15 - 30 ml
corresponding to 10 - 20 g
lactulose
PAEDIATRIC POPULATION
Starting dose
Maintenance dose
Adolescents over 14 years
15 - 45 ml
corresponding to 10 - 30 g
lactulose
15 - 30 ml
corresponding to 10 - 20 g
lactulose
Children
(7-14 years)
15 ml
corresponding to 10 g
lactulose
10 - 15 ml
corresponding to 7 - 10 g
lactulose
Children
(1-6 years)
5 - 10 ml
corresponding to 3 - 7 g
lactulose
Babies
up to 5 ml
corresponding to up to 3 g
Health Products Regulatory Authority
15 June 2022
CRN00CY48
Page 2 of 5
lactulose
If diarrhoea occurs, the dosing regimen should be reduced.
TREATMENT OF PORTAL SYSTEMIC ENCEPHALOPATHY - FOR ADULTS ONLY:
Beginning with 30 - 50 ml 3times daily (corresponding to 60 - 100 g
Lactulose daily).
The dosag